Genentech's Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-cell Lymphoma
Results from the SUNMO study will be submitted to global health authorities, including the U.S. Food and Drug Administration (FDA). The National Comprehensive Cancer Network ® (NCCN ®) has recently added Lunsumio and Polivy to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) as a category 2A recommendation for the treatment of people with second-line (2L) diffuse large B-cell lymphoma (DLBCL) who are not intended to proceed to transplant. †
'Lunsumio and Polivy represent the first combination of a bispecific antibody and antibody-drug conjugate, which could avoid chemotherapy and potentially provide an alternative option for some patients with relapsed or refractory LBCL,' said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. 'We are also encouraged by the favorable safety profile and potential for outpatient use of this regimen, which may suit diverse patient and healthcare system needs.'
At a median follow-up of 23.2 months, the Lunsumio and Polivy combination demonstrated a 59% reduction in risk of disease progression or death compared to R-GemOx (hazard ratio [HR] 0.41, 95% confidence interval [CI]: 0.28–0.61; p<0.0001). Median PFS was three times longer with Lunsumio and Polivy at 11.5 months (95% CI: 5.6-17.6), compared to 3.8 months for R-GemOx (95% CI: 2.9-4.1) and 12-month PFS was more than doubled at 48.5% (95% CI: 39.6-57.4) vs.17.8% (95% CI: 5.4-30.3), respectively. This PFS benefit was consistent across subgroups, including in high-risk patients with primary refractory disease (HR 0.46, 95% CI: 0.29–0.72). At the interim analysis, overall survival (OS) data were not yet mature. OS numerically favored the Lunsumio and Polivy combination with a median of 18.7 months (95% CI: 14.1–not evaluable [NE]) compared to 13.6 months for R-GemOx (95% CI: 9.9–NE; HR 0.80; 95% CI: 0.54 - 1.20).
'There remains a clear need for effective and well-tolerated treatments for people with this difficult-to-treat disease,' said Jason Westin, professor of lymphoma and director of lymphoma clinical research, The University of Texas, MD Anderson Cancer Center. 'If approved, this off-the-shelf treatment combination of mosunetuzumab-axgb and polatuzumab vedotin-piiq could be administered over a fixed period of time, without mandatory hospitalization or traditional chemotherapy, which could provide a meaningful option for patients with relapsed or refractory LBCL.'
In the Lunsumio and Polivy arm, 30% more patients achieved an objective response (70.3%, 95% CI: 61.9-77.8) compared to R-GemOx (40.0%; 95% CI: 28.5-52.4), and the complete response rate was doubled at 51.4% (95% CI: 42.8-60.0) versus 24.3% (95% CI: 14.8-36.0). Nearly 75% of patients with a complete response were still in remission after one year (72.6%; 95% CI: 61.4-83.8) compared to 44.1% for R-GemOx (95% CI: 13.2-74.9).
The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines, potentially allowing use across outpatient and community settings. The incidence of cytokine release syndrome (CRS) events in the Lunsumio plus Polivy arm was low, occurring in one in four patients, with less than 5% of patients experiencing Grade 2 or 3 CRS events. No immune effector cell-associated neurotoxicity syndrome events were reported. Rates of Grade 3–4 (58.5% vs. 57.8%) and Grade 5 (5.2% vs. 6.3%) adverse events (AEs) were similar between the combination and R-GemOx, with fewer AEs leading to treatment discontinuation in the Lunsumio and Polivy arm (2.2% vs. 4.7%).
High-dose chemotherapy followed by stem-cell transplant has traditionally been the standard 2L treatment for people with R/R LBCL. While 2L therapies have advanced, DLBCL can progress rapidly and many people are not candidates for, cannot tolerate, or do not have access to latest therapies. There is an urgent need for treatments that are rapidly available upon a diagnosis of relapse, that can manage the disease and improve long-term outcomes.
Genentech's lymphoma portfolio is one of the broadest in the industry, providing a unique and much-needed opportunity to combine regimens with different and complementary mechanisms of action. We are exploring our CD20xCD3 bispecifics, Lunsumio and Columvi ® (glofitamab-gxbm), alongside Polivy to move one step closer towards our goal of improving the lives of as many patients with lymphomas as possible. This includes the Phase III STARGLO study [ NCT04408638 ] evaluating the efficacy and safety of Columvi in combination with GemOx versus R-GemOx alone in patients with R/R DLBCL who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy.
Lunsumio is already approved for people with R/R follicular lymphoma after two or more lines of therapy in more than 60 countries worldwide. Polivy in combination with R-CHP is approved for people with previously untreated diffuse large B-cell lymphoma (DLBCL) in more than 100 countries worldwide and in combination with bendamustine and Rituxan for R/R DLBCL in more than 90 countries worldwide.
†NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way
About the SUNMO study
The SUNMO [ NCT05171647 ] study is an international, multi-center, randomized Phase III trial evaluating the efficacy and safety of subcutaneously administered Lunsmio ® (mosunetuzumab-axgb) in combination with intravenous Polivy ® (polatuzumab vedotin-piiq) compared to Rituxan ® (rituximab), gemcitabine and oxaliplatin (R-GemOx), in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for autologous stem cell transplant. Outcome measures include progression-free survival and objective response rate (dual primary endpoints), overall survival, duration of objective response, complete response rate, duration of complete response, safety and tolerability, and patient-reported outcomes.
About Lunsumio ® (mosunetuzumab-axgb)
Lunsumio is a first-in-class CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting activates and redirects a patient's existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other indications.
About Polivy ® (polatuzumab vedotin-piiq)
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as those expressing CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL.
About large B-cell lymphoma (LBCL)
Large B-cell lymphomas (LBCL), composed predominantly of diffuse large B-cell lymphoma (DLBCL), are the most common type of non-Hodgkin lymphoma (NHL) that affect B-cell lymphocytes, a type of white blood cells. DLBCL is the most common form of aggressive NHL and makes up about 80% of LBCLs. While it can arise in lymph nodes, it can also occur in organs outside of the lymphatic system. Approximately 160,000 people worldwide are diagnosed with DLBCL each year, with comparable incidence rates across regions. Medical practices, including pathological classification, diagnosis, staging, initial treatment and relapse management, are similarly approached worldwide. While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes.
Lunsumio U.S. Indication
Lunsumio (mosunetuzumab-axgb) is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer.
It is not known if Lunsumio is safe and effective in children.
The conditional approval of Lunsumio is based on response rate. There are ongoing studies to establish how well the drug works.
What is the most important information I should know about Lunsumio?
Lunsumio may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Lunsumio and can also be severe or life-threatening.
Get medical help right away if you develop any signs or symptoms of CRS at any time, including:
fever of 100.4°F (38°C) or higher
chills
low blood pressure
fast or irregular heartbeat
tiredness or weakness
difficulty breathing
headache
confusion
feeling anxious
dizziness or light-headedness
nausea
vomiting
Due to the risk of CRS, you will receive Lunsumio on a 'step-up dosing schedule.'
The step-up dosing schedule is when you receive smaller 'step-up' doses of Lunsumio on Day 1 and Day 8 of your first cycle of treatment
You will receive a higher dose of Lunsumio on Day 15 of your first cycle of treatment
If your dose of Lunsumio is delayed for any reason, you may need to repeat the step-up dosing schedule
Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS
Your healthcare provider will check you for CRS during treatment with Lunsumio and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Lunsumio, if you have severe side effects.
What are the possible side effects of Lunsumio?
Lunsumio may cause serious side effects, including:
neurologic problems. Lunsumio can cause serious and life-threatening neurological problems. Your healthcare provider will check you for neurologic problems during treatment with Lunsumio. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with Lunsumio, including:
headache
numbness and tingling of the arms, legs, hands, or feet
dizziness
confusion and disorientation
difficulty paying attention or understanding things
forgetting things or forgetting who or where you are
trouble speaking, reading, or writing
sleepiness or trouble sleeping
tremors
loss of consciousness
seizures
muscle problems or muscle weakness
loss of balance or trouble walking
tiredness
serious infections. Lunsumio can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with Lunsumio, including:
fever of 100.4° F (38° C) or higher
cough
chest pain
tiredness
shortness of breath
painful rash
sore throat
pain during urination
feeling weak or generally unwell
hemophagocytic lymphohistiocytosis (HLH). Lunsumio can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with Lunsumio. Your health care provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
fever
enlarged spleen
easy bruising
low blood cell counts
liver problems
low blood cell counts. Low blood cell counts are common during treatment with Lunsumio and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with Lunsumio. Lunsumio can cause the following low blood cell counts:
low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection
low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems
growth in your tumor or worsening of tumor related problems (tumor flare). Lunsumio can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with Lunsumio:
chest pain
cough
trouble breathing
tender or swollen lymph nodes
pain or swelling at the site of the tumor
Your healthcare provider may temporarily stop or permanently stop treatment with Lunsumio if you develop severe side effects.
The most common side effects of Lunsumio include: tiredness, rash, fever, and headache.
The most common severe abnormal blood test results with Lunsumio include: decreased phosphate, increased glucose, and increased uric acid levels.
Before receiving Lunsumio, tell your healthcare provider about all of your medical conditions, including if you:
have ever had an infusion reaction after receiving Lunsumio
have an infection, or have had an infection in the past which lasted a long time or keeps coming back
have or have had Epstein-Barr Virus
are pregnant or plan to become pregnant. Lunsumio may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Lunsumio
Females who are able to become pregnant:
your healthcare provider should do a pregnancy test before you start treatment with Lunsumio
you should use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of Lunsumio
are breastfeeding or plan to breastfeed. It is not known if Lunsumio passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of Lunsumio
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while receiving Lunsumio?
Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.
These are not all the possible side effects of Lunsumio. Talk to your healthcare provider for more information about the benefits and risks of Lunsumio.
You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see Important Safety Information, including Serious Side Effects, as well as the Lunsumio full Prescribing Information and Medication Guide or visit https://www.Lunsumio.com.
Polivy U.S. Indication
Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL).
Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies.
Important Safety Information
Possible serious side effects
Everyone reacts differently to Polivy therapy, so it's important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.
Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy
Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections
Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication
Side effects seen most often
The most common side effects during treatment were
Nerve problems in arms and legs
Nausea
Tiredness or lack of energy
Diarrhea
Constipation
Hair loss
Redness and sores of the lining of the mouth, lips, throat, and digestive tract
Polivy may lower your red or white blood cell counts and increase uric acid levels.
Polivy may not be for everyone. Talk to your doctor if you are
Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby
Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment
Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose
These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment.
You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the full Prescribing Information and visit https://www.Polivy.com for additional Important Safety Information.
About Columvi® (glofitamab-gxbm)
Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Genentech's broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development program that also includes Lunsumio® (mosunetuzumab-axgb), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Genentech is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma.
Columvi U.S. Indication
Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer.
It is not known if Columvi is safe and effective in children.
The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.
What is the most important information I should know about Columvi?
Columvi can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death.
Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including:
fever of 100.4°F (38°C) or higher
chills or shaking
fast or irregular heartbeat
dizziness or light-headedness
trouble breathing
shortness of breath
Due to the risk of CRS, you will receive Columvi on a 'step-up dosing schedule'.
A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1).
You will start the Columvi step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller 'step-up' doses of Columvi on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose.
You will receive your first full dose of Columvi a week after the second step-up dose (this will be Day 1 of Cycle 2).
If your dose of Columvi is delayed for any reason, you may need to repeat the 'step-up dosing schedule'.
If you had more than mild CRS with your previous dose of Columvi, you should be hospitalized during and for 24 hours after receiving your next dose of Columvi.
Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions.
Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects.
Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away.
What are the possible side effects of Columvi?
Columvi may cause serious side effects, including:
Cytokine Release Syndrome.
Neurologic problems. Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including:
headache
confusion and disorientation
difficulty paying attention or understanding things
trouble speaking
sleepiness
memory problems
numbness, tingling, or weakness of the hands or feet
dizziness
shaking (tremors)
Serious Infections. Columvi can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat.
Growth in your tumor or worsening of tumor related problems (tumor flare). Tell your healthcare provider if you get any of these signs or symptoms of tumor flare:
tender or swollen lymph nodes
pain or swelling at the site of the tumor
chest pain
cough
trouble breathing
The most common side effects of Columvi include: CRS, muscle and bone pain, rash, and tiredness.
The most common severe abnormal lab test results with Columvi include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).
Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects.
Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you:
have an infection
have kidney problems
are pregnant or plan to become pregnant. Columvi may harm your unborn baby
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with Columvi.
You should use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi.
are breastfeeding or plan to breastfeed. Columvi may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while receiving Columvi?
Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.
These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi.
You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see Important Safety Information, including Serious Side Effects, as well as the Columvi full Prescribing Information and Medication Guide or visit https://www.Columvi.com.
About Genentech in hematology
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we're investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Genentech Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
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"People with wet AMD often experience suboptimal outcomes with real-world anti-VEGF treatment, largely due to the frequency of injections," said study investigator John Kitchens, M.D., Retina Associates of Kentucky, who presented the data at ASRS. "Continuous delivery of treatment with Susvimo may preserve vision in patients with wet AMD for longer in real-world clinical use than IVT injections." In the Portal study (n = 352), people originally treated with Susvimo in Archway continued to receive Susvimo refills every six months (Susvimo cohort; n = 220), while those originally treated with monthly intravitreal (IVT) ranibizumab injections in Archway received Susvimo and then refills every six months (IVT-Susvimo cohort; n = 132). Five-year results showed consistent and sustained disease control and retinal drying in a population who entered Archway with vision at or near peak levels after receiving an average of five intravitreal injections per standard of care. In the Susvimo cohort, best-corrected visual acuity (BCVA) was 74.4 letters at baseline and 67.6 letters at 5 years. In the IVT-Susvimo cohort, BCVA was 76.3 letters at baseline and 68.6 at 5 years. Half of all patients had better than 20/40 vision at five years (Snellen visual acuity test). Average central subfield thickness (CST) remained stable, with a 1.0 (95% CI: -13.1, 11.1) µm reduction from baseline in the Susvimo cohort, and a 10.3 (95% CI: -25.7, 5.0) µm reduction in the IVT-Susvimo cohort. The cohort of people who entered the Portal study from Archway is the largest cohort of people with wet AMD to be followed prospectively and continuously for five years in a clinical study. Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye, addressing certain retinal conditions that can cause vision loss. About the Archway study and its open-label extension study (Portal) Archway (NCT03677934) was a randomized, multicenter, open-label Phase III study evaluating the efficacy and safety of Susvimo refilled every six months at fixed intervals, compared to monthly IVT ranibizumab 0.5 mg in 415 people living with wet AMD. Patients were randomized 3:2 to Susvimo (n = 248) or intravitreal (IVT) ranibizumab injections (n = 167). Patients enrolled in Archway were responders to prior treatment with anti-VEGF therapy. In both study arms, patients were treated with at least three anti-VEGF injections within the six months prior to their Archway screening visit, with an average of five anti-VEGF injections before randomization. The primary endpoint of the study was the change in BCVA score from baseline at the average of Week 36 and Week 40. Secondary endpoints include safety, overall change in vision (BCVA) from baseline and change from baseline in center point thickness over time. Patients who completed the study at week 96 were eligible to enter the Portal open-label extension study. In Portal, people originally treated with Susvimo in Archway continued to receive Susvimo refills every six months (Susvimo cohort), while those originally treated with monthly IVT ranibizumab injections in Archway received the Susvimo implant and then refills every six months (IVT-Susvimo cohort). Portal is ongoing. About Wet Age-Related Macular Degeneration (AMD) Age-related macular degeneration (AMD) is a condition that affects the macula, the part of the eye that provides sharp, central vision needed for activities like reading. It is a leading cause of blindness for people aged 60 and over in the U.S. Wet, or neovascular, AMD is an advanced form of the disease that can cause rapid and severe vision loss. Approximately 20 million people in the U.S. have some form of AMD, and of those, about 1.5 million have late-stage AMD, which includes wet AMD. Wet AMD is caused by growth of abnormal blood vessels, also referred to as choroidal neovascularization (CNV), into the macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This process results in a deterioration of sight over a period of months to years. Genentech is committed to helping people access the medicines they are prescribed and offers comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or Visit for additional information. About Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is a refillable implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customized formulation of ranibizumab over time. Susvimo is indicated for intravitreal use via the Susvimo eye implant only. Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels. Susvimo was previously called the Port Delivery System with ranibizumab in the U.S. The customized formulation of ranibizumab delivered by Susvimo is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis® (ranibizumab injection), which is approved to treat wet, or neovascular, age-related macular degeneration (AMD) and other retinal diseases. Lucentis was first approved for wet AMD by the FDA in 2006. Susvimo Indication Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR) who have previously responded to at least two intravitreal injections of a vascular endothelial growth factor inhibitor medication. Susvimo Important Safety Information WARNING: ENDOPHTHALMITISThe Susvimo implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Warnings and Precautions:The Susvimo implant and the procedures associated with inserting, filling, refilling, and (if medically necessary) removing the implant can cause other serious side effects, including: An eye infection (endophthalmitis). Endophthalmitis is an infection of the eyeball that can cause permanent damage to your eye, including blindness. Endophthalmitis requires urgent (same-day) medical or surgical treatment. A missing layer on top of the white part of the eye (conjunctival erosion). Conjunctival erosion is an area that becomes missing (defect) in the layer (conjunctiva) that covers the white part of the eye, which may result in exposure of the implant. Conjunctival erosion may require surgical treatment. An opening of the layer that covers the white part of the eye (conjunctival retraction). Conjunctival retraction is an opening or gaping in the layer (conjunctiva) that covers the white part of the eye, which may cause the implant to be exposed. Conjunctival retraction may require surgical treatment. Tear and separation of layers of the retina (rhegmatogenous retinal detachment). Rhegmatogenous retinal detachment is a tear and separation of one of the layers of the retina in the back of the eye that senses light. Rhegmatogenous retinal detachment requires surgical treatment. Implant movement (implant dislocation): This movement may require surgical treatment to correct. Implant damage: Damage to the implant that prevents continued treatment (refills) with Susvimo. If the implant is not able to be properly refilled, a patient's wet AMD may be inadequately treated and a physician may remove the implant and/or change the treatment. Bleeding (vitreous hemorrhage): Vitreous hemorrhage is bleeding within the gel-like substance (vitreous) inside of your eye. This may require an additional eye surgery. Bump on top of the white layer of the eye (conjunctival bleb): Conjunctival bleb is a small bulge in the layer (conjunctiva) that covers the white part of the eye where the implant is inserted. This may be due to leakage of fluid from the inside of the eye. This may require medical or surgical treatment. Temporary decrease in vision after the Susvimo procedure. Who should not receive Susvimo? Patients who have an infection in or around their eye, have active inflammation in their eye, or have had an allergic reaction to ranibizumab or any of its ingredients in Susvimo in the past. Information for patients who are of childbearing potential If patients are pregnant, think that they might be pregnant, or plan to become pregnant. It is not known if Susvimo will harm an unborn baby. Patients should use birth control (contraception) during treatment with Susvimo and for 12 months after the last refill of Susvimo. If patients are breastfeeding or plan to breastfeed. Susvimo is not recommended during breastfeeding. It is not known if Susvimo passes into breast milk. Adverse Reactions The most common adverse reactions were blood on the white of the eye, redness in the white of the eye, sensitivity to light, and eye pain. These are not all the possible side effects of Susvimo. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see additional Important Safety Information in the full Susvimo Prescribing Information, including BOXED WARNING or visit About Lucentis® (ranibizumab injection) Lucentis® is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV). Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. Outside the United States, Lucentis is approved in more than 120 countries to treat adult patients with wet AMD, and for the treatment of visual impairment due to DME, due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), and due to choroidal neovascularization (CNV). Lucentis Important Safety Information Lucentis is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in Lucentis. Hypersensitivity reactions may manifest as severe intraocular inflammation. Intravitreal injections, including those with Lucentis, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Increases in intraocular pressure have been noted both pre-injection and post-injection with Lucentis. Although there was a low rate of arterial thromboembolic events (ATEs) observed in the Lucentis clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). Fatal events occurred more frequently in patients with DME and DR at baseline treated monthly with Lucentis compared with control. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded. Retinal vasculitis and/or retinal vascular occlusion have been reported. Patients should be instructed to report any change in vision without delay. In the Lucentis Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. For additional safety information, please see Lucentis full Prescribing Information, available here: About Genentech in Ophthalmology Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases, including rare and inherited conditions. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit View source version on Contacts Media Contact:Nicole Burkart (650) 467-6800Advocacy Contact:Meg Harrison (617) 694-7060Investor Contacts:Loren Kalm (650) 225-3217Bruno Eschli +41 61 687 5284 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Roche's Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD)
Susvimo is the only continuous delivery treatment to provide reliable, long-term vision outcomes in nAMD, the leading cause of vision loss in people over the age of 60 With two refills per year, Susvimo maintained vision and stabilised the retina for five years, with durability maintained in approximately 95% of patients Susvimo was well tolerated over five years and has a well-characterised safety profile Basel, 01 August 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new, five-year efficacy, safety and durability data from the Phase III Portal study, a long-term extension of the Phase III Archway study, of Susvimo® (ranibizumab injection) for the treatment of people with nAMD.1 Results show that Susvimo's immediate and predictable durability was sustained over five years, with approximately 95% of people receiving treatment every six months requiring no supplemental treatment before each refill. The data were presented at the American Society of Retina Specialists (ASRS) 2025 Annual Meeting in Long Beach, California, United States. 'These long-term results reinforce Susvimo's ability to maintain vision and retinal drying over a long period of time for people with nAMD, the leading cause of vision loss in people over age 60,' said Levi Garraway, MD, PhD, Roche's chief medical officer and head of Global Product Development. 'These robust data reinforce our confidence in Susvimo's unique therapeutic approach, providing an effective alternative to regular eye injections while preserving vision in a sustained manner.' 'People with nAMD often experience suboptimal outcomes with real-world anti-VEGF treatment, largely due to the frequency of injections,' said study investigator John Kitchens, M.D., Retina Associates of Kentucky, who presented the data at ASRS. 'Continuous delivery of treatment with Susvimo may preserve vision in patients with nAMD for longer in real-world clinical use than IVT injections.' In the Portal study (n = 352), people originally treated with Susvimo in Archway continued to receive Susvimo refills every six months (Susvimo cohort; n = 220), while those originally treated with monthly intravitreal (IVT) ranibizumab injections in Archway received Susvimo and then refills every six months (IVT-Susvimo cohort; n = 132). Five-year results showed consistent and sustained disease control and retinal drying in a population who entered Archway with vision at or near peak levels after receiving an average of five intravitreal injections per standard of care. In the Susvimo cohort, best-corrected visual acuity (BCVA) was 74.4 letters at baseline and 67.6 letters at 5 years. In the IVT-Susvimo cohort, BCVA was 76.3 letters at baseline and 68.6 at 5 years. Half of all patients had better than 20/40 vision at five years (Snellen visual acuity test). Average central subfield thickness (CST) remained stable, with a 1.0 (95% CI: -13.1, 11.1) µm reduction from baseline in the Susvimo cohort, and a 10.3 (95% CI: -25.7, 5.0) µm reduction in the IVT-Susvimo cohort. The cohort of people who entered the Portal study from Archway is the largest cohort of people with nAMD to be followed prospectively and continuously for five years in a clinical study.1 Susvimo provides continuous delivery of a customised formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye, addressing certain retinal conditions that can cause vision loss. About the Archway study and its open-label extension study (Portal)1,2Archway (NCT03677934) was a randomised, multicentre, open-label phase III study evaluating the efficacy and safety of Susvimo refilled every six months at fixed intervals, compared to monthly IVT ranibizumab 0.5 mg in 415 people living with nAMD. Patients were randomized 3:2 to Susvimo (n = 248) or IVT ranibizumab injections (n = 167). Patients enrolled in Archway were responders to prior treatment with anti-VEGF therapy. In both study arms, patients were treated with at least three anti-VEGF injections within the six months prior to their Archway screening visit, with an average of five anti-VEGF injections before randomization. The primary endpoint of the study was the change in BCVA score from baseline at the average of Week 36 and Week 40. Secondary endpoints include safety, overall change in vision (BCVA) from baseline and change from baseline in centre point thickness over time. Patients who completed the study at week 96 were eligible to enter the Portal open-label extension study. In Portal, people originally treated with Susvimo in Archway continued to receive Susvimo refills every six months (Susvimo cohort), while those originally treated with monthly intravitreal (IVT) ranibizumab injections in Archway received the Susvimo implant and then refills every six months (IVT-Susvimo cohort). Portal is ongoing. About neovascular age-related macular degenerationAge-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading.3 Neovascular or 'wet' AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.4,5 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.5 Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.3,6,7 About Susvimo® (Port Delivery System with ranibizumab)Approved in the United States by the Food and Drug Administration (FDA) for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR), Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure.8,9 Susvimo continuously delivers a customised formulation of ranibizumab over time.8,9 Ranibizumab is a VEGF inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.8-10The customised formulation of ranibizumab delivered by Susvimo is different from the ranibizumab IVT injection, a medicine marketed as Lucentis® (ranibizumab injection)*, which is approved to treat nAMD and other retinal diseases.11 About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. *Lucentis® (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. References[1] Kitchens J, et al. Five Year Outcomes in nAMD Patients Enrolled in the Archway Study and Treated With the PDS. Presented at: The American Society of Retina Specialists (ASRS) 2025 Annual Meeting; 2025 August 01; Long Beach, California, United States.[2] Regillo C, et al. Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results. Ophthalmology. 2023;130(7):735-747.[3] Bright Focus Foundation. Age-related macular degeneration (AMD): facts & figures. [Internet; cited July 2025]. Available from: [4] Pennington KL, et al. Epidemiology of AMD: associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.[5] Little K, et al. Myofibroblasts in macular fibrosis secondary to nAMD - the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.[6] Connolly E, et al. Prevalence of AMD associated genetic risk factors and four-year progression data in the Irish population. British Journal of Ophthalmology. 2018 Feb;102:1691-95.[7] Wong WL, et al. Global prevalence of AMD and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health. 2014 Feb;2:106-16.[8] US Food and Drug Administration (FDA). Highlights of prescribing information, Susvimo. 2021. [Internet; cited July 2025]. Available from: [9] Holekamp N, et al. Archway randomised phase III trial of the PDS with ranibizumab for neovascular age-related macular degeneration (nAMD). Ophthalmology. 2021.[10] Heier JS, et al. The angiopoietin/tie pathway in retinal vascular diseases: A review. The Journal of Retinal and Vitreous Diseases. 2021;41:1-19.[11] US FDA. Highlights of prescribing information, Lucentis. 2012. [Internet; cited April 2025]. Available from: [12] US FDA. Highlights of prescribing information, Vabysmo. 2024. [Internet; cited April 2025]. Available from: [13] European Medicines Agency. Summary of product characteristics, Vabysmo. [Internet; cited April 2025]. Available from: Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: Attachment Media Investor Release Susvimo Archway study english
