Immatics announces presentation of data from ongoing Phase 1b trial on IMA203
Immatics (IMTX) announced the presentation of expanded data from the ongoing Phase 1b clinical trial evaluating IMA203 PRAME cell therapy in heavily pretreated patients with metastatic melanoma. The longer follow-up of patients demonstrates a consistent and favorable tolerability profile as well as durable responses with a confirmed ORR of 56%. In addition, the Company provided details from a Trial in Progress poster on SUPRAME, the ongoing Phase 3 clinical trial evaluating IMA203 in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor. The most frequent treatment-emergent adverse events were anticipated cytopenias associated with lymphodepletion. Expected and manageable cytokine release syndrome was mostly Grades 1 and 2, which is consistent with the mechanism of action. The expected median PFS in this post-checkpoint inhibitor patient population6 is 2-3 months, and the IMA203 Phase 1b data presented today at ASCO indicate a continued median PFS of greater than or equal to 6 months.
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2 hours ago
- Yahoo
New analyses reinforce long-term benefit of DARZALEX® (daratumumab) subcutaneous-based quadruplet regimen for patients with newly diagnosed multiple myeloma
Sustained MRD negativity (10-5) rates at 24 months or longer were more than doubled in transplant eligible patients treated with daratumumab-VRd vs VRd alone in the Phase 3 PERSEUS study1 Data from the Phase 3 CEPHEUS study show daratumumab-VRd significantly reduced the risk of progression or death by 49 percent vs VRd alone in transplant-ineligible newly diagnosed patients2 BEERSE, BELGIUM, June 03, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced data from two studies highlighting that DARZALEX® (daratumumab) subcutaneous (SC) formulation with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd) demonstrated deep and sustained minimal residual disease (MRD) negativity rates, and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.1,2 Findings were highlighted as oral presentations of an analysis of sustained MRD in transplant-eligible patients from the Phase 3 PERSEUS study (Abstract #7501) and a subgroup analysis of transplant-ineligible patients in the Phase 3 CEPHEUS study (Abstract #7516) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.1,2 'Daratumumab-based quadruplet regimens are redefining frontline treatment in multiple myeloma, offering the potential for deeper, more durable responses from the start, bringing patients closer to long-term remission,' said Ester in't Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. 'The latest data presented at ASCO further support the role of the PERSEUS and CEPHEUS regimens as a standard of care in patients with newly diagnosed disease, regardless of transplant eligibility.' A new analysis from the Phase 3 PERSEUS study shows the addition of daratumumab-VRd followed by a maintenance regimen of daratumumab SC with lenalidomide (daratumumab-R), led to improved and deepened rates of overall and sustained MRD negativity (10-5) compared to VRd induction and consolidation with R maintenance.1 At a median follow-up of 47.5 months, sustained MRD negativity (10-5) rates were more than doubled with daratumumab-VRd followed by daratumumab-R maintenance compared to VRd and R maintenance at both 12 months or longer (64.8 percent vs 29.7 percent; odds ratio, 4.42; 95 percent confidence interval [CI], 3.22–6.08; p<0.0001) and 24 months or longer (55.8 percent vs 22.6 percent; odds ratio [OR], 4.36, 95 percent CI, 3.15–6.05, p<0.0001).1 Among patients achieving sustained MRD negativity for 12 months or longer, the 48-month PFS rate for daratumumab-VRd followed by daratumumab-R maintenance was 95.3 percent compared to 94.2 percent for VRd and R maintenance (hazard ratio [HR], 0.83; 95 percent CI,0.3–2.3)—reinforcing the importance of achieving sustained MRD negativity for prolonged disease remission.1 'The data show that daratumumab-VRd followed by a daratumumab-R maintenance regimen is a highly effective treatment option for transplant-eligible patients with newly diagnosed multiple myeloma,' said Philippe Moreau, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France and presenting author.* 'The depth and durability of MRD negativity observed—paired with high rates of progression-free survival at four years—underscore the long-term benefit the daratumumab SC-based regimen can offer patients early in their treatment journey.' Additional data from Phase 3 CEPHEUS study explore the benefits of daratumumab SC in transplant-ineligible patients across cytogenetic risk status The post-hoc analysis of the Phase 3 CEPHEUS study focused exclusively on transplant-ineligible patients, reinforcing that adding daratumumab SC to VRd significantly deepens response and prolongs PFS compared to VRd alone in this patient population.2 At a median follow-up of 58.7 months, patients receiving daratumumab-VRd achieved markedly higher overall MRD negativity rates at the 10⁻⁵ sensitivity threshold with 60.4 percent vs 39.3 percent with VRd (OR, 2.37; 95 percent CI, 1.47–3.80; p=0.0004).2 Furthermore, treatment with daratumumab-VRd resulted in high MRD-negativity rates at the 10⁻⁶ threshold with 45.8 percent compared to 26.9 percent with VRd (OR, 2.28; 95 percent CI, 1.40–3.73; p=0.0010).2 These deeper responses translated into improved long-term outcomes, with 69.0 percent of patients remaining progression-free at 54-months when treated with daratumumab-VRd vs 48.0 percent with VRd (HR, 0.51; 95 percent CI, 0.35–0.74; p=0.0003).2 Overall survival (OS) numerically favoured daratumumab-VRd (HR, 0.66; 95 percent CI, 0.42–1.03, p=0.0682), with an even greater benefit observed after censoring for COVID-19-related deaths (HR, 0.55; 95 percent CI, 0.34–0.90, p=0.0159).2 Additional data presented at ASCO included a subgroup analysis of the CEPHEUS trial for both transplant-ineligible and deferred NDMM patients who were considered high-risk for cytogenetic abnormalities (Abstract #7529).3 At a median follow-up of 58.7 months, overall MRD negativity rate was improved for patients with standard risk in daratumumab-VRd vs VRd.3 Although rates of MRD negativity by treatment arm in patients with protocol-defined high-risk were comparable, PFS trended toward improvement with daratumumab-VRd.3 'Across multiple studies, the growing body of data on daratumumab-based regimens indicates impressive, deep responses and meaningful progression-free survival in patients with newly diagnosed multiple myeloma, including high-risk,' Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. 'These consistent results across patient populations, regardless of transplant eligibility, reinforce the role of daratumumab SC as a cornerstone of frontline therapy.' In the PERSEUS and CEPHEUS studies, the safety profiles were consistent with the known safety profile for daratumumab SC.1,2,3 Safety results of daratumumab-VRd in the PERSEUS study were previously reported in The New England Journal of Medicine.4 The most common haematologic adverse reactions (≥20 percent) in patients with multiple myeloma who received daratumumab-VRd vs VRd included neutropenia (69.2 percent vs 58.8 percent), thrombocytopenia (48.4 percent vs 34.3 percent), and anaemia (22.2 percent vs 20.7 percent).4 Similarly, in the CEPHEUS study, daratumumab-VRd showed no additional safety concerns in the transplant-ineligible subgroup compared with the intent to treat population.2 The most common Grade 3/4 haematologic treatment-emergent adverse events (TEAEs) were neutropenia (43.8 percent vs 31.7 percent), thrombocytopenia (30.6 percent vs 23.2 percent) and anaemia (12.5 percent vs 12.7 percent).2 About the PERSEUS and CEPHEUS studiesThe PERSEUS study (NCT03710603) is being conducted in collaboration with the European Myeloma Network as the sponsor.5 PERSEUS is an ongoing, randomised, open-label, Phase 3 study comparing the efficacy and safety of daratumumab, bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) and autologous stem cell transplant (ASCT) followed by D-R maintenance vs standard bortezomib, lenalidomide, and dexamethasone (VRd) and ASCT followed by R maintenance in patients with transplant eligible newly diagnosed multiple myeloma (NDMM) (n=355).4 The primary endpoint is progression-free survival (PFS), and secondary endpoints include overall complete response or better rate, overall minimal residual disease (MRD) negativity (in patients with complete response or better) and overall survival (OS).4 Daratumumab subcutaneous (SC) formulation was discontinued after at least 24 months of D-R maintenance therapy in patients who had a complete response or better and had sustained MRD negative status for at least 12 months.4 The median age is 61.0 (range, 32-70) years for patients in the daratumumab-VRd arm and 59.0 (range, 31-70) years for patients in the VRd arm.4 The study is being conducted in 13 countries in Europe and Australia.5 On 23 October 2024, an indication extension for daratumumab-VRd was approved by the European Commission for NDMM who are eligible for ASCT, based on the results of the PERSEUS study.6,7 CEPHEUS (NCT03652064) is an ongoing, randomised, open-label, Phase 3 study comparing SC daratumumab-VRd with standard VRd.8,9 The trial has enrolled 395 patients with NDMM who are either ineligible for stem cell transplantation (SCT) or for whom SCT is not planned.9 The primary endpoint is overall MRD-negativity rate.9 The minimum age for participation is 18 years for patients in both the daratumumab-VRd arm and VRd arm, with a median patient age of 70 (range 31-80).8 The study is being conducted in 13 countries across North America, South America and Europe.9 On 7 April 2025, an indication extension for daratumumab-VRd was approved by the European Commission for NDMM, based on the results of the CEPHEUS study.9,10 About daratumumab and daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 618,000 patients worldwide.11 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.12 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.12 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.12 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.12 Daratumumab may also have an effect on normal cells.12 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.8,13,14,15,16,17,18,19,20 For further information on daratumumab, please see the Summary of Product Characteristics at: About Multiple MyelomaMultiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.21,22 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.22 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.23 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy 24,25 while remissions become progressively shorter.24,25,26 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.27 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow. and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. *Philippe Moreau, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France, has provided consulting, advisory, and speaking services to Janssen-Cilag International NV; he has not been paid for any media work. 1 Moreau P, et al. Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trial. Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.2 Facon T, et al. Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS study. Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.3 Bahlis N.J, Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): phase 3 CEPHEUS trial cytogenetic subgroup analysis. Poster presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.4 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med 2024; 390:301-313.5 Daratumumab, VELCADE (bortezomib), lenalidomide and dexamethasone compared to VELCADE, lenalidomide and dexamethasone in subjects with previously untreated multiple myeloma (Perseus). NCT03710603. Available at: Last accessed: May 2025.6 Rodríguez-Otero P, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): analysis of minimal residual disease (MRD) in the PERSEUS trial. 2024 American Society for Clinical Oncology (ASCO) Annual Meeting. June 3, 2024.7 Johnson & Johnson Innovative Medicine EMEA. DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Available at: Last accessed: May 2025.8 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients With Transplant-ineligible or Transplant-deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral presentation. 21st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024.9 A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy. NCT03652064. Available at: Last accessed: May 2025.10 European Commission approves Johnson & Johnson's subcutaneous DARZALEX® (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility. Available at: Last accessed: May 2025.11 Johnson & Johnson [data on file]. RF-430506. Number of patients treated with DARZALEX® worldwide as of 30 June 2024.12 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: Last accessed: May 2025.13 Moreau P, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, openlabel, phase 3 study. Lancet 2019;394(10192):29-38.14 Facon T, et al. MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med 2019;380(22):2104-2115.15 Mateos MV, et al. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. The Lancet 2020;395:P132-141.16 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol 2021;22(6):801-812.17 Palladini G, et al. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood 2020;2;136(1):71-80.18 Chari A, et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood 2017;130(8):974-981.19 Bahlis NJ, et al. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study. Leukemia 2020;34(7):1875-1884.20 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma: Three-year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk 2020;20(8):509-518.21 Abdi J, et al. Drug resistance in multiple myeloma: latest findings on molecular mechanisms. Oncotarget 2013;4(12):2186-2207.22 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: Last accessed: May 2025.23 ECIS - European Cancer Information System. Estimates of cancer incidence and mortality in 2022, by country. Multiple myeloma. Available at: Last accessed: May 2025.24 Bhatt P, Kloock C, Comenzo R. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347.25 Hernández-Rivas JÁ, et al. The changing landscape of relapsed and/or refractory multiple myeloma (MM): fundamentals and controversies. Biomark Res. 2022;10(1):1-23.26 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430.27 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: Last accessed: May 2025. CP-520659 May 2025 CONTACT: Media contact: Jenni Mildon jmildon@ +44 7920 418 552 Investor contact: Lauren Johnson investor-relations@
Medscape
4 hours ago
- Medscape
Atezolizumab + Chemo Improves Colon Cancer Survival
The addition of postsurgical atezolizumab immunotherapy to standard-of-care chemotherapy in patients with stage III deficient DNA mismatch repair (dMMR) colon cancer significantly improved survival in the phase 3 ATOMIC trial. 'These data established this combination as a new standard treatment for patients with stage III colon cancer and deficient mismatch repair,' said study author Frank A. Sinicrope, MD, during a press conference at the American Society of Clinical Oncology (ASCO) 2025 annual meeting. 'We regard this as a highly impactful study that will change clinical practice, and it actually represents the first immunotherapy adjuvant study in colon cancer.' The standard treatment for stage III colon cancer, regardless of dMMR status, is surgical resection followed by fluoropyrimidine-oxaliplatin chemotherapy (FOLFOX), but about 15% of patients have dMMR and display resistance to chemotherapy, he explained during a press conference at the meeting. 'These tumors are unable to repair their DNA and therefore accumulate mutations that trigger an immune response that is ineffective due to immune checkpoint proteins. Therefore, the use of immune checkpoint inhibitors is very attractive in this setting,' noted Sinicrope, who is professor of medicine and oncology and co-leader of the GI Cancer Program at Mayo Clinic in Rochester, Minnesota. While approved for dMMR metastatic cancers, it was unknown if an immune checkpoint inhibition would improve outcomes in stage III disease, he added. Study Methods and Results ATOMIC included 712 patients at least 12 years of age, who had resected stage III dMMR colon cancer without prior chemotherapy or radiation. They were randomized within 10 weeks of surgery to FOLFOX chemotherapy alone for 6 months (n = 357) or combined with atezolizumab, which was continued for an additional 6 months (n = 355). For the primary endpoint of disease-free survival, the 3-year rate was 86.4% vs 76.6% in the chemo-immunotherapy arm vs FOLFOX alone arm. 'This corresponds to a hazard ratio of 0.5, which is a 50% reduction in recurrence and death related to the treatment, so a very substantial survival benefit was achieved here,' Sinicrope said. This benefit held up across all subgroup analysis, showing that 'no matter what their age, their sex, their race, their tumor location, their T-stage, or N-stage, they are doing better with the addition of immunotherapy to chemotherapy,' he added. The safety profile 'was in line with the known safety profiles of each drug,' he noted, with an expected but manageable increase in nonfebrile neutropenia in the immunotherapy-containing arm (43% vs 36% for grade 3/4). Regarding immune-related adverse events, there were no clinically significant differences between groups in grade 4 or greater events, but there were notable increases in grades 1 and 2 events in the immunotherapy arm, specifically, hyperglycemia (17.9% vs 9%), hypothyroidism (20.5% vs 3.6%), and maculopapular rash (13.3% vs 6%), he reported. Calling the results 'dramatic,' Joel Saltzman, MD, a hematologist/oncologist and vice chair of Regional Oncology at Taussig Cancer Center, Cleveland Clinic, Cleveland, and an ASCO expert in gastrointestinal cancers, agreed that the study was practice-changing. 'The most important thing is that this is a real population that I'll see this coming week in clinic. We have had patients for years that we've known immunotherapy would likely be helpful, but we just weren't sure if we could integrate that into their care,' he said during the press conference. Discussant Touts Benefits of Neoadjuvant Immunotherapy The discussant for the study, Myriam Chalabi, MD, PhD, a medical oncologist at the Netherlands Cancer Institute in Amsterdam, the Netherlands, suggested that while the FOLFOX-atezolizumab combo 'is an option to consider' for patients who undergo upfront surgery, neoadjuvant immunotherapy 'is generally more effective and allows for de-escalation of chemotherapy, and of surgery, and also of the duration of immunotherapy.' Additionally, 'it would be important to investigate what the added benefit is of neoadjuvant immunotherapy in this patient population compared to surgery alone, and how that balances against the adverse events,' she suggested. Is Chemotherapy Helpful? In the adjuvant setting, Chalabi questioned whether chemotherapy might be abandoned altogether. 'What we haven't talked about is whether chemotherapy could even be blunting the T-cell response,' she said, suggesting a third arm of the study might have evaluated atezolizumab alone. Echoing Chalabi's comments, Anwaar Saeed, MD, emphasized that ATOMIC's results 'should not be viewed as the endpoint, but a launchpad,' and agreed that a critical unanswered question is whether chemotherapy even remains necessary with immunotherapy in this setting. 'Does oxaliplatin-based chemotherapy meaningfully enhance survival when paired with immune checkpoint blockade, or could it be modified — or even omitted — without compromising outcomes? As the field moves forward, future trials must interrogate whether reduced-intensity or chemo-free regimens could offer comparable efficacy with fewer toxicities,' said the associate professor of medicine and the chief of the Gastrointestinal Medical Oncology Program at the University of Pittsburgh, University of Pittsburgh Medical Center (UPMC), and UPMC Hillman Cancer Center in Pittsburgh, in an interview with Medscape Medical News . 'This question is especially relevant in light of the accumulating data from early-phase neoadjuvant studies, many of which suggest that immunotherapy alone may induce profound pathological responses in resectable dMMR [colorectal cancer] CRC. How these findings in the neoadjuvant setting harmonize with ATOMIC's adjuvant strategy remains to be seen, but the direction is clear: Immunotherapy should now be considered foundational in the treatment of resectable dMMR colon cancer,' Saeed said. Saeed also expressed enthusiasm about the study, during the interview. 'The ATOMIC trial represents a watershed moment in the treatment of stage III dMMR colon cancer,' she said. 'This trial effectively redefines the standard of care for this patient population, with definitive phase 3 validation that immunotherapy has earned a place in the adjuvant treatment of dMMR colon cancer. But more importantly, it opens the door to deeper questions that must now guide the next generation of clinical investigation.' The study was funded by the National Institutes of Health, the National Cancer Institute, Genentech, Inc., and the Alliance Foundation. Sinicrope disclosed employment from MedVal, stock, and other ownership interests with Eli Lilly and Company; a consulting or advisory role with Guardant Health and Roche; and research funding from Ventana Medical Systems. He also disclosed patent royalties related to immune markers in colon cancer and a patent jointly held with Roche/Ventana Medical Systems. Saltzman disclosed stock and other ownership interests with Eli Lilly and Company, GoodRx, and Sana Biotechnology. Chalabi disclosed a consulting or advisory role with Bristol Myers Squibb/Celgene, MSD, and Roche/Genentech; research funding from Agenus, Bristol Myers Squibb, MSD, and Roche/Genentech; and travel, accommodations, and expenses from Bristol Myers Squibb. Saeed disclosed a consulting or advisory rolewith Arcus Therapeutics, Astellas Pharma, AstraZeneca, Autem Therapeutics, Bristol Myers Squibb, Exelixis, Pfizer, Regeneron, Replimune, Taiho Pharmaceutical, and Xilio Therapeutics.
Associated Press
4 hours ago
- Associated Press
Press Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector
ASCO: new Sarclisa data support subcutaneous administration with on-body injector Paris, June 3, 2025. New data from two clinical studies of the investigational use of Sarclisa administered subcutaneously (SC) via an on-body injector (OBI) (also referred to as an on-body delivery system) in relapsed or refractory multiple myeloma (R/R MM) support the potential use of this innovative delivery method to advance patient care, while upholding Sarclisa's efficacy and safety profile. The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and include full data from the IRAKLIA phase 3 study, the first to incorporate the use of an OBI in the treatment of MM, and demonstrate non-inferior efficacy and pharmacokinetics compared to Sarclisa intravenous (IV) infusion. Alyssa Johnsen, MD, PhD Global Therapeutic Area Head, Immunology and Oncology Development 'Our subcutaneous clinical program is rooted in our mission to address patient needs and reduce treatment burden in multiple myeloma. We believe the novel on-body injector represents a significant innovation thatcouldimprove and streamline the treatment process for both patients and providers. We are pleased to share thesedata, the first to evaluate an on-body injector with a multiple myeloma treatment, and look forwardtopotentiallybringing this formulation and administrationoptionto the multiple myeloma community.' The OBI offers the potential to improve the overall patient experience in MM treatment. Recent studies and surveys suggest the use of an OBI may be associated with greater convenience, flexibility, and patient satisfaction compared to IV or manual SC administration methods.1 In addition, an OBI may also streamline the administration process for providers, potentially reducing the physical burden on nurses and enabling them to possibly move freely through the use of a hands-free device while monitoring the patient during injection. The IRAKLIA phase 3 study and the IZALCO phase 2 study presented at ASCO were conducted using Enable Injections' enFuse® hands-free OBI, an automated injector designed to subcutaneously administer high-volume medicines beginning with the click of a button, to administer the hyaluronidase-free SC formulation of Sarclisa. The enFuse device uses a 30 gauge, hidden, and retractable needle that is smaller compared to some of the commonly used large-volume SC injection needles, which may support patient comfort. The safety and efficacy of Sarclisa SC administered with the OBI or manual administration are investigational and have not been approved for use by any regulatory authority. IRAKLIA phase 3 study IRAKLIA is a global, randomized, open-label, pivotal phase 3 non-inferiority study comparing Sarclisa SC administered via an OBI and Sarclisa IV, both in combination with pomalidomide and dexamethasone (Pd) in adult patients with R/R MM who have received at least one prior line of treatment. At the data cut-off of November 6, 2024, and a median follow-up of 12 months, the study demonstrated: Primary endpoints Secondary endpoints The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd, but with a notably lower rate of systemic IRs. No new safety concerns were observed, except for low-grade local injection site reactions (ISRs) associated with SC administration that occurred with a low incidence (0.4%, n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2. Xavier Leleu, MD, PhD Head of the Department of Hematology and Myeloma Clinic at the Hôpital La Mileterie and study investigator 'Results from the IRAKLIA phase 3 study represent a potentially transformational advancement in the administration of multiple myeloma treatment. These data not only establish non-inferiority between Sarclisa administered both subcutaneously and intravenously across several key endpoints but reinforce the positive impact that this on-body injector could have on the patient treatment experience, as demonstrated by patient satisfaction scores.' In addition to the oral presentation at ASCO, the full data were simultaneously published in the Journal of Clinical Oncology. IZALCO phase 2 study In addition to the IRAKLIA phase 3 study, Sanofi also presented new data from the randomized, sequential, open-label, IZALCO phase 2 study evaluating the efficacy and safety of Sarclisa SC administered via manual push or an OBI, in combination with carfilzomib and dexamethasone (Kd) in adult patients with R/R MM who have received one to three prior lines of therapy. At a median follow-up of 10.1 months, the study demonstrated: The overall safety profile of Sarclisa SC-Kd observed in this study was consistent with the established safety profile of Sarclisa IV-Kd, with no new safety concerns observed. Advancing patient and provider-centric innovation in MM While SC administration is currently available for certain MM treatment regimens through a manual injection, administering large-volume medicines manually can present significant challenges, including a labor-intensive process for nurses, risk of strain and needlestick injuries, and potential need for larger needles that may compromise patient comfort and increase anxiety. Mehul Desai, PharmD, MBA Vice President, Medical Affairs, Enable Injections 'We believe multiple myeloma patients deserve a more convenient and comfortable treatment experience and recognize the crucial role providers play in delivering that care. Through our collaboration with Sanofi, we've aspired to advance an on-body injector that could transform the treatment experience for patients and providers alike. The results from the IRAKLIA and IZALCO studies represent a significant step toward our ambition and validate the potential of the on-body injector to deliver the same high standard of efficacy established with intravenous Sarclisa.' In addition to IRAKLIA and IZALCO, Sanofi is also evaluating Sarclisa SC administration via an OBI in the front-line treatment setting. The ISASOCUT phase 2 study conducted by the University of Poitiers, is evaluating Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) in adult patients with newly diagnosed MM (NDMM) not eligible for autologous stem-cell transplant (ASCT), while the German-speaking Myeloma Multicenter Group (GMMG)-HD8 phase 3 study, conducted in collaboration with the GMMG and the German Multiple Myeloma Study Group Consortium (DSMM), is evaluating Sarclisa SC-VRd induction in NDMM patients who are eligible for ASCT. In addition, results from the IZALCO, IRAKLIA and ISASOCUT studies will be presented at the European Hematology Association Congress later this month. The IRAKLIA abstract was also hand-selected to be included in the 2025 Best of ASCO program, held later in the summer of 2025, following the ASCO Annual Meeting. The data from these studies, collectively, will form the basis for global regulatory submissions. Sarclisa administered subcutaneously via the on-body injector or manual administration is investigational and has not been approved for any use by any regulatory authority. The safety and efficacy of this formulation and delivery method have not been established. About the IRAKLIA and IZALCO studies IRAKLIA is a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa SC formulation administered at a fixed dose SC via an OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes being assessed are ORR, defined as the proportion of patients with stringent CR, CR, VGPR, and partial response (PR) according to the 2016 IMWG criteria assessed by Independent Review Committee (IRC), and observed C trough at steady state (pre-dose at C6D1), defined as observed Sarclisa plasma concentrations. IZALCO is a two-part, randomized, sequential, open-label, phase 2 study evaluating the efficacy and safety of Sarclisa SC formulation administered SC via manual push or an OBI in adult patients with R/R MM who have received one to three prior lines of therapy. The primary objective is ORR, as assessed by IRC. The secondary objective is patient preference for the OBI versus manual administration of Sarclisa SC. About Enable Injections Based in the US (Cincinnati, OH), Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of enFuse. enFuse is an innovative wearable drug delivery platform that is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit About Sarclisa Sarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, EU and Japan in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy; this combination is also approved in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, UK, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility. At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need. For more information on Sarclisa clinical studies, please visit About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul | +33 6 25 09 14 25 | [email protected] Evan Berland | +1 215 432 0234 | [email protected] Léo Le Bourhis | +33 6 75 06 43 81 | [email protected] Victor Rouault | +33 6 70 93 71 40 | [email protected] Timothy Gilbert | +1 516 521 2929 | [email protected] Investor Relations Thomas Kudsk Larsen |+44 7545 513 693 | [email protected] Alizé Kaisserian | +33 6 47 04 12 11 | [email protected] Felix Lauscher | +1 908 612 7239 | [email protected] Keita Browne | +1 781 249 1766 | [email protected] Nathalie Pham | +33 7 85 93 30 17 | [email protected] Tarik Elgoutni | +1 617 710 3587 | [email protected] Thibaud Châtelet | +33 6 80 80 89 90 | [email protected] Yun Li | +33 6 84 00 90 72 | [email protected] Sanofi forward-looking statements All trademarks mentioned in this press release are the property of the Sanofi group with the exception of enFuse. Attachment
