Latest news with #Imdelltra
Yahoo
4 days ago
- Health
- Yahoo
ASCO 2025: DeLLphi-304 helps Amgen to pave the way for BiTEs in solid cancers
Small cell lung cancer (SCLC) accounts for 10-15% of all lung cancer cases annually, with 250,000 incident cases diagnosed every year and 200,000 deaths occurring. With such a high healthcare burden, rapid advancements have been made with the advent of programmed cell death protein-1 checkpoint inhibition and immunotherapy, although they have only been proven successful in the first-line paradigm. Unlike non-small cell lung cancer (NSCLC), the treatment options for SCLC are more limited, as it is more aggressive and develops resistance to available treatments rapidly. One of the current standards of care (SOC) is the use of platinum-based chemotherapy such as cisplatin in combination with Roche's Tecentriq or AstraZeneca's Imfinzi in the first-line treatment for extensive-stage SCLC (ES-SCLC). Following treatment, many patients with NSCLC will develop platinum resistance through strengthened DNA-repair capabilities and reduced chemotherapy uptake in the cancerous cells. Amgen's Imdelltra, a bispecific T-cell engager (BiTE) that targets Delta-like canonical Notch ligand 3 (DLL3) and cluster of differentiation 3 (CD3) receptors, received US Food and Drug Administration approval for the treatment of patients with ES-SCLC following disease progression or following platinum-based chemotherapy, based on results from the DeLLphi-301 trial. While the approval is a historic event for the BiTE drug class in solid tumours, the market share opportunity is restricted as DeLLphi-301 was a Phase II trial with only one arm and no comparator. Results from the American Society of Clinical Oncology 2025 have shown the latest in Imdelltra's clinical results from the DeLLphi-304 trial. DeLLphi-304 enrolled 254 patients receiving Imdelltra and 255 receiving one of the following: topotecan, amrubicin, or Jazz Pharmaceutical's Zepzelca. Zepzelca and topotecan are preferred systemic treatment options for SCLC. Imdelltra was found to increase overall survival by 5.3 months (hazard ratio: 0.60, P<0.001) and increase median progression-free survival. There was also a large difference in grade 3 treatment-related adverse events, with Imdelltra reducing the rate by 35% compared to the control arm. Absent any competing immunotherapies with a preferred National Comprehensive Cancer Network opinion, Imdelltra is expected to be an attractive option for many patients looking to enhance their care. The annual cost of Imdelltra therapy totals $167,600 per patient. As a result, Imdelltra will likely struggle to receive reimbursement outside of the US. Despite the high cost, the clinical benefits are clear and Imdelltra's US market share uptake will be enhanced with these positive results, particularly owing to its more manageable safety profile when compared to existing options for this segment. Leading data and analytics company GlobalData's indication-based forecast shows Imdelltra will reach $1.76bn globally by 2031. "ASCO 2025: DeLLphi-304 helps Amgen to pave the way for BiTEs in solid cancers" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
Reuters
02-06-2025
- Business
- Reuters
Amgen drug cuts small cell lung cancer death risk by 40%
June 2 (Reuters) - Amgen's (AMGN.O), opens new tab Imdelltra reduced the risk of death by 40% compared to chemotherapy for small cell lung cancer patients whose disease had worsened after an initial round of chemo, according to interim data from a late-stage trial presented at a major medical meeting on Monday. The Phase 3 trial of 509 patients showed that Imdelltra extended median overall survival by more than five months to 13.6 months, compared with 8.3 months for standard-of-care chemotherapy, the company said. The median length of time patients lived without their disease worsening, a measure known as progression-free survival, was 4.2 months for the Imdelltra group and 3.7 months for patients who received chemotherapy. Amgen said the trial results are intended to serve as confirmatory evidence to support last year's accelerated approval by the U.S. Food and Drug Administration of Imdelltra for patients with extensive stage small cell lung cancer whose disease worsened on or after platinum-based chemotherapy. The findings were presented at the American Society of Clinical Oncology's annual meeting in Chicago and published in The New England Journal of Medicine. Most lung cancer cases are non-small cell, while up to 15% are the more aggressive small cell variety targeted by Imdelltra, according to the American Cancer Society. The Amgen drug belongs to a class of treatments called bispecific antibodies designed to attach to a cancer cell and an immune cell, bringing them together so that the body's immune system can kill the cancer. Amgen said 27% of trial patients treated with Imdelltra experienced serious side effects, including low white blood cell counts, compared with 62% of chemotherapy patients. Patients on Imdelltra reported improvements in cough and shortness of breath compared to the chemotherapy group. Cytokine release syndrome, a potentially dangerous condition that occurs when the body's immune system responds over aggressively to infection or immunotherapy drugs, was primarily low-grade and manageable, Amgen said.
Yahoo
14-04-2025
- Business
- Yahoo
Amgen's Phase III trial of Imdelltra meets primary endpoint for SCLC
Amgen's global Phase III DeLLphi-304 trial of Imdelltra (tarlatamab-dlle) has met its primary endpoint at a planned interim analysis for treating small cell lung cancer (SCLC) patients who advanced on or following a single line of platinum-based chemotherapy. The open-label, randomised, controlled study aims to assess the therapy's safety and efficacy for this patient population. In the trial, the therapy showed a meaningful improvement in overall survival (OS), which is the primary outcome measure of the trial, against local standard-of-care (SOC) chemotherapy. Subjects received SOC treatment or therapy, with topotecan being received in every nation excluding Japan; amrubicin in Japan; and lurbinectedin in Australia, Canada, Korea, Singapore, and the US. According to Amgen, Imdelltra's safety profile was found to be 'consistent' with the known profile. Engineered by the company's researchers, this immunotherapy targets delta-like ligand 3 (DLL3), a protein prevalent in the majority of SCLC cells but rare in healthy cells. The therapy works by activating T cells to destroy cancer cells expressing DLL3, offering an approach for SCLC treatment. Amgen Research and Development executive vice-president Jay Bradner said: "SCLC is one of the most aggressive malignancies, with a high unmet need for more effective therapies. The topline results from DeLLphi-304 demonstrate overwhelming clinical benefits for people living with this devastating disease and affirm Imdelltra as a standard of care. "We look forward to sharing these results with the scientific community and health authorities as we continue our efforts to bring Imdelltra to patients worldwide." The company's DeLLphi trials encompass several studies investigating tarlatamab as a single agent and as combined regimens in prior SCLC lines. These include trials for first-line and maintenance treatments, as well as alternative dosing regimens. Last month, the company reported that the 24-week Phase III IGNITE trial of two dose strengths of rocatinlimab in individuals with moderate to severe atopic dermatitis met the co-primary endpoints. "Amgen's Phase III trial of Imdelltra meets primary endpoint for SCLC" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
26-01-2025
- Health
- Yahoo
WVU Cancer Institute offers pioneering lung cancer treatment
Jan. 26—MORGANTOWN — The WVU Cancer Institute is the first provider in the state to offer a new and promising treatment for extensive-stage small cell lung cancer. Extensive stage means the cancer has spread within the lung, to the other lung, or into the body, to summarize various medical sources. It's not curable, said Dr. Mohammed Almubarak, section chief of solid tumors in the Department of Medical Oncology. The new drug is Imdelltra, made by Amgen, a biotechnology medicine developer. "It has shown very good results and is fairly durable for many people, " Almubarak said. "It gives them more time with such an aggressive disease." Small-cell lung cancer is the deadliest form, he said. Imdelltra is FDA approved as a treatment when the cancer has metastasized and the patient has progressed beyond first-line treatment — chemotherapy and immunotherapy — and is offered as a second-or third-line therapy. The FDA approved it mid-2024, he said, and the Cancer Institute participated in the clinical trials preceding approval. "So we had experience with it even before it got approved by the FDA." Imdelltra is a form of BiTE (bispecific T-cell engager) therapy, he said. It connects to a marker on the cancer cells and a marker on the T-lymphocytes (immune cells). The connection between the cancer and immune cells results in a response that kills the cancer cells. It's administered as an infusion, in the Cancer Institute's infusion center, with "step-up dosing." That means it starts with a small initial dose. If the patient does OK, they come back the next week for a higher dose. And if they do OK with that, they move to the regular bi-weekly dose. The reason for the step-up is the risk for serious complications, Almubarak said. They try to make sure the patient lives close — within an hour — or can stay close for the first two treatments. The patient needs a caretaker. The patient requires close monitoring, should complications arise, so they can get immediate treatment for the complications. "It's one of those situations where there's definitely high reward, bu there's also high risk involved with it, " he said. Amgen reports that in a study of 99 adult patients who had two or more prior treatments, 40 % responded to Imdelltra, meaning their tumor shrank or disappeared. Two saw their tumor completely disappear, and 38 patients saw their tumor partially shrink by at least 30 %. Almubarak said the drug can be administered until it stops working, or if toxicity or side effects arise, or if the patient just wants to stop it. It's early in the experience with Imdrellta, he said, but it appears about half the patients get an additional year of life out of it. From there, they may switch to another approved therapy. They have people still alive who participated in the trials. They've used it on three or four patients so far, and have some referrals, but they're being careful and selective as they go. "It's a process to get through this." BiTE therapy has been used for blood cancers for a few years, he said, so he and his colleagues are familiar with the type of treatment and its complications. But Imdrellta creates a whole different category of people who are eligible for this treatment. He emphasized that there are risks, and the patient needs good support and close monitoring. The treatment isn't offered at any WVU Medicine regional sites, only at the Cancer Institute, because of the level of monitoring needed and available services if complications arise. "For such a tough cancer, a very aggressive cancer, this is a treatment that has shown promise." Up to this point, they haven't had a lot of success getting treatments for it. "It's exciting that we have something like this now. ... We have one more thing we can offer to the patients."
