Amgen Announces Significant Survival Benefit for Lung Cancer Drug IMDELLTRA in Phase 3 Trial
Amgen Inc. (NASDAQ:AMGN) is one of the 11 most profitable NASDAQ stocks to buy now. On June 2, Amgen announced new interim results from the global Phase 3 DeLLphi-304 trial for its drug IMDELLTRA (tarlatamab-dlle). The data were presented at the 2025 ASCO Annual Meeting and published in The New England Journal of Medicine.
It showed that IMDELLTRA reduced the risk of death by 40% and extended median overall survival by over 5 months compared to standard-of-care/SOC chemotherapy in patients with small cell lung cancer/SCLC who had progressed on or after one line of platinum-based chemotherapy. IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen.
A pharmacist filling a prescription for a complex drug developed by the company.
It binds to DLL3, which is a protein expressed on the surface of SCLC cells in ~85-96% of patients but minimally on healthy cells, and CD3 on T-cells. This dual binding activates T-cells to specifically target and kill DLL3-expressing SCLC cells. The DeLLphi-304 trial is a global Phase 3, randomized, controlled, and open-label clinical study. It enrolled 509 patients. The results support the potential conversion of IMDELLTRA's accelerated FDA approval, which was granted last year based on tumor response rates, into a full approval.
Amgen Inc. (NASDAQ:AMGN) discovers, develops, and manufactures human therapeutics globally.
While we acknowledge the potential of AMGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the .
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Disclosure: None. This article is originally published at Insider Monkey.
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Business Wire
13 minutes ago
- Business Wire
Vertex Presents Positive Data for Zimislecel in Type 1 Diabetes at the American Diabetes Association 85th Scientific Sessions
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Results from the study to date continue to demonstrate the transformative potential of zimislecel with consistent and durable patient benefit with longer follow-up. All 12 participants: Demonstrated engraftment with glucose-responsive endogenous C-peptide production, which was durable through one year of follow-up. Achieved the ADA targets of HbA1c <7% and time in range of >70%. Were free of SHEs from day 90 onwards. Had a reduction in exogenous insulin use (mean reduction in daily insulin dose: 92%). 10/12 (83%) no longer required exogenous insulin at Month 12. Achieved the Phase 1/2 primary endpoint of elimination of SHEs with HbA1c <7%. Zimislecel continues to be generally well tolerated. Most adverse events (AEs) were mild or moderate, and there were no serious AEs related to zimislecel treatment. As previously reported, two patient deaths occurred, both unrelated to treatment with zimislecel. The safety profile is generally consistent with the immunosuppressive regimen used in the study, the infusion procedure, and complications from long-standing diabetes. 'These data on the first fully differentiated, stem cell-derived, off-the-shelf islet cell therapy continue to be unprecedented. The magnitude, consistency and durability of the results from all 12 patients with more than one year of follow-up reinforce the transformative potential of zimislecel for people living with T1D complicated by severe hypoglycemia,' said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. 'We are excited to complete enrollment and dosing in the Phase 1/2/3 Program and look forward to potential regulatory submissions next year.' 'It's remarkable to see 12 out of 12 patients with baseline HbA1c above 7% and multiple severe hypoglycemic events reach consensus targets for glycemic control by both HbA1c and time in range as well as elimination of severe hypoglycemic events,' said Michael R. Rickels, M.D., M.S., Medical Director, Pancreatic Islet Cell Transplant Program, Willard and Rhoda Ware Professor in Diabetes and Metabolic Diseases, Presenting Author and Steering Committee Co-Chair for the zimislecel clinical program, and author on the New England Journal of Medicine paper. 'As I think about my patients and the unmet need in the type 1 diabetes community, the results we've seen so far for restoring endogenous insulin secretion with a stem cell-derived islet therapy bring me hope and confidence for a transformative treatment option for individuals with type 1 diabetes in the not-so-distant future.' About Type 1 Diabetes T1D results from the autoimmune destruction of insulin-producing beta cells in pancreatic islets. Insulin deficiency results in hyperglycemia and can lead to acute life-threatening complications such as diabetic ketoacidosis. People with T1D are reliant on lifelong treatment with exogenous insulin that requires careful monitoring of blood glucose levels. Even with the availability of advanced exogenous insulin delivery and glucose monitoring systems, people with T1D can have periods of very low and very high blood sugar levels. Exogenous insulin has a narrow therapeutic range and carries an inherent risk of causing low blood sugar levels or hypoglycemic events, which can potentially result in arrhythmias, seizures, coma and even death. Due to the limitations and complexities of exogenous insulin treatment, it can be difficult for people with T1D to achieve and maintain good glucose control. 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Zimislecel is investigational and has not been approved by health authorities globally. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. 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Rickels, M.D., M.S., in this press release, (ii) plans, expectations for, and the potential benefits of zimislecel, (iii) expectations for the Phase 1/2/3 clinical trial for zimislecel, including expectations for the trial to complete enrollment and dosing, and (iv) plans for potential regulatory submissions next year. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. 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(VRTX-GEN) Vertex will host an investor event on Friday, June 20, 2025, at 7:15 p.m. CT/8:15 p.m. ET, in Chicago, to discuss the positive zimislecel data in type 1 diabetes. A live webcast of the presentation and Q&A portions can be accessed through the Investor Relations section of Vertex's website at An archived webcast will be available on the company's website.
Associated Press
14 minutes ago
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Associated Press
14 minutes ago
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This collective ecosystem approach is focused on identifying solutions to key challenges in partnership with the community, with the goal of creating lasting, transformative change. The place-based concept was piloted in 2019 in Detroit's Gratiot & Seven Mile neighborhood. Two years later, the program expanded into the Neighborhood Program, adding nine additional neighborhoods in seven states. Through the Neighborhood Program, Fifth Third has directly invested nearly $255 million across the nine neighborhoods. That investment helped catalyze over $200 million in additional investment. The result: $455 million in total Fifth Third-driven investments and tangible community impact, including: ### About Fifth ThirdFifth Third is a bank that's as long on innovation as it is on history. Since 1858, we've been helping individuals, families, businesses and communities grow through smart financial services that improve lives. Our list of firsts is extensive, and it's one that continues to expand as we explore the intersection of tech-driven innovation, dedicated people and focused community impact. Fifth Third is one of the few U.S.-based banks to have been named among Ethisphere's World's Most Ethical Companies® for several years. With a commitment to taking care of our customers, employees, communities and shareholders, our goal is not only to be the nation's highest performing regional bank, but to be the bank people most value and trust. Fifth Third Bank, National Association is a federally chartered institution. Fifth Third Bancorp is the indirect parent company of Fifth Third Bank and its common stock is traded on the NASDAQ® Global Select Market under the symbol 'FITB.' Investor information and press releases can be viewed at Deposit and credit products provided by Fifth Third Bank, National Association. Member FDIC. CONTACT Amanda Nageleisen (Media Relations) [email protected] Matt Curoe (Investor Relations) [email protected] | 513-534-2345 Visit 3BL Media to see more multimedia and stories from Fifth Third Bancorp
