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THOUSAND OAKS, Calif. - Amgen (NASDAQ:AMGN), a biotechnology leader with a market capitalization of $151.3 billion and impressive gross margins of nearly 69%, reported that its Phase 3 DeLLphi-304 clinical trial, evaluating IMDELLTRA (tarlatamab-dlle) for small cell lung cancer (SCLC) patients who have progressed after platinum-based chemotherapy, has met its primary endpoint. InvestingPro analysis shows Amgen maintains strong financial health scores, particularly in profitability metrics. The trial demonstrated a statistically significant improvement in overall survival (OS) over standard-of-care chemotherapy.
The trial involved patients with SCLC, a highly aggressive cancer with limited treatment options after initial chemotherapy failure. IMDELLTRA is a novel immunotherapy that targets DLL3 on tumor cells and CD3 on T cells, activating the latter to destroy the cancer cells. With revenue growth of 18.57% in the last twelve months and EBITDA of $15.16 billion, Amgen demonstrates strong commercial execution in bringing innovative therapies to market.
Jay Bradner, M.D., executive vice president of Research and Development at Amgen, stated that the results affirm IMDELLTRA as a standard of care for SCLC. Amgen plans to present detailed data from the trial at an upcoming medical congress and aims to make the treatment available worldwide.
IMDELLTRA's safety profile in the trial was consistent with previous findings. The drug is already approved in the U.S. for extensive-stage SCLC patients with disease progression after platinum-based chemotherapy under accelerated approval, which is contingent on further clinical benefit verification.
The DeLLphi-304 trial is part of Amgen's broader tarlatamab development program, which explores the drug both as a monotherapy and in combination regimens for earlier lines of SCLC treatment.
SCLC accounts for about 15% of the more than 2.4 million annual lung cancer diagnoses globally. Despite high initial response rates to chemotherapy, relapse is common, necessitating new treatments.
This announcement is based on a press release statement from Amgen. The company, a pioneer in biotechnology, has been recognized for its innovation and has a diverse pipeline of medicines in development for cancer and other diseases.
In other recent news, Amgen has announced that the U.S. Food and Drug Administration (FDA) has approved Uplizna as the first treatment for Immunoglobulin G4-related disease (IgG4-RD). This approval is based on the MITIGATE trial, which demonstrated a significant reduction in disease flares for patients using Uplizna. The drug is expected to contribute to Amgen's revenue growth, with projections estimating $516 million in sales by 2025. Piper Sandler maintains an Overweight rating on Amgen stock with a $329 price target, highlighting the potential for stable revenue and EBITDA through the end of the decade. Meanwhile, Citi analysts have maintained a Neutral rating with a $295 price target, noting the potential impact of upcoming data presentations for other Amgen products. Additionally, prescription data revealed notable volume growth for Repatha and Tezspire, supporting Piper Sandler's positive outlook. These developments reflect Amgen's strategic advancements in its product offerings and its potential for sustained growth in the biotechnology sector.
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