Cecilia Brown

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The phase 3 DeLLphi-304 trial has met its primary end point, demonstrating a &ldquo;statistically significant and clinically meaningful improvement&rdquo; in overall survival (OS) with tarlatamab-dlle (Imdelltra, Amgen) compared with local standard-of-care chemotherapy, according to an announcement from Amgen.The global trial is evaluating the safety and efficacy of the first-in-class immunotherapy in patients with patients with small cell lung cancer (SCLC)&nbsp;that&nbsp;progressed during or after a single line of platinum-based chemotherapy. Investigators randomized patients to receive tarlatamab or local standard-of-care chemotherapy. The chemotherapy was topotecan in all countries except&nbsp;Japan; lurbinectedin in the&nbsp;US,&nbsp;Canada,&nbsp;Australia,&nbsp;Singapore,&nbsp;Korea; and amrubicin in&nbsp;Japan. The primary outcome measure of the trial is OS.Jay Bradner, MD, executive vice president of research and development at&nbsp;Amgen, weighed in on the results of the preplanned interim analysis in a statement.&ldquo;Small cell lung cancer is one of the most aggressive malignancies, with a high unmet need for more effective therapies.&nbsp;The topline results from DeLLphi-304 demonstrate overwhelming clinical benefit for people living with this devastating disease and affirm IMDELLTRA as standard of care,&rdquo; Dr. Bradner said. &ldquo;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.&rdquo;Officials explained that the safety profile of tarlatamab &ldquo;was consistent with its known profile&rdquo; and that &ldquo;detailed data from DeLLphi-304 will be presented at an upcoming medical congress.&rdquo;Tarlatamab-dlle is currently indicated for the treatment of adults with extensive-stage SCLC who have disease progression during or after platinum-based chemotherapy.&ldquo;This indication is approved under accelerated approval based on overall response rate and duration of response,&rdquo; officials said in the announcement. &ldquo;Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).&rdquo;Source:Imdelltra&reg; demonstrated superior overall survival in small cell lung cancer. News release. Amgen. April 11, 2025. Accessed April 13, 2025. <a href="https://wwwext.amgen.com/newsroom/press-releases/2025/04/imdelltra-demonstrated-superior-overall-survival-in-small-cell-lung-cancer?linkId=100000357149894" target="_blank" rel="noopener">https://wwwext.amgen.com/newsroom/press-releases/2025/04/imdelltra-demonstrated-superior-overall-survival-in-small-cell-lung-cancer?linkId=100000357149894</a>

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Phase 3 DeLLphi-304 Trial: Tarlatamab Shows Significant OS Improvement in SCLC

Small Cell Lung Cancer

The phase 3 DeLLphi-304 trial met its primary end point, showing an improvement in overall survival with tarlatamab in small cell lung cancer.