2024 World Conference on Lung Cancer (WCLC) - Posters-P1.13A.02 Tarlatamab Plus Durvalumab as First-Line Maintenance in Extensive-Stage Small Cell Lung Cancer: DeLLphi-305 Phase 3 Trial

P1.13A.02 Tarlatamab Plus Durvalumab as First-Line Maintenance in Extensive-Stage Small Cell Lung Cancer: DeLLphi-305 Phase 3 Trial

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The DeLLphi-305 Phase 3 trial evaluates the efficacy and safety of combining tarlatamab, a bispecific T-cell engager immunotherapy, with durvalumab as maintenance therapy for patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC). Tarlatamab, which targets DLL3-expressing cancer cells by engaging T-cells, received accelerated FDA approval in May 2024 for ES-SCLC that progressed following platinum-based chemotherapy.<br /><br />DeLLphi-305 is an open-label, multicenter, randomized study comparing tarlatamab plus durvalumab to durvalumab alone for patients who completed four cycles of platinum-etoposide chemotherapy with concurrent durvalumab without disease progression. This trial's primary endpoint is overall survival, with secondary endpoints including progression-free survival, overall response, disease control rate, duration of response, safety, and quality of life.<br /><br />The trial involves patients stratified by factors such as the presence of brain/liver metastases, response to first-line chemo-immunotherapy, and type of platinum received. Tarlatamab is administered at 10 mg every two weeks, with durvalumab given every four weeks. The trial is currently recruiting 550 patients globally from various countries including the USA, China, Japan, and several others.<br /><br />Previous studies, like DeLLphi-301, demonstrated tarlatamab's anticancer activity and manageable safety profile, supporting the ongoing DeLLphi-305 trial. With a median follow-up of 10.6 months in previous evaluations, tarlatamab showed a 40% objective response rate. The focus on safety and efficacy continues, with results crucial for determining the future of tarlatamab as a viable maintenance therapy option for ES-SCLC.

Asset Subtitle

Maurice Perol

Meta Tag

Speaker Maurice Perol

Topic SCLC & Neuroendocrine Tumors

Keywords

DeLLphi-305

tarlatamab

durvalumab

ES-SCLC

bispecific T-cell engager

immunotherapy

FDA approval

overall survival

progression-free survival

platinum-etoposide chemotherapy