Amgen: IMDELLTRA plus Imfinzi improves overall survival in first‑line maintenance ES‑SCLC
- Phase 3 DeLLphi‑305 met its primary endpoint at a pre‑specified interim analysis, showing a statistically significant and clinically meaningful overall survival benefit for IMDELLTRA (tarlatamab‑dlle) plus durvalumab versus durvalumab alone.
- The combination also produced statistically significant improvements in progression‑free survival (PFS) and objective response rate (ORR).
- Five hundred sixty‑three patients who completed initial durvalumab plus platinum‑based chemotherapy and etoposide were randomized 1:1 to receive IMDELLTRA plus durvalumab or durvalumab alone.
- No new or unexpected safety signals were identified; patients were monitored 1–2 hours after infusion (6–8 hours in some regions) on Cycle 1 Day 1 and Day 8.
Trial results
Phase 3 DeLLphi‑305 met its primary endpoint at a pre‑specified interim analysis, showing a statistically significant and clinically meaningful overall survival (OS) benefit for IMDELLTRA (tarlatamab‑dlle) in combination with AstraZeneca's durvalumab versus durvalumab alone when used as first‑line maintenance treatment for extensive‑stage small cell lung cancer (ES‑SCLC) after initial treatment with durvalumab, platinum‑based chemotherapy and etoposide. The study also demonstrated statistically significant improvements in progression‑free survival (PFS) and objective response rate (ORR).
Safety and administration
The safety profile of the combination was consistent with the known safety profiles of the individual agents and no new or unexpected safety signals were identified. The study design included monitoring in a healthcare setting for 1–2 hours (6–8 hours in certain regions including Europe) following IMDELLTRA infusion on Cycle 1 Day 1 and Cycle 1 Day 8.
Trial design and scale
Five hundred sixty‑three patients who completed initial treatment with durvalumab, platinum‑based chemotherapy and etoposide were randomized 1:1 to receive IMDELLTRA in combination with durvalumab or durvalumab alone until progression or unacceptable toxicity. The trial included patients with both treated and untreated asymptomatic brain metastases at baseline and used OS as the primary outcome with PFS and ORR as key secondary endpoints.
Clinical context and next steps
This is the first Phase 3 study of a Bispecific T‑cell Engager (BiTE®) therapy to demonstrate an OS benefit in the first‑line maintenance ES‑SCLC setting. Amgen intends to present detailed data from DeLLphi‑305 at an upcoming international medical congress and share the results with regulatory authorities. The company noted SCLC remains aggressive, accounting for about 13–15% of global lung cancers, with median survival from start of first‑line maintenance around one year and roughly 40% of patients receiving second‑line therapy.
Source: Amgen