Imfinzi plus tarlatamab shows survival gains in lung cancer trial

AstraZeneca's (NYSE: AZN) Imfinzi (durvalumab), combined with Amgen's tarlatamab, demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared with Imfinzi alone as a first-line maintenance treatment in patients with extensive-stage small cell lung cancer (ES-SCLC), according to a planned interim analysis of the Phase III DeLLphi-305 trial.

The trial enrolled patients with ES-SCLC who had not progressed following induction treatment with Imfinzi combined with platinum-based chemotherapy and etoposide. A total of 563 patients were randomized 1:1 to receive either Imfinzi plus tarlatamab or Imfinzi alone. The combination also showed a statistically significant improvement in objective response rate, a secondary endpoint.

The DeLLphi-305 trial is sponsored by Amgen, with partial funding and Imfinzi supplied by AstraZeneca. AstraZeneca said the safety profile of the combination was consistent with the known profiles of the individual treatments, with no new safety signals identified.

Jacob Sands, MD, Associate Chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said: "Given the aggressive nature of small cell lung cancer, many patients quickly relapse on current therapy and never reach second-line treatment. In my career treating people with extensive-stage small cell lung cancer, these are among the most compelling survival results I have seen."

Imfinzi is currently approved in the US, EU, Japan, China and other markets as a standard-of-care treatment for both ES-SCLC and limited-stage SCLC. Median OS with the current standard of care in ES-SCLC is approximately one year, according to the press release. An estimated 195,000 people globally will be treated for ES-SCLC in 2026.

AstraZeneca said the data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. No regulatory submission timeline was disclosed.

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