Imfinzi plus Imdelltra improves survival in Phase III extensive stage small cell lung cancer trial

AstraZeneca has reported positive high level findings from the Phase III DeLLphi 305 trial, showing that Imfinzi, also known as durvalumab, combined with Amgen’s Imdelltra, or tarlatamab, significantly improved survival in patients with extensive stage small cell lung cancer.

The trial evaluated the combination as first line maintenance treatment in patients whose disease had not progressed after standard induction therapy with Imfinzi alongside platinum chemotherapy and etoposide.

At a planned interim analysis, maintenance treatment with Imfinzi plus tarlatamab produced a statistically significant and highly clinically meaningful improvement in overall survival compared with Imfinzi alone.

The combination also delivered statistically significant and clinically meaningful benefits in progression free survival and objective response rate, both of which were secondary endpoints in the study.

Extensive stage small cell lung cancer is an aggressive and rapidly progressing form of lung cancer that can spread quickly to other parts of the body, including the brain and liver.

AstraZeneca estimates that approximately 195,000 people worldwide will receive treatment for extensive stage small cell lung cancer during 2026.

Immune checkpoint inhibitors such as Imfinzi have already improved survival outcomes and established a first line standard of care for the disease. However, many patients continue to experience progression because of the aggressive nature of small cell lung cancer, and median overall survival with current standard treatment remains approximately one year.

Susan Galbraith, Executive Vice President of Oncology Haematology Research and Development at AstraZeneca, said the results suggest that induction therapy based on Imfinzi followed by maintenance treatment with Imfinzi and tarlatamab could deliver an unprecedented improvement in overall survival for patients with this aggressive form of lung cancer.

She added that the findings further support the role of Imfinzi as a core immunotherapy in small cell lung cancer across different stages of disease.

Jacob Sands, MD, Associate Chief of the Lowe Center for Thoracic Oncology at Dana Farber Cancer Institute, said many patients with small cell lung cancer relapse quickly following current treatment and may never reach second line therapy.

He described the DeLLphi 305 findings as among the most compelling survival results he has seen in extensive stage small cell lung cancer and said they suggest the possibility of meaningfully extending survival for more patients.

The safety and tolerability profile of Imfinzi plus tarlatamab was consistent with the known safety profiles of the individual treatments. No new safety signals were identified.

AstraZeneca plans to present the full findings at a forthcoming medical meeting and share the results with regulatory authorities worldwide.

Imfinzi is already approved in the US, European Union, Japan, China and several other countries for extensive stage small cell lung cancer based on findings from the Phase III CASPIAN trial.

The therapy is also approved for limited stage small cell lung cancer following results from the Phase III ADRIATIC study.

---

---

Related Topics and Keywords

AstraZeneca, cancer research, clinical trials, Imfinzi, IMFINZI® (durvalumab), lung cancer, Oncology, pharma news, small-cell lung cancer