AstraZeneca has shared phase 3 results for Imfinzi plus Imdelltra in extensive-stage small cell lung cancer (ES-SCLC). The DeLLphi-305 phase 3 trial showed Imfinzi (durvalumab) plus Amgen’s Imdelltra (tarlatamab) demonstrated a statistically significant and highly clinically meaningful improvement in overall survival (OS) versus Imfinzi alone as a 1st-line maintenance treatment.
The trial included patients with ES-SCLC who had not progressed following standard induction treatment with Imfinzi in combination with platinum chemotherapy (either carboplatin or cisplatin) and etoposide.
Imfinzi plus tarlatamab also demonstrated a statistically significant improvement in progression-free survival (PFS) and objective response rate.
Jacob Sands, 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. These patients do not have time to wait, making substantial progress in the first-line setting critically important.
“[This trial] represents an unprecedented milestone and suggests we may be entering a new era where meaningfully longer survival is possible for more patients.”
In 2026, an estimated 195,000 people globally will be treated for ES-SCLC, a highly aggressive, fast-growing form of lung cancer characterised by rapid tumour progression and metastatic spread to organs such as the brain and liver. Immune checkpoint inhibitors such as Imfinzi have led to significant improvements in OS in ES-SCLC, establishing a first-line standard of care. However, many patients still experience disease progression due to the aggressive nature of the disease and median OS with the current standard of care is approximately one year.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “These results show that Imfinzi-based induction therapy followed by maintenance treatment with Imfinzi plus tarlatamab demonstrates an unprecedented improvement in overall survival for patients with this highly aggressive form of lung cancer.”
The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
Imfinzi is approved in the US, EU, Japan, China and many other countries around the world as the standard-of-care treatment for ES-SCLC and limited-stage SCLC (LS-SCLC) based on the CASPIAN and ADRIATIC phase 3 trials, respectively.