IMFINZI® (durvalumab) plus tarlatamab-dlle reduced the risk of death by 58% in 1st-line extensive-stage small cell lung cancer in the DeLLphi-305 Phase III trial

Novel combination demonstrated a median overall survival of nearly two years, the longest benefit ever reported in extensive stage disease in a Phase III trial

Results reinforce IMFINZI as the backbone immunotherapy across stages of small cell lung cancer

WILMINGTON, Del., October 24, 2026--Landmark results from the DeLLphi-305 Phase III trial showed IMFINZI® (durvalumab) plus Amgen's tarlatamab-dlle demonstrated a statistically significant and highly clinically meaningful improvement in the primary endpoint of overall survival (OS) and in the key secondary endpoint of progression-free survival (PFS) versus IMFINZI alone as a 1st-line maintenance treatment. The trial included patients with extensive-stage small cell lung cancer (ES-SCLC) who had not progressed following standard induction treatment with IMFINZI plus platinum chemotherapy (investigator's choice of carboplatin or cisplatin) and etoposide.

These results will be presented today in a Proffered Paper session during Presidential Symposium I at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (abstract #LBA3).1 They were also simultaneously published in The New England Journal of Medicine.

In a planned interim analysis, IMFINZI plus tarlatamab-dlle reduced the risk of death by 58% compared to IMFINZI alone (based on an OS hazard ratio [HR] of 0.42; 95% confidence interval [CI] 0.32-0.54; p<0.001) at a median follow-up of approximately 16 months. Median OS was 21.1 months for the combination versus 12.7 months for IMFINZI alone. An estimated 79% of patients treated with the combination were alive at one year compared to 53% for IMFINZI alone.

Results from the key secondary endpoint of PFS showed the combination reduced the risk of disease progression or death by 66% compared to IMFINZI alone (based on a PFS HR of 0.34; 95% CI 0.28-0.42; p<0.001) at a median follow-up of 13.9 months. Median PFS was 7.4 months for the combination versus 1.9 months for IMFINZI alone. An estimated 38% of patients treated with the combination were alive and had not experienced disease progression at one year compared to 10% for IMFINZI alone.

The OS and PFS benefits observed were consistent across all prespecified subgroups, including patients with brain or liver metastases.

Confirmed objective response rate (ORR) with the combination was six times higher compared to IMFINZI alone (26.4% versus 4.1%; p<0.001). Median duration of response (DOR) for the combination exceeded 1 year (12.7 months) versus 5.6 months for IMFINZI alone.