THOUSAND OAKS, CALIF., October 24, 2026 — A new combination therapy from Amgen and AstraZeneca has shown unprecedented survival gains in patients with extensive-stage small cell lung cancer (ES-SCLC). The Phase 3 DeLLphi-305 trial revealed that combining Imdelltra (tarlatamab-dlle) with Imfinzi (durvalumab) reduced the risk of death by 58% in first-line maintenance treatment, offering new hope for patients and their families.
Landmark Trial Results Presented at ESMO Congress
The DeLLphi-305 trial results, presented at the 2026 European Society for Medical Oncology (ESMO) Congress and published in *The New England Journal of Medicine*, mark a significant milestone in the treatment of ES-SCLC. According to Amgen, the combination therapy extended median overall survival (OS) to 21.1 months, compared to 12.7 months with Imfinzi alone. Nearly 80% of patients in the combination group were alive at one year, versus 53% in the control group.
Mechanisms Behind the Combination Therapy
Imdelltra, a bispecific antibody, targets delta-like ligand 3 (DLL3), a protein highly expressed in small cell lung cancer cells. When combined with Imfinzi, an immune checkpoint inhibitor, the therapy enhances the immune system’s ability to recognize and attack cancer cells. This dual approach has proven particularly effective in controlling disease progression and improving survival rates.
Survival and Progression-Free Survival Metrics
The trial’s data highlights remarkable improvements in both overall survival and progression-free survival (PFS). Median PFS more than tripled, reaching 7.4 months with the combination therapy compared to 1.9 months with Imfinzi alone. The objective response rate was 26.4% for the combination group, significantly higher than the 4.1% observed in the control group. These findings underscore the therapy’s potential to transform the standard of care for ES-SCLC.
Clinical Implications for Extensive-Stage SCLC
For patients with ES-SCLC, a disease historically difficult to treat, these results offer a new horizon. Jacob Sands, M.D., of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, noted that the benefits were consistent across subgroups, including patients with brain or liver metastases. This broad efficacy suggests the combination could become a new standard-of-care frontline maintenance option.
Safety Profile and Regulatory Outlook
While the combination therapy showed significant benefits, it also came with increased side effects. Grade 3 or higher treatment-related adverse events occurred in 20.9% of patients on the combination therapy, compared to 10.8% on Imfinzi alone. About half of the patients experienced cytokine release syndrome, though most cases were mild. Amgen is now moving to share these results with regulatory authorities worldwide, with the hope of making this therapy widely available to patients.
For families and patients facing ES-SCLC, these findings represent a beacon of hope. While the data is promising, it’s important to consult with your doctor or oncologist to understand how this therapy might fit into your treatment plan. The human side of this breakthrough lies in the potential to extend lives and improve quality of life for those battling this aggressive disease.
Future Outlook And Potential Impact
According to Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen, the results of the DeLLphi-305 trial represent an unprecedented advance for patients with extensive-stage small cell lung cancer, demonstrating a magnitude of survival benefit rarely seen in this aggressive disease. The company is now moving to share these results with regulatory authorities worldwide, with the hope of making this therapy widely available to patients.
Chief Medical Officer Paul Burton called the trial results “a true watershed moment” for the disease, and noted that the potential prize for Imdelltra could be substantial, with the current label covering about 13,000 U.S. patients, and potentially reaching 35,000 to 40,000 if Amgen’s other earlier-line trials succeed.
Sources
- IMDELLTRA® IN COMBINATION WITH IMFINZI® REDUCED RISK OF DEATH BY AN UNPRECEDENTED 58% IN FIRST-LINE EXTENSIVE STAGE SMALL CELL LUNG CANCER| Amgen
- Amgen’s Imdelltra Cut Lung Cancer Deaths by 58%. Is It Already in the Stock?
- Tarlatamab Maintenance Combo Extends Survival in Extensive-Stage SCLC | CancerNetwork
Photo: FDV (CC BY-SA 4.0)
