Full results from a 563-patient Phase 3 trial presented at the ESMO Congress show that adding Amgen's Imdelltra to AstraZeneca's Imfinzi reduced the risk of death by 58% in extensive-stage small cell lung cancer. The combination extended median survival to 21.1 months compared to 12.7 months with Imfinzi alone. While serious adverse events affected 20.9% of dual-therapy patients, treatment discontinuations remained low at 5.7%.
Small cell lung cancer statistics
- ▪Small cell lung cancer represents up to 15% of all lung cancer cases, with about 250,000 new cases diagnosed worldwide each year and an overall 5-year survival rate of around 9%
- ▪Extensive-stage small cell lung cancer is a fast-growing disease that accounts for 60% to 70% of the approximately 31,000 new U.S. small cell lung cancer cases diagnosed each year
Trial design and publication
- ▪The Phase 3 trial presented at ESMO on October 24, 2026 evaluated 563 patients with extensive-stage small cell lung cancer receiving Imdelltra and Imfinzi as first-line maintenance therapy following initial treatment with Imfinzi and chemotherapy
- ▪Full results of the 563-patient trial of Imdelltra and Imfinzi were presented at the European Society for Medical Oncology meeting in Madrid on October 24, 2026 and published in the New England Journal of Medicine
Overall survival benefits
- ▪Nearly 80% of patients in the 563-patient trial receiving the Imdelltra and Imfinzi combination were alive at one year compared with 53% of patients receiving Imfinzi alone
- ▪A Phase 3 trial presented at the ESMO Congress on October 24, 2026 showed that adding Amgen's Imdelltra to AstraZeneca's Imfinzi reduced the risk of death by 58% compared to Imfinzi alone in extensive-stage small cell lung cancer
- ▪Trial investigator Dr. Jacob Sands reported survival benefits across subgroups of extensive-stage small cell lung cancer patients, including those whose cancer spread to the brain or liver
- ▪Patients receiving the Imdelltra and Imfinzi combination achieved a median overall survival of 21.1 months compared to 12.7 months for patients receiving Imfinzi alone
Safety and side effects
- ▪Cytokine release syndrome occurred in 49.6% of patients in the 563-patient trial treated with Imdelltra, with only one case rated as serious and no CRS-related deaths reported
- ▪Serious side effects occurred in 20.9% of patients in the 563-patient trial on the Imdelltra-Imfinzi combination therapy compared to 10.8% of patients receiving Imfinzi alone
- ▪Adverse events led to treatment discontinuation in 5.7% of patients in the 563-patient trial on the Imdelltra-Imfinzi combination therapy and 5.8% of patients receiving Imfinzi alone
Imdelltra sales and pricing
- ▪Imdelltra carries a U.S. list price of approximately $30,000 per cycle or over $390,000 per year, with Wall Street analysts estimating annual sales reaching $2.5 billion by 2030
- ▪Imdelltra generated $288 million in sales during the second quarter and $627 million in total global sales in 2025
Imdelltra mechanism and current approval
- ▪Imdelltra is a bispecific antibody that targets DLL3 on cancer cells and CD3 on T cells to bring immune cells into direct contact with tumor cells
- ▪Imdelltra is currently approved for adults with advanced small cell lung cancer that has worsened despite chemotherapy, based on data showing the drug reduced the risk of death by 40%
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