FDA OKs Durvalumab in Limited-Stage SCLC

Results from the phase 3 ADRIATIC trial led to the approval of durvalumab in limited-stage SCLC.

The FDA has approved durvalumab (Imfinzi) for patients with limited-stage small cell lung cancer who have not progressed after concurrent platinum-based chemotherapy and radiation therapy, according to a press release from the agency.¹

Results from the phase 3 ADRIATIC trial (NCT03703297) led to the approval.² A total of 730 patients were enrolled and randomly assigned 1:1:1 to either durvalumab monotherapy, durvalumab in combination with tremelimumab (Imjudo), or placebo.

Durvalumab was given at 1500 mg every 4 weeks if patients weighed 30 kg or more and 20 mg/kg every 4 weeks for those who weighed less than 30 kg.

Topline data included an overall survival (OS) of 55.9 months (95% CI, 37.3-not reached) in the monotherapy arm, and 33.4 months (95% CI, 25.5-39.9) in the placebo arm. Additionally, there was a significant progression-free survival (PFS) improvement compared with the placebo arm (HR, 0.76; 95% CI, 0.61-0.95; P = .0161).

The median PFS was 16.6 months (95% CI, 10.2-28.2) in the monotherapy arm and 9.2 months (95% CI, 7.4-12.9) in the placebo arm.

The most common adverse effects included pneumonitis or radiation pneumonitis and fatigue.

References

1. FDA approves durvalumab for limited-stage small cell lung cancer. News release. FDA. December 4, 2024. Accessed December 4, 2024. https://shorturl.at/0eID1
2. Senan S, Spigel D, Cho BC, et al. Durvalumab as consolidation therapy in limited-stage SCLC (LS-SCLC): outcomes by prior concurrent chemoradiotherapy (cCRT) regimen and prophylactic cranial irradiation (PCI) use in the ADRIATIC trial. Presented at the 2024 European Society for Medical Oncology Congress (ESMO); September 13-17, 2024; Barcelona, Spain. LBA81.