Durvalumab Wins FDA Approval in Limited-Stage Small Cell Lung Cancer

• The FDA has approved durvalumab (Imfinzi) for the treatment of limited-stage small cell lung cancer (SCLC) that has not progressed following platinum-based concurrent chemoradiotherapy.
• The approval is supported by the phase 3 ADRIATIC study (NCT03703297).
• With this approval, a new standard of care is available for this disease state.

Durvalumab is now an FDA-approved therapy for the treatment of patients with limited-stage SCLC whose disease has not progressed following platinum-based concurrent chemotherapy.¹

The approval is supported by data from the phase 3 ADRIATIC trial, and findings were presented in a plenary session at the 2024 American Society of Clinical Oncology Annual Meeting.

“I think this establishes a new standard of care for the treatment of limited-stage small cell lung cancer. That is, chemotherapy and radiation should continue to be the core treatment of those patients. But after that is completed and patients are safe, and there are no other issues, they should go on to receive up to 2 years of durvalumab given monthly because of these benefits that have been seen in this study,” said David Spigel, MD, chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, and primary investigator of the trial, in an interview with Targeted Oncology^TM.

Durvalumab reduced the risk of death by 27% compared with placebo (HR, 0.73; 95% CI, 0.57-0.93, P =.0104). The estimated median overall survival (OS) was 55.9 months (95% CI, 37.3-not estimable) with durvalumab vs 33.4 months with placebo (95% CI, 25.5-39.9). Further, durvalumab resulted in an estimated 57% of patients still alive at 3 years vs 48% of patients on placebo.^2,3

Risk of disease progression or death was reduced by 24% (HR, 0.76; 95% CI, 0.61-0.95; P =.0161) with durvalumab vs placebo. The median progression-free survival (PFS) was 16.6 months (95% CI, 10.2-28.2) with durvalumab vs 9.2 months (95% CI, 7.4-12.9) with placebo. An estimated 46% of patients receiving durvalumab did not experience disease progression at 2 years vs 34% receiving placebo.

The safety profile of durvalumab observed in ADRIATIC was in line with the known profile, and no new safety signals were identified.

“One controversial area in the treatment of limited-stage small cell lung cancer is prophylactic cranial irradiation, or PCI,” explained Spigel in the interview. “In this study, patients were allowed to get it or not get it; it was up to the treating physician and the patient and their family. About half got it, so 54% did not get it,but it did not seem to matter. The benefits [seen] with durvalumab for OS and PFS did not seem to be contingent on whether [the patient receives] PCI or no PCI.”

“I think that is reassuring for doctors like [me] who favor not giving prophylactic cranial radiation. That benefits still exists,” Spigel added.

REFERENCES:

1. FDA approves durvalumab for limited-stage small cell lung cancer. News release. FDA. December 4, 2024. Accessed December 4, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-limited-stage-small-cell-lung-cancer?utm_medium=email&utm_source=govdelivery

2. Spigel D, Cheng Y, Cho B, et al. ADRIATIC: durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC). J Clin Oncol. 2024; 42(suppl 17):abstr LBA5doi:10.1200/JCO.2024.42.17_suppl.LBA5

3. Imfinzi granted Priority Review and Breakthrough Therapy Designation for patients with limited-stage small cell lung cancer in the US. News release. AstraZeneca. August 15, 2024. Accessed September 5, 2024. https://tinyurl.com/2vsfvykf