FDA Grants Priority Review for Durvalumab to Treat Small Cell Lung Cancer

The FDA has granted priority review for a supplemental biologics license application (sBLA) for durvalumab (Imfinzi; AstraZeneca) to treat limited stage small cell lung cancer (LS-SCLC) among individuals whose disease has not progressed following platinum-based concurrent chemoradiotherapy (cCRT). Durvalumab was also previously granted breakthrough therapy designation by the FDA in this setting.¹

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Lung cancer accounts for one-fifth of all cancer deaths among men and women, and 15% of cases are classified as SCLC. This aggressive form of lung cancer recurs and results in rapid progression, despite chemotherapy and radiotherapy treatment. LS-SCLC impacts 30% of SCLC diagnoses, generally effecting one lung or one side of the chest—causing limited prognosis and low survival rates. Study authors noted that only 15% to 30% of individuals surpass the 5-year survival rate following the diagnosis.^1,2

“Many patients treated for limited-stage small cell lung cancer face disease recurrence and the standard of care has remained unchanged for decades,” Suresh Senan, PhD, professor of clinical experimental radiotherapy at the Amsterdam University Medical Center in the Netherlands and principal investigator, said in a news release.³

Durvalumab could offer additional treatment options for individuals with LS-SCLC because of its role as a human monoclonal antibody that binds to the PD-L1 protein. The binding prevents PD-L1 from interacting with PD-1 and CD80 proteins, aiming to counter the tumors immune-evading strategies and provide better immune response.^1,2

“This priority review reinforces the potential of Imfinzi to transform outcomes for patients as the first and only immunotherapy to demonstrate a survival benefit in limited-stage small cell lung cancer. There is an urgent need for new treatment options that improve upon the standard of care in this setting, which has not changed in 40 years, and we look forward to working with the FDA to bring Imfinzi to patients as quickly as possible,” Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, said in a news release.¹

The sBLA was granted based on results from the ADRIATIC (NCT03703297) phase 3 trial that assessed durvalumab compared to placebo among individuals with LS-SCLC. The study authors noted that the outcomes displayed statically significant and clinically meaningful improvements in overall survival and progression-free survival in patients with LS-SCLC that has not advanced after concurrent chemoradiotherapy (cCRT).^1,2

The study included 730 individuals with LS-SCLC that had not progressed following cCRT. The individuals were randomly assigned to receive a 1500 mg fixed dose of durvalumab with or without 75 mg of tremelimumab (Imjudo; AstraZeneca)—a monoclonal antibody that targets action of cytotoxic T-lymphocyte-associated protein 4. The doses were received every 4 weeks for up to 4 cycles each, extending for 24 months, according to study authors.^1,2

The results displayed that durvalumab reduced the risk of death by 27% and reduced the risk of disease progression by 24%. Additionally, 57% of individuals treated with durvalumab were alive at 3 years compared with 48% treated with placebo. At 2 years, 46% of individuals on durvalumab did not experience disease progression compared with 36% on placebo, according to study authors.¹

“ADRIATIC is the first global phase 3 immunotherapy trial to deliver significant, clinically meaningful improvement in survival in this setting, marking a breakthrough for patients with this devastating disease,” Senan said in a news release.³

The study authors noted that the safety profile for durvalumab was tolerated and followed the known safety profile for the drug, with no new safety signals.¹

References

1. Imfinzi granted Priority Review and Breakthrough Therapy Designation for patients with limited-stage small cell lung cancer in the US. AstraZeneca. News release. August 15, 2024. Accessed August 15, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-granted-priority-review-and-breakthrough-therapy-designation-for-patients-with-limited-stage-small-cell-lung-cancer-in-the-us.html.

2. Ferruggia K. Durvalumab Shows Improvements in Overall Survival, Progression-Free Survival for Small Cell Lung Cancer. Pharmacy Times. News release. April 12, 2024. Accessed August 15, 2024. https://www.pharmacytimes.com/view/durvalumab-shows-improvements-in-overall-survival-progression-free-survival-for-small-cell-lung-cancer.

3. Imfinzi significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial. AstraZeneca. News release. April 5, 2024. Accessed August 15, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-improved-os-and-pfs-in-limited-stage-sclc.html.