AstraZeneca’s Imfinzi (durvalumab) has secured US Food and Drug Administration (FDA) approval to treat adult patients with limited-stage small cell lung cancer (LS-SCLC).
This approval applies to patients whose disease has not progressed after concurrent platinum-based chemotherapy and radiation therapy.
The approval followed priority review and breakthrough therapy designation, based on positive results from the randomised, double-blind, placebo-controlled, multi-centre global ADRIATIC Phase 3 trial.
In the trial, Imfinzi significantly improved outcomes for patients with LS-SCLC, reducing the risk of death by 27% compared to placebo.
Median overall survival (OS) was 55.9 months for the drug compared to 33.4 months for placebo. At three years, 57% of patients on Imfinzi were alive, compared to 48% on placebo.
Imfinzi also reduced the risk of disease progression or death by 24%. Median progression-free survival (PFS) was 16.6 months for Imfinzi, compared to 9.2 months for placebo. At two years, 46% of patients on Imfinzi had not experienced progression, compared to 34% on placebo.
The safety profile of Imfinzi was manageable and consistent with its known profile, with no new safety concerns identified.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “This approval for Imfinzi marks a breakthrough for patients with limited-stage small cell lung cancer, allowing them to receive immunotherapy for the first time.
“The ADRIATIC trial showed an improvement in median overall survival of 22.5 months, setting a new benchmark.
“Imfinzi is now the only immunotherapy approved for both limited- and extensive-stage small cell lung cancer, underscoring our commitment to improving survival rates.”
The drug is also approved in Switzerland for the treatment of LS-SCLC based on the positive ADRIATIC trial results.
Regulatory applications are currently under review in the European Union (EU), Japan, and several other countries for this indication.
Imfinzi is approved for multiple cancer indications, including LS-SCLC, unresectable Stage 3 non-small cell lung cancer (NSCLC), and extensive-stage SCLC.
It’s also approved for biliary tract cancer, unresectable hepatocellular carcinoma (HCC), and advanced/recurrent endometrial cancer.
The drug is under review for perioperative treatment in combination with neoadjuvant chemotherapy for NSCLC.
In August, the FDA approved durvalumab plus chemotherapy to treat resectable early-stage (2A-3B) NSCLC with no known EGFR mutations or anaplastic lymphoma kinase (ALK) rearrangements.
