Durvalumab Plus Chemotherapy Approved in China as First-Line Management of Extensive-stage SCLC

Durvalumab Plus Chemotherapy Approved in China as First-Line Management of Extensive-stage SCLC

Industry News & Regulatory Approvals
Jul 30, 2021
Regulatory Approval

July 19—The National Medical Products Administration in China approved durvalumab in combination with standard-of-care platinum chemotherapy (as defined as etoposide plus carboplatin or cisplatin) for the first-line management of extensive-stage SCLC. This approval joins those in more than 55 countries for this indication. 

The approval was based on the CASPIAN phase III trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival for the durvalumab combination. The trial administered 1,500 mg of durvalumab in combination with chemotherapy every 3 weeks for four cycles and then every 4 weeks as monotherapy until disease progression. Median OS was 13.0 months for the combination compared with 10.3 months for chemotherapy alone. The objective response rate was 68% vs 58%, respectively, and the risk of death was reduced by 27% with the combination (HR = 0.73; CI: 0.59, 0.91; p = 0.0047). 

Updated CASPIAN data with a median follow up of more than 2 years showed median OS of 12.9 vs. 10.5 months, respectively. At 24 months, approximately 22.2% of patients who received the combination were alive vs. 14.4% who received chemotherapy alone. Safety and tolerability were consistent with the known safety profiles.

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