AstraZeneca's Imfinzi (durvalumab) Receives the US FDA's Approval for Extensive-Stage Small Cell Lung Cancer
Shots:
- The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and carboplatin / cisplatin CT- or Imfinzi + CT + tremelimumab vs CT as monothx. in 805 patients with ES-SCLC across 23 countries
- The Phase III CASPIAN study results: Imfinzi + SOC- reduction in risk of death by 27% with mOS (13.0 vs 10.3 mos.); increased in ORR (68% vs 58%). The safety and tolerability are consistent with the known safety profile
- Imfinzi (durvalumab) is mAb targeting PD-L1- acts by blocking the interaction of PD-L1 with PD-1 & CD80- received its first approval in Singapore for ES-SCLC in Feb’2020 and is under review in combination with etoposide and carboplatin/ cisplatin as 1L treatment for ES-SCLC in the EU & Japan
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Ref: AstraZeneca | Image: StraitTime
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