Shots:

• The approval is based on P III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi + CT + tremelimumab vs PBO in 805 patients with ES-SCLC in 200 centers across 23 countries. The approval follows the CHMP’s positive opinion received in July’2020
• Results: the study met its 1EPs of OS (13.0 vs 10.3mos.); ORR (68% vs 58%); 27% reduction in risk of death with delay in time for disease symptoms to worsen. Updated analysis: m-OS (12.9 vs 10.5 mos.); safety & tolerability is consistent with a known safety profile
• Imfinzi is a mAb targeting PD-L1 and blocks PD-L1 interaction with PD-1 and CD80- currently being evaluated as monothx. and in combination with tremelimumab for multiple cancer indications and in P-III ADRIATIC trial for patients with limited-stage SCLC

­ Ref: AstraZeneca | Image: Los Angeles Times