Shots:

• The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi & CT+ tremelimumab vs CT as monothx. as 1L treatment in 805 patients with ES-SCLC. The trial used an FD of Imfinzi (1-500mg- q3w for 4 cycles) while in combination with CT and then q4w until disease progression
• Results: the study met its 1EPs of OS in Jun’2019- demonstrated a 27% reduction in risk of death with m-OS (13.0 vs 10.3 mos.); ORR (68% vs 58%). An updated analysis demonstrated sustained efficacy after a median follow up 2+ yrs.- m-OS (12.9 vs 10.5 mos.)
• Imfinzi is a mAb targeting PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80- countering the tumor's immune-evading tactics and releasing the inhibition of immune responses

­ Ref: AstraZeneca | Image: Clinical Lab Products