The NMPA has approved Hansizhuang (anti-PD-1 mAb) for ES-SCLC in combination with carboplatin & etoposide. The approval was based on the P-III trial (ASTRUM-005) results evaluating Hansizhuang + CT vs PBO + CT in a ratio (2:1) in 585 patients at 128 sites in multiple countries incl. China, Turkey, Poland & Georgia
The results showed a 38% reduction in risk of death, m-OS (15.8 vs 11.1mos.) & Asians subgroup also showed a 4.8mos. longer m-OS, m-PFS as assessed by IRRC per RECIST v1.1 (5.8 vs 4.3mos.). Hansizhuang + CT brings significant benefits to previously untreated ES-SCLC patients
The trial also met the pre-defined 1EPs criteria & had good safety and tolerability. The result were presented at ASCO 2022 & published in JAMA
Ref: PRNewswire | Image: Henlius
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