NMPA Accepts Junshi Biosciences’ Toripalimab + CT Supplemental Filing for Resectable Stage II–III NSCLC
Shots:
- NMPA has accepted the supplemental application of toripalimab + Pt-containing CT as perioperative treatment & subsequent monotx. as adj. therapy for the treatment of adult pts with resectable stage II-III NSCLC
- Filing was based on P-III (NEOTORCH) trial (n=501), which showed perioperative toripalimab + CT met 1EP of improved EFS by 60% (mEFS: not reached vs 15.1mos.) in interim analysis; pCR rate was 24.8% vs 1% & MPR rate was 48.5% vs 8.4%
- A post hoc analysis showed that toripalimab + CT reduced surgery cancellations (17.8% vs 26.7%) without increasing perioperative risks. Among pts who underwent surgery, the combination achieved higher tumor (80.7% vs 50.7%) & lymph node downstaging rates (67.5% vs 48.6%) & improved EFS
Ref: Globenewswire | Image: Junshi Biosciences | Press Release
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