Junshi Biosciences Reports P-III (TORCHLIGHT Study) Results of Toripalimab for Advanced Triple-Negative Breast Cancer
Shots:
- The P-III (TORCHLIGHT Study) evaluating the safety & efficacy of toripalimab + paclitaxel vs PBO + paclitaxel in patients with an initial diagnosis of stage IV or recurrent/metastatic TNBC
- The trial met its pre-defined efficacy boundary & the interim analysis showed prolonged PFS in PD-L1+ patients, and improved OS in PD-1+ patients & all patients regardless of PD-1 status. The safety data were consistent with known risks with no new safety signals
- The company will communicate with the regulatory authorities regarding matters related to the sNDA shortly. The BLA of toripalimab + gemcitabine/cisplatin & toripalimab as monotx. for recurrent or metastatic NPC is currently under the US FDA’s review
Ref: Globenewswire | Image: Junshi Biosciences
Related Post:- Junshi and Coherus's Toripalimab Receive the US FDA's Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma
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