The company has submitted an MAA to the MHRA for toripalimab in patients with locally recurrent or metastatic NPC in combination with cisplatin & gemcitabine and unresectable LA/recurrent or metastatic ESCC with paclitaxel & cisplatin
The submission was based on the P-III (JUPITER-02) trial for NPC in 289 patients & the P-III (JUPITER-06) trial for ESCC in 514 patients evaluating toripalimab + CT vs PBO + CT. The (JUPITER-02) trial showed a longer PFS with m-PFS (21.4 vs 8.2mos.), presented at ASCO 2021 & published in Nature Medicine & (JUPITER-06) trial showed better OS & PFS with an m-OS (17 vs 11mos.), presented at ESMO 2022 & published in Cancer Cell
If toripalimab is approved, it will be 1st drug approved for NPC in the US & also received ODD from the US FDA for ESCC
Ref: Globenewswire | Image: Junshi Biosciences
