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Junshi Biosciences Reports MAA Submission of Toripalimab to the MHRA for Nasopharyngeal Carcinoma and Esophageal Squamous Cell Carcinoma

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Junshi Biosciences Reports MAA Submission of Toripalimab to the MHRA for Nasopharyngeal Carcinoma and Esophageal Squamous Cell Carcinoma

Junshi Biosciences Reports MAA Submission of Toripalimab to the MHRA for Nasopharyngeal Carcinoma and Esophageal Squamous Cell Carcinoma

Shots:

  • 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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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