Innovent Presents Final Analysis P-III Study (ORIENT-15) Results of Sintilimab as 1L Treatment of Esophageal Squamous Cell Carcinoma at AACR 2023
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- The P-III study (ORIENT-15) evaluating sintilimab + CT vs PBO + CT in 746 patients with unresectable LA, recurrent or metastatic ESCC
- At the data cutoff date Aug 2022 with the median follow-up of 32.2mos., the results showed improvement in the m-OS. In all randomized & PD-L1+ patients, 33.9% & 36.5% reduction in risk of death & 4.6 & 3.9mos. improvement in m-OS (17.4 vs 12.8mos.) & (18.4 vs 14.5mos.)
- Estimated OS rates were 64.0% vs 53.5% @12mos., and 41.4% vs 22.9% @24mos. respectively in all randomized patients. The safety profile was consistent with prior reported studies & no additional safety signals was seen with ~16mos. of extended follow-up. Sintilimab, a PD-1 immunoglobulin G4 mAb was marketed as Tyvyt in China
Ref: PRnewswire | Image: Innovent
Related News:- Innovent Presents P-II Study (CIBI375A201) Results of Pemazyre (pemigatinib) for Advanced Cholangiocarcinoma at AACR 2023
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