- Shanghai Junshi Biosciences Co Ltd and Coherus BioSciences Inc CHRS announced positive interim results from CHOICE-01 Phase 3 trial evaluating toripalimab plus chemotherapy for squamous or non-squamous non-small cell lung cancer (NSCLC).
- Related: Toripalimab-Chemo Combo Beat Chemo Alone in Nose & Throat Cancer Trial.
- Total 465 treatment-naive advanced NSCLC patients (220 squamous and 245 non-squamous) were randomized.
- A significant improvement in progression-free survival (PFS) was detected for toripalimab over placebo (hazard ratio (HR)=0.58) with a median PFS of 8.3 vs. 5.6 months.
- The 1-year PFS rates for toripalimab and placebo arms were 32.6% and 13.1%, respectively.
- Toripalimab, in combination with chemotherapy, as compared with chemotherapy alone, resulted in a better objective response rate 6858.
- The median duration of response 68.
- Overall survival (OS) data were not yet mature as of March 7, 2021. There was a trend favoring the toripalimab arm [median OS of 21.0 vs. 16.0 months, HR = 0.81
- On the safety front, the toripalimab combination regime showed a manageable safety profile with no new safety signal observed.
- The incidence of severe/serious adverse events (AEs) was 76.3% in the toripalimab arm vs. 80.1% in the control arm.
- AEs leading to discontinuation of toripalimab or placebo were 12.3% vs. 1.9%, respectively.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: CHRS shares are up 9.97% at $15.55 during the premarket session on the last check Thursday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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