Bristol Myers' Neoadjuvant Opdivo/Chemo Therapy Yet To Reach Overall Survival Endpoint In Early-Stage Lung Cancer

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Bristol Myers Squibb Co BMY announced results from the Phase 3 CheckMate -816 trial in resectable non-small cell lung cancer (NSCLC).

  • The data showed that neoadjuvant treatment with three Opdivo (nivolumab) cycles combined with chemotherapy significantly improved event-free survival (EFS) than chemotherapy alone.
  • With a minimum follow-up of 21.0 months, Opdivo with chemotherapy reduced the risk of disease recurrence, progression, or death by 37% across randomized patients when administered before surgery. 
  • Related: FDA Approves Bristol Myers' Opdivo Plus Chemo In Neoadjuvant Lung Cancer Setting.
  • In patients receiving the combination, median EFS was 31.6 months, compared to 20.8 months for patients treated with chemotherapy alone.
  • However, the new data unveiled, Opdivo's secondary overall survival measure, did not reach statistical significance.
  • According to Bristol Myers, 83% of patients taking Opdivo combined with chemotherapy were alive after two years, compared to 71% on chemo alone. 
  • Bristol Myers noted overall survival (OS) would continue to be followed for additional analyses.
  • Price Action: BMY shares are down 1.30% at $76.76 during the market session on the last check Monday.
  • Editor's Note: The post has been updated to clarify that overall survival data are immature and analyses are ongoing.
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Posted In: BiotechLarge CapNewsHealth CareGeneralBriefsNon-Small Cell Lung CancerPhase 3 Trial
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