Statement: Bristol-Myers Squibb Validates Predictive Role of Tumor Mutation Burden in Phase 3 CheckMate -227 Program in First-Line Non-Small Cell Lung Cancer

Monday, February 5, 2018 7:12 am EST

Dateline:

PRINCETON, N.J.

Our pivotal Phase 3 CheckMate -227 trial in first-line non-small cell lung cancer (NSCLC) met its co-primary endpoint for the Opdivo plus Yervoy combination, demonstrating highly statistically significant progression-free survival compared with chemotherapy in patients who have high levels of an emerging biomarker called tumor mutation burden (TMB).    

  • Today’s announcement is exciting news for patients and we believe these data are a breakthrough in advancing the science in cancer research.  TMB has the potential to be an important, predictive independent biomarker that can identify a population of first-line NSCLC patients who can potentially benefit from I-O therapy.
  • This is also an important first data readout in our broad lung cancer program, with many more to come. In addition to these important findings, a second part of the trial, which is assessing overall survival with the Opdivo plus Yervoy combination, is continuing as planned. 
  • This is a true example of the innovation that is core to our strategy, and we would like to thank the patients and researchers who participated in these clinical trials  without whom this scientific advance would not be realized.        

These results bring us one step closer to a new, more personalized approach to treating lung cancer and we look forward to discussing the findings with regulatory authorities.

Today’s news is a good reminder to keep an intense focus on our mission  discovering, developing and delivering innovative medicines that help patients with serious disease.

Read our press release here.

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.  

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