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news.Bristol-Myers Squibb has reported positive results from CheckMate -017, a Phase III, open-label, randomized study evaluating Opdivo versus docetaxel in previously treated patients with advanced squamous non-small cell lung cancer.
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In CheckMate -017, at one year, Opdivo showed an overall survival rate of 42% versus 24% for docetaxel, with a median overall survival of 9.2 months versus six months, respectively.
In the trial, Opdivo reduced the risk of death by 41% and its safety profile was consistent with prior studies and favorable versus docetaxel.
Sarah Cannon Research Institute Dr David Spigel said: "Historically, treatment options for lung cancer patients have been limited. The Opdivo data presented today offer patients the first major advance in the treatment of squamous non-small cell lung cancer in more than a decade.
"In this study, Opdivo not only demonstrated superior overall survival and objective response rate versus chemotherapy, the standard of care, but these benefits were sustained over time.
"The study also showed that squamous non-small cell lung cancer has a unique biology that resulted in similar efficacy across levels of PD-L1 expression."
The company said that in the trial Opdivo showed a consistent statistically significant superiority over docetaxel across all secondary endpoints including overall response rate and progression-free survival.
Bristol-Myers Squibb senior vice-president and head of Development, Oncology Michael Giordano said: "The results from CheckMate -017 are an important milestone in cancer research. This study marked the first time a PD-1 immune checkpoint inhibitor demonstrated a survival benefit in lung cancer, thereby establishing a new treatment modality for the disease."