Opdivo (Nivolumab) Demonstrates Superior Survival Compared to Standard of Care (Docetaxel) for Previously-Treated Squamous Non-Small Cell Lung Cancer in Phase III Trial

Bristol-Myers Squibb Company (NYSE:BMY) today announced results from CheckMate -017, a Phase III, open-label, randomized study evaluating Opdivo (n=135) versus docetaxel (n=137) in previously treated patients with advanced squamous non-small cell lung cancer. At one year, Opdivo demonstrated an overall survival rate of 42% versus 24% for docetaxel, with a median overall survival of 9.2 months versus 6 months, respectively. In the trial, Opdivo reduced the risk of death by 41%, based upon a hazard ratio of 0.59 (95% CI, 0.44-0.79; P = 0.00025). The safety profile of Opdivo in CheckMate -017 was consistent with prior studies and favorable versus docetaxel. Findings from CheckMate -017 were published today in The New England Journal of Medicine and presented during an oral abstract session at the 51st Annual Meeting of the American Society of Clinical Oncology (Abstract #8009).

“ ‘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,’ said David Spigel, MD, Sarah Cannon Research Institute. ‘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.’ “


AstraZeneca and MedImmune Present Positive Immuno-Oncology Combination Data at ASCO 2015

“AstraZeneca AZN, -0.75% and MedImmune, AstraZeneca’s global biologics research and development arm, today presented encouraging results from their novel combination-focused immuno-oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015.

“Overall, data indicated clinical activity with manageable safety profiles for the anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody MEDI4736, both as monotherapy and in combination with other immuno-oncology and small molecule therapies across different tumor types and tumor biology.

“MEDI4736 and tremelimumab combination shows clinical activity and tolerability in both PD-L1 positive and PD-L1 negative advanced non-small cell lung cancer (NSCLC) patients; dose confirmed for future studies

“Results from the combination study of MEDI4736 and tremelimumab, a cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody, in the treatment of advanced NSCLC, demonstrated clinical activity in heavily-pretreated patients with a manageable safety profile, establishing appropriate doses to move forward into Phase III combination trials.”


Pivotal Results from Phase III Trial Show Combination of Ipilimumab and Nivolumab or Nivolumab Alone Increase Progression-Free Survival in Advanced Melanoma Patients

“Treating advanced melanoma patients with either a combination of the immunotherapy drugs nivolumab (Opdivo™) and ipilimumab (Yervoy™) or nivolumab alone significantly increases progression-free survival (PFS) over using ipilimumab alone, according to new findings from researchers at Memorial Sloan Kettering Cancer Center (MSK) simultaneously presented today at the American Society of Clinical Oncology (ASCO) annual meeting and published online in the New England Journal of Medicine (NEJM). Examining specific characteristics of each patient’s tumor has also given researchers clearer understanding of which patients should receive the combination.

“These initial findings from the phase III clinical trial confirm the results of the phase II trial, presented just weeks ago at the American Association of Cancer Research annual meeting in Philadelphia and published by MSK researchers online in NEJM.”