Opdivo is the first and only PD-1 inhibitor to demonstrate superior overall survival versus docetaxel in non-squamous non-small cell lung cancer, with an 18-month overall survival rate of 39%
Longer term data from CheckMate -057 show benefit with Opdivo in overall population with greater magnitude of survival benefit among PD-L1 expressors
Safety and tolerability profile of Opdivo is favorable versus docetaxel and consistent with prior Opdivo studies
Results from CheckMate -057 published in the New England Journal of Medicine
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced longer term (18 month) survival data from CheckMate -057, an open-label, randomized Phase 3 study evaluating Opdivo (n=292) versus docetaxel (n=290) in previously treated patients with advanced, non-squamous (NSQ) non-small cell lung cancer (NSCLC). Opdivo continued to demonstrate superior overall survival (OS) – the study’s primary endpoint – with an estimated 39% of patients alive at 18 months (95% CI, 34-45) versus 23% for docetaxel, based on a minimum follow-up of 17.1 months. Opdivo also continued to demonstrate a reduction in the risk of death by 28% (a hazard ratio of 0.72; 95% CI, 0.60 - 0.88). In the study, Grade 3-4 treatment-related adverse events were reported in 10% of patients treated with Opdivo versus 54% in the docetaxel arm. These data will be presented on Monday, September 28 during the 2015 European Cancer Congress (ECC 2015) (Abstract # 3010) and published in the New England Journal of Medicine.
“These longer term survival results for nivolumab in advanced, non-squamous non-small cell lung cancer support the potential for this Immuno-Oncology agent in treating lung cancer patients,” said Leora Horn, M.D., Vanderbilt-Ingram Cancer Center. “CheckMate -057 builds upon its critical findings and now, data show a sustained survival benefit for nivolumab in this hard-to-treat disease that is incredibly encouraging for oncologists, and most importantly, for our patients.”
CheckMate -057 clinical results were first reported at the 51st Annual Meeting of the American Society of Clinical Oncology, marking the first time a PD-1 inhibitor demonstrated superior OS versus docetaxel in previously treated patients with NSQ NSCLC. Data from this trial have been accepted for regulatory review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency to expand the respective Opdivo indications to include previously treated patients with NSQ NSCLC. This application has also been granted Priority Review in the U.S., and Opdivo has received Breakthrough Therapy Designation for this indication.
“At the core of our Immuno-Oncology approach is an unrelenting focus to fundamentally change survival expectations for all cancer patients. Today, we are driving insights into how advanced lung cancer may be treated – from defining the role of PD-L1 expression to showing clinical efficacy resulting in deep and durable responses for these patients,” said Michael Giordano, senior vice president, head of Development, Oncology. “The 18-month data from CheckMate -057 reinforce the potential for Opdivo, across PD-L1 expression levels, to offer patients durable overall survival benefit with lower incidence of serious adverse events versus chemotherapy.”
About CheckMate -057
CheckMate -057 is a Phase 3, open-label, randomized clinical trial that evaluated patients with advanced NSQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. The trial included patients regardless of their PD-L1 status. Secondary endpoints included objective response rate (ORR) and progression-free survival (PFS). Patients enrolled in the trial received Opdivo 3 mg/kg every two weeks versus standard of care, docetaxel, at 75 mg/m2 every three weeks. In the trial, Opdivo demonstrated continued superior OS benefit, with an estimated 51% of patients alive at one year versus 39% for docetaxel, and an estimated 39% of patients alive at 18 months (95% CI, 34-45) versus 23% for docetaxel, based on a minimum follow-up of 17.1 months.
CheckMate -057 also evaluated the efficacy of Opdivo by tumor PD-L1 expression. Of randomized patients, 78% (455/582) had tumor samples evaluable for PD-L1 expression. Rates of PD-L1 expressing tumors were balanced between groups. PD-L1 status was predictive for benefit from Opdivo, across pre-specified 1%, 5%, and 10% expression levels. In PD-L1 non-expressors, OS was similar between Opdivo and docetaxel, with improved durability of responses seen in patients treated with Opdivo versus docetaxel.
In addition, clinical results showed confirmed ORR was significantly higher for Opdivo (19%) than docetaxel (12%). For patients administered Opdivo, median duration of response was 17.2 months and 5.6 months for docetaxel. One-year PFS was 19% for Opdivo (95% CI, 14-23) and 8% for docetaxel (95% CI, 5-12). Median PFS was 2.3 months for Opdivo (95% CI, 2.2-3.3) and 4.2 months for docetaxel (95% CI, 3.5-4.9).
The safety profile of Opdivo in CheckMate -057 was consistent with prior studies and similar across expressors and non-expressors. Treatment-related adverse events were low in severity with Opdivo and occurred less frequently (any grade: 69%; grade 3-4: 10%) than docetaxel (any grade: 88%; grade 3-4: 54%), including both hematologic and non-hematologic toxicities. Treatment-related serious adverse events were reported less frequently with Opdivo (any grade: 7%; grade 3-4: 5%) than docetaxel (any grade: 20%; grade 3-4: 18%). Discontinuation due to treatment–related adverse events was less frequent with Opdivo (5%) than docetaxel (15%).
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally, resulting in more than 1.5 million deaths each year, according to the World Health Organization. Lung cancer results in more deaths worldwide than colorectal, breast and prostate cancers combined. Non-small cell lung cancer is one of the most common types of the disease and accounts for approximately 85% of cases.
About Opdivo
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as a monotherapy or in combination with other therapies – in which more than 8,000 patients have been enrolled worldwide.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the FDA as a monotherapy in two cancer indications. Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world on July 4, 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. In the U.S., the Food and Drug Administration (FDA) granted its first approval for Opdivo for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. On March 4, 2015, Opdivo received its second FDA approval for the treatment of patients with metastatic squamous (SQ) non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. On July 20, 2015 the European Commission approved Nivolumab BMS for the treatment of locally advanced or metastatic SQ NSCLC after prior chemotherapy.
