Bristol-Myers Squibb have presented overall survival data from CheckMate -069, a Phase 2 trial and the first randomized study to evaluate the Opdivo and Yervoy combination regimen in patients with previously untreated advanced melanoma. In the trial, the Opdivo and Yervoy combination regimen demonstrated a two-year overall survival (OS) rate of 69% compared to 53% for Yervoy alone (HR=0.58 [95% CI: 0.31-1.08]) in patients with BRAF wild-type advanced melanoma. Overall survival was an exploratory endpoint in this trial. The safety profile of the Opdivo and Yervoy combination regimen in this study was consistent with previously reported studies. These data will be presented today as an oral presentation at the American Association for Cancer Research (AACR) 2016 Annual Meeting during the Immuno-Oncology Clinical Trials I Plenary Session from 2:15 – 4:00 P.M. CT in New Orleans, Louisiana (Late-Breaking and Clinical Trial Abstract #CT002).
Bristol-Myers Squibb is also presenting extended follow-up data, including five-year OS rates, from the Phase 1 dose escalation study, CA209-003, evaluating Opdivomonotherapy in heavily pretreated advanced melanoma patients. These data represent the longest survival follow-up of patients who received an anti-PD-1 therapy in a clinical trial. At five years, patients who received Opdivo showed an OS rate of 34%, with an evident plateau in survival at approximately four years. The safety profile of Opdivo in study -003 was similar to previously reported studies, with no new safety signals identified. These data were featured during the Congress’ official press program today at 12:30 P.M. CT, and will be presented as an oral presentation during the Immuno-Oncology Clinical Trials I Plenary Session from 2:15 – 4:00 P.M. CT (Late-Breaking and Clinical Trial Abstract #CT001).
“The data from CheckMate -069 and study -003 showed durable responses for some patients with advanced melanoma using new Immuno-Oncology approaches. These data contribute to our growing understanding of this aggressive cancer and are promising news for advanced melanoma patients. In particular, we are seeing further data that evaluate the potential survival benefit of the nivolumab and ipilimumab combination,” said F. Stephen Hodi, M.D., director of the Melanoma Center at Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School.
Melanoma continues to be the most aggressive and deadliest form of skin cancer, with an increase in global incidence rates over the last 30 years. Despite advances in treatment, patients with advanced stages of the disease have lower survival rates, with a five-year survival of 15% - 20% for Stage IV disease.
Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb, commented, “We are encouraged to see that the Opdivo and Yervoy combination showed improvement in overall survival versus Yervoy alone based on two-year follow-up from CheckMate -069, the registrational study of the combination regimen. These data further validate our scientific rationale for studying the combination of these Immuno-Oncology agents. Additionally, study -003 shows five-year overall survival withOpdivo monotherapy in heavily pretreated advanced melanoma patients. These data provide important information about the possible role of Opdivo as a single agent in improving long-term survival for these patients.”