Opdivo (nivolumab) in combination with Yervoy (ipilimumab), as well as Opdivo alone, outperformed Yervoy monotherapy in terms of overall survival in a Phase 3 clinical trial of previously untreated patients with advanced melanoma, Bristol-Myers Squibb announced.
The CheckMate -067 clinical trial (NCT01844505) was a long-term study of the three treatments, with overall survival data analyzed after nearly four years. The company presented the data at the American Association for Cancer Research Meeting 2017 April 1-5 in Washington, D.C.
While the median survival in patients treated only with Yervoy was 20 months, those in the two Opdivo treatment groups lived for so long it was not possible to calculate a median survival time at the time of the analysis. Participants were followed for at least 28 months.
When used in combination with Yervoy, Opdivo reduced the risk of death by 45%, and when used as the sole treatment, by 37%, compared to the risk in the Yervoy monotherapy group.
After two years, 64% of participants in the combination group were still alive, compared to 59% in the Opdivo group, and 45% in the Yervoy group.
“It is encouraging to see such positive data from this trial, which further supports the scientific rationale to combine immuno-oncology agents as a potential treatment option for this aggressive form of melanoma,” James Larkin, PhD, FRCP, consultant medical oncologist at the Department of Medical Oncology, The Royal Marsden in the U.K., said in a press release.
“These CheckMate -067 survival data bolster our understanding of potential ways to combat untreated advanced melanoma and ultimately advance cancer care for patients,” he added.
The study also confirmed that the treatments did not produce any cumulative toxicity. Side effects were similar as in earlier trials of the two drugs. Moderate or severe grade 3 and 4 side effects were seen in 58% of patients receiving the combination, and in 21% and 28% of the Opdivo and Yervoy monotherapy groups, respectively.
Compared to earlier analyses, more patients in all three groups had a complete response. In the combination group, the number was 17.2% — an increase from the earlier reported 12.1%. In the Opdivo alone and Yervoy alone groups, 14.9% and 4.4% had a complete response, respectively.
“This first disclosure of overall survival data from CheckMate -067 helps to advance our understanding of the potential longer term benefits of Opdivo in combination with Yervoy in advanced melanoma, a cancer that historically has been difficult to treat,” said Vicki Goodman, MD, development lead for melanoma and genitourinary cancers at Bristol-Myers Squibb.