publication date: Feb. 28, 2017
Gastric Cancer Opdivo Demonstrated Improved Survival in Advanced Gastric Cancer in Phase III Study
Bristol-Myers Squibb Company announced the results of ONO-4538-12 demonstrating Opdivo (nivolumab) significantly reduced the risk of death by 37% (HR 0.63; p<0.0001) in patients with previously treated advanced gastric cancer refractory to or intolerant of standard therapy, a condition without current standard-of-care treatments.
ONO-4538-12 is a phase III, randomized, double-blind, placebo-controlled clinical trial evaluating Opdivo’s efficacy and safety in such patients.
The primary endpoint of the study is overall survival (OS). Median OS was 5.32 months (95% CI: 4.63 to 6.41) for patients treated with Opdivo, compared to 4.14 months (95% CI: 3.42 to 4.86) (p<0.0001) for those treated with placebo.
In addition, the 12-month OS in theOpdivo group was 26.6% (95% CI: 21.1 to 32.4) versus 10.9% (95% CI: 6.2 to 17.0) in the placebo group. Patients treated with Opdivo also experienced an objective response rate of 11.2% (95% CI: 7.7 to 15.6) compared to 0% (95% CI: 0.0 to 2.8) with placebo and a median duration of response of 9.53 months (95% CI: 6.14 to 9.82), which were secondary endpoints.
The safety profile of Opdivo was consistent with previously reported studies in solid tumors. Treatment-related adverse events of any grade and Grade 3/4 occurred in 42.7% versus 26.7% and 10.3% versus 4.3% of Opdivo-treated and placebo-treated … Continue reading CCL Feb 2017 – Opdivo Demonstrated Improved Survival in Advanced Gastric Cancer in Phase III Study
To access this members-only content, please log in.
If you're not a subscriber why not join today?
If you believe you should be able to view this area but cannot log in, then please contact us
and we will try to rectify this issue as soon as possible.
To gain access to the members only content click here
You will be given immediate access to premium content on the site.Click here to join.