Clear Benefit With Adjuvant Nivolumab in Resected Melanoma
MADRID ― Patients with melanoma who have successfully undergone resection but who are at high risk for relapse have substantially better outcomes with nivolumab (Opdivo, Bristol-Myers Squibb) than the current standard-of-care ipilimumab (Yervoy, Bristol-Myers Squibb).
The new results come from the phase 3 CheckMate 238, which was stopped early owing to benefit. Adjuvant nivolumab increased relapse-free survival by a significant 35% compared to adjuvant ipilimumab while also reducing the rate of grade ≥3 adverse effects by approximately a third.
Speaking at an ESMO press conference for the study, Jeffrey S. Weber, MD, PhD, deputy director, Laura and Isaac Perlmutter Cancer Center, and professor of medicine, NYU Langone Medical Center, New York City, said: "Nivolumab clearly showed a very clinically and statistically significant improvement in relapse-free survival vs high-dose ipilimumab for patients with surgically resected stages IIIB, IIIC, and IV melanoma.
"The benefit for nivolumab was observed for virtually all of the prespecified subgroups, whether you look at stage, PD-L1 staining, BRAFmutational status, age, ulceration of the primary tumor, etc."
Dr Weber also highlighted the superior safety profile of nivolumab in comparison with ipilimumab, saying: "In my opinion, nivolumab provides a very acceptable benefit-risk ratio as adjuvant therapy for high-risk resected melanoma and I think has the potential to be an effective treatment option for patients with resected stage III and IV disease."
Commenting for ESMO, John Haanen, MD, PhD, Division of Medical Oncology, the Netherlands Cancer Institute, Amsterdam, said in a release that data presented at the ESMO 2016 Congress showed that although ipilimumab offered "a survival advantage over placebo, it was highly toxic."
No comments:
Post a Comment