Canadian cohort expanded-access program of nivolumab plus ipilimumab in advanced melanoma.

Autor:	Hogg D; Princess Margaret Cancer Centre, Toronto, ON., Monzon JG; Tom Baker Cancer Centre, Calgary, AB., Ernst S; Children's Hospital, London Health Sciences Centre, London, ON., Song X; The Ottawa Hospital Cancer Centre, Ottawa, ON., McWhirter E; Juravinski Cancer Centre, McMaster University, Hamilton, ON., Savage KJ; Department of Medical Oncology, BC Cancer, Vancouver, BC., Skinn B; Bristol Myers Squibb, Princeton, NJ, U.S.A., Romeyer F; Bristol Myers Squibb, Saint-Laurent, QC., Smylie M; Cross Cancer Institute, Edmonton, AB.
Jazyk:	angličtina
Zdroj:	Current oncology (Toronto, Ont.) [Curr Oncol] 2020 Aug; Vol. 27 (4), pp. 204-214. Date of Electronic Publication: 2020 Aug 01.
DOI:	10.3747/co.27.5985
Abstrakt:	Background: The combination of nivolumab and ipilimumab is approved in several jurisdictions (United States, European Union, Canada) for the first-line treatment of patients with advanced melanoma. CheckMate 218 is a North American expanded-access program (eap) of nivolumab plus ipilimumab in patients with advanced melanoma. Here, we report safety and survival outcomes for the Canadian cohort in the eap. Methods: Eligible patients were those 18 years of age or older with unresectable stage iii or iv melanoma, an Eastern Cooperative Oncology Group performance status of 0 or 1, and no prior anti-PD-1 or anti-ctla-4 therapy. Patients were treated with nivolumab 1 mg/kg and ipilimumab 3 mg/kg every 3 weeks for 4 cycles (induction phase); they then continued with nivolumab 3 mg/kg every 2 weeks (maintenance phase) until progression, unacceptable toxicity, or a maximum of 48 weeks, whichever occurred first. Safety and overall survival (os) data were collected. Results: Of 194 patients enrolled, 174 were treated, and 51% continued on nivolumab maintenance. Median follow-up was 12.9 months. All-grade and grades 3-4 treatment-related adverse events were reported in 98% and 60% of patients respectively and led to treatment discontinuation in 40% and 28% of patients. Two treatment-related deaths were reported. The 12- and 18-month os rates were 80% [95% confidence interval (ci): 73% to 86%] and 76% (95% ci: 67% to 82%) respectively. Conclusions: In this Canadian population, nivolumab plus ipilimumab demonstrated a safety profile and survival outcomes consistent with phase ii and iii clinical trial data. Competing Interests: CONFLICT OF INTEREST DISCLOSURES We have read and understood Current Oncology’s policy on disclosing conflicts of interest, and we declare the following interests: DH reports personal fees for advisory board roles from Bristol Myers Squibb, emd Serono, Merck, Novartis, and Roche, and for a lecture role from Novartis. JGM reports personal fees for advisory board roles from Bristol Myers Squibb, Celgene, emd Serono, Merck, Novartis, and Roche, and grant funding from Merck. SE reports personal fees for advisory board roles from Bristol Myers Squibb, emd Serono, Merck, Novartis, and Sanofi. XS reports personal fees for advisory board roles from Bristol Myers Squibb, Merck, and Novartis, and has served as a research investigator for trials sponsored by Bristol Myers Squibb, Merck, Novartis, and Roche. EM reports personal fees for advisory board roles from Bristol Myers Squibb, Merck, Novartis, and Roche. KJS reports personal fees for advisory board roles from AbbVie, AstraZeneca, Bristol Myers Squibb, Merck, and Seattle Genetics; honoraria from AbbVie, AstraZeneca, Bristol Myers Squibb, Merck, Seattle Genetics, and Verastem; a consulting role with Servier; and institutional trial research funding from Bristol Myers Squibb, Merck, and Novartis. MS reports personal fees (honoraria) from Bristol Myers Squibb, emd Serono, Merck, and Novartis. BS and FR are employees of Bristol Myers Squibb. (2020 Multimed Inc.)
Databáze:	MEDLINE
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