RT Journal Article
T1 5-Year Outcomes with Cobimetinib plus Vemurafenib in BRAFV600 Mutation-Positive Advanced Melanoma: Extended Follow-up of the coBRIM Study.
A1 Ascierto, Paolo A
A1 Dréno, Brigitte
A1 Larkin, James
A1 Ribas, Antoni
A1 Liszkay, Gabriella
A1 Maio, Michele
A1 Mandalà, Mario
A1 Demidov, Lev
A1 Stroyakovskiy, Daniil
A1 Thomas, Luc
A1 de la Cruz-Merino, Luis
A1 Atkinson, Victoria
A1 Dutriaux, Caroline
A1 Garbe, Claus
A1 Hsu, Jessie
A1 Jones, Surai
A1 Li, Haocheng
A1 McKenna, Edward
A1 Voulgari, Athina
A1 McArthur, Grant A
AB The randomized phase III coBRIM study (NCT01689519) demonstrated improved progression-free survival (PFS) and overall survival (OS) with addition of cobimetinib to vemurafenib compared with vemurafenib in patients with previously untreated BRAFV600 mutation-positive advanced melanoma. We report long-term follow-up of coBRIM, with at least 5 years since the last patient was randomized. Eligible patients were randomized 1:1 to receive either oral cobimetinib (60 mg once daily on days 1-21 in each 28-day cycle) or placebo in combination with oral vemurafenib (960 mg twice daily). 495 patients were randomized to cobimetinib plus vemurafenib (n = 247) or placebo plus vemurafenib (n = 248). Median follow-up was 21.2 months for cobimetinib plus vemurafenib and 16.6 months for placebo plus vemurafenib. Median OS was 22.5 months (95% CI, 20.3-28.8) with cobimetinib plus vemurafenib and 17.4 months (95% CI, 15.0-19.8) with placebo plus vemurafenib; 5-year OS rates were 31% and 26%, respectively. Median PFS was 12.6 months (95% CI, 9.5-14.8) with cobimetinib plus vemurafenib and 7.2 months (95% CI, 5.6-7.5) with placebo plus vemurafenib; 5-year PFS rates were 14% and 10%, respectively. OS and PFS were longest in patients with normal baseline lactate dehydrogenase levels and low tumor burden, and in those achieving complete response. The safety profile remained consistent with previously published reports. Extended follow-up of coBRIM confirms the long-term clinical benefit and safety profile of cobimetinib plus vemurafenib compared with vemurafenib monotherapy in patients with BRAFV600 mutation-positive advanced melanoma.
YR 2021
FD 2021
LK https://hdl.handle.net/10668/27587
UL https://hdl.handle.net/10668/27587
LA en
DS RISalud
RD Apr 5, 2025