Article ; Online: Phase 1b study of cobimetinib plus atezolizumab in patients with advanced BRAF
European journal of cancer (Oxford, England : 1990)
2022 Volume 178, Page(s) 180–190
Abstract: Objective: To evaluate the efficacy and safety of cobimetinib plus atezolizumab in the treatment of patients with advanced BRAF: Patients and methods: This phase 1b, open-label, international multicentre study enrolled 3 cohorts. Herein, we report on ...
| Abstract | Objective: To evaluate the efficacy and safety of cobimetinib plus atezolizumab in the treatment of patients with advanced BRAF Patients and methods: This phase 1b, open-label, international multicentre study enrolled 3 cohorts. Herein, we report on patients in cohorts A and B who had progressed on prior anti‒PD-1 therapy. Patients in cohort A received cobimetinib 60 mg once daily for 21 days followed by a 7-day break and concurrent intravenous atezolizumab 840 mg every 2 weeks. Patients in cohort B received the same dosing regimen as cohort A except for cycle 1 in which patients received cobimetinib only for the first 14 days prior to initiation of atezolizumab on cycle 1 day 15. Coprimary end-points were objective response rate and disease control rate. Secondary end-points were duration of response, progression free survival and overall survival. Results: Between 19th June 2017 and 12th December 2018, 103 patients were enrolled. Median follow-up was 6.9 months (interquartile range, 4.8-10.1 months); objective response rate was 14.6% and disease control rate was 38.8% (95% confidence interval, 29.39-48.94). The median duration of response, progression-free survival and overall survival was 12.7 months, 3.8 months and 14.7 months, respectively. The most common adverse events were diarrhoea (75/103; 72.8%), dermatitis acneiform (57/103; 55.3%) and nausea (52/103; 50.5%). Thirty-four patients (33.0%) died: 33 (91.7%) due to progressive disease and one (1%) due to treatment-related oesophagitis. Conclusions: Combination therapy with cobimetinib and atezolizumab in patients with advanced BRAF Clinical trial registration: This study is registered with ClinicalTrials.gov; NCT03178851. |
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| MeSH term(s) | Humans ; Proto-Oncogene Proteins B-raf/genetics ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Mutation ; Melanoma/drug therapy ; Melanoma/genetics |
| Chemical Substances | cobimetinib (ER29L26N1X) ; atezolizumab (52CMI0WC3Y) ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1) ; BRAF protein, human (EC 2.7.11.1) |
| Language | English |
| Publishing date | 2022-11-02 |
| Publishing country | England |
| Document type | Multicenter Study ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 82061-1 |
| ISSN | 1879-0852 ; 0277-5379 ; 0959-8049 ; 0964-1947 |
| ISSN (online) | 1879-0852 |
| ISSN | 0277-5379 ; 0959-8049 ; 0964-1947 |
| DOI | 10.1016/j.ejca.2022.10.019 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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