Phase II study of atezolizumab in combination with bevacizumab in patients with advanced cervical cancer. Issue 2 (1st October 2020)

• Record Type: Journal Article
• Authors: Friedman, Claire F; Snyder Charen, Alexandra; Zhou, Qin; Carducci, Michael A; Buckley De Meritens, Alexandre; Corr, Bradley R; Fu, Siqing; Hollmann, Travis J; Iasonos, Alexia; Konner, Jason A; Konstantinopoulos, Panagiotis A; Modesitt, Susan C; Sharon, Elad; Aghajanian, Carol; Zamarin, Dmitriy
• Is Part Of: Journal for immunotherapy of cancer. Volume 8:Issue 2(2020)
• Publication Date: 2020-10-01
• Subjects: tumor biomarkers -- programmed cell death 1 receptor -- genital neoplasms -- female -- drug therapy -- combination; Cancer -- Immunotherapy -- Periodicals; Cancer -- Immunological aspects -- Periodicals; Tumors -- Immunological aspects -- Periodicals; Immunotherapy -- Periodicals; 616.99406105
• DOI: 10.1136/jitc-2020-001126
• Languages: English
• ISSNs: 2051-1426

Abstract

Abstract : Background: There are limited treatment options for patients with metastatic or recurrent cervical cancer. Platinum-based chemotherapy plus the anti-vascular endothelial growth factor antibody bevacizumab remains the mainstay of advanced treatment. Pembrolizumab is Food and Drug Agency approved for programmed death ligand 1 (PD-L1) positive cervical cancer with a modest response rate. This is the first study to report the efficacy and safety of the PD-L1 antibody atezolizumab in combination with bevacizumab in advanced cervical cancer. Methods: We report the results from a phase II, open-label, multicenter study (NCT02921269 ). Patients with advanced cervical cancer were treated with bevacizumab 15 mg/kg intravenous every 3 weeks and atezolizumab 1200 mg intravenous every 3 weeks. The primary objective was to measure the objective response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: In the total evaluable population (n=10), zero patients achieved an objective response as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) V.1.1, resulting in a confirmed ORR of 0%. Of note, there were two patients who achieved an unconfirmed PR. The DCR by RECIST V.1.1 was 60% (0% complete response, 0% partial response, 60% stable disease). Median PFS was 2.9 months (95% CI, 1.8 to 6) and median OS was 8.9 months (95% CI, 3.4 to 21.9). Safety results were generally consistent with the known safety profile of both drugs, notably with two high-grade neurologic events. Conclusions: The combination of bevacizumab and atezolizumab did not meet the predefined efficacy endpoint, as addition of bevacizumab to PD-L1 blockade did not appear to enhance the ORR in cervical cancer.