Scientific publications
Atezolizumab Combined With Platinum and Maintenance Niraparib for Recurrent Ovarian Cancer With a Platinum-Free Interval >6 Months: ENGOT-OV41/GEICO 69-O/ANITA Phase III Trial. Scientific Publication
Antonio González-Martín 1 2 , María Jesús Rubio 2 3 , Florian Heitz 4 5 6 , René Depont Christensen 2 , Nicoletta Colombo 7 8 9 , Toon Van Gorp 10 11 , Margarita Romeo 12 13 , Isabelle Ray-Coquard 13 14 , Lydia Gaba 2 15 , Alexandra Leary 14 16 , Luis Miguel De Sande 2 17 , Coriolan Lebreton 14 18 , Andrés Redondo 2 19 , Michel Fabbro 14 20 , Maria-Pilar Barretina Ginesta 2 21 , Philippe Follana 14 22 , J Alejandro Pérez-Fidalgo 2 23 , Manuel Rodrigues 14 24 , Ana Santaballa 2 25 , Renaud Sabatier 14 26 , Maria José Bermejo-Pérez 2 27 , Jean-Pierre Lotz 14 28 , Beatriz Pardo 2 29 , Gloria Marquina 2 30 , Luisa Sánchez-Lorenzo 2 31 , María Quindós 2 32 , Purificación Estévez-García 2 33 , Eva Guerra Alía 2 34 , Luis Manso 2 35 , Victoria Casado 2 36 , Stefan Kommoss 6 37 38 , Germana Tognon 9 39 , Stéphanie Henry 11 40 , Ilan Bruchim 41 42 , Ana Oaknin 2 43 , Frédéric Selle 14 44
Purpose: To evaluate atezolizumab combined with platinum-based chemotherapy (CT) followed by maintenance niraparib for late-relapsing recurrent ovarian cancer.
Methods: The multicenter placebo-controlled double-blind randomized phase III ENGOT-OV41/GEICO 69-O/ANITA trial (ClinicalTrials.gov identifier: NCT03598270) enrolled patients with measurable high-grade serous, endometrioid, or undifferentiated recurrent ovarian cancer who had received one or two previous CT lines (most recent including platinum) and had a treatment-free interval since last platinum (TFIp) of >6 months. Patients were stratified by investigator-selected carboplatin doublet, TFIp, BRCA status, and PD-L1 status in de novo biopsy and randomly assigned 1:1 to receive either atezolizumab or placebo throughout standard therapy comprising six cycles of a carboplatin doublet followed (in patients with response/stable disease) by maintenance niraparib until progression. The primary end point was investigator-assessed progression-free survival (PFS) per RECIST v1.1.
Results: Between November 2018 and January 2022, 417 patients were randomly assigned (15% BRCA-mutated, 36% PD-L1-positive, 66% TFIp >12 months, 11% previous poly [ADP-ribose] polymerase inhibitor after frontline CT, and 53% previous bevacizumab). Median follow-up was 28.6 months (95% CI, 26.6 to 30.5 months). Atezolizumab did not significantly improve PFS (hazard ratio, 0.89 [95% CI, 0.71 to 1.10]; P = .28). Median PFS was 11.2 months (95% CI, 10.1 to 12.1 months) with atezolizumab versus 10.1 months (95% CI, 9.2 to 11.2 months) with standard therapy. Subgroup analyses generally showed consistent results, including analyses by PD-L1 status. The objective response rate (ORR) was 45% (95% CI, 39 to 52) with atezolizumab and 43% (95% CI, 36 to 49) with standard therapy. The safety profile was as expected from previous experience of these drugs.
Conclusion: Combining atezolizumab with CT and maintenance niraparib for late-relapsing recurrent ovarian cancer did not significantly improve PFS or the ORR.
CITATION J Clin Oncol. 2024 Sep 18:JCO2400668. doi: 10.1200/JCO.24.00668
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