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

• Published in: Journal of clinical oncology p. JCO2400668
• Main Authors: González-Martín, Antonio, Rubio, María Jesús, Heitz, Florian, Depont Christensen, René, Colombo, Nicoletta, Van Gorp, Toon, Romeo, Margarita, Ray-Coquard, Isabelle, Gaba, Lydia, Leary, Alexandra, De Sande, Luis Miguel, Lebreton, Coriolan, Redondo, Andrés, Fabbro, Michel, Barretina Ginesta, Maria-Pilar, Follana, Philippe, Pérez-Fidalgo, J Alejandro, Rodrigues, Manuel, Santaballa, Ana, Sabatier, Renaud, Bermejo-Pérez, Maria José, Lotz, Jean-Pierre, Pardo, Beatriz, Marquina, Gloria, Sánchez-Lorenzo, Luisa, Quindós, María, Estévez-García, Purificación, Guerra Alía, Eva, Manso, Luis, Casado, Victoria, Kommoss, Stefan, Tognon, Germana, Henry, Stéphanie, Bruchim, Ilan, Oaknin, Ana, Selle, Frédéric
• Format: Journal Article
• Language: English
• Published: United States 18-09-2024
• ISSN: 0732-183X; 1527-7755; 1527-7755
• DOI: 10.1200/JCO.24.00668

To evaluate atezolizumab combined with platinum-based chemotherapy (CT) followed by maintenance niraparib for late-relapsing recurrent ovarian cancer.
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,
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.
Between November 2018 and January 2022, 417 patients were randomly assigned (15%
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];
= .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.
Combining atezolizumab with CT and maintenance niraparib for late-relapsing recurrent ovarian cancer did not significantly improve PFS or the ORR.