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.

Autores de IIS La Fe

• Ana Santaballa Bertrán

  Autor

Participantes ajenos a IIS La Fe

• Gonzalez-Martin, Antonio
• Rubio, Maria Jesus
• Heitz, Florian
• Depont Christensen, Rene
• Colombo, Nicoletta
• Van Gorp, Toon
• Romeo, Margarita
• Ray-Coquard, Isabelle
• Gaba, Lydia
• Leary, Alexandra
• De Sande, Luis Miguel
• Lebreton, Coriolan
• Redondo, Andres
• Fabbro, Michel
• Barretina Ginesta, Maria-Pilar
• Follana, Philippe
• Perez-Fidalgo, J Alejandro
• Rodrigues, Manuel
• Sabatier, Renaud
• Bermejo-Perez, Maria Jose
• Lotz, Jean-Pierre
• Pardo, Beatriz
• Marquina, Gloria
• Sanchez-Lorenzo, Luisa
• Quindos, Maria
• Estevez-Garcia, Purificacion
• Guerra Alia, Eva
• Manso, Luis
• Casado, Victoria
• Kommoss, Stefan
• Tognon, Germana
• Henry, Stephanie
• Bruchim, Ilan
• Oaknin, Ana
• Selle, Frederic

Grupos

• Grupo de Investigación en tumores ginecológicos, cáncer de mama y cáncer hereditario.

  Investigador Principal

  Víctor Lago Leal

Abstract

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.

Keywords

• DOUBLE-BLIND; THERAPY; CHEMOTHERAPY