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.

González-Martín, Antonio;Rubio, María Jesús;Heitz, Florian;Depont Christensen, René;Selle, Frédéric;et.al.
(2024) Journal of clinical oncology — Vol. 42, n° 36, p. 4294-4304 (2024)

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  • González-Martín, Antonioorcid-logo
    Author
  • Rubio, María Jesúsorcid-logo
    Author
  • Heitz, Florianorcid-logo
    Author
  • Depont Christensen, René
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  • Henry, Stéphanieorcid-logoUCLouvain
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  • Selle, Frédéric
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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.
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González-Martín, A., Rubio, M. J., Heitz, F., Depont Christensen, R., Colombo, N., Van Gorp, T., Romeo, M., Ray-Coquard, I., Gaba, L., Leary, A., De Sande, L. M., Lebreton, C., Redondo, A., Fabbro, M., Barretina Ginesta, M.-P., Follana, P., Pérez-Fidalgo, J. A., Rodrigues, M., Santaballa, A., et al. (2024). 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. Journal of clinical oncology, 42(36), 4294-4304. https://doi.org/10.1200/JCO.24.00668 (Original work published 2024)