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Introduction/Background Standard therapy for recurrent ovarian cancer (rOC) with a platinum-free interval (TFIp) >6 months includes PARPi maintenance if disease responds to platinum-based chemotherapy. ANITA (NCT03598270) evaluated combining atezolizumab with platinum-based chemotherapy and maintenance PARPi in this population. Methodology Eligible patients had measurable high-grade serous, endometrioid or undifferentiated rOC, ≤2 prior lines of chemotherapy (most recent including platinum) and TFIp >6 months. Prior PARPi for rOC and/or prior immune checkpoint inhibitor were prohibited. Patients were stratified by carboplatin doublet (paclitaxel, gemcitabine or PLD), TFIp (6–12 vs >12 months), BRCA status (mutated vs non-mutated) and PD-L1 status (PD-L1-expressing immune cells on Results Between November 2018 and January 2022, 417 patients were randomised (14% BRCA-mutated, 36% PD-L1-positive, 66% TFIp >12 months, 11% prior PARPi after front-line chemotherapy, 54% prior bevacizumab); most (71%) received carboplatin+PLD. At the data cut-off (15 April 2023), median follow-up was 36 months. PFS was not significantly improved with the addition of atezolizumab overall or in most subgroups (figure 1). Overall response rates (ORRs) were 45% (95% CI 39–52%) with atezolizumab+chemotherapy and 43% (95% CI 36–49%) with placebo+chemotherapy. In 306 patients (73%) who received maintenance, PFS from initiating maintenance numerically favoured atezolizumab+niraparib vs placebo+niraparib (hazard ratio 0.80, 95% CI 0.62–1.03; median 6.7 vs 5.3 months; not statistically significant). The safety profile was as expected from prior experience of these drugs. Conclusion Combining atezolizumab with chemotherapy and maintenance niraparib for late-relapsing rOC did not significantly improve PFS, ORR or maintenance PFS. Disclosures Study drug and funding for this investigator-initiated study are provided by F. Hoffmann-La Roche and GSK. AGM reports grants/research support from GSK, Roche, ISCiii and AECC, honoraria/consultation fees from Alkermes, Amgen, AstraZeneca, Clovis, Genmab, GSK, HederaDx, Immunogen, Kartos, Karyopharm, Illumina, Mersana, MSD, Novartis, Novocure, Oncoinvent, PharmaMar, Roche, SOTIO, SUTRO, Seagen, Takeda and Tubulis, and participation in company-sponsored speaker's bureau for AstraZeneca, Clovis, GSK, Immunogen, Mersana, MSD, Novocure, PharmaMar, Roche and Takeda. Disclosures for coauthors have been provided separately.
González‐Martín et al. (Fri,) studied this question.