Mirvetuximab soravtansine in folate receptor alpha (FRα)-high platinum-resistant ovarian cancer: final overall survival and post hoc sequence of therapy subgroup results from the SORAYA trial.

The single-arm, phase II SORAYA trial (NCT04296890) of mirvetuximab soravtansine-gynx in folate receptor alpha (FRα)-high platinum-resistant ovarian cancer (n=105 (efficacy-evaluable)) met its primary endpoint with an objective response rate of 32.4% (95% CI, 23.6 to 42.2). Here we report final SORAYA trial results for overall survival and post hoc objective response rates in subgroups by sequence and number of prior therapies. Eligible patients had high-grade serous platinum-resistant ovarian cancer with high FRα expression and one to three prior therapies (prior bevacizumab required). Enrolled participants received 6 mg/kg mirvetuximab soravtansine-gynx adjusted ideal body weight intravenously once every 3 weeks until progressive disease, unacceptable toxicity, withdrawal of consent, or death. Final overall survival and post hoc objective response rates were assessed in efficacy-evaluable participants. The safety population included all patients who received ≥1 dose of mirvetuximab soravtansine-gynx. At data cut-off (December 22, 2022; n=105), final median overall survival was 15.0 months (95% CI, 11.5 to 18.7). Median overall survival in participants with one to two prior therapy lines was 18.7 months (95% CI, 13.8 to not estimable (NE)) and 11.6 months (95% CI, 7.1 to 16.7) with three prior therapy lines. Median overall survival was 15.0 months (95% CI, 11.5 to NE) in participants with prior poly (ADP-ribose) polymerase inhibitor (PARPi) treatment versus 14.0 months (95% CI, 7.1 to NE) in those without. Objective response rate (data cut-off: November 17, 2021) differed among participants who received mirvetuximab soravtansine-gynx as their first treatment in the platinum-resistant setting (34.8%; 95% CI, 23.5 to 47.6) versus a different first treatment (28.2%; 95% CI, 15.0 to 44.9) or had received prior bevacizumab in a platinum-sensitive (34.0%; 95% CI, 24.6 to 44.5) versus platinum-resistant setting (17.6%; 95% CI, 3.8 to 43.4). No new safety signals were observed. These results support the clinically meaningful efficacy of mirvetuximab soravtansine-gynx in FRα-expressing platinum-resistant ovarian cancer, irrespective of prior treatment or sequence.

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Competing interests: RLC: Research funding and consulting or advisory fees: AstraZeneca/MedImmune, Clovis Oncology. Consulting and advisory fees: Genentech/Roche, Genmab, Tesaro, OncoMed, Sotio, Oncolytics, AbbVie/Stemcentrx, ImmunoGen, AbbVie, Agenus, Novocure, Merck, OncXerna Therapeutics, Alkermes, Gradalis, Regeneron. Research funding: AstraZeneca, Merck, Roche/Genentech, Abbott/AbbVie, ImmunoGen. DL: Research funding and consulting or advisory fees: PharmaMar, Clovis Oncology, GSK, MSD, AstraZeneca, Amgen, Seagen/Genmab, Sutro, ImmunoGen, Merck Serono. Research funding: Clovis, Incyte, Novartis, Roche, Concept. AO: Research funding and consulting or advisory fees: Clovis Oncology, Eisai Limited, F. Hoffmann-La Roche. Consulting or advisory fees: Roche, AstraZeneca, PharmaMar, Tesaro, ImmunoGen, Genmab, Mersana Therapeutic, GSK, Deciphera Pharmaceutical, AGENUS, Corcept Therapeutics, Eisai, EMD Serono, Got It Consulting, KL Logistics, Medison Pharma, Merck Sharp & Dohme, Novocure, prIME Oncology, Sattucklabs, Sutro Biopharma, iTheos. Research funding: AbbVie Deutschland, Ability Pharmaceuticals, Advaxis Inc., Aeterna Zentaris, AMGEM, SA, Aprea Therapeutics, AB, Regeneron Pharmaceuticals. SCC: Research funding and consulting or advisory fees: Roche, Pfizer. Consulting or advisory fees: PharmaMar, Tesaro, Clovis Oncology. Research funding: AstraZeneca, MSD. HD: Consulting or advisory fees: Pfizer, Roche, PharmaMar, AstraZeneca, Eli Lilly and Company, Novartis, Amgen, GSK, MSD, Seagen, and Gilead. Travel, accommodations, expenses: Pfizer, Roche, PharmaMar, Teva, AstraZeneca, MSD, GSK and Gilead. Research grant: Gilead. All payments institutional. NC: Consulting or advisory fees: Roche/Genentech, AstraZeneca, Clovis Oncology, Pfizer, MSD Oncology, Tesaro, GSK, ImmunoGen, Pfizer, Mersana, Eisai, Advaxis. TvG: Consulting or advisory fees: AstraZeneca, BioNTech SE, Eisai, GSK, ImmunoGen, Incyte, MSD/Merck, OncXerna Therapeutics, Seagen, and Tubulis. Travel, accommodations, and/or expenses: AstraZeneca, GSK, ImmunoGen, MSD/Merck, and PharmaMar. Research funding: Amgen, Roche, and AstraZeneca. All payments institutional. JAK: Consulting or advisory fees: AstraZeneca, Clovis Oncology. Research funding: ImmunoGen. MRM: Consulting or advisory fees: Tesaro/Glaxo, AstraZeneca, Roche, Eisai, Pfizer. PH: Honoraria: Amgen, AstraZeneca, GSK, Roche, Sotio, Stryker, Zai Lab, MSD, Clovis, Eisai, Mersana, Exscientia. Advisory Board: AstraZeneca, Roche, GSK, Clovis, ImmunoGen, MSD, Miltenyi, Novartis, Eisai. Institutional research funding: AstraZeneca, Roche, GSK, Genmab, DFG, European Union, DKH, ImmunoGen, Seagen, Clovis Oncology, Novartis. CM: Honoraria: Janssen Pharmaceuticals. Travel, accommodations, and/or expenses: Pfizer, Inc., Bayer AG. YW: ImmunoGen employee. BE: ImmunoGen employee. MM: ImmunoGen employee. UM: Consulting or advisory fees: NextCure, Allarity, Ovarian Cancer Research Alliance, Pfizer, Profound Bio, Eisai, CureLab, ImmunoGen, Trillium, Agenus, Novartis, Boehringer Ingelheim. Participation in a Data Safety Monitoring Board: Alkermes, Symphogen. Speakers Bureau: Med Learning Group.