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
Coleman, Robert L. (US Oncology Research)
Lorusso, Domenica (Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Roma, Itàlia))
Oaknin, Ana (Vall d'Hebron Institut d'Oncologia)
Cecere, Sabrina Chiara (Istituto Nazionale Tumori IRCCS Fondazione G. Pascale (Nàpols, Itàlia))
Denys, Hannelore (Universitair Ziekenhuis Gent)
Colombo, Nicoletta (University of Milan-Bicocca (Milan, Itàlia))
Van Gorp, Toon (UZ Leuven)
Konner, Jason A. (Memorial Sloan Kettering Cancer Center)
Marin, Margarita Romeo (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Harter, Philipp (KEM Kliniken Essen-Mitte (Alemanya))
Murphy, Conleth (Cancer Centre and Cancer Trials. Bon Secours Hospital Cork (Irlanda))
Wang, Yuemei (ImmunoGen Inc (Waltham, Estats Units d'Amèrica))
Esteves, Brooke (ImmunoGen Inc (Waltham, Estats Units d'Amèrica))
Method, Michael (ImmunoGen Inc (Waltham, Estats Units d'Amèrica))
Matulonis, Ursula (Dana-Farber Cancer Institute (Boston, Estats Units d'Amèrica))

Data:	2024
Resum:	Objective 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. Methods 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. Results 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. Conclusion These results support the clinically meaningful efficacy of mirvetuximab soravtansine-gynx in FRα-expressing platinum-resistant ovarian cancer, irrespective of prior treatment or sequence.
Nota:	The study was funded by ImmunoGen, Inc. and performed according to the principles of the Declaration of Helsinki, Good Clinical Practice guidelines of the International Council for Harmonisation, and local regulatory requirements. A central institutional review board (WCG WIRB; Approval Number: 20200077), along with an independent ethics committee at each investigative site, approved the protocol. All participants (or legally authorized representatives) provided written informed consent.
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Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	International Journal of Gynecological Cancer, Vol. 34 Núm. 8 (may 2024) , p. 1119-1125, ISSN 1525-1438

DOI: 10.1136/ijgc-2024-005401
PMID: 38858103

7 p, 641.6 KB

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