Mirvetuximab soravtansine in folate receptor alpha (FRa)-high platinum-resistant ovarian cancer: final overall survival and post hoc sequence of therapy subgroup results from the SORAYA trial
Por:
Coleman, RL, Lorusso, D, Oaknin, A, Cecere, SC, Denys, H, Colombo, N, van Gorp, T, Konner, JA, Marin, MR, Harter, P, Murphy, C, Wang, YM, Esteves, B, Method, M and Matulonis, U
Publicada:
1 ago 2024
Ahead of Print:
1 jun 2024
Resumen:
Objective The single-arm, phase II SORAYA trial (NCT04296890) of mirvetuximab soravtansine-gynx in folate receptor alpha (FR alpha)-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 FR alpha 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 FR alpha-expressing platinum-resistant ovarian cancer, irrespective of prior treatment or sequence.
Filiaciones:
Coleman, RL:
US Oncol Res, Texas Oncol, The Woodlands, TX 77380 USA
Lorusso, D:
Fdn Policlin Univ Agostino Gemelli IRCCS, Rome, Italy
Oaknin, A:
Vall dHebron Inst Oncol, Gynaecol Canc Programme, Barcelona, Spain
Cecere, SC:
Ist Nazl Tumori IRCCS Fdn Pascale, Dept Expt Urogynecol Oncol, Naples, Italy
Denys, H:
Ghent Univ Hosp, Ghent, Belgium
Colombo, N:
European Inst Oncol IRCCS Lib, Milan, Italy
Univ Milano Bicocca, Milan, Italy
van Gorp, T:
Univ Hosp Leuven, Leuven Canc Inst, Leuven, Belgium
Konner, JA:
Mem Sloan Kettering Canc Ctr, New York, NY USA
:
Hosp Badalona Germans Trias & Pujol, Inst Catala Oncol, Badalona, Spain
Harter, P:
KEM Kliniken Essen Mitte, Essen, Germany
Murphy, C:
Bon Secours Hosp Cork, Canc Ctr & Canc Trials, Cork, Ireland
Wang, YM:
ImmunoGen Inc, Waltham, MA USA
Esteves, B:
ImmunoGen Inc, Waltham, MA USA
Method, M:
ImmunoGen Inc, Waltham, MA USA
Matulonis, U:
Dana Farber Canc Inst, Boston, MA USA
hybrid, Green Published
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