Maintenance olaparib after platinum-based chemotherapy for advanced/metastatic endometrial cancer: GINECO randomized phase IIb UTOLA trial

Florence Joly (), Alexandra Leary, Isabelle Ray-Coquard, Bernard Asselain, Manuel Rodrigues, Laurence Gladieff, Guillaume Meynard, Sophie Abadie-Lacourtoisie, Coriolan Lebreton, Leïla Bengrine Lefevre, Pierre Fournel, Rémy Largillier, Frédéric Selle, Jean-Sébastian Frenel, Yolanda Fernandez Diez, Cyril Foa, Philippe Follana, Jérôme Meunier, Michel Fabbro, Anne-Claire Hardy Bessard, Isabelle Cojean-Zelek, Emilie Kaczmarek, Elise Bonnet, Antoine Arnaud, Sophie Roche, Karen Leroy, Pierre-Alexandre Just, Raphaël Leman, Corinne Jeanne, Céline Callens, Benoit You and Jérôme Alexandre
Additional contact information
Florence Joly: UniCaen University
Alexandra Leary: Gustave Roussy
Isabelle Ray-Coquard: Centre Léon Bérard and University of Lyon
Bernard Asselain: ARCAGY-GINECO
Manuel Rodrigues: lnstitut Curie
Laurence Gladieff: IUCT Oncopole
Guillaume Meynard: CHRU Besançon – Hôpital Jean Minjoz
Sophie Abadie-Lacourtoisie: lnstitut de Cancérologie de l’Ouest (ICO) – Site Paul Papin
Coriolan Lebreton: lnstitut Bergonié
Leïla Bengrine Lefevre: Centre Georges-François Leclerc
Pierre Fournel: Pôle de Cancérologie
Rémy Largillier: Centre Azuréen de Cancérologie
Frédéric Selle: Groupe Hospitalier Diaconesses Croix Saint-Simon
Jean-Sébastian Frenel: ICO – Site René Gauducheau
Yolanda Fernandez Diez: lnstitut de Cancérologie de Lorraine – Centre Alexis Vautrin
Cyril Foa: Hôpital Saint-Joseph
Philippe Follana: Centre Antoine Lacassagne
Jérôme Meunier: Centre Hospitalier Régional d’Orléans
Michel Fabbro: Val d’Aurelle
Anne-Claire Hardy Bessard: Centre CARIO – HPCA
Isabelle Cojean-Zelek: Centre Hospitalier Intercommunal de Créteil
Emilie Kaczmarek: Centre Oscar Lambret
Elise Bonnet: Groupe Hospitalier Mutualiste de Grenoble
Antoine Arnaud: Institut du Cancer Avignon-Provence
Sophie Roche: Institut Inter-Régional de Cancérologie – Centre Jean Bernard
Karen Leroy: Hôpital Européen Georges Pompidou
Pierre-Alexandre Just: Hôpital Cochin
Raphaël Leman: Centre François Baclesse
Corinne Jeanne: Centre François Baclesse
Céline Callens: Institut Curie
Benoit You: University Lyon 1
Jérôme Alexandre: Cochin Port-Royal

Nature Communications, 2025, vol. 16, issue 1, 1-11

Abstract: Abstract Single-agent maintenance poly(ADP-ribose) polymerase (PARP) inhibition may represent an effective strategy in patients with advanced/metastatic endometrial cancer responding to platinum-based chemotherapy, including for molecular subtypes with suboptimal options. To explore this approach, we initiated the randomized phase IIb UTOLA trial (NCT03745950). Female patients without progression following front-line platinum-based chemotherapy for advanced/metastatic endometrial cancer were randomized 2:1 to twice-daily maintenance oral olaparib 300 mg or placebo until progression or intolerance, stratified by p53 status, mismatch repair status, and response to initial chemotherapy. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. Secondary endpoints were PFS in subgroups, time to second progression or death, time to first and second subsequent therapy, objective response rate, overall survival, patient-reported outcomes, and safety. In the intention-to-treat population (n = 145), there was no PFS difference between olaparib and placebo (median 5.6 vs. 4.0 months, respectively; hazard ratio 0.94, 95% confidence interval 0.65–1.35; p = 0.74). However, intriguing numerical PFS effects were observed in exploratory analyses of pre-specified subgroups (p53-abnormal, complete response to initial chemotherapy, chromosomal instability). There was no overall survival difference between treatments. Grade 3/4 adverse events occurred in 36% versus 10% of olaparib- versus placebo-treated patients and were consistent with the olaparib safety profile in other cancers. Maintenance olaparib did not improve PFS, but promising numerical effects in subsets of patients warrant prospective evaluation.

Date: 2025
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DOI: 10.1038/s41467-025-62678-x

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