Neoadjuvant and adjuvant pembrolizumab in advanced high-grade serous carcinoma: the randomized phase II NeoPembrOV clinical trial

Isabelle L. Ray-Coquard (), Aude-Marie Savoye, Camille Schiffler, Marie-Ange Mouret-Reynier, Olfa Derbel, Elsa Kalbacher, Marianne LeHeurteur, Alejandra Martinez, Corina Cornila, Mathilde Martinez, Leila Bengrine Lefevre, Frank Priou, Nicolas Cloarec, Laurence Venat, Frédéric Selle, Dominique Berton, Olivier Collard, Elodie Coquan, Olivia Saux, Isabelle Treilleux, Sophie Gouerant, Antoine Angelergues, Florence Joly and Olivier Tredan
Additional contact information
Isabelle L. Ray-Coquard: University Claude Bernard
Aude-Marie Savoye: GINECO and Institut Jean Godinot
Camille Schiffler: University Claude Bernard
Marie-Ange Mouret-Reynier: Centre Jean Perrin
Olfa Derbel: Hôpital Privé Jean Mermoz
Elsa Kalbacher: GINECO and Centre Hospitalier Universitaire Jean Minjoz
Marianne LeHeurteur: Centre Henri-Becquerel
Alejandra Martinez: Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
Corina Cornila: GINECO and Centre Hospitalier Régional d’Orléans
Mathilde Martinez: GINECO and Clinique Pasteur
Leila Bengrine Lefevre: GINECO and Centre Georges-François Leclerc
Frank Priou: GINECO and Centre Hospitalier Départemental Vendée
Nicolas Cloarec: GINECO and Centre Hospitalier Henri Duffaut d’Avignon
Laurence Venat: GINECO and Centre Hospitalier Universitaire Dupuytren
Frédéric Selle: GINECO and Groupe Hospitalier Diaconesses Croix Saint-Simon
Dominique Berton: Centre René Gauducheau
Olivier Collard: GINECO and Institut de Cancérologie de la Loire
Elodie Coquan: Centre François Baclesse, University Caen Normandie
Olivia Saux: University Claude Bernard
Isabelle Treilleux: University Claude Bernard
Sophie Gouerant: Centre Henri-Becquerel
Antoine Angelergues: GINECO and Groupe Hospitalier Diaconesses Croix Saint-Simon
Florence Joly: Centre François Baclesse, University Caen Normandie
Olivier Tredan: Centre Léon Bérard

Nature Communications, 2024, vol. 15, issue 1, 1-11

Abstract: Abstract This open-label, non-comparative, 2:1 randomized, phase II trial (NCT03275506) in women with stage IIIC/IV high-grade serous carcinoma (HGSC) for whom upfront complete resection was unachievable assessed whether adding pembrolizumab (200 mg every 3 weeks) to standard-of-care carboplatin plus paclitaxel yielded a complete resection rate (CRR) of at least 50%. Postoperatively patients continued assigned treatment for a maximum of 2 years. Postoperative bevacizumab was optional. The primary endpoint was independently assessed CRR at interval debulking surgery. Secondary endpoints were Completeness of Cytoreduction Index (CCI) and peritoneal cancer index (PCI) scores, objective and best response rates, progression-free survival, overall survival, safety, postoperative morbidity, and pathological complete response. The CRR in 61 pembrolizumab-treated patients was 74% (one-sided 95% CI = 63%), exceeding the prespecified ≥50% threshold and meeting the primary objective. The CRR without pembrolizumab was 70% (one-sided 95% CI = 54%). In the remaining patients CCI scores were ≥3 in 27% of the standard-of-care group and 18% of the investigational group and CC1 in 3% of the investigational group. PCI score decreased by a mean of 9.6 in the standard-of-care group and 10.2 in the investigational group. Objective response rates were 60% and 72%, respectively, and best overall response rates were 83% and 90%, respectively. Progression-free survival was similar with the two regimens (median 20.8 versus 19.4 months in the standard-of-care versus investigational arms, respectively) but overall survival favored pembrolizumab-containing therapy (median 35.3 versus 49.8 months, respectively). The most common grade ≥3 adverse events with pembrolizumab-containing therapy were anemia during neoadjuvant therapy and infection/fever postoperatively. Pembrolizumab was discontinued prematurely because of adverse events in 23% of pembrolizumab-treated patients. Combining pembrolizumab with neoadjuvant chemotherapy is feasible for HGSC considered not completely resectable; observed activity in some subgroups justifies further evaluation to improve understanding of the role of immunotherapy in HGSC.

Date: 2024
References: View complete reference list from CitEc
Citations: View citations in EconPapers (1)

Downloads: (external link)
https://www.nature.com/articles/s41467-024-46999-x Abstract (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-46999-x

Ordering information: This journal article can be ordered from
https://www.nature.com/ncomms/

DOI: 10.1038/s41467-024-46999-x

Access Statistics for this article

Nature Communications is currently edited by Nathalie Le Bot, Enda Bergin and Fiona Gillespie

More articles in Nature Communications from Nature
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().