Paclitaxel plus carboplatin and durvalumab with or without oleclumab for women with previously untreated locally advanced or metastatic triple-negative breast cancer: the randomized SYNERGY phase I/II trial

Laurence Buisseret (), Delphine Loirat, Philippe Aftimos, Christian Maurer, Kevin Punie, Véronique Debien, Paulus Kristanto, Daniel Eiger, Anthony Goncalves, François Ghiringhelli, Donatienne Taylor, Florent Clatot, Tom Mooter, Jean-Marc Ferrero, Hervé Bonnefoi, Jean-Luc Canon, Francois P. Duhoux, Laura Mansi, Renaud Poncin, Philippe Barthélémy, Nicolas Isambert, Zoë Denis, Xavier Catteau, Roberto Salgado, Elisa Agostinetto, Evandro Azambuja, Françoise Rothé, Ligia Craciun, David Venet, Emanuela Romano, John Stagg, Marianne Paesmans, Denis Larsimont, Christos Sotiriou, Michail Ignatiadis and Martine Piccart-Gebhart
Additional contact information
Laurence Buisseret: Institut Jules Bordet
Delphine Loirat: Institut Curie
Philippe Aftimos: Institut Jules Bordet
Christian Maurer: University of Cologne
Kevin Punie: University Hospitals Leuven
Véronique Debien: Institut Jules Bordet
Paulus Kristanto: Institut Jules Bordet
Daniel Eiger: Institut Jules Bordet
Anthony Goncalves: Institut Paoli-Calmettes
François Ghiringhelli: Centre Georges-François Leclerc
Donatienne Taylor: CHU-UCL-Namur - Site Sainte-Elisabeth
Florent Clatot: Centre Henri Becquerel
Tom Mooter: GZA Ziekenhuizen Campus Sint-Augustinus
Jean-Marc Ferrero: Centre Antoine Lacassagne
Hervé Bonnefoi: Institut Bergonié
Jean-Luc Canon: Grand Hôpital de Charleroi - Site Notre Dame
Francois P. Duhoux: Cliniques Universitaires Saint-Luc (UCLouvain)
Laura Mansi: CHU Besançon - Hôpital Jean Minjoz
Renaud Poncin: Clinique Saint-Pierre
Philippe Barthélémy: Institut de Cancérologie Strasbourg Europe (ICANS)
Nicolas Isambert: CHU Poitiers
Zoë Denis: Institut Jules Bordet
Xavier Catteau: CurePath Laboratory (CHU Tivoli, CHIREC)
Roberto Salgado: GZA-ZNA Hospitals
Elisa Agostinetto: Institut Jules Bordet
Evandro Azambuja: Institut Jules Bordet
Françoise Rothé: Institut Jules Bordet
Ligia Craciun: Institut Jules Bordet
David Venet: Institut Jules Bordet
Emanuela Romano: PSL Research University
John Stagg: Faculté de Pharmacie et Institut du Cancer de Montréal
Marianne Paesmans: Institut Jules Bordet
Denis Larsimont: Institut Jules Bordet
Christos Sotiriou: Institut Jules Bordet
Michail Ignatiadis: Institut Jules Bordet
Martine Piccart-Gebhart: Institut Jules Bordet

Nature Communications, 2023, vol. 14, issue 1, 1-15

Abstract: Abstract Chemo-immunotherapy is the first-line standard of care for patients with PD-L1 positive metastatic triple-negative breast cancer (mTNBC). SYNERGY (NCT03616886) is a dose-finding phase I and a randomized phase II, open-label trial evaluating if targeting the immunosuppressive adenosine pathway can enhance the antitumor activity of chemo-immunotherapy. The phase I part included 6 patients with untreated locally-advanced or mTNBC to determine the safety and recommended phase II dose of the anti-CD73 antibody oleclumab in combination with the anti-PD-L1 durvalumab and 12 cycles of weekly carboplatin and paclitaxel. In the phase II part, 127 women were randomized 1:1 to receive chemo-immunotherapy, with (arm A) or without (arm B) oleclumab. The primary endpoint was the clinical benefit rate at week 24, defined as stable disease, partial or complete response per RECIST v1.1. Secondary endpoints included objective response rate, duration of response, survival outcomes (progression-free survival and overall survival), and safety. The trial did not meet its primary endpoint, as the 24-week clinical benefit rate was not significantly improved by adding oleclumab (43% vs. 44%, p = 0.61). Exploratory median progression-free survival was 5.9 months in arm A as compared to 7.0 months in arm B (p = 0.90). The safety profile was manageable in both arms.

Date: 2023
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DOI: 10.1038/s41467-023-42744-y

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