“We are very enthusiastic about the promising signals of nadunolimab clinical activity generated thus far and are looking forward to presenting our new data in triple-negative breast cancer at the ESMO Congress,” said Göran Forsberg, CEO of Cantargia.

In the phase Ib/II TRIFOUR trial, conducted in close collaboration with the Spanish Breast Cancer Group (GEICAM), 15 first- or second-line patients with metastatic TNBC have been treated in the initial dose-escalation stage. Among twelve patients evaluable for efficacy analysis, one showed confirmed complete response (CR) and five showed confirmed partial responses (PR), bringing a preliminary total response rate (RR) to 50%. This compares favorably to the historical response rate of approximately 30% reported for gemcitabine and carboplatin alone [1], the chemotherapy doublet used in combination with nadunolimab in the trial. Among the other six evaluated patients, four showed stable disease and two showed progressive disease. The combination was well tolerated, in line with previous trials combining nadunolimab and chemotherapy. Notably, prophylactic use of G-CSF was incorporated to the study protocol to control neutropenia.

The abstract can now be accessed at the ESMO Congress 2023 website (link) and is based on results obtained in connection with the press release issued on February 23, 2023. Additional and more mature data will be presented in a poster session at the conference; see more information below. At the time of presentation, the poster will also be made available at Cantargia’s webpage (link).

Abstract title: Phase Ib safety and efficacy of nadunolimab/gemcitabine/carboplatin (NadGC) in metastatic triple negative breast cancer (mTNBC)
Date and time: October 21, 2023, 12:00 – 1:00 PM CEST
Presenter: Dr. Sara López-Taruella

TRIFOUR, which is conducted at 24 clinical sites in Spain, has progressed to the randomized phase II part, which may include up to 98 additional patients.

References
[1] O’Shaughnessy, J Clin Oncol 2014, 32:3840-3847