On February 23, 2023 Cantargia (Cantargia AB) (NASDAQ Stockholm: CANTA) reported favorable safety and promising early signs of efficacy following an initial analysis of the phase Ib part of the clinical trial TRIFOUR (Press release, Cantargia, FEB 23, 2023, View Source [SID1234627659]). In collaboration with the Spanish Breast Cancer Group (GEICAM), this trial investigates the IL1RAP-binding antibody nadunolimab (CAN04) in combination with chemotherapy for treatment of triple-negative breast cancer (TNBC). In 12 patients treated long enough for evaluation, the response rate was well above previously reported data for chemotherapy alone. The trial is now expanding into the randomized phase II part where the combination will be compared to a control group given chemotherapy only.
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TNBC is a difficult-to-treat disease which accounts for 10-15% of all breast cancer cases. To date, 15 first- or second-line patients with metastatic TNBC have been enrolled and treated in the dose-escalation part of the phase Ib/II trial TRIFOUR. In an early efficacy assessment based on 12 patients, one showed confirmed complete response, while five showed confirmed partial response, equaling a preliminary response rate of 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 showed an acceptable safety profile, in line with previous trials combining nadunolimab and chemotherapy. Notably, prophylactic use of G-CSF was incorporated to the study protocol to control neutropenia. TRIFOUR, which is conducted at 24 clinical sites in Spain, will immediately progress to the randomized phase II part, which may include up to 98 additional patients. An interim futility analysis is planned for Q4 2023. Data from the study are also planned for presentation in H2 2023.
"These initial results in triple-negative breast cancer are exciting for several reasons. Most importantly, they show an early signal of efficacy in line with our previous data in pancreatic cancer and non-small cell lung cancer, which further illustrates the magnitude of opportunities for nadunolimab. Based on these results, we look forward to immediately progressing into the controlled part of this trial, and continuing our fruitful collaboration with GEICAM," said Göran Forsberg, CEO of Cantargia.
"Triple-negative breast cancer is a very aggressive type of breast cancer with limited therapeutic options. The initial results from the TRIFOUR trial are very promising, and certainly warrant further investigation of nadunolimab in the subsequent, randomized, part of the study," said Dr. Agostina Stradella, medical oncologist, member of GEICAM, and Principal Investigator in TRIFOUR at the Catalan Institute of Oncology, Duran i Reynals Hospital.
Additionally, various biomarker analyses will be performed on patient samples collected in TRIFOUR. The FERO Foundation, a private Spanish entity dedicated to the promotion of cancer research, recently awarded GEICAM with a grant for a research project aiming to identify predictive markers of nadunolimab efficacy. This project will be based on TRIFOUR patient samples and provide further insights into the mechanisms behind the apparent synergy between nadunolimab and chemotherapy.