“While the combined results, including the primary endpoint and subgroup analyses, indicate that the TRIFOUR study did not meet its objectives, we recognize the valuable insights gained from this trial,” said Hilde Steineger, CEO of Cantargia. “Although this is not the outcome we had hoped for, we remain confident in the strong potential of nadunolimab, particularly in pancreatic ductal adenocarcinoma (PDAC), where we see strong scientific rationale, robust data and significant opportunities for impact.”

“We view this outcome in TNBC as indication‑specific, not predictive and not translating to pancreatic or lung cancer, where the biology, standard of care, and heterogeneity of the TRIFOUR patient population differ significantly.” said Dr. Wolfram Dempke, Chief Medical Officer at Cantargia.

The Phase 1b/2 TRIFOUR trial, conducted by the Spanish Breast Cancer Group (GEICAM), randomized 99 metastatic TNBC patients eligible for first- or second-line GC treatment to receive either nadunolimab + GC (n=51) or GC alone (n=48). Nadunolimab (2.5 mg/kg) was administered twice per cycle.

The preliminary mOS was evaluated after 39 events had occurred in the 99 TNBC patients included in the efficacy analyses. Both the nadunolimab + GC and the chemotherapy arms achieved mOS of 26 months, substantially longer than expected for this patient population.

As previously reported, no difference was observed between the two study groups with regards to the primary endpoint of the TRIFOUR study – overall response rate (ORR). Although the trial was exploratory and not powered for statistical significance, no differences in efficacy were observed. Subgroup analyses have shown comparable outcomes across treatment groups. Based on these results, Cantargia will discontinue further development in TNBC.

Safety was in line with previous nadunolimab data, with neutropenia and asthenia being the most common adverse events and no significant safety differences between treatment groups, confirming that nadunolimab can be added to standard chemotherapy without increasing toxicity.

Since some patients in both groups continue to benefit from the study therapy, treatment and follow-up will continue for ethical reasons, although the overall assessment of the study is unlikely to change. Final TRIFOUR results will be communicated at an upcoming scientific conference and published in a peer-reviewed journal in due course.