Cantargia has announced preliminary topline efficacy results from the Phase 2 TRIFOUR trial, which evaluated nadunolimab in patients with advanced triple-negative breast cancer (TNBC).

The TRIFOUR trial, conducted by the Spanish Breast Cancer Group (GEICAM), is an exploratory Phase 1b/2 study aimed at assessing early efficacy signals of nadunolimab, a drug targeting IL1RAP, with unconfirmed ORR as the primary endpoint.

In the Phase 1b portion, 15 patients showed a promising 73% unconfirmed ORR, with a confirmed ORR of 60% in metastatic TNBC, indicating strong early efficacy signals.

The Phase 2 part involved 99 patients, with 51 receiving nadunolimab plus chemotherapy (carboplatin and gemcitabine) and 48 receiving chemotherapy alone, with treatment cycles lasting 3 to 4 weeks and evaluated using RECIST 1.1 criteria.

The preliminary efficacy results from the trial exceeded the historical response rate of approximately 30% for chemotherapy alone, suggesting potential benefit from nadunolimab.

The combination of nadunolimab with chemotherapy demonstrated an overall response rate of 40%, similar to the 43% response rate observed with chemotherapy alone, indicating no significant improvement in ORR.

Safety assessments showed that nadunolimab was well tolerated, with common side effects like neutropenia and asthenia, and no significant safety differences between treatment groups.

Cantargia’s interim CEO, Damian Marron, noted that although the Phase 2 ORR results did not match the promising results from Phase 1b, the company is awaiting further analyses and mature survival data to better understand the drug’s efficacy.

Nadunolimab has been tested in over 300 patients across various metastatic cancers and has received FDA Fast Track designation for pancreatic cancer patients with high IL1RAP expression, with ongoing testing in other indications.

Dr. Eva Carrasco, CEO of GEICAM, emphasized the importance of exploring new treatments for TNBC, which is known for its high unmet medical need, and expressed anticipation for further data analyses.

Results from the TRIFOUR study will be discussed at an upcoming scientific conference, and Cantargia plans to further develop nadunolimab following recent agreements.

The initial Phase 1b results showed a promising 73% unconfirmed ORR among first- and second-line metastatic TNBC patients, highlighting early efficacy signals in earlier treatment lines.