New HER3-Targeted Therapy Shows Potential for Resistant Tumors

A novel antibody-drug conjugate, DB-1310, has demonstrated early effectiveness in patients suffering from advanced solid tumors that have proven resistant to conventional therapies. This is particularly evident in individuals with EGFR-mutant non-small cell lung cancer (NSCLC), as reported from a significant international clinical trial led by researchers at UCLA Health Jonsson Comprehensive Cancer Center.

Findings from the study will be presented at the annual conference of the American Society of Clinical Oncology. The clinical trial results indicate that among patients diagnosed with EGFR-mutant NSCLC, 44% experienced considerable tumor shrinkage. The treatment also managed to delay cancer progression for an average of seven months, contributing to a median overall survival rate of 18.9 months for this group. In total, 31% of participants across all cancer types in the trial responded positively to the treatment, with a median overall survival of 14.4 months.

The side effects associated with DB-1310 were largely manageable, with the most frequently reported issues being low blood counts and nausea. The lead investigator noted that this Phase 1/2a trial highlights the potential for DB-1310 as a viable new treatment option for patients with advanced solid tumors who have exhausted standard therapies.

DB-1310 functions as an antibody-drug conjugate, which is a therapeutic approach that directs a potent chemotherapy agent precisely to cancer cells, thereby minimizing harm to healthy tissues. The medication combines a specially engineered antibody that targets HER3, a protein commonly present on the surface of many cancer cells, with a powerful cytotoxic drug.

By facilitating direct delivery of the chemotherapy to cancerous cells, DB-1310 aims to enhance the precision of treatment while reducing the adverse effects associated with traditional chemotherapy methods. Enrollment for the study continues, with 172 patients who had previously undergone several rounds of standard treatments included in the cohort at the time of the data analysis. Among these, 108 had NSCLC, with 62 being diagnosed with the EGFR mutation. Additionally, 24 participants had brain metastases.

The ongoing Phase 1 segment of this first-in-human trial is focused on evaluating the intravenous application of DB-1310 every three weeks at varying dosage levels to determine both safety and efficacy. The subsequent Phase 2 segment will assess the drug's effectiveness across more diverse tumor types.

Researchers express optimism regarding these findings, especially for patients with EGFR-mutant lung cancer who often have limited treatment alternatives after the failure of standard therapies. While larger studies are necessary to further validate these results, the preliminary data suggests that DB-1310 may represent a promising new therapeutic strategy for individuals battling advanced solid tumors.

The study was funded by Duality Biologics.