On June 22, 2026 PharmaMar (MSE: PHM) reported the enrollment of the first patient in its Phase 1/2 clinical trial evaluating PM54 in combination with pembrolizumab for the treatment of patients with advanced-stage solid tumors. The study, for which the IND application was cleared by the FDA in December 2025, is designed to assess the safety, tolerability, and preliminary efficacy of this combination therapy in patients with previously treated advanced malignancies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The primary objectives of the study include the evaluation of the safety and tolerability of PM54 in combination with pembrolizumab and to establish the recommended dose, as well as the assessment of the antitumor activity, in terms of clinical benefit rate (CBR) and objective response rate (ORR) based on investigator evaluation. The study includes patients with tumors characterized by significant unmet medical needs, including advanced-stage melanoma, endometrial cancer, extrapulmonary neuroendocrine tumors and mesothelioma.

For more information on the study, please visit clinicaltrials.gov

PM54 in combination with pembrolizumab is intended to enhance antitumor immune responses and provide a potential new treatment option for patients with advanced-stage solid tumors.

(Press release, PharmaMar, JUN 22, 2026, View Source [SID1234668856])