PSMA-targeting radioligand, Lutetium (177Lu) DGUL, is being studied in combination with an anti-PD-1 therapy (Keytruda) in patients with advanced prostate cancer. This trial is the first in Korea to assess radioligand therapy combined with an immune checkpoint inhibitor.

Following promising interim data from a phase 2 trial of Lu-177-DGUL, discussions with the partner led to the current joint clinical trial agreement.

The phase 1 trial will enroll about 30 taxane-naïve, treatment-resistant prostate cancer patients who will receive either Lu-177-DGUL alone or in combination with Keytruda, with safety as the primary endpoint and progression-free and overall survival as key secondary endpoints.

If successful, the collaboration between the two companies involved will accelerate development efforts and expand into a phase 2 combination study in the U.S.

Meanwhile, a separate phase 2 trial of Lu-177-DGUL in Korea is nearing completion, with final enrollment expected in the first half of the year and results anticipated by year-end.

Source.