pharm edaily

[Yu Jin-hee, Edaily Reporter]SEOUL, South Korea-Cellbion announced Thursday that its investigational prostate cancer therapy 177Lu-DGUL demonstrated both efficacy and safety in a phase 2 clinical trial, paving the way for a conditional approval filing later this year.



The trial enrolled 91 patients with progressive prostate cancer unresponsive to existing treatments. Of these, 78 patients who received at least one dose and were evaluable for tumor response were included in the efficacy analysis. An independent imaging review committee assessed outcomes using RECIST v1.1 (Response Evaluation Criteria in Solid Tumors), PCWG-modified RECIST v1.1 (Prostate Cancer Working Group) and mPERCIST (modified PET Response Criteria in Solid Tumors).

According to the analysis, the objective response rate (ORR) under RECIST v1.1 reached 35.9 percent (28 patients). Complete responses (CR) were observed in 8.97 percent of patients and partial responses (PR) in 26.9 percent. The results exceeded those of the global phase 3 VISION study, in which Novartis’ Pluvicto combined with standard of care achieved an ORR of 29.8 percent (CR 6.8 percent, PR 23.0 percent). Cellbion emphasized that despite the stricter criteria of its single-arm phase 2 study, the therapy produced favorable outcomes.

Safety findings also underscored the treatment’s potential. Xerostomia (dry mouth), a common adverse event with PSMA-targeted therapies, was reported in 13.2 percent (12 patients), significantly lower than the 38.8 percent incidence in the VISION study.

Additional measures confirmed efficacy. The ORR by PCWG-modified RECIST v1.1 was 41.0 percent (32 patients). Using PET/CT scans under the mPERCIST criteria, 81.7 percent (58 patients) achieved either a complete metabolic response (CMR) or partial metabolic response (PMR).

A Cellbion official said, “Based on the results from this phase 2 study, we plan to receive the final clinical study report (CSR) in the fourth quarter and apply for conditional approval. We are committed to delivering a new treatment option swiftly to patients suffering from advanced prostate cancer.”