A new prostate cancer therapy from South Korea is showing promising results that could rival the established drug Pluvicto. We already covered this therapy, but now there is an important update.

In a phase 2 clinical trial, 177Lu-DGUL, a radiopharmaceutical designed to target metastatic castration-resistant prostate cancer (mCRPC), demonstrated impressive efficacy and safety outcomes, positioning it as a potential game-changer for patients in Korea and beyond. The findings, announced in September 2025, suggest that 177Lu-DGUL may outperform Pluvicto in key metrics, offering hope for more accessible and less toxic treatment options.

The trial, conducted across multiple South Korean hospitals, enrolled 91 patients with mCRPC that had progressed despite prior treatments. Of these, 78 patients were evaluable for tumor response, assessed by an independent imaging review committee using three standardized criteria: RECIST v1.1, PCWG-modified RECIST v1.1, and mPERCIST (via PET/CT scans). The results were striking: 177Lu-DGUL achieved an objective response rate (ORR) of 35.9% under RECIST v1.1, with 8.97% of patients experiencing complete tumor disappearance (complete response, CR) and 26.9% showing significant tumor shrinkage (partial response, PR).

By comparison, Pluvicto, evaluated in the global phase 3 VISION trial, reported a slightly lower ORR of 29.8%, with 6.8% CR and 23.0% PR under the same criteria.

When assessed with PCWG-modified RECIST v1.1, tailored for prostate cancer, 177Lu-DGUL’s ORR rose to 41.0%. Using mPERCIST criteria, which leverage PET/CT imaging for greater precision, the ORR soared to 81%, underscoring the drug’s ability to target PSMA-expressing cancer cells effectively.

While direct comparisons are tempered by differences in trial design (this study was a single-arm phase 2 trial, while VISION was a larger, randomized phase 3 trial) these results suggest 177Lu-DGUL could hold a competitive edge in shrinking tumors.

Safety is where 177Lu-DGUL shines even brighter. A common side effect of PSMA-targeted radiotherapies like Pluvicto is xerostomia (dry mouth), which affected 38.8% of patients in the VISION trial. In contrast, only 13.2% of patients on 177Lu-DGUL reported this issue, indicating significantly lower toxicity to healthy tissues such as the salivary glands.

This reduced side effect profile could improve patients’ quality of life, a critical factor for those undergoing treatment for advanced prostate cancer. Both drugs use lutetium-177, a beta-emitting radioisotope, to deliver radiation directly to cancer cells expressing prostate-specific membrane antigen (PSMA), sparing surrounding healthy tissues. However, 177Lu-DGUL appears to offer a more refined approach, potentially due to its molecular design, which enhances targeting precision and minimizes off-target effects.

The developer is expected to file for conditional approval in South Korea later in 2025, aiming to bring the therapy to market swiftly.

Source.