Noxopharm to benefit from Novartis’ ASCO data in advanced prostate cancer

Pharma News: Australian clinical-stage drug development company, Noxopharm, acknowledged the release of clinical data relating Novartis’ Lu-PSMA-617, a targeted radioligand therapy, in metastatic castration-resistant prostate cancer (mCRPC) which will be presented during 2021 American Society of Clinical Oncology (ASCO) plenary.

Dr Graham Kelly, Noxopharm CEO and Managing Director, said “This result is positive news for Noxopharm for two reasons. The first is that it confirms that Veyonda in combination with Lu-PSMA-617 provides a considerable survival advantage over Lu-PSMA-617 alone. The LuPIN mOS (median overall survival) outcome of 19.7 months still remains the best survival outcome of any drug approved for use in men with end-stage prostate cancer including enzalutamide, abiraterone, docetaxel, cabazitaxel, and now Lu-PSMA-617.

“The second is that having Lu-PSMA-617 likely to come to market as a 3rd line therapy provides a clear development pathway now for Veyonda to come to market itself, with a distinct opportunity to make the Veyonda/Lu-PSMA-617 combination a new standard of care for end-stage prostate cancer,” he added.

The VISION study compared Lu-PSMA-617 with standard of care in men with mCRPC who had received at least two previous lines of therapy. The trial met its primary endpoint of a median overall survival of 15.3 months versus 11.3 months for standard of care alone.

This compares with Noxopharm’s LuPIN trial that tested the combination of Lu-PSMA-617 and Veyonda in men with end-stage mCRPC who had progressed on at least three previous lines of therapy. The interim median overall survival from the LuPIN study currently stands at 19.7 months.

Due to the strong overall survival benefit in the VISION trial of 4 months (15.3 vs 11.3), Noxopharm believes that it will see Lu-PSMA-617 receive marketing approval in major territories such as the U.S. and EU with likely introduction to the market in early-2022.

Dr Gisela Mautner, Noxopharm Chief Medical Officer, said “Noxopharm welcomes this news because it has a major interest in seeing Lu-PSMA-617 come to market and become a standard of care for prostate cancer.

“The Company believes that the LuPIN study has demonstrated that Veyonda has the ability to enhance the efficacy of Lu-PSMA-617, with a greater survival benefit from the combination than Lu-PSMA-617 alone. This well-tolerated combination therapy should increase the attractiveness of radioligand therapy for men with late-stage prostate cancer even more,” she added.