Noxopharm Ltd (ASX:NOX) welcomes news that Novartis' experimental drug, 177Lutetium-PSMA-617 (Lu-PSMA-617), looks set to become an important new treatment for late-stage prostate cancer on the basis of new Phase 3 clinical trial data.
This has provided strong encouragement for Noxopharm given its recent LuPIN trial data showing even stronger survival outcome when the experimental radioligand Lu-PSMA-617 is combined with Veyonda®.
Novartis’ VISION study reported a median Overall Survival (mOS) of 15.3 months for Lu-PSMA-617 + standard of care versus 11.3 months for standard of care alone.
This compares with 19.7 months from the 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.
Full details will be presented on Monday morning (AEST) to the Annual Meeting of the American Society of Clinical Oncology (ASCO), the foremost cancer conference in the world.
NOX managing director and CEO Dr Graham Kelly 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 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 third-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.”
Due to the strong overall survival benefit in the VISION trial of four months (15.3 vs 11.3), Noxopharm believes that it will see Lu-PSMA-617 receive marketing approval in major territories such as the US and EC with likely introduction to the market in early-2022.
Greater survival benefit demonstrated
Noxopharm chief medical officer Dr Gisela Mautner 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.”