Australian clinical-stage drug development company Noxopharm Limited (ASX:NOX) reports that a new independent clinical trial supports company’s aim for Veyonda to become a standard companion drug for major anti-cancer therapies.
The company’s confidence has been boosted by the recent publication of independent clinical trial data involving the experimental radiopharmaceutical drug, 177lutetium-PSMA-617 (Lu-PSMA) owned by Novartis.
Known as the WARMTH (World Association of Radiopharmaceutical and Molecular Therapy) study, it is an 18-centre, multi-national, retrospective trial reviewing the experience of 319 men with late-stage progressive metastatic castrate-resistant prostate cancer (mCRPC) receiving Lu-PSMA following prior therapies
The trial data was published on-line in the European Journal of Nuclear Medicine and Molecular Imaging.
The key outcome of the WARMTH study is a median overall survival (mOS) outcome of 11.6 months. Given that both WARMTH and LuPIN studies involved men with similar disease status (end-stage, progressive) and similar pre-treatment histories, the company believes that the WARMTH trial provides meaningful context for the LuPIN trial.
That context is that the combination of Veyonda and Lu-PSMA in LuPIN delivered a median overall survival outcome of 19.7 months,2 a 71% increase in survival outcome over the WARMTH trial.
This result further supports the company’s belief that Veyonda has the potential to become a standard of care drug to be used in combination with the most common forms of anti-cancer treatments,” Dr Graham Kelly, Noxopharm’s CEO and Managing Director, said.
“In this instance, Veyonda is being combined with the Novartis radioligand, 177lutetium-PSMA- 617, for the treatment of metastatic prostate cancer.
“This particular combination is one of our so-called 4-Pillars oncology programme where we are looking to use Veyonda to improve survival prospects across a range of cancer treatments and forms of cancer.
“Based on early data from our CEP-1 and DARRT-1 clinical studies, we believe that the unique multiple anti-cancer actions of Veyonda have the potential to produce meaningful survival benefits as a combination treatment across multiple treatment combinations.
“The striking difference in mOS outcomes between the LuPINand WARMTH trials serves to further support that belief.”
LuPIN Study
The LuPIN study completed the final treatment of the last (56th) patient in October 2020 and will conclude formally in October 2021, after which the final data, including the final mOS outcome, will be announced.
The LuPIN trial involved Veyonda doses 400-1200 mg. Since then, Noxopharm has established in its NOXCOVID trial that a 1800 mg dosage is well tolerated with the potential for an even greater anti-cancer effect.
A larger Phase 2 LuPIN study is under consideration in light of the anticipated pending marketing approval of 177lutetium-PSMA-617 and its likely adoption as a standard treatment.