Noxopharm Ltd (ASX:NOX)’s pre-clinical study has confirmed the survival advantage of the use of Veyonda to enhance the survival benefit of its lutetium-PSMA-617 (LuPSMA) treatment in men with metastatic castrate-resistant prostate cancer.
The pre-clinical evidence confirms the ability of Veyonda to enhance the cancer-killing effect of the LuPSMA treatment.
The contributory role of Veyonda led to the impressive median overall survival (OS) outcome of 19.7 months in the phase I/II LuPIN study in combination with the Novartis drug.
It now positions Veyonda for a major commercial future in the rapidly growing field of radioligand therapy, not just in prostate cancer, but across the broad cancer spectrum.
Full clinical details of the LuPIN study has been published this week in the highly respected The Journal of Nuclear Medicine.
The developments further support the company’s belief in Veyonda’s key role in the emerging multi-billion dollar radioligand therapy market.
Survival outcome deemed "impressive"
Noxopharm CEO Graham Kelly said: “Men with prostate cancer that has spread and stopped responding to all available therapies have very limited survival prospects, generally in the order of 5-8 months, which is why a median overall survival outcome of 19.7 months in the LuPIN trial was so impressive.
“Based on the published survival experience of LuPSMA therapy alone, we were in little doubt that Veyonda had played a major role in that outcome.
“However, for some, the question of a combination effect versus a LuPSMA therapy alone effect remained, a question we are confident now has gone a long way to being answered by the animal study.
“In that study, LuPSMA on its own had an impressive anticancer effect, but nothing like the effect when Veyonda was added and the tumours mostly disappeared.
“Major commercial future”
Kelly continued: “We see Veyonda having a major commercial future in the rapidly growing field of radioligand therapy, not just in prostate cancer, but across the broad cancer spectrum.
“With a wide and growing number of companies developing novel radioligand drugs, this is a commercial opportunity that the company is able to carve out as a separate market segment while it undertakes the other three programs, IONIC, DARRT and CEP, in its four-pillars strategy.”
Pre-clinical study
The study was conducted by a research group led by Professor Kristofer Thurecht at The University of Queensland, aimed at separating a combination effect (Veyonda + LuPSMA) from that of either drug alone.
Professor Thurecht said: “The combination of Veyonda with LuPSMA exhibited an impressive synergistic therapeutic response, with sustained and almost complete regression of the tumour and minimally-observed systemic toxicity.
“This combined response was not observed in any of the animals treated with monotherapy.”
The study involved mice bearing tumours of human PSMA-positive prostate cancer (PC3-PIP) cells.
Tumour size was recorded and mice were euthanised when tumours reached a pre-determined size, leading to a calculation of median OS (the time when 50% of animals had died).
LuPSMA alone had a clear anti-cancer effect in this model, slowing down tumour growth and extending survival substantially.
However, the addition of Veyonda had an even more profound anti-cancer effect, going beyond blocking tumour growth into full regression of most of the tumours, to the extent that median OS could not be determined.
Journal publication
The abstract of the LuPIN Phase I/II clinical trial data in The Journal of Nuclear Medicine is available here.
The data is the more detailed version of a presentation in February 2021 to the American Society of Clinical Oncology (ASCO) GU meeting.
The final tumour response data for this Phase I/II study in 56 men is: 86% had a reduction in PSA levels; 61% had a PSA reduction >50%; median PSA progression-free survival was 7.5 months; median OS was 19.7 months.