Noxopharm to present survival data in prostate cancer that exceeds expectations

Pharma News: Australian clinical-stage drug development company Noxopharm reported on the publication in abstract form of the latest survival data from the LuPIN study ahead of a formal presentation to the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (11-13 Feb 2021).

Noxopharm CEO, Dr Graham Kelly, said “This data has been generated in an independent study and is being shared on the world stage by leading Australian researchers. The reported median overall survival (OS) outcome of 19.7 months means that at least half of men who have progressive end-stage prostate cancer, and who have come to the end of their treatment journey, are being offered at least another 20 months of life. This is an extraordinary outcome and easily exceeds that obtained with any of the current treatments for Stage 4 prostate cancer in their registration studies. That difference is even more remarkable when you consider that those other treatments were tested in men with considerably less advanced disease than those in the LuPIN study.”

“Today’s clinical data continues to cement the view that Veyonda (NOX66) is on track to become a major new immunotherapy oncology drug of medical and commercial significance. The DARRT program has already suggested this and the LuPIN program now confirms it. All of which augurs well for our upcoming IONIC program. Collectively, these three programs highlight the diversity of use and potential value of Veyonda,” Kelly added.

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A team of eminent medical researchers from Sydney’s St Vincent’s Hospital and Melbourne’s Peter MacCallum Cancer Centre and led by Professor Louise Emmett conducted the independent Phase I/II study. They reported that Veyonda was safe and efficacious in combination with Lu-PSMA-617, an experimental radiopharmaceutical acquired by major Swiss pharma company, Novartis, three years ago for US$6 billion across a series of transactions.

The LuPIN data reinforces the company’s belief that a combination of Veyonda and 177lutetium-PSMA-617 represents the long-awaited forward leap in the treatment of mCRPC, offering a patient with end-stage disease that has progressed on all standard treatments, a high chance of his cancer continuing to respond to treatment and with a potential survival outcome justifying the additional treatment (Figure 1).

The investigators deliberately chose to test the LuPIN combination in men with truly end-stage disease as being the most stringent test possible. The median overall survival of 19.7 months shows that the drug combination passed this test beyond the Company’s expectations.

While the LuPIN data justifies a strategy of bringing the LuPIN drug combination to market as a new final treatment, moving the treatment to earlier in the disease process is an obvious next step.

The standard treatment for mCRPC involves three separate courses of therapy designated 1st, 2nd and 3rd line treatment. This comprises two lines of chemotherapy (docetaxel and cabazitaxel) and one line of hormone therapy – Astellas’ Xtandi (enzalutamide) or Janssen’s Zytiga (abiraterone), all used in various sequences.

All four current therapies were approved for use on the basis of offering median overall survival outcomes in the range of 14.8 – 18.4 months. Not only has the LuPIN outcome exceeded these outcomes, but it has done so in men whose cancer has progressed on all those therapies.

As part of its next step, Noxopharm has assembled a business development team comprising legal and ex-major pharmaceutical industry executives to advise on appropriate clinical, commercial and transactional strategies in light of the company’s multiple opportunities.