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The LuPIN Trial at St Vincent's Hospital, Sydney

The LuPIN trial at St Vincent’s Hospital, Sydney

 Two matters were raised this week following the LuPIN data announcements at the 2021 ASCO Genitourinary Cancers Symposium. Both highly relevant.

 

The LuPIN trial at St Vincent’s Hospital, Sydney

 Two matters were raised this week following the LuPIN data announcements at the 2021 ASCO Genitourinary Cancers Symposium. Both highly relevant.

9 February 2021 MajorSurvivalBenefitinProstateCancerPatientsAnnounced (noxopharm.com)

15 February 2021 LuPINSurvivalOutcomeConfirmedbyConferencePresentation (noxopharm.com)

Where does the LuPIN program fit in to our future plans?

I have been asked how critical LuPIN is to our plans. The short answer is that it is an important part, but not the whole part. In our efforts of developing Veyonda as a major new anti-cancer drug, you certainly don’t ignore clinical data of the promise that we announced this week. But there is a context to bear in mind.

That context is a deliberate strategy of positioning Veyonda as a unique drug whose purpose is to boost the effectiveness of other cancer therapies …. not just one form of therapy to the exclusion of all others, but to most forms of cancer therapy, something not achieved before, but very much needed.

We currently are testing Veyonda in combination with external beam radiotherapy (DARRT), intravenous radiotherapy (LuPIN), immune checkpoint inhibitors (IONIC), and standard chemotherapy (IONSA).

The concept of combination drug therapy is not new in cancer therapy – combinations involving chemotherapy, radiotherapy and immune checkpoint inhibitors in various mixes are becoming the norm. What is new is the concept of a single drug boosting the effectiveness of therapies as diverse as chemotherapy, radiotherapy and checkpoint inhibitors.

With such diversity of opportunity on offer, in working towards a potential industry deal, we need a potential deal to be based on that opportunity carrying the highest value possible. Not that the late-stage prostate cancer market is small: enzalutamide, one of the 3 major drugs used in late-stage prostate cancer was acquired by Pfizer in a US$14 billion deal a few years ago, and sales of enzalutamide were US$4 billion last year; and Novartis thought enough of the 177lutetium-PSMA-617 (Lu-PSMA) opportunity to spend US$6 billion to buy it.

But the prostate cancer market is a single cancer market and that opportunity pales in comparison to those that our DARRT and IONIC programs are targeting, where a broader range of cancer types are involved.  The immune checkpoint inhibitor (ICI) market, for example, currently is worth about US$20 billion p.a., with the potential for multiples of that - if a way could be found to overcome resistance to ICI drugs, something that we are confident Veyonda can and will do.

So, of course we will pursue the LuPIN opportunity vigorously. But …… tempered with the broader opportunity on offer. Noxopharm wants a possible deal based around the greatest value of Veyonda that we can substantiate.

As announced, an in-house business development capability, combined with external advisors, has been assembled to meet this anticipated upcoming industry interest.

Where to from here with the LuPIN program?

A median overall survival outcome of 19.7 months in men with end-stage prostate cancer with notoriously poor survival prospects showed that a considerable anti-cancer effect had occurred in those men. So, where to next?

We need to be clear about the objective of the LuPIN trial. It wasn’t to prove that the Veyonda/LuPSMA combination was a new final treatment for this disease, as important as that might be. It was a pilot proof-of-concept study that the Veyonda/LuPSMA combination was better than LuPSMA on its own to a degree that would make the combination compelling, irrespective of where the combination is used in the treatment process.

The next step is deciding where we are going to use the Veyonda/LuPSMA combination in the disease process, a decision that will go a long way to contributing to the ultimate value of Veyonda.

  • Lu-PSMA originally was intended for men at or near the end of their treatment journey. That was the basis of Novartis’s Stage 3 VISION study that finished late last year.
  • Then in June 2020, Novartis issued an Oncology Pipeline Update that said that they wanted to take the drug even earlier in the treatment journey, pointing out that with the high attrition rate throughout that journey, it made better sense to be offering a treatment to more patients and in patients whose cancers were likely to be more responsive to treatment. That would shift the market in major countries (US, EU, Japan) from about 25,000 men, which was the market originally being eyed, up to about 265,000 men, depending on how early in the treatment journey you wanted to go.

June 2020 Novartis Oncology Pipeline Update

  • An Australia-wide study known as the TheraP Study, addressed this by going one step earlier and giving Lu-PSMA to men with one remaining treatment (cabazitaxel) left. That study was published this week showing a considerably better short-term anti-cancer response compared to cabazitaxel.
  • But in their 2020 Oncology Pipeline Update, Novartis have flagged going even earlier than where the TheraP study is, including even further upstream into men with metastatic hormone sensitive cancer and closer to the Novartis goal of treating a quarter of a million men each year.

It is our contention that the effectiveness of the Veyonda/Lu-PSMA combination, plus its high degree of tolerability, makes a compelling case for taking this treatment as early in the disease process as possible.