The whole purpose of LuPIN was to see whether the addition of...

The whole purpose of LuPIN was to see whether the addition of NOX66 would increase the number of cycles patients could complete before suffering disease progression.  This had been made clear by both Noxopharm and Louise Emmett.

Treatment with Lu-PSMA involves an IV injection every 6 weeks. You can keep giving the drug every 6 weeks providing the patients keeps responding, and in theory there is no maximum to the number of shots, but typically it is maxed out at 6 (= an 8-month course).

Novartis will be in the business of getting as many men as possible to receive as many shots as possible, and that comes down to 2 factors:

1. Using Veyonda means men stay on treatment longer = more shots. The average number in the WARMTH study was 3. In LuPIN,  the average was close to 5, with 46% of men receiving 6 cycles
2. Novartis is going to have to convince men and their doctors (and reimbursers like our PBS) that it is worth their while to fork out some $200-300k for a treatment likely to give them an average 3-4 month extra life. By adding Veyonda and extending that number by another 6 months or so, they might be persuaded to undergo one last treatment.

Anyone’s guess what they will charge, but based on other treatments, let’s say upwards of US$50K per injection.

If Veyonda means more men will be willing to try the treatment, and each man receives on average 2 more cycles, then that would put a value of about $100K per patient to Novartis in terms of using Veyonda.

About 100,000 men die in the US and Europe each year from prostate cancer. That’s a $10 billion value that could be ascribed to Veyonda.


With respect to WARMTH:

1. With 4 approved treatments (2x androgen receptor inhibitors – enzalutamide and abiraterone; 2 taxanes – docetaxel and cabazitaxel), enormous variations in patients, and individual preferences of doctors, no two studies are ever going to have identical situations.
2. However …. What we do know about LuPIN is that it is one of the few studies that has only taken patients who have exhausted all approved treatments. That isn’t the case with the studies in WARMTH
3. As the meta-analysis points out in analysing the data, the most significant pointer to outcome is number of lesions. LuPIN had almost 50% more patients with >20 lesions than WARMTH
4. Yes, some WARMTH patients received a radium drug (Xofigo) for bone mets, while no LuPIN patient did. There is a good reason for this and that is because Xofigo is not approved in Australia or the US or many countries because it is considered to offer no meaningful survival benefit.

NOX that is sitting on clinical trial data that has produced a sufficiently meaningful benefit likely to gain marketing approval.  Quibbling over exact percentages misses this point.