As a single agent right now we treated the very worst NET metastatic to the liver cases with no hope. Yet we got stable disease in 10 out of 12 patients (83%). Overall survival of 22.5 months and counting. 50% of patients still were being studied in follow up at the point of cutoff for data to present at conferences.
Here is the caveat of the study. The first six patients only got to get one injection to one tumor per cycle. The second six patients could get all tumors injected per cycle of treatment.
All this was for refractory to all other drugs treating metastatic NET to the liver. Mgt will try to get TGA approval for this indication. Australia docs would also like to see treating NET before it is metastatic using PV-10 as a combo. Notice that Simone Leyden (CEO of NeuroEdocrine Cancer of Australia and a Chair of International Neuroendocrine Cancer Alliance Research) says this will be a phase 2 study. That means mono therapy NET is wrapping up fully for early TGA approval application and the next step in Australia for PV-10 will be a phase 2 combo in stage 2 or 3…..not a phase 1 combo…..but a phase 2 combo. Australia may be showing the paths they want this drug to take. Remember, unlike the FDA, the TGA in Australia is comprised of treating physicians…not regulators.
Once approved for NET metastatic to the liver….doctors in Australia could finally prescribe off label use for stage III intransit met melanoma.