Now, how about some positive speculation before I head off to T-Day dinner. We all know that Robbins has said since last year that they could/would approach the FDA for expedited approval after the latest -102 results are out. What has happened since then? Lawrence Recht, M.D. announced at the beginning of August, the start of a Phase 2 study of etirinotecan pegol in patients with bevacizumab (Avastin)-resistant high-grade glioma being conducted at Stanford Cancer Institute. "Patients with bevacizumab-resistant high-grade glioma currently have little to no treatment options to help them manage their disease," said Dr. Recht.
OK, now what happens and what might this mean? Obviously this new study is at the very least an indication of something potentially positive that has been seen by a cancer specialist who wants to give -102 to his very highly at risk patients. This study is/was short term in nature and about the time first endpoints were to be evaluated, lo and behold, the FDA announces fast track status for -102. One might conclude that the FDA has had a look at that study, and are getting their ducks quickly in a row to make this available to patients with NO OTHER options.
Is this a connect the dot scenario that ultimately leads to a quick approval of -102? Who knows? But I believe it is speculation which is at least as credible as some I have seen this week(especially as some have been proven wrong already). We will see.
IMO a mindset that makes complete sense is you have made Irinotecan/SN-38 (a known effective cytotoxic) more effective, and significantly less toxic. Everybody seems to assume there just isn't enough data to justify AA. If we were talking about a complete NCE I'd tend to agree, but we aren't. You can hear it in the tone of the clinicians they want this tool available, and it's a VERY defensible AA for the FDA.
NKTR tested a very intuitive hypothesis about cytotoxics and more specifically Topo-1 inhibitors: If we reduce C-Max we might improve safety, and if we can have sustained exposure it might improve efficacy (there was already a body of data suggesting this to be so for Topo 1 inhibitors). The data suggests right on both counts, and perhaps it's even better than expected (whether it's due to improvements in distribution due to EPR, or something unknown).
On NKTR-102 I'm closer to Klaus' super superior position than not, but that doesn't change the fact that he's smokin something when he starts talking about 12B in sales, but if we have an AA and a drug that has real and growing utility. Move the decimal to 1.2B and I'll still be a VERY happy camper!
So what happens if the FDA grants AA, but only on the condition that NKTR start a Phase III study? HR stated previously that NKTR wouldn't run a second line OC Phase III. Does it hang unless a partner is signed up? Will it present urgency to partner the pain meds? The mu-opioid antagonist safety dust up with the FDA has added risk to cash flow projections. They may not have money to do everything.
Part of the story about NKTR 102 is there are patients in Phase I rolled over to Phase II rollover to Phase IIB rollover to phase III. NKTR has a good ideal of what the survival months is for each indication, base on a small group. As HR said NKTR 102 will become the standard of care for cancer. Many here do not know what standard of care means. All CANCER PATIENTS WILL BE ON NKTR 102.meaning 12B dollar drug. +/- SUPER DUPER CANCER AGENT