Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) Q2 2020 Earnings Conference Call - Final Transcript
Aug 10, 2020 • 04:30 pm ET
Thank you. [Operator Instructions] We have your first question from Maury Raycroft from Jefferies. Your line is open.
Hi, everyone. Congrats on the updates and thanks for taking my questions. I think you guys have been asked this on other calls in a couple of different ways, but just for poziotinib, wanted to dig into the pre-specified 17% number a little bit more again. And so, I'm wondering if you could provide more background and thoughts on the assumptions that went into that pre-specified 17% ORR number for pozi and how this was established with FDA.
Yeah. Maury, Good to speak with you. So the discussions are derived from a review of the literature. And as you know, there is no approved drug for HER2 exon 20 mutations. But there is a number of reports in the literature giving us some guidance. Now, in large part, these -- the data that's in the literature is usually a small number of patient retrospective analysis, very small number of patients at one site, etc. So that's how it was arrived. After reviewing this information, there was a discussion with the FDA and then various calculation were established as the -- that -- what would be our pre-specified endpoint. I, obviously, communicated with the FDA and eventually finalized in a statistical analysis plan. So that's -- I hope that answers your question. And you probably will ask, was the HER2 one specific for doing? The answer is yes. It was -- the literature is a little different than the EGFR data.
Got it. Yeah, that's -- it's helpful additional perspective. And then we're guessing that FDA will likely want you to resolve some of the differences in data that you're seeing in Cohort 1 versus Cohort 2. And you guys talked about this on the last conference call, and some of the ideas on how you could resolve this with explanations. And so I'm just wondering if -- I guess, how are you thinking about this and is there a plan in place to address some of the differences that you're observing between Cohort 1 and Cohort 2 in the pre-NDA meeting?
Yeah, you're absolutely right. We obviously expect that we'll need to provide some explanation rationale to explain the result, and as I've indicated, I think last time, the obvious one is that there is a different receptor at play here. We don't think that that's necessarily the main difference. We believe that the investigator had gained experience with the drug by the time they were doing and enrolling patient in the year too, so that could explain, in part, some of the results. There is ongoing analysis here. So we're looking for, are there country difference investigators, site difference, etc, the use of concurrent medication.
So all of those factors are being looked at as we speak. There is a possibility that the number of sites in Cohort 2 coming from any particular region could be different. Comorbidities are