Exelixis, Inc. (NASDAQ:EXEL) Q2 2023 Earnings Call Transcript

Vicki Goodman: Yeah. I really can’t speculate on that. And again based on the data, we’ll have the conversation about filing potential with FDA.

Silvan Tuerkcan: Great. Well, thank you so much for taking my question.

Vicki Goodman: Of course, Silvan. Thank you.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Etzer Darout with BMO Capital Markets. Your line is open.

Etzer Darout: Great. Thanks for taking my question. A couple from me, both from sort of the pipeline. First on STELLAR-303, wondered if you could talk at all about the performance of regorafenib in patients with or without liver mets and whether or not that impacts sort of the performance of the control group at all. And then for planned STELLAR-005 study, I am assuming this will be maybe like IKNOTE-048 with the PD-L1 scores of CPS greater than 1 and then I guess, is that what the primary analysis would be based on the CPS greater than 1 population. Thank you.

Vicki Goodman: Yes, sure. So I’ll take the 303 question first. I mean regorafenib, response rates are very low, around 2% kind of across-the-board. So we don’t really see much differentiation there between liver mets and non-liver mets from a response perspective. Again, I think when we look at the data for the various IO combos, it’s becoming increasingly clear that from an IO perspective, the benefit appears to be in the non-liver mets patients. And again, that’s where we think we have the greatest probability of a successful outcome. There really is an unmet need in both patient populations. So, we are enrolling regardless of liver mets to give us an opportunity to be able to show benefit if it’s there in both patients with and without liver mets.

Again, a big unmet need here with poor options in terms of standard-of-care. So, in terms of 305, pembro is again approved in that setting. So we’ll be studying the population in which pembro was approved. They demonstrated an overall survival benefit relative to standard-of-care, which led to the approval, as you pointed out in CPS greater than or equal to one. And — however, the response rates here are quite low. So we believe there really is opportunity, again, to add benefit here and with Zanza’s safety profile, we believe that we’re well-placed to do that, again, based on the activity that we did see with cabo in combination with pembro and those data were presented last year at ASCO with the response rate of 54%, so.

Etzer Darout: Great. Thank you.

Michael Morrissey: You’re welcome.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Derek Archila with Wells Fargo. Your line is open.

Derek Archila: Hey, everyone. Thanks for taking the questions. Just two from us. So to piggyback on an earlier question on CONTACT-02, maybe you can just help frame the market opportunity you see for cabo-atezo combo in the pre-chemo setting in prostate? And then the second question, with the recent changes to the Board, are there any plans to kind of review the current cost base to identify any efficiencies? And if so, when — would that be communicated? Thank you.

Michael Morrissey: Thanks for the questions. PJ, you want to take the first one about CONTACT-02?

P.J. Haley: Yeah. I mean, I think a couple of things with regards to the market. Certainly, should we have positive data and approval to be a market, we’re excited about. You know prostate cancer is obviously very large market and even in that kind of second line plus metastatic CRPC setting, there’s well north of 50,000 patients. In that setting — and I guess what I’d say more broadly is, market research and conversations with KOLs, couple of things. There is significant unmet medical need in this setting, just generally speaking and there is also a strong desire to delaying chemo. So, I think a combination of a checkpoint inhibitor and the TKI would be extremely well-received based on the feedback we’ve gotten in that setting. So we’re certainly optimistic about the potential opportunity.