Arvinas Inc to Discuss Vepdegestrant (ARV-471) Data Presented at 2023 San Antonio Breast Cancer Symposium and Plans to Expand Vepdegestrant Development Program Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Eli Merle - UBS Equities - Analyst : Hey, guys, thank you so much for taking the question. And just in terms of the Phase 3 run-in study, can you give us a little bit more color on when you expect to be able to make the dose selection? And what updates we might get, if any, in terms of the safety as that's ongoing with the lower doses? Thanks.

Question: Eli Merle - UBS Equities - Analyst : Okay. Understood. Thanks.

Question: Jon Miller - Evercore ISI - Analyst : Hey, guys, congrats on the results and thanks for taking my question. To me, first, on the planned CDK combo in second-line Phase 3, the Pfizer's palbo or potentially other CDK4/6. And I was wondering if you could give us a little more color on when you plan to make a choice here. What other CDKs you're considering, and maybe what you're hoping to see that will help guide that decision? And then secondly, maybe a little -- just broadly, the comps that you showed were very illuminating, aren't for any of the other next-gen estrogen receptor drugs that are in development, maybe for obvious reasons. But we haven't seen CDK combos for those drugs mostly there, should we be expecting similar PFS increments and CDK combo from other estrogen-receptor drugs? Or do you think there's something special about your degrader platform that's leading to PFS benefit beyond what we might expect from other estrogen-receptor modulators?

Question: Jon Miller - Evercore ISI - Analyst : That makes sense. Thank you so much.

Question: Brad Canino - Stifel Nicolaus and Company, Incorporated - Analyst : Thank you. Looking at slide 18 where you outlined how the dose reductions in palbo did not sacrifice the durability effect, but I'd like to ask the question the other way as well to either Arvinas or Adam. And first is, if the 125 mg dose has a 50% AUC exposure increase, what is the effective palbo dose administered stated in mg? And for palbo, is there any evidence of the exposure response relationship for PFS? Thank you.

Question: Brad Canino - Stifel Nicolaus and Company, Incorporated - Analyst : The 125 mg dose, if there's a 50% exposure increase, what is that dose stated in mg in your estimation?

Question: Ashiq Mubarack - Citi - Analyst : Hi, guys, this is Ashiq Mubarack on for Yigal. Thanks for taking my questions and congrats on all the progress. I just had one broad question. How are you thinking about the relative contribution of efficacy from the combo for each of the components? I guess the question is based on the idea that maybe some of the benchmarks you showed and suggested that CDK4/6 wasn't necessarily adding much in a post-CDK4/6 population. And similarly, in your monotherapy experience you showed your monotherapy had the best efficacy in ESR1 populations. So I'm curious how you're thinking about the contribution of components, especially in this late-line setting? Thanks.

Question: Ashiq Mubarack - Citi - Analyst : Got it. Thanks very much.

Question: Christopher Liu - Leerink Partners - Analyst : Hey, guys, thanks for the question and congrats on the data. So just two questions for me. So the first one, based on the efficacy profile you guys have between ESR1 and ESR1 wild-type, it looks like you guys have efficacy in both sub groups. Do you feel like this is something unique to Arvinas, or something that we could also see with the other neuromodulators or degraders and oral surge? And then for the second question, more of an enrollment one. I guess, for Phase 3, do you feel like having a lower dose of palbo is going to affect enrollment at all?

Question: Eli Merle - UBS Equities - Analyst : Good morning. This is [Shay] on for Peter. Thanks for taking our question. In regards to the new trials that you're doing with Pfizer, it looks like you're looking to get feedback from regulatory agencies in second half of '24. So should we be thinking that this could be an early 2025 start? And could you help add some color for how these will fit in with the current Phase 3 trials you have going? And related to that, maybe help touch on the rationale for why adding vepdeg could help with the retreatment of the CDK4/6 inhibitors?

Question: Srikripa Devarakonda - Truist Securities - Analyst : Hey, guys, congrats on the data, and thank you so much for taking my question. I understand that these are small numbers but given the subset analysis in the CDK4/6 naive patients, and you showed 19 months of PFS, I was wondering if there's any -- if you've done any analysis yet about different dose exposure of palbo between patients who had prior CDK4/6 and who are naive? And just wondering how this might impact dose exposure and dose selection, especially for the frontline study? Thank you.

Question: Srikripa Devarakonda - Truist Securities - Analyst : Got it. And if I can ask a follow-up question, this is about the ESR1 mutant and the wild-type data. With the combination, it seems like the response rate and the PFS seem comparable. Again, small numbers of patients, but I was wondering if your level of confidence that the combo works across all comers and that this could be an all-comer opportunity. And if there's anything in the baseline characteristics that the regulators might pick at.

Question: Srikripa Devarakonda - Truist Securities - Analyst : Great. Thank you so much. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.