Arvinas Inc at Stifel Targeted Oncology Days (Virtual) Transcript

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

Question: Brad Canino - Stifel Financial Corp. - Analyst : Yeah. And Sean, if I just could have you start out with a quick overview of the company, maybe status of the clinical oncology programs as well that we'll be discussing for the rest of the talk.

Question: Brad Canino - Stifel Financial Corp. - Analyst : Thanks, Sean. And maybe just to kick off on 471, which I will now also try to call vepdegestrant. Yeah, I'd like to open with just an update on the second line HR positive metastatic breast cancer trial, which was versus fulvestrant that started in March of this year. I look on clin trials, it's got a primary completion for August '24 and that's pretty rapid accrual for the size of that trial. You're working with Pfizer there, just comfort level with that, right, kind of guiding post to potential ending with the first two months of experience for that trial.

Question: Brad Canino - Stifel Financial Corp. - Analyst : Okay. And then obviously you've got a new oral SERD competitor in the market with the elacestrant. Is thoughts on that label being restricted to ESR1 mutant patients and how that impacts the opportunity of 471 monotherapy?

Question: Brad Canino - Stifel Financial Corp. - Analyst : Yeah. And can you remind us of any of the key differences between your second line trial and something like the elacestrant trial?

Question: Brad Canino - Stifel Financial Corp. - Analyst : Okay. And then thinking forward to your frontline trial, which I mentioned will be initiating in the second half of this year, you've announced that you'll do some dose optimization with the palbo component and you'll be using lower doses of palbo. I guess what's your confidence that you won't compromise efficacy of that CDK 4/6 component when you're using lower doses in that trial?

Question: Brad Canino - Stifel Financial Corp. - Analyst : Okay. Now you have plans to combine vepdegestrant with abema and ribo, the other CDK 4/6 inhibitors, I guess, are you worried that there's going to be potential exposure effects for those molecules as well, and those tend to have GI and cardiac exacerbations instead of neutropenia, which could clinically manifest into adverse events that are a bit more serious than the lab detail.

Question: Brad Canino - Stifel Financial Corp. - Analyst : Okay. Sean, you mentioned the adjuvant studies. I guess is there any thinking about a preferred trial design because there are differences between the Roche and Lilly SERDs when I look at those trials, you know, Lilly is capturing a high risk patient group that's received two to five years of prior endocrine therapy. Roche isn't really having that detail, I think you can say to date on that or is that a stay tuned?

Question: Brad Canino - Stifel Financial Corp. - Analyst : Okay. Now on to the prostate programs. I guess as we think about the pivotal trial initiation for bavdegalutamide in the second half of this year, what are the remaining gating steps for getting that up and running? I think we saw data from the last ASCO from the complete Phase 1 for that.

Question: Brad Canino - Stifel Financial Corp. - Analyst : Okay. And then we don't know exactly your trial design yet. It's going to be in a later-line prostate population. So I don't actually know what are your takeaways from the commercial opportunity that potentially could be there launching the Novartis Pluvicto launch that's been taking place over the last year?

Question: Brad Canino - Stifel Financial Corp. - Analyst : Yeah, you mentioned 766 had a nice showing at ACR where the structure was disclosed and highlighted some preclinical data. I guess what would you highlight from that overview? And I guess help us understand what you expect to show for first clinical data in second quarter of this year as well.

Question: Brad Canino - Stifel Financial Corp. - Analyst : Okay. And then going forward, should we expect 766 to be developed in a similar manner initially, is bavdegalutamide late line, but expand that biomarker population out to include the L702H or might this have a different development path?

Question: Brad Canino - Stifel Financial Corp. - Analyst : Yeah. And now the patients with 878 and 875 mutations that you're going after with bavdegalutamide, some of those in your Phase 1 for bav had additional mutations like L702H, would you expect there to be potentially higher efficacy with 766 in those patients?

Question: Brad Canino - Stifel Financial Corp. - Analyst : Okay. And moving on to some of the new assets that Sean mentioned at the top, BCL6, I guess in his talk generally about this transcriptions factor, in fact, the role in liquid cancers and why you've prioritized this as one of the first novel undruggable targets that you've decided to go after.

Question: Brad Canino - Stifel Financial Corp. - Analyst : Okay. Now help us understand in the initial Phase 1 development path here, what types of patients might be included and what might we be able to learn from that besides just safety PK/PD, as you think about movement into dose expansion cohorts for particular patient groups?

Question: Brad Canino - Stifel Financial Corp. - Analyst : Okay. And then moving beyond that, some list then still is in preclinical development, you're still interested in KRAS mutant selective degraders. You've essentially narrowed your focus to D and V mutations, though, but what's your current thinking on developing selective mutant, selective degraders for KRAS, especially with the monotherapy data that we've seen evolve from the G12C inhibitors around shorter durability than I think we would have expected?

Question: Brad Canino - Stifel Financial Corp. - Analyst : Yeah. And should we anticipate any more preclinical data this year on your KRAS franchise this year?

Question: Brad Canino - Stifel Financial Corp. - Analyst : Yeah, okay. And then lastly, just shown on balance sheet and cash runway, a quick reminder there would be helpful.

Question: Brad Canino - Stifel Financial Corp. - Analyst : Okay. Well, Sean, Ian, thank you so much for the quick conversation on the oncology pipeline; really appreciate it.