Verastem, Inc. H.C. Wainwright 28th Annual Global Investment Conference
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I'd like to welcome everybody back to our afternoon session. My name is Andres Maldonado. I'm a Senior Biotech Analyst here at H.C. Wainwright, and happy to have you guys here. The next company that we have presenting is Verastem Oncology, and it is my pleasure to welcome Jonathan Pachter, the Chief Scientific Officer, and Nate Sanburn, the Chief Business Officer. Welcome, gentlemen. Thank you. Pleasure to have you.
Always good to see you. I guess a good place to start is for investors less familiar with the Verastem Oncology story, could you give us a brief update on the pipeline overview and walk us through what the company's current strategy is for building RAS/MAPK-driven immunotherapy therapies?
Sure. Yeah. Good afternoon. It's a great opportunity to be here, and it's a very exciting time at Verastem Oncology. When I joined about four and a half years ago from Lilly, there were opportunities within the company that I really saw were going to continue to deliver, and together with John as well as others, the teams have continued to do that. We're two platforms, one that's the commercial stage program, our avutametnib plus defactinib, or AVMAPKI FAKZYNJA CO-PACK, now approved in low-grade serous ovarian cancer in the KRAS-mutated population, followed by our VS-7375, which is our KRAS G12D program. Both very exciting programs. As we move forward to deliver RAS pathway inhibiting molecules for cancer, the programs have continued to go very well.
As we look through this year, we've had very good opportunities going from Q1 to Q2 on our commercial product, and we continue to work to deliver on our development of our VS-7375, with phase II programs that are open across pancreas, lung, and colorectal, and working toward what would be phase III trials, opening in pancreas, lung, and colorectal as well, by the first half of 2027. Delivering commercially in the ovarian as well as moving forward very quickly across multiple tumor types for VS-7375.
Great. Starting with a couple questions on the CO-PACK. How should we be thinking about the launch through the lens of the balance between new patient starts, duration on therapy, refills, and continuations, discontinuations, et cetera?
Sure. These are obviously the priorities for us. As we've come from launch now many months in, we've made some changes in the first quarter that have continued to deliver. You saw that in the second quarter results. We continue to work on that. Obviously, we saw some seasonality in the first quarter, which we know with this disease state is going to be a reality. As we move through this year, we continue to emphasize and deliver on what were our Q1 changes, both in people as well as tactics, and continuing to work on that commercially through the end of 2026.
Great. Maybe a quick follow-up there. The launch has seen thus far strong uptake from both gynecologic oncologists and medical oncologists. I guess, where do you still see the largest opportunity to expand that prescriber depth, especially regarding academic centers in the community setting?
Sure. As you can imagine, as we had our clinical trials in the academic setting predominantly, we've continued to penetrate the community practices. That is going well, with the ratio of academics to community being roughly 60/40 as we look forward. We continue to work on how we are engaging those community physicians, the gynecologic oncologists specifically, but also the medical oncologists. When we think about new patient starts as well as keeping patients on therapy, this is an effort of the team, and we'll continue to work to deliver on that in the near term.
I'll just add that in our phase II RAMP 201 that led to the accelerated approval, the average time of patients with KRAS-mutated LGSOC on therapy was 18 months.
Initially in the launch, we got a lot of patients that were relatively sicker, as you do in a new oncology launch, there's a real effort to be able to go to patients that are earlier and toward first recurrence, that could more replicate the kinds of benefits that we could see for patients in the phase II. That's a real effort of the company, in addition to finding new patients, getting them on earlier in their journey.
Great. Maybe to kind of round out the CO-PACK line of questioning. As investors think of the confirmatory phase III, the RAMP 301 study, I guess, where do you see that data effectively resonating with physicians the most, and where can the launch trajectory change the greatest when you garner that confirmatory trial? Maybe if you can also wrap in some of the recent updates from RAMP, I believe it was 205, and how that kind of fits in the overall ecosystem of the CO-PACK.
Sure. Let me address the 301 study. As we have said publicly, that is fully enrolled and continuing to look to read out next year. As far as the data, it is a confirmatory trial for the mutant population, and then we would read out data as it pertains to the wild type. In this population, about 30% of the LGSOC market is mutated, and 70% in KRAS, and 70% KRAS wild type. We have a number of pieces of data that we are working to analyze, some of which will be coming up at the IGCS Congress here next month, which is a very important gynecologic oncology conference, which has some of the 201 data analysis, as well as an external control analysis where we have compared What are the treatment arms from the 201 study to an external control from the GOG-0281 study?
This is a study that involved trametinib. It was a phase III trial. We are very keen on how does our therapy compare to what would be the standard of care in the LGSOC setting. Those will be important coming out at IGCS. The 301 data, as we look at next year, would look to confirm the mutation patients, as well as have the opportunity to expand that into the wild type KRAS setting.
The other thing exciting, and you alluded to this, RAMP 205 was a trial that looked at the same two agents that we got accelerated approval for in ovarian, which are avutametnib, which is a RAF/MEK inhibitor, and defactinib, which is a FAK inhibitor, with chemotherapy, with gemcitabine and Abraxane, saying in frontline metastatic pancreatic cancer. We saw a 52% response rate there, which is great. It was about a year of overall survival. So very promising. We actually started that before any RAS inhibitor was in the clinic. That was 29 patients, a meaningful number of patients. We feel that people have not thought. Well, I am sure we will talk about RAS inhibitors Yeah for most of this conversation.
I think that people may not have thought enough about after a patient, for example, with pancreatic cancer, if their cancer progresses on a RAS inhibitor, where do you go?
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