Summit Therapeutics Inc. Q3 FY2024 earnings call

Bob Duggan highlighted recent accomplishments with ivonescimab, including amending the HARMONi-3 trial to include non-squamous histology patients, completing enrollment of HARMONi trial, and receiving fast track designation. Maky Zanganeh discussed clinical achievements like HARMONi-2 results showing ivonescimab reduced disease progression risk, expansion of Phase 2 data in various solid tumor settings, collaboration with Akeso, and partnership with the University of Texas MD Anderson Cancer Center. Manmeet Soni provided financial updates, noting cash position of ~$487 million after a $235 million private placement, and discussed clinical operations like completing enrollment ahead of schedule for HARMONi and increased enrollment activity for squamous patients.

Expected top line data from HARMONi trial in mid-2025; planning to initiate HARMONi-7 in early 2025; amending HARMONi-3 to include non-squamous histology patients with expanded patient population.

Q: Just wanted to know on the expansion of the HARMONi-3 trial. Who are the likely first line non-squamous patients that you could likely enroll? And specifically, how do you think about recruiting patients who would otherwise be good candidates for KEYTRUDA? How do you think about getting those patients to participate in this study?

A: Bob Duggan said the expansion is similar to the population in KEYNOTE-189 study, non-squamous patients like adeno patients, chemo will be platinum pemetrexate. Manmeet Soni added they're in planning phase and haven't given further splits yet.

Q: On the addition of PFS to the primary endpoint of HARMONi-3, can you talk about what types of regulatory feedback and clinical investigator feedback that went into that decision? And then related and sorry to push with a question like this, but we all know that investors are keenly aware and awaiting for an OS answer from your partner, Akeso. And a change like this before we get that naturally makes one wonder what the confidence of management is to achieve a clinically meaningful OS benefit in the frontline among setting. So can you talk about both of those elements?

A: Bob Duggan said no change in confidence for HARMONi-2 OS data, magnitude of PFS benefit in HARMONi-2 was striking. Allen Yang mentioned regulatory feedback involved communications with FDA prior to changes.

Q: So just thinking a little bit more about the HARMONi-3 amendment which you announced. I'm just curious, did you consider just simply starting a new study in non-squamous so you could preserve the timelines for HARMONi-3 or is the argument that because you're amending to PFS, you're going to win back time on the time to primary endpoint since you're no longer looking at OS?

A: Manmeet Soni said amending was faster to add non-squamous arm, using existing sites, and it increases market opportunity. Allen Yang added physician feedback is positive about the change.

Q: We've gotten a lot of questions on HARMONi-2 hitting on OS. As you know, it's been a significant debate. I'm just wondering if you could kind of walk through the logic as far as the confidence you have that HARMONi-2 will eventually hit on OS? Obviously, people have been making comparisons, perhaps inappropriate comparisons to HARMONi-A and the strong PFS there and then the OS which is trending well, but obviously not hitting stats yet. So just wondering if you could frame that and talk about how you see the path to confidence on hitting OS in HARMONi-2, which would obviously be a very big win and translate positively to everything you're doing over in the United States?

A: Dave Gancarz said confidence hasn't changed, strong PFS hazard ratio in HARMONi-2 makes OS benefit likely, referencing other frontline non-small cell lung cancer studies where strong PFS led to OS endpoints