TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) Q1 2020 Earnings Conference Call - Final Transcript
May 13, 2020 • 04:30 pm ET
[Operator Instructions] I show our first question comes from Maury Raycroft from Jefferies. Please go ahead.
Hi, Charles. Thanks for taking my questions. First one is just on enva. I was wondering, if enva does not hit your expected 15% overall response rate in the combo with Yervoy, and it produces results that are close to -- the double agent produces results that are close to the SARC 028 study with pembro, in the mid-20% range in six months' durability, I guess would that be sufficient for approval or do you think there's risk you might have to run another study with Yervoy alone? I guess, what's the best reference out there for the combo arm?
Yes. It's a great point, Maury. So the reason for the combo arm really is the current Alliance trial, which show that Opdivo single-agent activity in all sarcoma, to be clear, not just UPS, was only 5%. But the combination of Opdivo and Yervoy in all sarcoma was 16%, which is fairly remarkable. So if we were to have a trial, whereby the doublet of envafolimab and Yervoy achieved a 20% to 30% response rate, just think what that would mean to patients who currently have a standard of care with a 4% response rate. That would clearly meet the endpoint of the trial, and we would suspect that would be sufficient for approval.
The reason I say that is, Yervoy as a single agent has been studied in sarcoma. In fact, there are 3 separate published studies for Yervoy as a single agent. And in each case, it was highly ineffective, meaning almost no response rate whatsoever. So I think the whole community in sarcoma is pretty confident that Yervoy, as a single agent, is much -- is ineffective in sarcoma and, for instance, much less active than single-agent PD-1 or PD-L1s.
So in response to your question, we hope that we see the response rates that would allow approval as a single agent based on, say, 15% response rate and also the combination of Yervoy and envafolimab based on potentially a 30% response rate. That gives the physicians the most options in treating their patients. But if we see that the combination is really what's needed for significant activity, we would be very pleased. That would mean a huge advance in the standard of care for patients with refractory UPS and MFS. It would set up the stage for additional studies of that combination, other subtypes, even potentially in the first-line setting because remember, Maury, in first-line sarcoma, doxorubicin's response rate is about 17%. So that's why if we can see its response rate with that combination, in the 20% to 30%, maybe 40% range, that literally would be a revolutionary treatment for sarcoma patients.
Got it. Yeah. That's helpful. And then so for the pembro data from SARC 028, it's -- that's probably an outlier. Is that kind of what you're thinking in that respect then?
Yes. So it's interesting, yes. There