Bristol-Myers Squibb Company Earnings Call Insights: PD-1 Program and Dosing Details

Bristol-Myers Squibb Company (NYSE:BMY) recently reported its first quarter earnings and discussed the following topics in its earnings conference call.

PD-1 Program

Jami Rubin – Goldman Sachs: This is for Elliot and Francis, can you comment on your PD-1 program in the context of Fast Track status versus Breakthrough designation. There seems to be some confusion in the marketplace. And then, to that end, you did receive Breakthrough status for your DDDA hep C therapy which is interesting because I know that Gilead didn’t receive Breakthrough status. So, what do you think this all means? Then secondarily, we did see some early data on Roche’s PD-L1. Just interested in your take in how you see that comparing to your PD-1? Thanks.

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Elliott Sigal, M.D., Ph.D. – EVP, CSO and President, R&D: Thank you Jami, this is Elliot. I will start and Francis will chime in. I agree that people are trying to figure out the exact implications of the new designation of Breakthrough therapy. It’s a new tool that we all welcome for the FDA. Its implications are going to evolve, and it’s added to a host of other existing tools. My impression is that it is an opportunity for early programs to receive regular interaction with the FDA and to gain input on the development of the registrational program. So, to that end, we certainly welcome the Breakthrough designation on our triple regimen in hepatitis C. This is a Phase II program. I can only speculate that the FDA was attracted to this because it is a non-nuc-based regimen. It has no Ribavirin potentially and has no Ritonavir. But again, the implications are not clear .The FDA oncology division has historically identified programs and use all the tools including Fast Track and other tools to their advantage to advance programs that can benefit patients in the areas of unmet need. Fast Track is what we took advantage of in three tumor types and over the last year or so we’ve had in my opinion, very high quality frequent interactions great input and have moved from standing start, as I call it from a Phase I and II, six registrational trials, including five randomized Phase III programs. So, I’m very pleased with where we are. I acknowledge that the field is competitive and we were attracted to this field back in 2004 and have been developing the science that is leading the way. But it is a competitive field. Our program is broad, comprehensive in multiple tumor types and has multiple opportunities for acceleration and early approvals. Francis would you like to add to that.

Francis Cuss – SVP, Research R&D: Certainly, well I am certainly very excited talking – moving to the HCV program for the recent data that was presented at EASL. As you’re well aware, this is non-Interferon, (non-Ribavirin), non-Ritonavir triple, and we showed very impressive efficacy data in the well-tolerated regimen and I think we’ve had numerous very good interactions with the FDA and I think it reflects the potential importance they see in this regimen in its profile. We also have advance here being able to move quickly, we’ve accelerated to the Phase III into the fourth quarter of this year and I’m confident we will have a fixed dose combination to take into Phase III, which will be presumed to be a simple one tablet twice a day regimen for 12 weeks. Just moving to PD-1, PD-L1; as you know, we published in the New England Journal last year our experience both with PD-1 and PD-L1. We have the advantage of being the only (company) been able to look at both of these regimens, and based on the data we saw of both efficacy and safety, we are moving forward with PD-1 with an opportunity to accelerate that forward. I think it’s important to note that we also talked about biomarkers in those publications and we will be looking at biomarkers, but we’ve left ourselves open with the option of a program that doesn’t necessarily rely on a biomarker, the data that would support it.

Dosing Details

Tim Anderson – Sanford Bernstein: Again on PD-1. My understanding is that you can get both Fast Track and Breakthrough and my question is did you ask for Breakthrough designation and is that request still pending or have you been denied? I don’t think it really means that much, but it is a little bit unusual that Merck got that designation because your compound is the one that’s in the press a lot. And then a question on dosing; in Phase III if I understand the dosing right its 3 mg per kg. I think in the Phase II you went all the way up to 10 mg per kg. Is there a dose limit in toxicity with the drug, and if so, what is it? Or maybe I asked differently, are there any dose dependent side effects with the product? Then just on your comment about L1 versus 1, are you saying that you saw worse safety with your PD-L1?

John Elicker – SVP, Public Affairs and IR: Okay Tim, this is Elliott and Francis will follow. I’ll deal with the different classifications that you talked about and Francis will address the fact that we’re selecting a dose, then with regard to the dose side effects, the choice of PD-1 versus PD-L1 and the different ligands. It is true that these different designations of including Fast Track and Breakthrough are not mutually exclusive, and I think however the way I am viewing this, I am very pleased with the interactions we’ve had when our program was at an earlier stage, and now has a well-designed broad set of possibilities for indications, early approval acceleration. These designations don’t convey any guarantee for downstream action, like early approval priority review, et cetera. But our program is designed to take advantage of the full array of opportunities here.

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Francis Cuss – SVP, Research R&D: Just on the dose of Nivolumab, we obviously tested comprehensively different doses and as always, we make an analysis of the best therapeutic index. So, our analysis of this taken together with the dosing regimen came out that (3) was the optimum does. As far as PD-L1 versus PD-1 is concerned, you can certainly read the data we presented last year in New England Journal. I will tell you as an overview, we’ve seen similar toxicity for both PD-1 and PD-L1 of similar degree. So our analysis was we were somewhat ahead on PD-1 there was a suggestion perhaps of greater efficacy, but of course it’s very early studies and we were able to accelerate PD-1 forward.