Avid Bioservices Inc (CDMO)

[jakedogman1]

from Merck cc:

excerpts from q&a... good overview of I-O landscape... lots more info in call... note chemo is still in the picture and the level of activity w/ Pdl and other combos... would love to get MassH's take on all this...

this is not the time to do IST's imo w/ the battle raging... also note drugs are being approved w/ relatively small trials with follow up confirmation ....

https://finance.yahoo.com/news/edited-transcript-mrk-earnings-conference-175612276.html

One for Adam, one for Roger. So for Adam, can you talk a little bit about what you anticipate with respect to pent-up demand or expected use going forward for chemo combos with KEYTRUDA just ahead of the PDUFA date? And then for Roger, I realize that we'll see data at ASCO, but what was the tipping point in moving forward with the 6 additional trials of epacadostat? Was it more data-driven? Or was it reflecting the competition?

Adam H. Schechter, Merck & Co., Inc. - EVP and President of Global Human Health [3]

Geoff, this is Adam. So let me start by saying that we're pleased with the progress that we have with KEYTRUDA across indications, including lung. And if you look at what we've done with our approved indication, the vast majority of patients within our indication are already being prescribed KEYTRUDA for first-line lung. And KEYTRUDA is now the most prescribed drug for first-line lung in the marketplace. As we start to think about KEYNOTE-021G, first of all, it obviously expands the market opportunity in non-squamous patients, and it also includes patients with low or no PD-L1 expression. So basically, it opens up the rest of the market. But with that said, there's a couple of other things to consider. First of all, we believe that physicians will look at individual patients and decide whether or not combination therapy is right to start those patients. So if you have a younger patient that's relatively healthy, you might think about treating that patient with combo differently than if you have an older patient that is more complicated. In addition to that, we believe that since we studied the drug with ALIMTA, that early adoption will probably use -- where physicians would use ALIMTA. Over time, that will expand, we believe, to other chemotherapies as the physicians start to see the results with the combination that we studied. So in summary, we believe it's a very significant opportunity. It's not a pent-up demand. I would look at it as a build as new patients come into the market, and I think that it really is exciting opportunity for lung cancer patients but also to establish KEYTRUDA further as a real preferred treatment therapy.

Roger M. Perlmutter, Merck Research Laboratories - President [4]

Geoff, it's Roger. With regard to epacadostat, the Incyte IDO1 inhibitor, it's really a data-driven decision process. We've been looking at a lot of different combinations, and as you know, there's a lot of interesting data, some of which was presented at AACR, showing activity of KEYTRUDA in combination with a variety of inter-tumoral injections, including IL-12 and electroporation, toll-like receptor agonists of different kinds. We've previously reported data with TVEC oncolytic virus. There's other virologic data. One of the nice things about IDO1 is the systemic therapy is extremely well tolerated, and from the studies that we've been doing, some data that was reported at AACR and more data that will be at ASCO, there's evidence for improvement in response. The ability to provide an additional systemic therapy with improved response and really very little penalty that we can see in terms of toxicity is extremely attractive.

Roger M. Perlmutter, Merck Research Laboratories - President [38]

And Chris, with -- this is Roger. With respect to the impact of IDO and other agents, I mean, it's worth stepping back and remembering what the goal has been from the beginning, which is -- we see KEYTRUDA, which is the first really broad-spectrum antineoplastic agent introduced into clinical practice, we see it as foundational and transformational for oncologists. And while we recognize that chemotherapy has evolved over a period of decades, it's effective in a lot of different tumor types, provides meaningful responses, the goal has been to actually change the shape of the survival curve for patients with malignant disease. And it's both the high response rates and the durability of those response rates that we see with KEYTRUDA that's so impressive. And the thought is that in combination with other immuno-active agents, particularly those that have relatively little toxicity, we'll be able to change those curves still further. In the best circumstance, ultimately, the role would be to have KEYTRUDA in combination with these other agents end up being first line across a broad spectrum of malignant disease, anticipating that chemotherapy would be used in a relapse setting as a second- or third-line therapy. We'd like to get rid of the toxicity of chemotherapy, but we also recognize that chemotherapy has been used for a long time. Oncologists have become very comfortable in using chemotherapy. They know how to administer it, and they get results that are meaningful with it. So I don't see chemotherapy being displaced completely or going away. My hope is that we're going to find the combinations of agents that work better.