Kite Pharma (NASDAQ: KITE) made a splash at the American Society of Hematology conference earlier this month when management reported that its CAR-T cancer therapy for B-cell cancers will land on regulators' desks in 2017. Will this CAR-T therapy revolutionize how doctors treat relapsing and refractory non-Hodgkin's lymphoma?
In this clip of The Motley Fool's Industry Focus: Healthcare podcast, healthcare analyst Kristine Harjes and contributor Todd Campbell update investors on KTE-C19's latest trial data and management's plans for next year.
A full transcript follows the video.
This podcast was recorded on Dec. 7, 2016.
Kristine Harjes: We're going to talk about the 21st Century Cures Act, which I think is very exciting and good merry news. But first, before we get to that, we're going to talk a little bit about a very important meeting that happened in the healthcare world earlier this week. It is the annual meeting of the American Society of Hematology, so, blood and blood cancer. It's ASH, you'll hear us call it. This was out in San Diego. It was from December 3rd through 6th. Essentially, what this is, is all the biggest names in biotech that work in this space get together, they release their data, they announce new drugs, and everybody gets to rub elbows and share research and results, and it's very exciting for scientists and patients, and also for investors.
Todd Campbell: Yeah. Some years it's not as exciting for investors, it's more of a blase event, but this year is not the case. We have some really interesting data that got presented this year, that is impacting and moving stocks, and could impact and move stocks in 2017 and into 2018. In looking through all of the data, especially given the fact that last week, Michael and I were talking about Juno's stumbles in developing a new class of drugs called CAR-Ts, I thought it might be nice to talk about some positive things that are happening in CAR-T development.
Harjes: Sounds good. CAR-Ts were certainly front and center at this conference. I think that probably received the most attention of any other topic there. And there were a handful of companies that presented data, and it seemed like it was all pretty good data.
Campbell: Yeah. It was pretty positive data. There were two companies that stood out to me, only because they presented data from registration-ready or pivotal trials that could allow them to obtain FDA-accelerated approval in 2017. So, it's not necessarily just, "Hey, we have some really interesting early stage data." It's, "We have some early stage data plus a chance at commercialization in relatively short order." Just to go back in history for a second, and remind any new listeners what we're talking about with CAR-Ts, it's an entirely new way to battle back against cancer. It's a process that involves removing T cells from patient's bloodstream, re-engineering them so that they can better find and destroy cancer, and then reinserting them back into the patient. It's a very new approach, it's a targeted type approach, toward getting rid of cancer, specifically blood cancer, which seems to be very amenable to this type of approach. Two of the companies that are in the leadership position in this CAR-T space are Kite Pharma and the goliath, Novartis.
Harjes: Right. Kite is a really interesting story, here. It seems to me like they will probably be the first one to cross the finish line of the CAR-T race, if things continue to go well. Reported really positive data on Tuesday at the conference. The drug is called KTE-C19. The trial that it was going through is called ZUMA-1.
Campbell: Yeah. This is an awesome advance, potentially, for a very tough-to-treat group of patients who are diagnosed with something called diffuse large B-cell lymphoma.
Harjes: Which is the most common type of non-Hodgkin's lymphoma.
Campbell: Exactly, the most common type, about 35% of non-Hodgkin's lymphoma. Specifically, this drug would be used in patients who failed to respond or saw their disease return after current standard treatments. So, this would not be a front-line use -- at least initially. It would be used in the toughest-to-treat patients. Historically, that patient subgroup has not had a good prognosis.
Harjes: However, really good trial results. 76% of the patients that were being studied experienced an objective response, and 47% of them went into complete remission -- which, just to emphasize the point about these patients not receiving their first-line drugs, they have already been through therapy, and it has failed. So, these are patients who have a really strong need. So, to see numbers like this is pretty incredible.
Campbell: Yeah. Kite went back and did a retroactive analysis study to try and see what has happened with this patient subset in the past, prior to developing this CAR-T. What they found is the response rate is typically only about 26%, and the complete responder rate is only around 8%. It's very low. So, theoretically, this is a major advance for... it's not a huge patient population, but, a patient population that, theoretically, if this drug gets approval, could still be worth a pretty good amount of revenue to investors, starting as early as late next year.