Novartis' Big News at ASH? It's Still in the CAR-T Race

By Motley Fool Staff Markets Fool.com

Novartis (NYSE: NVS) may not get the splashy coverage bestowed on CAR-T competitors Juno Therapeutics (NASDAQ: JUNO) and Kite Pharma (NASDAQ: KITE), but that doesn't mean that Novartis isn't still among the leaders in developing this revolutionary new way of fighting cancer. At the American Society of Hematology conference earlier this month, Novartis' management updated industry-watchers on the progress of its CAR-T treatment, CTL-019, and its plans to file for the therapy's approval next year. Will Novartis' CTL-019 reshape how doctors treat pediatric acute lymphoblastic leukemia?

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In this clip from The Motley Fool's Industry Focus: Healthcare podcast, analyst Kristine Harjes is joined by contributor Todd Campbell to discuss CTL-019's latest data.

A full transcript follows the video.

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Kristine Harjes: We also mentioned Novartis a little bit. Novartis is definitely not a pure CAR-T play in the way that Kite is, but they do have a really interesting CAR-T program. The drug is called CTL-019, and that had, also, some really awesome data coming out of this conference.

Todd Campbell:I know! Eight-two percent complete response rate within pediatric patientsdiagnosed with acute lymphoblastic leukemia. You're talking about, wow, what a potentially great advance in treatment, again, for a tough-to-treat group of patients that don't have a tremendous number of other treatment options available to them.

Harjes:And this AL is the most common cancer diagnosed in children.

Campbell:Right, about 2,500 cases in the United States annually in children. Interestingly enough, this drug, CTL019, it targets thesame protein that's expressed on the cancer cells targeted by Kite's drug and Juno's drug. I don't know why Juno's drug is delivering such safety concerns, necessarily. But one thing that's interesting is Novartis' drug appears to bemuch safer, but the trial that Novartis conducted was in children, whereas Juno's trial was in adults. Obviously, there could be some differences associated with that. Regardless, this drug's performance in trials so far is good enough that Novartis expects to be able to file for FDA approval on an accelerated pathway next year. So, Kite's already filed a rolling submission that they're going to complete in early Q1. Novartis thinks that they're going to be able to file for approval at some point next year. Both of these drugs,conceivably, could be on the market and bringing in revenue for these companies in 2018, at least.

Harjes:This is a type of therapy that we have been watching for quite a while. So, to be getting this close to theapplications and the potential approvals, that's pretty exciting.

Campbell:Yeah, especially how quickly it happened. I think Kite's research into CAR-Ts, through a collaboration with theNational Cancer Institute, began in like 2012. From start to finish, you're talking only a few years to be able to get a drug potentially in the hands -- we have to say potentially. We always have to remind everybody who is listening that anything can happen from here. These drugs are not approved yet. They still have to pass the FDA's gauntlet. But it's still pretty impressive, that we could potentially have these drugs on the market within such a short period of time.

Harjes:And there are certainly black swans that could happen, as you mentioned. These drugs are a little bit infamous for having adverse affects and events associated with them. Definitely something to keep an eye on, maybe don't bet the ranch on them, but it's looking pretty good for the CAR-T space.

Kristine Harjes owns shares of Juno Therapeutics. Todd Campbell has no position in any stocks mentioned. The Motley Fool recommends Juno Therapeutics. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.