Why Kite Pharma Stock Is Already Up 62% This Year

Kite Pharma (NASDAQ: KITE) is researching a novel cancer-fighting approach that supercharges a patient's immune system to better find and destroy cancer cells. Promising results in clinical trials are paving the way to a filing for Food and Drug Administration approval, and potentially, commercialization of its CAR-T therapy, and that's causing investors to flock to this company's stock.

In this clip from The Motley Fool's Industry Focus: Healthcare podcast, analyst Kristine Harjes and contributor Todd Campbell discuss what's at stake for this promising biotech company, and what's next for investors.

Kristine Harjes: Our next one on the dock is Kite Pharmaceuticals, which is up 62% year to date.

Todd Campbell: We've talked about Kite Pharmaceuticals in the past, and I'm sure we're going to talk about it again. This company is making science fiction a reality, being able to take the T cells out of a patient's body, re-engineer them, put them back into the patient's body to find and better destroy cancer cells in certain types of cancer.

And what has really gotten investors excited about Kite Pharma this year is that Kite has now updated investors on the final data from its pivotal registration-ready study for Axi-Cel, which was formerly KTE-C19. Axi-Cel showed almost a third of patients with a form of non-Hodgkin lymphoma who were complete responders to this drug in trials. That's pretty amazing, because...people who were enrolled in this trial were pretty heavily treated and don't have a lot of treatment options. And that data really has everybody thinking they could file for approval. They're supposed to file for approval at the end of this month. And if they do that, they could get accelerated approval. This thing could get on the market before the end of this year, probably with a fairly high price tag, and start being used in thousands of patients as early as next year.

Harjes: And just to add one more detail to the trial data, that 31% of patients that had a complete response, that was after six months. Up until this point, the durability of the response had been a huge unknown. So, that particular note is, I think, what really had people excited for the first couple of months of this year after the data was released. I think that alone is accounting for the majority of this lift.

Campbell: You always hate to say "curative" when it comes to cancer, but you're finally getting to a point now where you're using language that's incredibly encouraging, especially in such a tough group of patients to treat. They did a retroactive analysis on people who were suffering from this disease and found that overall survival, historically, has been about 6.6 months for this patient group. At 8.7 months, they have yet to determine what the overall survival is on Axi-Cel.

Harjes: Which is great news.

Campbell: Yeah, it's very good news. Importantly, the safety profile looks pretty decent. We've talked in the past about how competitor Juno Therapeutics stumbled because of some safety concerns with their competing drug. Kite seems to have avoided that. So, for whatever reason, their drug has proven to be a little bit safer in trials. So, you have good safety, high complete response rate. Little wonder that investors are cheering that this year.