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.
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In this clip from The Motley Fool's Industry Focus: Healthcarepodcast, analyst Kristine Harjes and contributor Todd Campbell discuss what's at stake for this promising biotech company, and what's next for investors.
A transcript follows the video.
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Kristine Harjes:Our next oneon the dock isKite Pharmaceuticals, which is up62% year to date.
Todd Campbell:We'vetalked about Kite Pharmaceuticals in the past, and I'm sure we're going to talk about it again. Thiscompany 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 andbetter destroy cancer cells in certain types of cancer.
Andwhat has really gotten investors excited about Kite Pharma this year is that Kite has now updated investors on the final data from itspivotal registration-ready study for Axi-Cel, which was formerly KTE-C19. Axi-Cel showed almost a third of patients with a form ofnon-Hodgkin lymphomawho were complete responders to this drug in trials. That'spretty amazing, because...people who were enrolled in this trial werepretty heavily treated and don't have a lot of treatment options. And that data really has everybody thinking they couldfile for approval. They'resupposed to file for approval at the end of this month. And if they do that,they could get accelerated approval. This thingcould 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:Andjust to add one more detail to the trial data, that31% of patients that had acomplete response, that was after six months. Up until this point, the durability of the response had been a huge unknown. So, thatparticular note is,I think, what really hadpeople excited for the first couple of months of this yearafter the data was released. I think that alone isaccounting for the majority of this lift.
Campbell:Youalways hate to say "curative" when it comes to cancer,but you're finally getting to a point now where you're usinglanguage that's incredibly encouraging,especially in such a tough group of patients to treat. They did aretroactive analysis on people who were suffering from this disease and found thatoverall survival,historically, has been about6.6 months for this patient group. At 8.7 months, theyhave 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 lookspretty decent. We've talked in the past about howcompetitorJuno Therapeuticsstumbled because of some safety concerns with their competing drug. Kiteseems to have avoided that. So,for whatever reason, their drug hasproven 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.