ASH: Long-term CAR-T data look good for Gilead—but good enough to top its rivals?

Gilead is counting on sales of Yescarta to top-line gaps as its hep C therapies wane.

ATLANTA—Gilead got a boost over the weekend with some positive longer-term data on closely watched CAR-T drug Yescarta. But whether it’s enough to elevate the drug over its competitors remains to be seen.

Sunday at the American Society of Hematology (ASH) annual meeting, the Big Biotech rolled out results showing that at a median 15.4 months after Yescarta infusion, 42% of previously treated non-Hodgkin’s lymphoma patients were still responding to the therapy, and 40% continued to show complete responses.

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The data set marks an update on results presented in June with a median duration of 8.7 months, and “should be viewed positively, since the updated dataset demonstrates very minimal change in the number of ongoing responses at 15 months duration,” Leerink Partners analyst Geoffrey Porges wrote in a note to clients.

And what’s more, partial responders continued converting to complete responders as far as 15 months post-infusion.

As Porges put it, Yescarta’s “durability excites us,” but it’s still “too early to pick a winner” among the CAR-T treatments competing in the non-Hodgkin’s lymphoma arena. Novartis’ Kymriah, which won the class’ first approval in August as a treatment for a rare form of acute lymphoblastic leukemia, is also in the game with a new lymphoma filing, as is Juno candidate JCAR017.

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"We believe there are still outstanding questions regarding the competitive profiles among” the three drugs, Porges wrote, adding that he wouldn’t yet make adjustments to his Yescarta sales forecast for that reason.

Gilead is counting on Yescarta—a recent pickup from its $12 billion-buyout of Kite Therapeutics—to give its top-line a much-needed boost as its hepatitis C therapies flag. In October, the company—whose hep C sales have been freefalling for some time—tweaked its guidance downward, warning of tough times ahead for the franchise.

Gilead won FDA approval for Yescarta back in October—following Novartis into the field—and priced Yescarta at $373,000 for a one-time treatment. Novartis' Kymriah, which won its initial nod in pediatric and young adult patients with acute lymphoblastic leukemia, costs $475,000 per treatment. Still, Novartis is also going after a use in diffuse large B-cell lymphoma, which would set up a direct showdown with Gilead in certain patients if approved.

CAR-T drugs are made of a patient's own cells that are removed from the body, reengineered and injected back into the patient to recognize and destroy cancers. Aside from the scientific complexities involved are manufacturing and logistical challenges.