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Gilead’s Kite enters leukemia with Tecartus FDA approval, overlapping Novartis’ CAR-T rival Kymriah

Gilead Sciences’ Kite Pharma has expanded its second CAR-T cell therapy, Tecartus, into a leukemia market that overlaps a Novartis territory for Kymirah.

The FDA cleared Tecartus for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), adding to the drug’s existing indication for previously treated mantle cell lymphoma.

Friday’s go-ahead sets off a small collision between Tecartus and Novartis’ Kymriah. In August 2017, the Novartis CD19-directed drug became the first CAR-T therapy available in the U.S. thanks to an FDA approval for relapsed or refractory B-cell precursor ALL for children and young adults up to 25 years of age.

“Adults with ALL face a significantly poorer prognosis compared to children, and roughly half of all adults with B-ALL will relapse on currently available therapies,” Bijal Shah, M.D., of the Moffitt Cancer Center said in a statement. Shah is an investigator in the Zuma-3 trial, which earned Tecartus the ALL label.

In the single-arm Zuma-3 study, Tecartus eradicated signs of cancer in 65% of 54 evaluable patients after a median follow-up of 12.3 months. More than half of those patients were expected to remain in complete remission beyond 12 months. Among patients who responded to Tecartus, the response lasted a median 13.6 months.

During an update at this year’s ASCO event, the rate of complete remission or complete remission with incomplete hematological recovery reached 71% after a median follow-up of 16.4 months. In all responders, more than half of patients were still alive at that analysis.

Like other CAR-T therapies, Tecartus carries boxed warnings on cytokine release syndrome (CRS)—a dangerous immune overreaction—and neurologic side effects. In Zuma-3, serious CRS happened in 26% of patients who received Tecartus at the target dose, and the rate for serious neurologic events—grade 3 or above—was 35%.

ALL marks the first leukemia indication for Kite’s CAR-T stable. The company’s Yescarta, now the world’s leading CAR-T therapy by sales, boasts approvals in large B-cell lymphoma and follicular lymphoma.

About 1,000 adults are treated annually for relapsed or refractory ALL, with B-cell precursor ALL accounting for roughly 75% of cases, Kite said.

Although Tecartus and Novartis’ Kymriah only have a small overlap in young ALL patients, Kite is running the phase 1/2 Zuma-4 trial, which is enrolling patients 21 years and younger with relapsed or refractory B-ALL.