The FDA approved Kite Pharma Inc.’s Tecartus (brexucabtagene autoleucel, KTE-X19), the first cell-based gene therapy for adults with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment.

The CAR T-cell therapy’s July 24 approval came more than two weeks ahead of its Aug. 10 PDUFA date.

The approval was based on Tecartus’ phase II Zuma-2 pivotal, multicenter trial of 74 enrolled relapsed or refractory MCL patients who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a Bruton tyrosine kinase inhibitor (ibrutinib or acalabrutinib). The patients were followed for at least six months after their first objective disease response. Data showed a complete remission rate of 62% after treatment and an 87% objective response rate. Of patients evaluable for safety, 18% had grade 3 or higher cytokine release syndrome and 37% experienced grade 3 or higher neurologic toxicities.

The primary endpoint was objective response rate using the Lugano Classification, which is defined as the combined rate of complete response and partial responses as assessed by an independent radiologic review committee.

In December, Kite presented further results from the Zuma-2 study at the American Society of Hematology conference showing that after a single infusion, the best objective response via independent radiologic central review was 93%, with 67% having achieved complete response. The 12-month estimates of progression-free survival and overall survival were 61% and 83%, respectively.

Tecartus’ approval comes with a risk evaluation and mitigation strategy. It will be manufactured in Kite’s commercial facility in El Segundo, Calif.

MCL is a rare form of B-cell non-Hodgkin’s lymphoma. It usually strikes middle-aged or older adults and can be highly aggressive following relapse.

Tecartus received breakthrough therapy designation and priority review status. In January, the EMA validated KTE-X19’s MAA and in February the FDA accepted its BLA while granting a priority review designation.

Mizuho Securities analyst Salim Syed wrote Friday that the approval given ahead of the PDUFA date should “help quell at least in part any concerns that part two of the first wave of COVID-19 cases or the vaccine development race is distracting the FDA from approving important cancer medications.”

Kite, a unit of Foster City, Calif.-based Gilead Sciences Inc., claimed it is the first company with multiple approved CAR T therapies.

Beigene Ltd.’s BTK inhibitor, Brukinsa (zanubrutinib), is approved in the U.S. and China for treating adult patients with MCL who have received at least one prior therapy.

Oncternal Therapeutics Inc., of San Diego, has rights to applications of the naked antibody cirmtuzumab, which it's testing in combination with BTK inhibitor Imbruvica (ibrutinib, Abbvie Inc.). In June, Oncternal won FDA orphan status for cirmtuzumab in the treatment of MCL and chronic lymphocytic leukemia/small lymphocytic lymphoma.

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