FDA Approves Kite’s CAR-T Therapy for Adult Leukemia

Gilead subsidiary, Kite Pharma is racking up FDA approvals for its cell-based gene therapies at an impressive pace. The latest approval from the drug regulator comes for Tecartus (brexucabtagene autoleucel), Kite’s anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, to treat adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL).

This will make Kite’s fourth FDA-approved indication in cell therapy in under four years, said Christi Shaw, CEO of Kite.

“Tecartus has already transformed outcomes for adults living with mantle cell lymphoma, and we look forward to offering the hope for a cure to patients with ALL.”

Providing the Foundation for FDA Approval

The approval is based on the results from Kite’s ZUMA-3 Phase 1/2 study. In the global multicenter study, 65% of the 54 treated patients with ALL achieved complete remission, where their cancers disappeared completely.

The updated Phase 2 data, presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, showed nearly a third (31%) of patients were still responding to treatment at a median follow-up of 16.4 months. Of the responders, 97% were in deep molecular remission, where leukemia cells cannot be found in the bone marrow following tests.

“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,” said Bijal Shah, MD, a ZUMA-3 investigator and medical oncologist at the Moffitt Cancer Center in Tampa, Florida.

“We now have a new meaningful advancement in treatment for these patients. A single infusion of Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.”

Boxed Warning for Tecartus

While the FDA has acknowledged the benefits of Tecartus for ALL, the approval comes with a class-wide Boxed Warning for the risks of cytokine release syndrome (CRS) and neurologic toxicities. About 26% of patients treated at the target dose developed a more severe form of CRS, while neurological toxicity occurred in 35%. The silver lining is that the side effects were generally well-managed. A safety analysis reported in Lancet showed in patients who experienced a neurologic event, 94% of CRS events and 88% of neurologic events were resolved. 

Yescarta on its Way Towards a Third Approval

While Tecartus has secured two FDA approvals, Yescarta, also developed by Kite, may be on its way to collect a third approval. The company last Thursday submitted an application to the FDA to approve Yescarta (axicabtagene ciloleucel or axi-cel) as a second-line treatment for large B-cell lymphoma. 

Yescarta first won approval in October 2017 as a third-line treatment for patients with certain types of relapsed/ refractory large B-cell lymphoma, given when two or more lines of systemic therapy have failed. It bagged a second approval for indolent follicular lymphoma in March 2021. If approved this time, the drug could be provided for patients in the earlier, second-line treatment setting. 

CAR-T Rivals

Ever since Novartis’ Kymriah (tisagenlecleucel) won FDA approval for the first CAR-T therapy in the US in 2017, companies have been trying to get an edge in the market. Kite will have to watch out for Bristol-Myers Squibb’s Breyanzi (lisocabtagene maraleuel or liso-cel), which secured approval as a third-line treatment for relapsed/ refractory large B-cell lymphoma in February 2021.

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Joy Lin

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