Gilead’s Breakthrough CAR-T Becomes First to Get FDA Approval for Indolent Follicular Lymphoma

On March 5th, Kite Pharma, a Gilead Company, announced that Yescarta, a chimeric antigen receptor (CAR) T-cell therapy, has been approved for the treatment of relapsed or refractory follicular lymphoma (FL). Yescarta had previously received FDA Breakthrough Therapy Designation, and it is the first therapy of its kind to be approved for patients with FL.

FL is the second most common type of indolent non-Hodgkin lymphoma, a type of cancer that arises from B-lymphocytes. It accounts for 10-20% of all lymphomas in the Western World. In the US, almost 14,000 new cases of FL are diagnosed each year. Although several first-line treatments are available, most patients will relapse with 5 years. Therefore, highly effective second and third-line treatments are necessary to meet patient’s needs.

Yescarta and the ZUMA-5 Trial

Yescarta is a type of immunotherapy where the patient’s own T-cells are modified in the laboratory to express a chimeric antigen receptor that targets the CD-19 and is linked to two activator domains CD28 and CD3ζ. As a result, the CAR T cells release inflammatory molecules, which kill B lymphocytes.

The safety and efficacy of Yescarta are being tested in the ongoing ZUMA-5 trial, a single-arm, open-label, multicenter clinical trial. Results showed that 91% of patients responded to Yescarta after a single infusion, and 60% of patients achieved full remission. The duration of the remission is still unknown as the trial is still ongoing, but after 18 months, 74% of patients continue to be in remission.

Treatment with Yescarta resulted in 8% of patients developing a Grade 3 or higher cytokine release syndrome, and 21% developed neurologic toxicities.

“As we look to bring the hope of survival to more patients in need, today’s FDA decision represents a real step forward in our commitment to hematologic malignancies,” said Christi Shaw, Chief Executive Officer of Kite Pharma.

“Advancing CAR T therapies for patients across lymphomas remains a cornerstone of our cell therapy development program, and we are excited about the potential of Yescarta for patients with indolent follicular lymphoma.”

Acquisition of Kite Pharma

Gilead acquired Kite Pharma back in 2017 for a staggering $11.9 billion. The purchase was intended to immediately position Gilead as the leader in cell therapy. Gilead used a combination of cash on hand, bank debt, and senior unsecured notes to pay for this deal.

In the years since the purchase, Kite has received three FDA approvals for two different therapeutics. Yescarta has been approved to treat 1) relapsed or refractory follicular lymphoma and 2) relapsed or refractory large B-Cell lymphoma. Additionally, Tecartus was approved in 2020 for the treatment of mantle cell lymphoma.

In 2019, Yescarta sales reached $456 million, almost doubling from 2018. With this new approval, sales of Yescarta may increase. Furthermore, Yescarta is currently multiple other clinical trials for the treatment of other lymphomas. Together with the revenue to be generated by Tecartus, which is also in clinical trials for leukemia and non-Hodgins lymphoma, Gilead may start to see a return to their investment.

Related Article: AbbVie Signs Off-the-Shelf CAR-T Therapy Pact with Jennifer Doudna’s Caribou Biosciences

Author

Daniel Ojeda