Novartis isn’t giving up on its CAR-T therapy Kymriah despite a recent high-profile trial flop. The drug has just scored an FDA nod that allows it to compete with Gilead Sciences’ rival, Yescarta, in the most common indolent lymphoma.
Late Friday, Novartis said the FDA has granted an accelerated approval for Yescarta to treat patients with follicular lymphoma after two or more lines of therapy.
The latest indication adds onto Kymriah’s existing label for previously treated acute lymphoblastic leukemia and large B-cell lymphoma after two or more lines of systemic therapy. It comes more than a year after Yescarta became the first CAR-T therapy to enter follicular lymphoma.
Kymriah won over the FDA with data from the single-arm, phase 2 ELARA trial. After a median follow-up of about 17 months, 86% of patients who received Kymirah achieved a response, including 68% who saw their cancer completely gone in a complete response.
Among those who did achieve a complete response, an estimated 85% of patients would still be in response after another 12 months.
By comparison, in Yescarta’s ZUMA-5 trial, the Gilead CAR-T therapy triggered a response in 91% of follicular lymphoma patients after a median follow-up of 17.5 months, including 79% who experienced a complete response. About 74% of patients were estimated to have their tumors in continued remission after another 18 months.
As for safety, Novartis reported 53% of patients experienced cytokine release syndrome, a potentially dangerous immune overreaction commonly seen with CAR-T therapies. None of the cases were grade 3 or higher. The rate for grade 3 or higher neurologic toxicities, another common side effect of CAR-T drugs, came in at 6% for Kymriah in ELARA.
Grade 3 side effects are severe, while grade 4 side effects are potentially life threatening.
As for Yescarta, Gilead recorded grade 3 or higher cytokine release syndrome and neurologic side effects in 8% and 21% of patients, respectively, in the ZUMA-5 study.
Though not as big an indication—or as aggressive—as large B-cell lymphoma, follicular lymphoma is the most common indolent lymphoma and the second most prevalent type of lymphoma globally. Patients with follicular lymphoma could on average receive four lines of treatment, with some getting as many as 13 lines, according to Novartis.
“We hope this treatment option that has the potential for long-lasting results may help break the unrelenting cycle of treatment for patients with follicular lymphoma,” Victor Bulto, president of Novartis Innovative Medicines U.S., said of Kymriah in a statement.
Although Kymriah has now matched Yescarta in follicular lymphoma, the Novartis CAR-T therapy likely won’t be able to compete with the Gilead rival in a more important market: large B-cell lymphoma after one prior therapy.
Yescarta in April won a first-in-class nod to move up the treatment line into second-line large B-cell lymphoma, an indication that RBC Capital Market analysts have figured could bring the drug $1.5 billion in peak sales.
Bristol Myers Squibb’s CAR-T therapy, Breyanzi, expects an FDA decision on the same topic in June. But in a surprising failure, Kymriah didn’t move the needle in that setting.