Novartis is gunning for its third Kymriah indication, and Saturday it posted new data that just might win over regulators. But by the time the CAR-T therapy gets to tackle its new market, it may have to face down a familiar foe in Gilead Sciences' Yescarta.
In phase 2 study results presented Saturday at the American Society of Hematology (ASH) virtual annual meeting, Kymriah showed it could erase all signs of cancer in 65% of previously treated follicular lymphoma (FL) patients and spur a response in 83%.
Patients in the study, called Elara, were evaluated after at least three months of follow-up. But among those whose cancer had vanished after treatment, the median follow-up was much longer at 9.9 months, and 90% of those who achieved complete responses sustained those responses for six months or more, John Tsai, M.D., Novartis’ chief medical officer, said.
Follicular lymphoma—the second most common form of non-Hodgkin lymphoma, representing 22% of cases—“has been considered an incurable disease, with a very relapsing-remitting pattern,” Tsai said. “Patients progress; what often happens is they get multiple lines of therapy because they’re cycling through.”
With each line of treatment, patients become more and more intolerant to therapy and harder to treat, Tsai said, noting that most try five lines, and some get up to 12. “Any advance in this area is really seen as a breakthrough,” he added.
Novartis is hoping global regulators see things similarly. The company said in August that it plans to submit the data to the FDA and European Medicines Agency next year.
If Kymriah can bag a label expansion, FL will join diffuse large B-cell lymphoma (DLBCL) and pediatric acute lymphoblastic leukemia on the drug's list of approvals.
But while Kymriah leads CAR-T archrival Yescarta in terms of indication count, Gilead’s contender is leading the sales race—and the Big Biotech doesn’t intend to make it easy for Novartis in FL, either.
Saturday at ASH, Gilead's Kite Pharma highlighted its own CAR-T win in previously treated indolent non-Hodgkin lymphoma (iNHL), a group of diseases that encompasses FL. Ninety-two percent of Yescarta patients in the phase 2 Zuma-5 study benefited from Yescarta treatment, with 76% seeing their cancers completely disappear.
“It’s very promising data we’re excited to be sharing,” said Ibrahim Elhoussieny, VP and head of medical affairs for Kite, adding that “there’s a high level of excitement” about the results within the scientific community, too.
Importantly, Yescarta also showed safety results in iNHL that appeared to be better than what the drug has posted in DLBCL, with a lower instance of the more serious neurological side effects.
“We’re hearing scientific experts starting to … [see] Yescarta treatment [as] an option to potentially consider for the outpatient setting” in iNHL, which could make the drug a particularly appealing option at a time when the COVID-19 pandemic is straining hospitals.
Yescarta bears an FDA breakthrough therapy designation in FL and marginal zone lymphoma, and the agency is set to make decisions on those new indications by March 5—meaning Yescarta will likely have the head start on Kymriah in the FL market, not to mention broader use potential in the wider iNHL field.