- Novartis' cell therapy Kymriah could help treat patients with a type of blood cancer known as follicular lymphoma, potentially supporting the Swiss drugmaker's plans to ask U.S. and European regulators to expand approval of the treatment.
- Early results from a small trial testing the CAR-T therapy in follicular lymphoma were positive, Novartis said Tuesday, without offering specific details. The single-arm study, dubbed ELARA, was designed to test how well Kymriah could clear the cancer in patients who had previously received other treatments.
- Kymriah is already approved to treat acute lymphoblastic leukemia and another, more common type of lymphoma known as diffuse large B-cell. Expanding the drug's use into follicular lymphoma is part of Novartis' plans to widen the market for the complex drug, which has struggled commercially thus far.
Three years on from Kymriah's pioneering approval as the first CAR-T cell treatment, the drug remains a relatively niche product, used for leukemia and lymphoma patients whose cancers have resisted other treatments.
But Novartis, as well as its CAR-T competitor Gilead, have continued to study their therapies in new cancer types as well as in earlier lines of treatment.
Gilead, which sells Yescarta for diffuse large B-cell lymphoma, recently won U.S. approval for Tecartus, a slightly different version of Yescarta that is now cleared for treating patients with mantle cell lymphoma.
Sales of both Yescarta and Kymriah have grown steadily, although neither is yet the blockbuster product their respective makers made them out to be when they were approved.
CAR-T therapies have shown dramatic effectiveness in some patients with few other options. But the treatments are difficult to manufacture, requiring the genetic engineering of immune cells extracted from each patient. Manufacturing is done at several sites scattered throughout the U.S. and Europe, meaning cells must be carefully frozen and shipped from treating hospitals to company plants and back.
Remarkably, neither Novartis nor Gilead have missed a delivery of their respective CAR-T treatments due to the COVID-19 pandemic, according to recent executive comments on earnings calls.
Novartis, which has struggled to produce Kymriah at the correct commercial specifications, has had its manufacturing task made easier by the recent regulatory clearances of factories in Switzerland and France.
The Swiss company plans to submit data from the ELARA trial to the Food and Drug Administration and the European Medicines Agency in 2021. Detailed results will be shared at an upcoming medical meeting, likely the American Society of Hematology's now virtual conference in December.
After diffuse large B-cell, follicular lymphoma is the second most common type of non-Hodgkin lymphoma. Recent approved treatments include Verastem Oncology's Copiktra and Bayer's Aliqopa.