A Roche drug that treats follicular lymphoma by targeting two targets at the same time is now approved in Europe, making it the first of its kind to be licensed for this type of cancer.
Roche said Thursday that the European Commission approved the drug, mosunetzumab, to treat adults with relapsed follicular lymphoma or who have not responded to at least two earlier treatments. The Swiss pharma giant will market its new cancer drug under the name “Lunsomio”.
Follicular lymphoma is a slow-growing form of non-Hodgkin lymphoma, a cancer in which the body produces abnormal B lymphocytes (a type of white blood cell). Relapses are common. When the cancer does not respond to radiation and chemotherapy, further treatment can include chemotherapy with antibody drugs that target the CD20 protein on cancer cells’ B cells. Such therapies include two Roche drugs, Rituxan and Gazyva (Gazyvaro in the EU and Switzerland). Roche takes this approach a step further with the bispecific antibody Lunsomio. One arm of the drug targets CD20 and the other arm targets CD3, a protein on the surface of T cells. By tracking two targets at the same time, the drug is designed to allow a patient’s T cells to deplete cancer cells’ B cells.
The European regulatory decision for Lunsumio was based on results from a Phase 1/2 study, which showed a 60% complete response rate (54 of 90 patients) after a median follow-up of 18.3 months. The objective response rate was 80% (72 of 90 patients). The median duration of response was 22.8 months. The most common adverse reaction reported was an immune response called cytokine release syndrome. This effect is usually low-grade and resolves at the end of treatment, Roche said.
Other adverse reactions reported in clinical trials included low levels of a type of white blood cell called neutrophils, fever, low phosphorus levels in the blood and headache.The results of this study are came up with at the annual meeting of the American Society of Hematology last December. At the time, Roche said it planned to submit regulatory filings to the FDA “in the near future.”
Treatment of advanced follicular lymphoma carries risks. Approved uses for a class of drugs called PI3K inhibitors include follicular lymphoma, although some companies that make such drugs have voluntarily pulled them from the U.S. market. FDA Review of Potential Toxicity.
Gilead Sciences’ CAR T-cell therapy Yescarta is made by engineering a patient’s own T cells, Follicular lymphoma was added as an approved indication more than a year agoBut like other CAR T therapies, Yescarta’s safety risks include cytokine release syndrome and neurotoxicity. Additionally, the multi-step manufacturing process for CAR T therapies can take weeks. Roche noted that Lunsumio is an off-the-shelf drug that is readily available.
“Providing patients with follicular lymphoma with additional treatment options is critical to helping them achieve better outcomes,” Elizabeth Bude, a hematologic-oncologist and associate professor at City of Hope, said in a prepared statement. “It’s exciting to have a novel immunotherapy like Lunsumio, which offers an off-the-shelf, chemotherapy-free, fixed-duration treatment with great potential to provide durable remission without the need for ongoing treatment.”
European marketing authorization for Lunsumio is conditional, a regulatory decision reserved for products that address an unmet medical need. Conditional marketing authorization is granted when the benefits of bringing a drug to market earlier outweigh the risks of using less data than is typically required for a standard review to assess the drug’s risks. But this new Roche drug does have competition.Two weeks ago, Novartis Kymriah increases follicular lymphoma Approved indications for CAR T therapy. In addition, MEI Pharma’s antibody drug zandelisib is undergoing pivotal testing in follicular lymphoma.
Photo: Giuseppe Aresu, Bloomberg via Getty Images
