A Roche drug that treats follicular lymphoma by going after two targets simultaneously is now approved in Europe, making it the first drug in its class awarded marketing authorization for this form of cancer.
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The European Commission approved the drug, mosunetzumab, for treating adults whose follicular lymphoma has relapsed or has not responded to at least two earlier treatments, Roche said Thursday. The Swiss pharmaceutical giant will market its new cancer drug under the name “Lunsumio.”
Follicular lymphoma is a slow-growing form of non-Hodgkin lymphoma, a type of cancer in which the body makes abnormal B lymphocytes, a type of white blood cell. Relapse is common. When this cancer does not respond to radiation and chemotherapy, further treatment can include chemo combined with antibody drugs that target the protein CD20 on cancerous B cells. Such therapies include two Roche drugs, Rituxan and Gazyva (Gazyvaro in the European Union and Switzerland). Roche takes that approach a step further with Lunsumio, a bispecific antibody. While one arm of the drug targets CD20, the other targets CD3, a protein on the surface of T cells. By going after both targets simultaneously, the drug is meant to get a patient’s T cells to eliminate the cancerous B cells.
The European regulatory decision for Lunsumio is based on the results of a Phase 1/2 study that 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 effect reported was an immune response called cytokine release syndrome. Roche said that this effect was generally low grade and resolved by the end of the treatment.
Other adverse effects reported in the clinical trial include low levels of a type of white blood cell called a neutrophil, fever, low phosphorous levels in the blood, and headache. Results from the study were presented last December at the annual meeting of the American Society of Hematology. At that time, Roche said it planned a regulatory submission with the FDA “in the near future.”
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Treatments for advanced follicular lymphoma come with risks. The approved uses of a drug class called PI3K inhibitors include follicular lymphoma, though some companies that make such drugs have voluntarily withdrawn them from the U.S. market amid FDA scrutiny about potential toxicity.
Gilead Sciences’ CAR T cell therapy Yescarta, which is made by engineering a patient’s own T cells, added follicular lymphoma as an approved indication a little more than a year ago. But like other CAR T therapies, Yescarta’s safety risks include cytokine release syndrome and neurotoxicity. Also, the multi-step manufacturing process for a CAR T therapy can take weeks. Roche notes that Lunsumio is an “off-the-shelf” drug that is readily available.
“Having additional treatment options for people with follicular lymphoma, where multiple prior lines of therapy have failed, is critical to help them achieve better outcomes,” Elizabeth Budde, hematologic oncologist and associate professor at City of Hope, said in a prepared statement. “It is exciting to have a new class of immunotherapy like Lunsumio, offering a readily available, chemotherapy-free and fixed-duration treatment, with great potential to provide durable remissions without the need to stay on treatment continuously.”
The European marketing authorization for Lunsumio is a conditional one, a type of regulatory decision reserved for products that address an unmet medical need. Conditional marketing authorizations are made when the benefit of making the drug available sooner outweighs the risk of evaluating a drug with less data than is typically required in a standard review. But this new Roche drug does have competition on the way. Two weeks ago, Novartis’s Kymriah added follicular lymphoma to that CAR T therapy’s approved indications. Also, MEI Pharma antibody drug zandelisib is in pivotal testing in follicular lymphoma.
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