Months after securing the full rights to anti-CD19 antibody Monjuvi (tafasitamab) from partner MorphoSys, Incyte has the data to potentially back a label expansion into lymphoma.
Monjuvi (tafasitamab), paired with Bristol Myers Squibb's Revlimid and Roche's Rituxan, hit its primary endpoint of progression-free survival by investigator assessment in a phase 3 study in patients with relapsed or refractory follicular lymphoma patients, Incyte reported Thursday. The trial tested the regimen against the combination of placebo, Revlimid and Rituxan.
“While many patients with follicular lymphoma initially benefit from first-line treatment, relapse of the disease is common, underscoring the need for additional therapies,” chief medical officer Steven Stein, M.D., said in the company’s release. “These results demonstrate the potential of tafasitamab added to the standard of care to be a meaningful new treatment option for patients with FL whose disease has progressed after at least one prior therapy.”
With the results in hand, Incyte plans to file for a follicular lymphoma approval by the end of the year, specifically for patients who have failed at least one prior systemic anti-CD20 immunotherapy or chemotherapy. The company will also submit the full data for a presentation at an upcoming scientific meeting.
A label expansion could be key for the drug, which pulled $92 million last year. Follicular lymphoma is the most common slow-growing form of B-cell non-Hodgkin lymphoma and makes up some 13% to 26% of overall non-Hodgkin lymphoma cases, according to Incyte.
Additionally, the company has said that it is testing Monjuvi in first-line relapsed or refractory diffuse large B cell lymphoma and marginal zone lymphoma. Those studies are needed to drive growth, analysts at William Blair previously wrote in a note to clients.
Monjuvi launched after receiving accelerated approval from the FDA in 2020 to treat specific patients with relapsed or refractory diffuse large B-cell lymphoma in combination with Revlimid. Incyte picked up full global rights to the drug from MorphoSys in February for $25 million. Before that, the two had partnered on clinical development and commercialization, while Incyte had exclusive rights outside of the U.S.
MorphoSys previously projected 2024 sales of between $80 million and $95 million for Monjuvi. The two companies originally predicted peak U.S. sales of €500 million to €700 million from the drug’s current indication alone.