Incyte’s previously disclosed phase 3 win in relapsed or refractory follicular lymphoma (R/R FL) sent the company racing to file an expansion bid for its Monjuvi (tafasitamab) by year-end. Now, a clearer picture of the drug’s success in the patient population has been revealed courtesy of a research paper published ahead of this year’s American Society of Hematology Annual Meeting & Exposition.
In the phase 3 inMIND study, Monjuvi—added to Bristol Myers Squibb's Revlimid and Roche's Rituxan—triggered a 57% reduction in the risk of disease progression, relapse or death in R/R FL patients compared with those who were treated with placebo, Revlimid and Rituxan, according to the paper.
Researchers determined a median investigator-assessed progression free survival of 22.4 months for the treatment arm versus 13.9 months for the control group. The benefits in progression-free survival were consistent across subgroups, the researchers said.
In the 548-patient study, 45% of participants had already received at least two prior lines of therapy. Relapse is common for the slow-growing disease, the company has previously noted, raising the need for new therapies. While the overall survival data for the study were too immature to fully analyze, a “trend in favor of” Monjuvi was observed, according to researchers.
In the "conclusions" section of the paper, the researchers said the regimen "represents a potential new standard of care option" for patients with R/R FL.
“This late-breaking presentation provides valuable insights into the potential role of tafasitamab in improving outcomes for FL patients who currently face limited effective treatment options,” Incyte’s head of R&D Pablo J. Cagnoni, M.D, said in a Monday press release.
Incyte is aiming to file a supplementary biologics license for the indication with the FDA by the end of the year, the company pledged in its third-quarter earnings report last month.
Monjuvi won its original accelerated approval from the FDA in 2020 to treat certain patients with relapsed or refractory diffuse large B-cell lymphoma in combination with BMS' Revlimid. During the first nine months of the year, the drug has pulled in $86 million.
A potential approval in R/R FL would provide Monjuvi an opportunity to reach a sizable new patient population. Monjuvi in FL is one of three upcoming launches Incyte is counting on for growth as it prepares for the end-of-decade patent cliff for its top sales driver, Jakafi.
Along with Niktimvo and PD-1 inhibitor Zynyz, the trio is expected to pull in $800 million “or more” by 2029, CEO Hervé Hoppenot said on the company’s recent earnings call.
Incyte took over full rights to Monjuvi from partner MorphoSys in February for $25 million. MorphoSys had previously projected 2024 sales of between $80 million and $95 million for the drug.