Incyte's Combination Therapy Meets Primary Goal in Late-Stage DLBCL Trial, Paving Way for First-Line Approval
Incyte Corporation announced that its experimental combination therapy of tafasitamab and Bristol Myers Squibb's lenalidomide added to standard R-CHOP chemotherapy met its primary endpoint of progression-free survival in a late-stage trial of approximately 900 newly diagnosed diffuse large B-cell lymphoma patients. The company plans to seek expanded U.S. approval for first-line treatment in the first half of the year, with analysts projecting potential annual sales of $500 million to $1 billion if the therapy captures 15 to 20 percent of the first-line market.
Insights:
Incyte Corporation announced on Monday that its experimental combination therapy met its primary goal of improving progression-free survival in a late-stage clinical trial, positioning the company to pursue expanded approval for treating newly diagnosed diffuse large B-cell lymphoma patients. The trial tested tafasitamab combined with Bristol Myers Squibb's lenalidomide added to standard R-CHOP chemotherapy in approximately 900 adults newly diagnosed with DLBCL, the most common type of non-Hodgkin lymphoma in adults worldwide, accounting for about 40 percent of cases.
Patients receiving the combination therapy lived longer without disease worsening compared with those receiving standard treatment alone, according to the trial results. This progression-free survival benefit represents a significant clinical milestone for Incyteas the company prepares to seek expanded U.S. approval for the treatment as a first-line therapy for newly diagnosed patients in the first half of the year. Currently, tafasitamab, marketed as Monjuvi, has received accelerated approval only in combination with lenalidomide for patients whose disease has returned or did not respond to earlier treatment and who are not eligible for stem cell transplant.
