Incyte has reported that its pivotal Phase III frontMIND study showed benefits when Monjuvi / Minjuvi (tafasitamab) was combined with lenalidomide and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; Tafa-Len-R-CHOP) to treat high-risk diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL).
The combination was evaluated as a first-line treatment in adults with previously untreated DLBCL or HGBL.
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Eligible patients had an International Prognostic Index (IPI) score of three to five or an age-adjusted IPI of two to three for patients 60 years or younger.
The double-blind, placebo-controlled, randomised trial compared Tafa-Len-R-CHOP to R-CHOP alone, the current standard of care, for efficacy and safety.
Incyte executive vice-president, chief medical officer and late-stage development head Steven Stein said: “These frontMIND data reinforce the potential of Tafa-Len-R-CHOP to meaningfully change the first-line treatment landscape for patients with high-risk DLBCL or HGBL, for which outcomes have remained unchanged for decades.
“With encouraging efficacy observed across prespecified subgroups regardless of cell-of-origin (COO) molecular subtype, we believe these findings position this therapy as a compelling potential new standard of care and support our continued efforts to bring it to patients who are in need of other efficacious treatment options.”
The trial data demonstrated a 25% reduction in risk of disease progression or death with Tafa-Len-R-CHOP and progression-free survival (PFS) gains of 8.2% and 6.6% at two and three years, respectively, versus R-CHOP.
Positive results were observed across all prespecified subgroups by lymphoma and molecular subtype. Event-free survival also improved significantly, and interim analysis showed a trend towards improved overall survival.
The minimal residual disease-negativity rate was higher with Tafa-Len-R-CHOP (81.3%) compared to R-CHOP (66.7%).
Tafa-Len-R-CHOP was generally well tolerated. The most frequent treatment-emergent adverse events were neutropenia (70.7%), anaemia (46.3%), and peripheral neuropathy (40.6%).
Safety was consistent with expectations, and event rates for study drug discontinuation were similar across both cohorts.
The trial enrolled 899 adults and assessed PFS as the primary endpoint according to Lugano 2014 criteria, with secondary endpoints such as event-free and overall survival.
