Tafasitamab Combo Approved for r/r Follicular Lymphoma

The US Food and Drug Administration has approved tafasitamab (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory (r/r) follicular lymphoma (FL).

Lenalidomide with rituximab (R²) is already a common, chemotherapy-free option for FL in the first, and especially second, lines. Adding tafasitamab, an anti-CD19 immunotherapy, improved progression-free survival (PFS) from 14.1 to 22.4 months in inMIND, Incyte’s approval trial. 

The triple-agent regimen “may redefine the standard for relapsed patients, especially those not yet eligible for bispecifics or CAR-T, or for use after those therapies,” Khushali Jhaveri, MD, lymphoma specialist at Indiana University in Indianapolis, said in a recent Medscape Oncology commentary. “However,” she cautioned, “whether tafasitamab induces CD19 loss — and potentially affects eligibility for future CAR-T — remains an important open question.” 

Tafasitamab was previously approved with lenalidomide for r/r diffuse large B-cell lymphoma not otherwise specified and ineligible for autologous stem cell transplant.

The inMIND trial randomized 548 patients with grade 1-3a r/r FL to tafasitamab or placebo with R². Patients had a median of one prior line of systemic therapy; 25% and 20% had two, three, or more prior lines, respectively.

Incyte noted in a press release that the PFS benefit with tafasitamab add-on (hazard ratio, 0.43, P < .0001) held regardless of the number of prior treatment lines patients had. 

A third of tafasitamab patients in inMIND had serious adverse events, including serious infections in 24%. Other serious reactions included renal insufficiency (3.3%), second primary malignancies (2.9%), and febrile neutropenia (2.6%); 1.5% of patients died of adverse events.

The most common clinical adverse events were respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common grade 3/4 laboratory abnormalities were decreased neutrophils and lymphocytes.

The recommended dose of tafasitamab with lenalidomide and rituximab is 12 mg/kg IV for a maximum of 12 cycles. Powder for one 200-mg injection costs $1500.12, according to drugs.com. Incyte offers financial assistance to eligible patients. Information is available at www.incytecares.com.

Jhaveri had no relevant financial disclosures. 

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism fellow. Email: [email protected].