Tafasitamab Combo Now a Preferred Regimen for DLBCL Following NCCN Guidelines Update

Tafasitamab-cxi (Monjuvi) administered in combination with lenalidomide (Revlimid) is now listed as the preferred regimen to treat patients with diffuse large B-cell lymphoma (DLBCL) who are not candidates for transplant in the second-line setting, according to a press release by MorphoSys U.S., Inc, highlighting an update to the National Comprehensive Cancer Network Clinical (NCCN) Practice Guidelines in Oncology for B-cell Lymphomas.¹

"Updates to NCCN Guidelines are made periodically when additional efficacy and safety data are available, providing current information on the use of cancer therapies," said Joe Horvat, U.S. General Manager, MorphoSys. "Monjuvi is a targeted immunotherapy that addresses an immediate medical need for certain adult patients living with diffuse large B-cell lymphoma. We are gratified the NCCN panel acknowledged the additional data submitted for Monjuvi and updated the designation of Monjuvi in combination with lenalidomide to a preferred regimen in its Clinical Practice Guidelines in Oncology."

Tafasitamab’s inclusion as a preferred treatment in combination with lenalidomide comes 2 years after the FDA granted approval to the regimen for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma, and patients who are not eligible for autologous stem cell transplant (ASCT). The combination of tafasitamab and lenalidomide was granted approval based on results from the phase 2 L-MIND clinical trial (NCT02399085) in which the combination achieved a 58.5% objective response rate with a complete response rate of 41.3%. Further, tafasitamab/lenalidomide had a 346-month duration or response.

Recently, results were reported from the observational, retrospective RE-MIND study (NCT04697160) of tafasitamab plus lenalidomide in ASCT-ineligible patients with relapsed/refractory DLBCL versus standard therapy options like polatuzumab vedotin (Polivy) plus bendamustine and rituximab (Rituxan; Pola-BR) or rituximab plus lenalidomide (R2), and chimeric antigen receptor (CAR) T-cell therapy.²

The study matched patients across 9 variables, which including age, number of prior therapies, prior ASCT, ECOG performance status, and whether patients were primary refractory or refractory to last therapy line. After matching, 24 patients were in the Pola-BR arm, 33 were in the R2 arm, and 37 were in the CAR T-cell therapy arm.

In the study, tafasitamab/lenalidomide prolonged the median overall survival (OS) compared with standard treatments. The median OS observed with tafasitamab/lenalidomide was 20.1 months (95% CI, 8.6–not reached [NR]) compared with 7.2 months (95% CI, 4.9-11.6) with Pola-BR in matched patients with DLBCL (HR, 0.441; 95% CI, 0.203-0.956; P =.0340).

In the patients who matched those treated with R2 in the real-world setting, tafasitamab plus lenalidomide achieved a median OS of 24.5 months (95% CI, 12.1-NR) versus 7.4 months (95% CI, 4.2-11.1) with R2 (HR, 0.435; 95% CI, 0.224-0.847; P =.0122). Finally, the median OS was 22.5 months with tafasitamab plus lenalidomide compared with 15.0 months (HR, 0.953; 95% CI, 0.475-1.913; P =.8915) with CAR T cells.

Tafasitamab plus lenalidomide also demonstrated better responses compared with all 3 standard DLBCL treatments with response durability.

According to data from L-MIND, treatment with tafasitamab plus lenalidomide is a well-tolerated regimen in patients with relapsed/refractory DLBCL who were ineligible for ASCT. The most common grade ≥ 3 treatment-emergent adverse events (AEs) were neutropenia (48%), thrombocytopenia (17%), and febrile neutropenia (12%). Serious AEs were seen in 51% of patients, with the most frequent being pneumonia (6%), febrile neutropenia (6%), pulmonary embolism (4%), bronchitis (2%), atrial fibrillation (2%), and congestive cardiac failure (2%).³

_REFERENCES:

_{1. National Comprehensive Cancer Network(R) updates designation of Monjuvi(R) (tafasitamab-cxix) to preferred regimen in its clinical practice guidelines in oncology for b-cell lymphomas. News release. MorphSys U.S., Inc. https://bit.ly/3N0TxBC}

_{2. Nowakowski GS, Yoon DH, Mondello P, et al. Tafasitamab plus lenalidomide versus Pola‑BR, R2, and CAR T: comparing outcomes from RE-MIND2, an observational, retrospective cohort study in relapsed/refractory diffuse large B-cell lymphoma. Presented at: 2021 ASH Annual Meeting and Exposition; December 11-14, 2021; Atlanta, GA. Abstract 183.}

_{3. Salles G, Duell J, Barca EG, et al. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020;21(7);978-988. doi: 10.1016/S1470-2045(20)30225-4}