R/R Follicular Lymphoma | Image Credit:
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A supplemental application seeking the approval of an additional indication for tafasitamab (Minjuvi) plus rituximab (Rituxan) and lenalidomide (Revlimid) for the treatment of patients with previously treated follicular lymphoma has been submitted to the Agência Nacional de Vigilância Sanitária (ANVISA), the Brazilian health regulatory agency.1
The submission was supported by results from the phase 3 inMIND trial (NCT04680052).
In June 2025, the FDA approved tafasitamab-cxix (Monjuvi) plus rituximab and lenalidomide for the treatment of patients with relapsed/refractory follicular lymphoma who had a median of 1 prior line of systemic therapy.2 The approval was also supported by data from the inMIND trial, which demonstrated significant prolongation of the median progression-free survival (PFS) with the tafasitamab regimen compared with the control regimen, at 22.4 months (95% CI, 19.2-not evaluable) vs 13.9 months (95% CI, 11.5-16.4), respectively (HR, 0.43; 95% CI, 0.32-0.58; P < .0001).
“This regulatory submission for a new indication for tafasitamab in relapsed or refractory follicular lymphoma highlights our steadfast commitment to bringing innovation and enhancing quality of life and care,” Samira Sakhia, president and chief executive officer of Knight Therapeutics, stated in a news release.1 “If approved, the combination of tafasitamab, rituximab, and lenalidomide will be an important new therapeutic option for eligible adult patients with previously treated follicular lymphoma in Brazil. We look forward to continuing to work towards regulatory submissions and additional countries in Latin America over the next months.”
inMIND Trial Design
The randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of tafasitamab plus rituximab and lenalidomide for the treatment of patients 18 years of age or older with histologically confirmed grade 1, 2, or 3a follicular lymphoma or nodal marginal zone lymphoma (MZL), splenic MZL, or extra-nodal MZL.3 Patients were required to be able and be willing to receive adequate prophylaxis and/or therapy for thromboembolic events, based on the opinion of the investigator. Additionally, patients had previously received at least 1 prior systemic anti-CD20 immunotherapy or chemoimmunotherapy; had documented relapse, were refractory to, or had disease progression after, treatment with systemic therapy; and had an ECOG performance status of 0 to 2.
Patients who had any histology beyond follicular lymphoma and MZL or clinical evidence of transformed lymphoma, prior nonhematologic malignancy, congestive heart failure, hepatitis C virus positivity, chronic hepatitis B virus infection, or history of human immunodeficiency virus were not included in the study. Furthermore, patients with an active systemic infection, had central nervous system lymphoma involvement, any systemic anti-lymphoma and/or investigational therapy within 28 days before starting cycle 1, or prior use of rituximab plus lenalidomide were not permitted on the study.
In the study, published in Blood, patients were randomly assigned to receive either tafasitamab plus rituximab and lenalidomide (n = 273) or placebo (n = 275).4 Patients were either treated with tafasitamab at a dose level of 12 mg/kg or placebo on days 1, 8, 15, and 22 of cycles 1 through 3 and on days 1 and 15 of cycles 4 through 12, with standard dosing of rituximab plus lenalidomide for 12 28-day cycles.
The primary end point was investigator-assessed PFS. Secondary end points included PET complete response (PET-CR), overall survival, PFS by independent review committee, overall response rate (ORR), duration of response (DOR), safety, and time to next treatment (TTNT).
Additional Efficacy Data
The PET-CR rates in the tafasitamab vs placebo arms were 49.4% and 39.8% (P = .029), and the ORR was 83.5% vs 72.4% (P = .0014), respectively. Moreover, the DOR was improved with tafasitamab compared with placebo, with a median DOR of 21.2 months vs 13.6 months (HR, 0.47; 95% CI, 0.33-0.68; P < 0001). Notably, the TTNT was also improved with tafasitamab vs placebo; the median TTNT was not reached compared with 28.8 months in these respective arms (HR, 0.45; 95% CI, 0.31-0.64; P < .0001). OS also trended in favor of tafasitamab, although these data were immature at the cutoff date (HR, 0.59; 95% CI, 0.31-1.13).
References
- Knight Therapeutics announces regulatory supplemental submission of Minjuvi (tafasitamab) for follicular lymphoma in Brazil. News release. Knight Therapeutics. July 31, 2025. Accessed August 1, 2025. https://investors.knighttx.com/English/news/news-details/2025/Knight-Therapeutics-Announces-Regulatory-Supplemental-Submission-of-MINJUVI-tafasitamab-for-Follicular-Lymphoma-in-Brazil/default.aspx
- FDA approves tafastitamab-cxix for relapsed or refractory follicular lymphoma. FDA. June 18, 2025. Accessed August 1, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma
- A phase 3 study to assess efficacy and safety of tafasitamab plus lenalidomide and rituximab compared to placebo plus lenalidomide and rituximab in patients with relapsed/refractory (R/R) follicular lymphoma or marginal zone lymphoma. (InMIND). ClinicalTrials.gov. Updated July 8, 2025. Accessed August 1, 2025. https://clinicaltrials.gov/study/NCT04680052
- Sehn LH, Luminari S, Scholz CW, et al. Tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: results from a phase 3 study (inMIND). Blood. 2024;144(suppl 2):LBA-1. doi:10.1182/blood-2024-212970