Tafasitamab-Based Regimen Scores Australian Approval for R/R Follicular Lymphoma

Australia’s Therapeutic Goods Administration (TGA) has approved tafasitamab (Minjuvi) in combination with rituximab (Rituxan) and lenalidomide (Revlimid) for the treatment of adult patients with relapsed or refractory follicular lymphoma.¹

The regulatory decision was based on data from the phase 3 inMIND trial (NCT04680052), which showed that patients with relapsed or refractory follicular lymphoma who received tafasitamab plus rituximab and lenalidomide (n = 273) achieved a median progression-free survival (PFS) of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared with 13.9 months (95% CI, 11.5-16.4) for patients who received placebo plus rituximab and lenalidomide (n = 275), translating to a 57% reduction in the risk of disease progression or death (HR, 0.43; 95% CI, 0.32-0.58; P < .0001).

“The TGA registration of [tafasitamab] marks an important new advance for patients with relapsed or refractory follicular lymphoma, bringing Australian clinical practice in line with accepted global standards of care,” Judith Trotman, MD, stated in a news release.¹ Trotman is a senior staff specialist at Concord Repatriation General Hospital in Sydney, Australia.

The Australian approval follows the June 2025 FDA approval of tafasitamab-cxix (Monjuvi) in combination with lenalidomide and rituximab for adult patients with relapsed/refractory follicular lymphoma.³ This regulatory decision was also backed by data from inMIND.

How was inMIND designed?

The global, double-blind, randomized study enrolled patients at least 18 years of age with relapsed or refractory grade 1, 2, or 3a follicular lymphoma who received at least 1 prior line of systemic therapy featuring anti-CD20 immunotherapy or chemoimmunotherapy.⁴ The study also included patients with nodal, splenic, or extra nodal marginal zone lymphoma (MZL).

If patients had a prior non-hematologic malignancy; congestive heart failure; HCV positivity; chronic HBV infection; a history of HIV infection; an active systemic infection; or central nervous system lymphoma involvement, they were excluded from the trial.

Patients in the trial were randomly assigned to receive up to 12 28-day treatment cycles of either tafasitamab or a placebo in combination with rituximab and lenalidomide.² Patients received tafasitamab at 12 mg/kg intravenously (IV) on days 1, 8, 15, and 22 of their first 3 cycles and then on days 1 and 15 for the remaining cycles. Lenalidomide was administered to patients at a 20-mg oral dose for days 1 to 21 of every treatment cycle. Finally, IV rituximab was given at 375 mg/m² on days 1, 8, 15, and 22 of cycle 1, then only on day 1 of cycles 2 to 5.

PFS per investigator review served as the trial’s primary end point.⁴ Key secondary endpoints included PFS in the overall population (including those with MZL), overall survival, complete response rate per PET, and safety.

What additional data were reported for tafasitamab in R/R follicular lymphoma?

PFS per independent review committee (IRC) assessment also demonstrated a significant benefit with tafasitamab-based therapy (HR, 0.41; 95% CI, 0.29-0.56).²

Regarding safety, common any-grade adverse effects (AEs) reported with tafasitamab plus rituximab and lenalidomide comprised infections (68%), neutropenia (57%), viral infections (41%), rash (36.4%), asthenia (34.9%), bacterial infections (27%), pyrexia (19%), thrombocytopenia (17%), anemia (17%), infusion-related reactions (15.9%), pruritus (15.6%), and headache (10.4%).

Common serious AEs that occurred in patients included infections (26%), viral infections (13%), bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%).

"While most patients with follicular lymphoma respond well to initial treatment and patients' prognosis has improved, around 1 in 5 will see their lymphoma return within 2 years, which is often linked to poorer long-term outcomes," Judith Trotman, MD, a professor, senior staff specialist, and Lymphoma Group lead in the Haematology Department at Concord Repatriation General Hospital in Sydney, added in a news release.¹ "For these patients, current therapies do not always deliver durable responses, highlighting the urgent need for evidence-based options that can meaningfully extend and improve their lives."

References

1. Minjuvi (tafasitamab) for relapsed or refractory follicular lymphoma approved in Australia. News release. Specialised Therapeutics. April 23, 2026. Accessed April 23, 2026. https://stabiopharma.com/minjuvi-tafasitamab-for-relapsed-or-refractory-follicular-lymphoma-approved-in-australia/
2. Sehn LH, Hübel K, Luminari S, et al. Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial. Lancet. 2026;407(10524):133-146. doi:10.1016/S0140-6736(25)01778-7.
3. FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. FDA. June 18, 2025. Accessed April 23, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma
4. A phase 3 study to assess efficacy and safety of tafasitamab plus lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed/refractory (R/R) follicular lymphoma or marginal zone lymphoma. (InMIND). ClinicalTrials.gov. Updated December 22, 2025. Accessed April 23, 2026. https://clinicaltrials.gov/study/NCT04680052