Specialised Therapeutics (ST) recently announced that Minjuvi (tafasitamab), in combination with rituximab and lenalidomide, has been registered by the Therapeutic Goods Administration (TGA) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).

The TGA registration establishes Minjuvi as the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen to be approved in Australia for this group of patients.

"While most patients with follicular lymphoma respond well to initial treatment and patients' prognosis has improved, around one in five will see their lymphoma return within two years, which is often linked to poorer long-term outcomes," said Professor Judith Trotman, Senior Staff Specialist and Lymphoma Group Lead in the Haematology Department at Concord Repatriation General Hospital in Sydney. "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."

Follicular Lymphoma (FL) is the second most common form of Non-Hodgkin Lymphoma (NHL), accounting for 20-30 percent of all NHL cases. An estimated 1,500 Australians are newly diagnosed with FL each year.

"The TGA registration of Minjuvi 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," said Professor Trotman.

The TGA registration of Minjuvi, in combination with rituximab and lenalidomide in R/R FL, was based on the results from the global phase-III in MIND clinical study. This trial evaluated the efficacy and safety of the regimen in 652 patients, including 548 participants with R/R FL. Notably, 54 Australians participated across 12 local trial sites across the country.

In the clinical trial, patients receiving the Minjuvi combination regimen achieved a statistically significant and clinically meaningful improvement in median Progression-Free Survival (PFS) of 22.4 months (compared to 13.9 months in patients receiving placebo added to lenalidomide and rituximab)—representing a 57 percent reduction in the risk of disease progression, relapse or death.

Minjuvi was generally well-tolerated, with a manageable safety profile. The most common adverse reactions in the phase-III study (≥20 percent) in patients receiving Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain and cough.