New Chemotherapy-Free Immunotherapy Combination for Follicular Lymphoma Listed on the PBS
Key Insights
Minjuvi (tafasitamab) combined with rituximab and lenalidomide becomes the first chemotherapy-free CD19 (search)/CD20 (search) dual-targeted immunotherapy listed on Australia's PBS for relapsed or refractory follicular lymphoma (search).
The pivotal Phase 3 inMIND trial demonstrated a 57% reduction in risk of disease progression, relapse, or death, with median PFS of 22.4 months versus 13.9 months in the control arm (HR: 0.43; P<0.0001).
This marks the first new therapy reimbursed on the PBS for relapsed or refractory follicular lymphoma (search) in nine years, effective 1 August 2026.
Specialised Therapeutics (search) (ST) has announced that Minjuvi (tafasitamab), in combination with rituximab and lenalidomide, is now listed on Australia's Pharmaceutical Benefits Scheme (PBS) for the treatment of adults with relapsed or refractory follicular lymphoma (search) (R/R FL) Grade 1-3a. Effective 1 August 2026, this marks the first and only chemotherapy-free CD19 (search) and CD20 (search) dual-targeted immunotherapy combination regimen funded in Australia for this patient population, and the first new therapy reimbursed on the PBS for R/R FL in nine years.
The PBS listing follows the Therapeutic Goods Administration (TGA) registration of Minjuvi for R/R FL in April 2026, achieved via the Project Orbis process. ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) in 2021 to commercialise Minjuvi in Australia, New Zealand, and Singapore.
Clinical Evidence from the inMIND Trial
The PBS reimbursement is supported by data from the pivotal Phase 3 inMIND study (NCT04680052), a global, double-blind, randomised, placebo-controlled trial that evaluated the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide versus placebo plus rituximab and lenalidomide. The study enrolled 654 adults, including 548 participants with R/R FL, with 54 Australians participating across 12 local trial sites.
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS). Patients receiving the Minjuvi combination achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2–not evaluable [NE]) compared to 13.9 months (95% CI, 11.5–16.4) in the control arm, corresponding to a hazard ratio of 0.43 (95% CI, 0.32–0.58; P<0.0001). This represents a 57% reduction in the risk of disease progression, relapse, or death.
Results assessed by an Independent Review Committee (IRC) were consistent with investigator-based findings. Median PFS by IRC was not reached (95% CI, 19.3–NE) in the Minjuvi group versus 16.0 months (95% CI, 13.9–21.1) in the placebo group (HR: 0.41; 95% CI, 0.29–0.56).
Safety Profile
Minjuvi was generally well-tolerated with a manageable safety profile. In the inMIND study, the most common adverse reactions (≥20%) in patients receiving Minjuvi, excluding laboratory abnormalities, included respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common adverse reactions overall included infections (68%), neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion-related reaction (15.9%), pruritus (15.6%), and headache (10.4%). Serious adverse reactions included infections (26%), febrile neutropenia (2.8%), and pyrexia (1.8%). Treatment with tafasitamab can cause serious or severe myelosuppression, and complete blood counts should be monitored throughout treatment.
Disease Burden and Unmet Need
Follicular lymphoma (search) is the second most common non-Hodgkin lymphoma (NHL), with over 10,000 Australians living with the disease and approximately 1,500 new diagnoses each year. Associate Professor Philip Thompson, Clinical Haematologist at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, noted: "While follicular lymphoma can be a slow-growing disease that usually responds well to the first treatment, most patients are not cured. Many patients experience frequent relapses and require multiple therapies over their lifetime, which become progressively less effective, especially for those whose disease comes back soon after initial chemotherapy treatment."
Treatment Regimen and Mechanism of Action
Minjuvi is a humanised Fc-modified cytolytic CD19 (search)-targeting monoclonal antibody incorporating an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In combination with rituximab (targeting CD20 (search)) and lenalidomide, the regimen delivers a complementary immune-mediated approach.
Minjuvi is administered via intravenous infusion in a clinic or hospital setting. Patients receive up to 12 treatment cycles of Minjuvi, alongside oral lenalidomide capsules, while rituximab is delivered intravenously for the first five cycles.
Community Impact
Sharon Winton, Chief Executive Officer of Lymphoma Australia, stated: "Knowing that a chemotherapy-free immunotherapy is now funded by the PBS is an important development for the follicular lymphoma (search) community. As patients manage the challenges of recurring disease, this new treatment milestone offers a valuable option that is deeply meaningful to them and their families."
Carlo Montagner, ST Chief Executive Officer, added: "As the first new therapy to be reimbursed on the PBS for R/R FL in nine years, we are extremely proud to have partnered with Incyte to bring Minjuvi to Australia. After securing TGA registration for Minjuvi in R/R FL earlier this year, we have been focused on expediting PBS listing to ensure eligible Australian patients could have subsidised access to a new treatment option that may help lower the risk of disease progression, relapse or death, without delay."