First chemo-free combination therapy PBS listed in follicular lymphoma

Australians diagnosed with relapsed or refractory follicular lymphoma (FL) will now have access to the first chemotherapy-free, targeted combination treatment listed on the Pharmaceutical Benefits Scheme (PBS), marking a significant advancement in the management of this form of blood cancer.

The PBS listing of Minjuvi (tafasitamab), a CD19-targeting immunotherapy, in combination with Roche’s Rituxan (rituximab) and BMS’ Revlimid (lenalidomide), follows Therapeutic Goods Administration (TGA) approval in April and represents the only dual-targeted immunotherapy combination available for this patient cohort.

Follicular lymphoma is the second most common subtype of non-Hodgkin lymphoma (NHL), accounting for approximately 20%-30% of all NHL cases. Each year, an estimated 1,500 Australians are diagnosed with FL, while up to 600 Australians experience relapsed or refractory disease requiring additional treatment options.

Associate Professor Philip Thompson, Clinical Haematologist at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital in Melbourne, said the PBS listing represented an important step forward for patients and clinicians managing the complexities of recurrent FL.

“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,” explained A/Professor Thompson. “The PBS listing announcement is welcome news for the Australian clinical and patient community, providing us with a new, chemotherapy-free immunotherapy treatment for relapsed or refractory FL.”

The PBS listing is supported by results from the phase 3 inMIND study, which demonstrated that the addition of Minjuvi to Revlimid and Rituxan reduced the risk of disease progression, relapse or death by 57% compared with placebo, Revlimid and Rituxan. The study reported a median progression-free survival of 22.4 months for patients receiving the Minjuvi combination, compared with 13.9 months for those in the control group (p<0·0001). The global clinical trial also included Australian participation, with 54 patients enrolled across 12 local sites.

“Knowing that a chemotherapy-free immunotherapy is now funded by the PBS is an important development for the follicular lymphoma community,” said Sharon Winton, CEO of Lymphoma Australia. “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.”

The commercial pathway for Minjuvi was established through an exclusive distribution agreement between Specialised Therapeutics and Incyte in 2021, covering Australia, New Zealand and Singapore.

Carlo Montagner, CEO of Specialised Therapeutics, said “As the first new therapy to be reimbursed on the PBS for relapsed or refractory (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.”

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