On June 27, 2023 Independent biopharmaceutical company Specialised Therapeutics (ST) reported that a new therapy to treat the most common type of non-Hodgkin lymphoma in adults – diffuse large B-cell lymphoma – is now approved for use in Australia (Press release, Specialised Therapeutics Asia, JUN 27, 2023, View Source [SID1234632939]).

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The Therapeutic Goods Administration (TGA) has provisionally approved MINJUVI (tafasitamab) "in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT)".[1]

Australian lymphoma specialist and current chair of the Australasian Lymphoma Alliance, Professor Chan Cheah, said the MINJUVI approval was a great step forward for patients who had been diagnosed with DLBCL and relapsed, as the MINJUVI regimen provides an opportunity for longer-term disease management.

"I think it is great news for patients," Professor Cheah said. "We do have chemotherapy options and we cure about two-thirds of patients using that approach. Unfortunately, a substantial proportion of patients either don’t respond to chemotherapy, or the disease comes back after chemotherapy, and they need better treatments."

MINJUVI, a CD19-targeting immunotherapy that works by attaching to a protein on the surface of B-cell lymphoma cells, stimulating an immune response against the lymphoma, is also approved in the United States [as Monjuvi (tafasitamab-cxix)], Great Britain, Canada, Europe and other countries.

Professor Cheah added: "Access to novel immune therapies like MINJUVI is really important for Australian patients. Apart from CAR-T cell therapies – and these are only applicable to a certain proportion of patients with DLBCL – there have been no novel therapies for relapsed DLBCL approved in Australia. MINJUVI has a favourable side effect profile and (combined with lenalidomide) has demonstrated a high response rate in patients with relapsed disease. We now need to see it listed on the Pharmaceutical Benefits Scheme."

MINJUVI has been approved via a provisional regulatory pathway, with the TGA participating in the Modified Project Orbis initiative to accelerate availability to Australian patients. The approval was based on data from the Phase 2 L-MIND study, an open label, multi-center single arm study which evaluated its safety and efficacy in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who were not eligible for ASCT.[1,3]

Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory Phase 3 frontMIND study which has completed enrollment.[4]

Recently, five-year follow up data were presented which showed that MINJUVI plus lenalidomide followed by MINJUVI monotherapy provided prolonged, durable responses in adult patients with relapsed or refractory DLBCL. The overall response rate (ORR) was 57.5% with a complete response (CR) observed in 41.2% of patients, and a partial response (PR) in 16.2% of patients. The median overall survival was 33.5 months and median progression-free survival (PFS) was 11.6 months.[2] The most common adverse reactions with MINJUVI are infections (73%), neutropenia (51%), asthenia (40%), anaemia (36%), diarrhoea (36%), thrombocytopenia (31%), cough (26%), oedema peripheral (24%), pyrexia (24%), decreased appetite (22%). The most common serious adverse reactions were infection (26%) including pneumonia (7%), and febrile neutropenia (6%).[1]

ST Chief Executive Officer Mr. Carlo Montagner said securing TGA approval was a key regulatory milestone for the company, noting that the therapy was synergistic with the company’s mission to provide therapies that addressed unmet needs in rare patient populations.

"We are delighted to successfully register MINJUVI for Australian patients and look forward to working with the lymphoma community to ensure it is available at the earliest opportunity," he said.

ST markets MINJUVI under an exclusive distribution arrangement with international partner Incyte (NASDAQ: INCY).