Sobi has announced that Zynlonta (loncastuximab tesirine) has been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment option for two aggressive types of non-Hodgkin lymphoma.
The CD19-directed antibody-drug conjugate (ADC) has specifically been recommended for use in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL).
Those eligible will have received at least two systemic treatments, including Roche’s CD79b-directed antibody-drug conjugate Polivy (polatuzumab vedotin), unless this is contraindicated or not tolerated.
Over 10,000 people are diagnosed with a type of non-Hodgkin lymphoma every year in the UK.
In its final draft guidance, NICE noted the evolving treatment pathway and the need for new treatment options for people with DLBCL and HGBCL.
Sharon Hall, general manager at Sobi UK, said: “We are delighted with the news that NICE has positively recommended this important novel treatment for patients in England and Wales.
“As a chemotherapy-free treatment option with a manageable safety and tolerability profile, Zynlonta has the potential to fulfil an unmet need.”
The regulator’s decision was supported by results from the mid-stage LOTIS-2, which collected data on 145 people with relapsed or refractory DLBCL, including HGBL, that had not responded to two or more previous systemic treatments.
The primary outcome of overall response rate was 48.3%, and 24.8% of patients reached complete remission. Median overall survival was 9.53 months and median progression-free survival was 4.93 months.
“The addition of [Zynlonta] to the NICE-recommended options available for DLBCL and HGBCL is important news for patients with these aggressive forms of non-Hodgkin lymphoma,” said Andrew Davies, professor of haematological oncology at the University of Southampton.
“With its off-the-shelf availability, it provides additional options for patients experiencing rapid progression of disease and requiring urgent care,” he added.
In July 2022, ADC Therapeutics granted Sobi rights to develop and commercialise Zynlonta for all haematologic and solid tumour indications outside of the US, greater China, Singapore and Japan. Under the terms of the agreement outlined at the time, ADC Therapeutics is eligible to receive up to $435m.