Roche’s immunotherapy drug shows promising results for Australian patients with rare blood cancer

Pharma News: Roche’s immunotherapy drug has shown high response rates in patients with a rare form of blood cancer that had relapsed or become resistant to previous treatments.

In a clinical trial led by Peter MacCallum Cancer Centre, patients with mantle cell lymphoma (MCL) were treated with Roche’s Columvi (glofitamab), a bispecific monoclonal antibody, yielding promising results.

Professor Michael Dickinson, a Haematologist who heads the Aggressive Lymphoma stream at Peter Mac, emphasised the significance of the findings, saying that “complete responses” were observed in a majority of patients, despite their cancer remaining uncontrolled after an average of two prior treatments.

A complete response, where the blood cancer became undetectable, was achieved in 78% of participants, while the overall response rate – combining complete and partial responses – was 85%.

“These are impressive results in a group of patients with heavily pre-treated MCL, a cancer that is usually considered incurable,” said Professor Dickinson. “The exciting responses we’ve observed suggest a potential shift in practice, however, a larger Phase III clinical trial is underway globally and its results are eagerly awaited.”

Notably, positive responses were also seen in a particularly hard-to-treat group of MCL patients: those who had relapsed after treatment with a BTKi (bruton tyrosine kinase inhibitor) drug, typically facing a poor prognosis. In this subset, the complete response rate was 71%, with an overall response rate of 74%, far surpassing the lower response expected from chemotherapy, the current standard treatment.

In this Phase I/II trial, patients were pre-treated with Roche’s Gazyva (obinutuzumab) before receiving Columvi, in an effort to minimise the risk of cytokine release syndrome (CRS) – a common and potentially severe immune system overreaction. While CRS was still observed in 70% of participants, Professor Dickinson noted it was “manageable with appropriate support.”

Mantle cell lymphoma is an aggressive and relatively rare type of non-Hodgkin lymphoma, with around 500 Australians expected to be diagnosed with MCL this year, accounting for approximately 5% to 10% of all non-Hodgkin lymphomas.

In related news, the ongoing global Phase III trial, run in collaboration with the Australasian Leukaemia Lymphoma Group, will assess Columvi in combination with another drug, and its results are highly anticipated, offering further hope for MCL patients.

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