Australian clinicians uncover new toxicity linked to Roche’s lymphoma therapy

A team of Australian haematologists has uncovered a previously unreported immune-related toxicity associated with Roche Product’s dual-targeting CD3-CD20 bispecific antibody, Columvi (glofitamab), used in the treatment of B-cell non-Hodgkin lymphoma. The clinicians have documented the first known cases of immune-mediated enterocolitis linked to the therapy, shedding light on a critical safety signal for this novel immunotherapy.

In a case series published by specialists from the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, patients developed similar clinical presentations of colitis after treatment with Columvi. The findings could offer valuable clinical guidance for physicians managing patients with this newer class of bispecific antibody therapy.

“Clinicians should consider this toxicity in glofitamab-treated patients presenting with sustained diarrhoea or abdominal pain when infectious colitis has been comprehensively excluded,” the authors said.

While colitis has been previously reported following immunotherapies such as checkpoint inhibitors, anti-CD20 monoclonal antibodies (mAbs), and CAR-T cell therapies, the pattern seen with Columvi appears distinct.

Checkpoint inhibitor-induced colitis affects approximately 5% of patients treated with anti-PD1/PDL1 agents and tends to be more aggressive and less responsive to steroids than the Columvi-related cases described. Meanwhile, colitis associated with anti-CD20 mAbs – such as rituximab and obinutuzumab – remains a poorly defined clinical entity.

The precise mechanism behind Columvi-induced colitis is still unknown. However, the authors suggest a potential link to regulatory B-cell (Breg) depletion, which may lead to gastrointestinal mucosal injury through T-cell recruitment and cytokine-driven inflammation.

“Immune-mediated enterocolitis is a potential toxicity of glofitamab use. After demonstrating gastrointestinal tract inflammation and excluding infection, prompt steroid initiation may abrogate symptoms and allow for successful glofitamab rechallenge,” the authors concluded.

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