Roche upbeat on recent polatuzumab vedotin trial results

Roche announced longer-term data from the phase Ib/II GO29365 study on Monday, with positive results from ‘polatuzumab vedotin’ - an investigational anti-CD79b antibody drug conjugate (ADC) - in combination with ‘MabThera’/’Rituxan’ (rituximab) plus bendamustine (BR).

The Swiss drugmaking giant said the combination demonstrated a median overall survival of more than one year compared to the BR arm in people with relapsed or refractory diffuse large B-cell lymphoma not eligible for a haematopoietic stem cell transplant.

It said overall survival was an exploratory endpoint.

Adverse events were said to have been consistent with those seen in previous studies of polatuzumab vedotin, and of BR, with no new safety signals observed.

Roche explained that treatment with polatuzumab vedotin plus BR resulted in a 66% reduction in risk of disease progression or death - as measured by investigator-assessed progression free survival - with 40% achieving a complete response compared to 18% in the BR arm, which was the primary endpoint, as measured by positron emission tomography.

Furthermore, patients treated with polatuzumab vedotin plus BR achieved higher complete response rates and longer progression-free survival and overall survival compared with BR in all subgroups tested, including patients from cell-of-origin groups, germinal centre B-cell-like and activated B-cell-like, which were associated with a worse prognosis in diffuse large B-cell lymphoma.

“There is a significant need for new and more effective treatment options for the approximately 40% of people with diffuse large B-cell lymphoma whose disease either does not respond to initial treatment or returns - a situation that is associated with a very poor prognosis that worsens after each relapse," said Roche chief medical officer and head of global product development Sandra Horning.

“We are delighted that polatuzumab vedotin has demonstrated sustained clinical benefits and has the potential to hopefully improve survival rates in this population.

“We are working with health authorities to make this novel regimen available to patients worldwide.”

The company said the phase Ib/II GO29365 study was the first and only randomised study to suggest a survival benefit for relapsed or refractory diffuse large B-cell lymphoma patients who were ineligible for haematopoietic stem cell transplant.