In draft guidance published today (20 August 2020), NICE approves polatuzumab vedotin with rituximab and bendamustine as an option for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults who cannot have a haematopoietic stem cell transplant.
The positive recommendation follows consultation on a previous draft guidance which did not recommend the treatment. NICE says the company has since offered an updated commercial arrangement and submitted new analyses that address previous issues around the methods for estimating long-term survival. As a result of the new commercial agreement, the treatment is now considered a cost-effective use of NHS resources.
The clinical evidence to support the decision came from the multicentre, randomised, open-label trial GO29365 of polatuzumab vedotin with rituximab and bendamustine, compared with rituximab with bendamustine alone, in patients with relapsed or refractory disease.
The trial was small, with only 40 patients randomised to each arm. Three UK patients were included but the trial population was broadly reflective of the population seen in UK clinical practice in terms of age and previous treatments including haematopoietic stem cell transplants. However, non-white people were underrepresented in the trial.
GO29365 found that polatuzumab vedotin with bendamustine and rituximab led to a statistically significant 22.5% greater complete response rate than rituximab and bendamustine alone (95% CI 2.62-40.22; P=0.0261). At 30-month follow up, 23% of patients in the polatuzumab vedotin arm were in disease remission (8 complete, 1 partial) compared with 5% in the rituximab with bendamustine arm.
There were also statistically significant benefits in progression-free survival and overall survival. Mature data on overall survival are due in two years.
It is estimated that around 4800 people in England have DLBCL. Of these, approximately 530 will be eligible for the new treatment.
NICE expects to publish its final guidance on polatuzumab vedotin with rituximab and bendamustine for DLBCL in September 2020.