NICE will not be approving polatuzumab vedotin with rituximab and bendamustine for treating relapsed or refractory diffuse large B‑cell lymphoma in adults who cannot have a haematopoietic stem cell transplant, new draft guidance states.
NICE acknowledges that the clinical evidence from the multicentre, randomised, open-label GO29365 trial suggests people receiving polatuzumab vedotin plus rituximab and bendamustine have a statistically significant 22.5 percentage point greater complete response rate than rituximab and bendamustine alone (95% 2.62-40.22; P=0.0261). There were also statistically significant benefits in the secondary outcomes of progression-free survival and overall survival.
However, the trial was small, with just 40 patients randomised to each arm, of whom only three were from the UK.
NICE concluded that the cost-effectiveness estimates for polatuzumab vedotin with rituximab and bendamustine are very uncertain because of limitations in the data and methods. The combination is considered a life-extending treatment at the end of life, but the cost-effectiveness estimates are too uncertain, NICE has concluded.
The draft guidance is open for public comment until 18 March 2020.