The National Institute for Health and Care Excellence (NICE) has announced that it does not recommend Polivy (polatuzumab), Roche’s treatment for adults with diffuse large B-cell lymphoma (DLBCL).
The organisation has published a draft guidance rejecting the drug in combination with MabThera (rituximab) and bendamustine, for patients whose disease has relapsed or not responded to primary treatment and who cannot have a haematopoietic stem cell transplant.
The decision was made despite clinical trial evidence showing that the cancer became undetectable in around 40% of patients treated with Polivy, MabThera and bendamustine, compared with around 18% of patients treated with MabThera and bendamustine alone.
However, NICE is citing "substantial uncertainty in the submitted data” as a reason not to recommend the drug, and that the company’s submission “lacks strong long-term evidence on remission with the treatment.” The committee also found “flaws in the methods used to calculate the background mortality, which led to unreliable results,” as well as “limitations in the data”, which created uncertainty around the cost-effectiveness.
Roche responded to the "disappointing" decision, saying: "People with relapsed or refractory diffuse large B-cell lymphoma have limited treatment options, especially those who are not candidates for haematopoietic stem cell transplant. We will now have an opportunity to respond to NICE and continue to explore all potential funding options to work towards a positive final decision."
Rahul Doshi, haematology franchise lead at Roche reminded that the company's goal is to "make Polivy available for all eligible patients as soon as possible.”
In November last year a conditional marketing authorisation was recommended for the med, and last month it was cleared In the EU for people with previously treated aggressive lymphoma. The EU decision was based on the results from the phase Ib/II GO29365 study, the first and only clinical trial to show higher response rates and improved overall survival (OS) compared to MabThera in the indication.
The EU approval also followed the US Food and Drug Administration’s (FDA) accelerated approval of the combo in June last year.
DLBCL is a fast growing, high grade form of non-Hodgkin lymphoma, in which patients often have painless lumps in the neck, armpit or groin but may sometimes feel symptoms in other parts of the body such as the stomach or bowel.