FDA approves Roche’s $90,000 lymphoma combination

The FDA has quickly approved a new antibody treatment for an aggressive form of lymphoma from Roche – costing in the region of $90,000 for a four-month course.

Polivy (polatuzumab vedotin-piiq) has been granted accelerated approval in combination with bendamustine chemotherapy and Rituxan (rituximab) (BR) for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies.

The disease is also targeted by the CAR-T therapies from Roche’s rivals Novartis and Gilead and Roche has opted to price its new regimen in line with these expensive cell therapies.

Polivy’s dosage is based on weight by Roche, which said a four-month course will cost $90,000 on average.

The price compares favourably with one-off shots of CAR-Ts from Novartis and Gilead that cost $373,000 and $475,000 respectively, but Polivy’s price could still make prescribers think twice, at least until further clinical data is available.

Accelerated approval allows for drugs to be licensed using early stage data from mid-stage clinical trials, based on the understanding that effectiveness is likely to be confirmed by findings of a larger trial.

But the FDA has granted approval based on findings of the Phase 1b/2 GO29365 study in people with R/R DLBCL who are ineligible for a haematopoietic stem cell transplant.

Results of the study showed that 40% – 16 out of 40 – of those treated with Polivy plus BR achieved a complete response, meaning no cancer could be detected at the time of assessment compared with 18% treated with BR alone.

The study also showed that 45% of people on Polivy plus BR achieved an objective response at the end of treatment compared with 18% of people treated with BR alone.

Of the people treated with Polivy plus BR who achieved a complete or partial response, 16 (64%) had a duration of response lasting at least six months compared to 30% of people treated with BR alone.

While this data suggests the drug continued to work for an extended period, it’s not the same as the overall survival figures that oncologists will be looking for when they decide what to prescribe.

The figures from Polivy also don’t compare favourably to Gilead’s Yescarta (axicabtagene ciloleucel), which according to figures announced at the end of last year produced a response rate of 83% after two years, with 58% of patients having a complete response.

However, Polivy has the advantage of convenience and will not require a drawn-out manufacturing process like Yescarta and Novartis’ Kymriah (tisagenlecleucel).

Being an antibody-based therapy, Polivy does not produce the extreme side effects seen with CAR-T either, such as neurotoxicity and cytokine release syndrome (CRS).

Roche said adverse reactions occurred in at least 20% of patients, and at least 5% more frequently in patients treated with Polivy plus BR compared to BR alone, and included low white blood cell count, low platelet levels, low red blood cell count, numbness, tingling or pain in the hands and feet, diarrhoea, fever, decreased appetite and pneumonia.

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B-cells (an immune cell impacted in some types of non-Hodgkin lymphoma (NHL)), making it a promising target for the development of new therapies.

Polivy binds to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells.

Polivy is being developed by Roche using Seattle Genetics ADC technology and is currently being investigated for the treatment of several types of NHL.

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