Roche has won conditional approval for its anti-CD79b antibody-drug conjugate (ADC) Polivy (polatuzumab vedotin) in the European Union.
The EU approval clears Polivy for use in combination with chemotherapy drug bendamustine and anti-CD20 rituximab in adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for haematopoietic stem cell transplant.
Roche won the conditional approval on the strength of data from a phase 1b/2 clinical trial that linked the regimen to a 40% complete response rate. The complete response rate in the cohort of patients who received just bendamustine and rituximab was 17.5%.
Polivy outperformed the backbone regimen against other endpoints, too. Notably, overall survival in the Polivy arm was 12.4 months, as compared to 4.7 months in the control group.
The data have proven to be strong enough for Roche to win accelerated approval in the US and now a conditional authorisation in the EU. Conditional approval enables companies to get medicines that address major unmet needs to patients without generating all the clinical data typically required for authorisation.
Winning conditional approval in the EU positions Roche to build on what it described as a ‘strong’ US launch. Having won US Food and Drug Administration approval in June, Roche had generated sales of CHF21m (€19.5m) by September.
Roche attributed the early sales to use of Polivy as a third-line treatment for DLBCL and as a bridging therapy for patients waiting for an autologous CAR-T, such as Gilead Sciences’ Yescarta and Novartis’ Kymriah, to be ready for use.
The time lag between a doctor prescribing an autologous CAR-T and the therapy being ready for use stems from the production process, which entails processing a patient’s own cells. That lag, which will exist until off-the-shelf CAR-T therapies come to market, is one opportunity for Polivy.
If Roche gets its way, Polivy will also become established as a viable alternative to CAR-Ts. Talking to investors on a conference call last year, Bill Anderson, CEO of Roche Pharmaceuticals, set out how the delivery of CAR-T-like efficacy in an ADC modality could drive widespread use of Polivy.
“We estimated about 150 patients were treated with CAR-T in five months. We treated 150 patients with Polivy in the first five weeks. I think that's a real testament to the potential of a product like this,” Anderson said.
Roche is now working toward label expansions that will position Polivy to fulfil its potential. Filings for approval in first-line DLBCL and relapsed/refractory follicular lymphoma are pencilled in for 2021 and 2022, respectively.