EU green light for Roche’s Tecentriq

Roche has received European Commission approval for its anti-PD-L1 cancer immunotherapy Tecentriq (atezolizumab) to treat specific lung and bladder cancers. The green light means that it can be used as monotherapy for people in the EU with previously-treated locally advanced or metastatic non-small cell cancer (NSCLC), or those with metastatic urothelial carcinoma (mUC) who have received a platinum-based chemotherapy or who are ineligible to receive cisplatin chemotherapy.

This is good news for Roche: the company suffered a setback recently when Tecentriq failed to significantly improve overall survival compared to chemotherapy in pre-treated patients with advanced bladder cancer.

The NSCLC approval is based on the Phase III OAK study and Phase II POPLAR study: the former showed that it helped people in the overall study population live longer than those treated with docetaxel chemotherapy.

For bladder cancer, approval is based on results from the randomised Phase III IMvigor211 study and cohorts 1 and 2 from the single-arm Phase II IMvigor210 study – even though IMvigor211 did not meet its primary endpoint on OS. A secondary endpoint, median duration of response (mDOR), was 21.7 months in the overall study population, compared with 7.4 months for those receiving chemotherapy.

Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, said: "The totality of the data for Tecentriq across all indications including long-term responses in advanced bladder cancer and the overall survival advantage observed in our Phase III advanced lung cancer study means that we are able to extend the benefits of Tecentriq to people living with these types of cancer regardless of their levels of PD-L1 expression."

The brand already has US approval on a similar basis to the new EU nod. In August, it was rejected by NICE as a ‘routine’ treatment for advanced bladder cancer - but Roche was asked to submit a proposal for its inclusion within the Cancer Drugs Fund. It is available to UK patients with advanced bladder cancer who have already received chemotherapy through the Early Access to Medicines Scheme.