EU CHMP recommends Tecentriq (atezolizumab) as a monotherapy to treat adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) after chemotherapy- Roche

Roche announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq (atezolizumab) as a monotherapy for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) after they have been previously treated with chemotherapy. People with EGFR activating mutations or ALK positive tumour mutations should also have received targeted therapy before receiving atezolizumab. This positive recommendation is based on results from the large randomised Phase III OAK study and the randomised Phase II POPLAR study.

Comment: The OAK study showed that atezolizumab helped people in the overall study population live a median of 13.8 months – 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.73, 95% CI: 0.62, 0.87).

Comment: The POPLAR study was a phase II, multi-centre, international, randomised, open-label, controlled study. POPLAR, was conducted in patients with locally advanced or metastatic NSCLC who progressed during or following a platinum-containing regimen, regardless of PD-L1 expression. An updated analysis with a total of 200 deaths observed and a median survival follow-up of 22 months showed a median OS of 12.6 months in patients treated with atezolizumab, vs. 9.7 months in patients treated with docetaxel (HR of 0.69, 95% CI: 0.52, 0.92). ORR was 15.3% vs. 14.7% and median DOR was 18.6 months vs. 7.2 months for atezolizumab vs. docetaxel, respectively.