OAK study of Tecentriq (atezolimumab) reported in The Lancet shows improvement of overall survival versus docetaxel in NSCLC patients.-Genetech + Roche
The Phase III OAK study of Tecentriq (atezolimumab) from Genetech/Roche is the first randomised phase |III study to report results of a PD-L1-targeted therapy, resulting in a clinically relevant improvement of overall survival versus docetaxel in previously treated non-small-cell lung cancer, regardless of PD-L1 expression or histology, with a favourable safety profile.The study was reported in The Lancet.
Between March 11, 2014, and April 29, 2015, 1225 patients were recruited. In the primary population, 425 patients were randomly assigned to receive atezolizumab and 425 patients were assigned to receive docetaxel. Coprimary endpoints were overall survival in the intention-to-treat (ITT) and PD-L1-expression population TC1/2/3 or IC1/2/3. Overall survival was significantly longer with atezolizumab in the ITT and PD-L1-expression populations. In the ITT population, overall survival was improved with atezolizumab compared with docetaxel (median overall survival was 13·8 months [95% CI 11·8–15·7] vs 9·6 months [8·6–11·2]; hazard ratio [HR] 0·73 [95% CI 0·62–0·87], p=0·0003). Overall survival in the TC1/2/3 or IC1/2/3 population was improved with atezolizumab (n=241) compared with docetaxel (n=222; median overall survival was 15·7 months [95% CI 12·6–18·0] with atezolizumab vs 10·3 months [8·8–12·0] with docetaxel; HR 0·74 [95% CI 0·58–0·93]; p=0·0102). Patients in the PD-L1 low or undetectable subgroup (TC0 and IC0) also had improved survival with atezolizumab (median overall survival 12·6 months vs 8·9 months; HR 0·75 [95% CI 0·59–0·96]). Overall survival improvement was similar in patients with squamous (HR 0·73 [95% CI 0·54–0·98]; n=112 in the atezolizumab group and n=110 in the docetaxel group) or non-squamous (0·73 [0·60–0·89]; n=313 and n=315) histology. Fewer patients had treatment-related grade 3 or 4 adverse events with atezolizumab (90 [15%] of 609 patients) versus docetaxel (247 [43%] of 578 patients). One treatment-related death from a respiratory tract infection was reported in the docetaxel group.
Comment: Tecentriq was approved by the FDA in October 2016 to treat metastatic non-small cell lung cancer patients who have disease progression during or following platinum-containing chemotherapy.
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