Roche said Sunday that in the Phase III OAK study, patients with non-small-cell lung cancer (NSCLC) who received the anti PD-L1 cancer immunotherapy Tecentriq (atezolizumab) lived a median of 13.8 months, 4.2 months longer than those treated with docetaxel. The company announced last month that the trial met its co-primary endpoints and showed a significant and clinically meaningful improvement in overall survival (OS) versus docetaxel.
"Tecentriq is the first and only anti PD-L1 cancer immunotherapy to help patients with metastatic NSCLC live significantly longer than when treated with chemotherapy regardless of their PD-L1 expression level or their disease histology," commented chief medical officer Sandra Horning. "Even people whose disease had low or no observed PD-L1 expression still showed a significant benefit from the medicine," Horning added.
FirstWord reports in this therapy area - KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
The study randomised 1225 people with locally advanced or metastatic NSCLC whose disease had progressed following previous treatment with platinum-containing chemotherapy to receive either Tecentriq or docetaxel. The trial's co-primary endpoints were OS in all randomised patients and in a PD-L1-selected subgroup in the primary analysis population.
Dan Chen, head of cancer immunotherapy development at Roche, said that importantly, Tecentriq also helped patients whose immune systems didn't already show a strong response before treatment. Patients who already had a strong immune response fared even better on the drug, Chen noted, with these subjects living a median of more than 20 months, compared with a 8.9 months for those on docetaxel.
"The survival benefit that we're seeing here is unprecedented," Chen said, adding "this forms the foundation of our cancer immunotherapy development. Tecentriq will be used as a single agent but also in combination in the future." For related analysis, see ViewPoints: Roche throws curveball with Tecentriq data.
The drug was awarded accelerated approval by the FDA in May for the treatment of locally advanced or metastatic urothelial carcinoma, while the agency is scheduled to decide on an application seeking clearance for the treatment of people with PD-L1-positive NSCLC whose disease has progressed during or after platinum-based chemotherapy by October 19. Analysts predict that Tecentriq will generate sales across all cancers of $4 billion in 2021.
To read more Top Story articles, click here.