Roche reports positive late-stage results for Tecentriq, Avastin, chemotherapy combination in lung cancer

Roche announced Monday that results from a Phase III study showed that the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy provided a significant and clinically meaningful reduction in the risk of disease worsening or death compared to Avastin plus chemotherapy in the first-line treatment of people with advanced non-squamous non-small-cell lung cancer (NSCLC). The company added that initial data from the IMpower150 trial for the co-primary endpoint of overall survival (OS) are "encouraging."

"We are extremely encouraged by these results and will submit these data to health authorities globally with the goal of bringing a potential new standard of care for the initial treatment of lung cancer," remarked Sandra Horning, Roche's head of global product development. The company noted that the results are not yet fully mature, with the next OS analysis expected in the first half of 2018 (for further analysis, see ViewPoints: Roche delivers a key lung cancer win for Tecentriq – Answers and Questions).

Roche's Genentech unit and partner Chugai Pharmaceutical also reported Monday that a Phase III study of Hemlibra (emicizumab-kxwh) in adults and adolescents with haemophilia A without inhibitors to factor VIII met its primary endpoint. Commenting on the results, Jefferies analyst Jeffrey Holford said "Roche has delivered a best case scenario with both Tecentriq's IMpower150 and Hemlibra's HAVEN 3 studies meeting their primary endpoints." Shares in the drugmaker rose as much as 5.6 percent on the news.

The IMpower150 study randomised 1202 people with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease to receive Tecentriq plus carboplatin and paclitaxel, Tecentriq and Avastin plus carboplatin and paclitaxel or Avastin plus carboplatin and paclitaxel. Roche noted that patients with ALK and EGFR mutations were excluded from the primary intention-to-treat analysis.

The trial's co-primary endpoints were progression-free survival (PFS) and OS, with the analysis of the former goal only statistically powered to demonstrate a comparison between patients wo received Tecentriq and Avastin plus carboplatin and paclitaxel and those given Avastin plus carboplatin and paclitaxel. Roche said that results from the study will be presented at the European Society for Medical Oncology (ESMO) immuno-oncology congress next month.

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.

Tecentriq, a monoclonal antibody designed to bind with the PD-L1 protein, is approved in Europe, the US and more than 50 countries for people with previously treated metastatic NSCLC and for those with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.

In October, Merck & Co. withdrew its European application seeking approval of the PD-1 inhibitor Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic non-squamous NSCLC in combination with carboplatin and Eli Lilly's Alimta (premetrexed). At the time, the company also indicated that it is amending the Phase III KEYNOTE-189 trial to include OS as a co-primary endpoint, with a new study completion date of February 2019. The trial is evaluating platinum-Alimta chemotherapy with or without Keytruda in patients with first-line metastatic non-squamous NSCLC.

For related analysis, read ViewPoints: Slow and steady – Merck & Co. sticks to cautious approach with Keytruda.

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