Roche’s Tecentriq gains first-line approval in NSCLC but Keytruda reigns supreme, says GlobalData

Roche recently announced the Food and Drug Administration (FDA) approval of Tecentriq (atezolizumab) as a first-line monotherapy for the treatment of metastatic non-small cell lung cancer (NSCLC), marking its fourth approval in the indication and fifth in lung cancer overall. Despite this win for Roche’s Tecentriq, there are serious questions whether it will be able to compete with market leading Keytruda in this indication, says GlobalData, a leading data and analytics company.

Adam Pearson, PhD, Oncology and Hematology Analyst at GlobalData, comments: “The utility of checkpoint inhibitors in the NSCLC treatment paradigm has evolved dramatically in the last five years and Merck’s Keytruda has emerged as the clear winner. Specifically, it has gained pivotal first-line approvals, capturing the broadest subset of patients, years before its competitors. The dominance of Keytruda in NSCLC has secured the franchise’s position as the global marketing leading checkpoint inhibitor.

“Despite this latest approval for Roche, Merck was able to secure the same label for Keytruda as first-line monotherapy in 2016 with comparable efficacy, illustrating Merck’s first-to-market advantage and explaining the familiarity and loyalty prescribing health care professionals have for the agent. The approval for Tecentriq does provide competition in an indication once monopolized by Keytruda, but GlobalData expects that it will not be successful in capturing a significant market share for the reasons outlined.”

On May 15, the FDA approved the combination of Opdivo and Yervoy (Ipilimumab), marking the first dual immunotherapy approved in the first-line setting, providing further competition for Tecentriq in this space.

Pearson adds: “Bristol-Myers Squibb have opted for another strategy for Opdivo, which may prove more successful in capturing market share in the first-line setting. Importantly, the regimen provides a chemotherapy-free option and was approved by the FDA with a broad label for patients with PD-L1 expression ³1%, in both the non-squamous and squamous populations. Given patient preference for chemotherapy-free options and the broad patient population eligible for the therapy, GlobalData expects this strategy to be more successful in capturing market share in the first-line setting.”