On 19 May, Roche announced the 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 approval in lung cancer overall. The approval was based on data from the Phase III Impower110 trial which demonstrated an overall survival benefit in patients with high programmed death-ligand 1 (PD-L1) expression, defined as 50% or more tumour cells stained PD-L1-positive or PD-L1-stained tumour-infiltrating cells covering 10% or more of the tumour area. Immunotherapy is used for the majority of patients with advanced NSCLC. Three immune checkpoint inhibitors are currently approved for metastatic NSCLC: Bristol-Myers Squibb‘s Opdivo (nivolumab), Merck’s Keytruda (pembrolizumab), and Tecentriq. These three agents have gained approvals across different lines of therapy and within specific combinatorial regimens, as outlined in Table 1.

Table 1. FDA-Approved Immune Checkpoint Inhibitors for Metastatic NSCLC

Source: GlobalData

ALK = anaplastic lymphoma kinase; EGFR = epidermal growth factor receptor

The utility of checkpoint inhibitors in the NSCLC treatment paradigm has evolved in the last five years and Merck’s Keytruda has emerged as the clear winner. Specifically, it gained pivotal first-line approvals, capturing the broadest subset

of patients years before its competitors. The label recommending the use of Keytruda in the first line, regardless of PD-L1 expression in non-squamous and squamous populations, is understood to be a significant driver for the Keytruda franchise. This allowed Keytruda to overtake Opdivo as the global market-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 that health care professionals have for the agent. Tecentriq’s approval provides competition in an indication once monopolised by Keytruda, but GlobalData expects that it will not be successful in capturing a significant market share for the reasons outlined.

Bristol-Myers Squibb has opted for another strategy for Opdivo that may prove more successful in capturing market share in the first-line setting, providing further competition for Tecentriq in this space. On May 15, the FDA approved the combination of Opdivo and Bristol-Myers Squibb’s Yervoy (Ipilimumab), marking the first dual immunotherapy approved in the first-line setting for NSCLC. Importantly, the regimen provides a chemotherapy-free option with limited toxicity in the first line and was approved by the FDA with a broad label for patients with PD-L1 expression of 1% or more 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 lucrative first-line setting.