Drug Overview
Lorlatinib (Pfizer) is an orally administered anaplastic lymphoma kinase (ALK) and ROS1 tyrosine kinase inhibitor (TKI) with potential antineoplastic activity. Genetic alterations to ROS1 and ALK contribute to tumor cell proliferation and survival, and are among the key drivers of tumor development in non-small cell lung cancer (NSCLC). Kinase inhibition through lorlatinib administration leads to disruption of ALK- and ROS1-mediated signaling, and inhibits the growth of tumor cells with ALK and ROS1 overexpression.
Early-phase results have demonstrated promising overall response rates in both ALK rearrangement- and ROS1-positive patients, and Pfizer has filed for early approval in the US, Japan, and EU. The drug is also in Phase III development for use in first-line ALK rearrangement-positive NSCLC in a head-to-head trial with Xalkori (crizotinib; Pfizer/Merck KGaA), the historical standard of care in this setting. If results are positive, lorlatinib should be able to capture a sizable portion of the market share, although Alecensa (alectinib; Roche/Chugai) and Zykadia (ceritinib; Novartis) will be significant barriers to market entry.
Lorlatinib (Pfizer) is an orally administered anaplastic lymphoma kinase (ALK) and ROS1 tyrosine kinase inhibitor (TKI) with potential antineoplastic activity. Genetic alterations to ROS1 and ALK contribute to tumor cell proliferation and survival, and are among the key drivers of tumor development in non-small cell lung cancer (NSCLC). Kinase inhibition through lorlatinib administration leads to disruption of ALK- and ROS1-mediated signaling, and inhibits the growth of tumor cells with ALK and ROS1 overexpression.
Early-phase results have demonstrated promising overall response rates in both ALK rearrangement- and ROS1-positive patients, and Pfizer has filed for early approval in the US, Japan, and EU. The drug is also in Phase III development for use in first-line ALK rearrangement-positive NSCLC in a head-to-head trial with Xalkori (crizotinib; Pfizer/Merck KGaA), the historical standard of care in this setting. If results are positive, lorlatinib should be able to capture a sizable portion of the market share, although Alecensa (alectinib; Roche/Chugai) and Zykadia (ceritinib; Novartis) will be significant barriers to market entry.
Table of Contents
OVERVIEWDrug Overview
Product Profiles
lorlatinib : Non-small cell lung cancer (NSCLC)
LIST OF FIGURES
Figure 19: The authors drug assessment summary for Bavencio in non-small cell lung cancer
Figure 21: Bavencio sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
Figure 22: Cyramza for non-small cell lung cancer – SWOT analysis
LIST OF TABLES
Table 1: Lorlatinib drug profile
Table 2: Lorlatinib pivotal trial data in non-small cell lung cancer
Table 3: Lorlatinib sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 4: Lorlatinib patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
