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Real-World Insights: Effectiveness and Safety of Crizotinib in ROS1-Rearranged NSCLC

Lung cancer is one of the most incident malignancies and the leading cause of cancer death worldwide. Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancer cases and, with the emergence of genomic techniques, tumor genotyping has led to the identification of actionable driver alterations in NSCLC. The ROS1 gene encodes a tyrosine kinase receptor that plays an important role in the activation of several signaling pathways associated with cellular differentiation, proliferation, growth and survival. ROS1 gene rearrangement is rare and is detected as an oncogenic driver in 0.9% to 2.6% of NSCLC cases.

Crizotinib was first approved for ROS1 advanced NSCLC (aNSCLC) in the United States in 2016 and has received regulatory approval for the front-line treatment of patients with aNSCLC with ROS1 gene rearrangement in many countries worldwide. While clinical trial data has been instrumental in understanding the efficacy and safety of crizotinib in patients with ROS1-rearranged aNSCLC, real-world studies offer insight into its effectiveness and safety. We conducted a systematic literature review and meta-analysis to identify and quantitatively synthesize the real-world effectiveness and safety of crizotinib for patients with ROS1-rearranged aNSCLC.

The Value & Evidence team at EVERSANA (Sarah Kane, Lindsey Starkman, Beatrice Suero, Joanna Bielecki and Imtiaz A. Samjoo) synthesized data related to the real-world effectiveness and safety of crizotinib in the treatment of ROS1rearranged aNSCLC.

The systematic literature review identified 14 studies that met the prespecified inclusion criteria and were subsequently considered for meta-analysis. The primary analysis included all studies regardless of the line of therapy at which crizotinib was administered. Results of the primary meta-analysis indicated a pooled objective response rate of 70.6% (N=9 studies), a median real-world progression-free survival (rwPFS) of 14.5 months (N=11 studies), a median overall survival (OS) of 40.2 months (N=9 studies) and that Grade 3/4 adverse events occurred in 18.7% of patients (N=5 studies).

A subgroup analysis including only studies with patients receiving first-line crizotinib resulted in a pooled median rwPFS of 18.1 months (N=4 studies) and a median OS of 60.0 months (N=2 studies).

Overall, the results of this study are consistent with the clinical trial data. Taken collectively, they support crizotinib as a safe and effective treatment across different lines of therapy in patients with ROS1 aNSCLC in a real-world setting.

For a deeper understanding, access the article here:

Sarah Kane
Associate Director, HEOR

Sarah has 10+ years of professional experience across biotechnology and HEOR sectors. Within the Value & Evidence team at EVERSANA, Sarah supports numerous aspects of HEOR, including economic modelling, systematic literature reviews, meta-analyses and…

Lindsey Starkman
Associate Manager, Market Access and Pricing

Lindsey is an Associate Manager, Market Access and Pricing on the Value & Evidence Team at EVERSANA. Since joining the EVERSANA team, she has leveraged her knowledge on the Canadian reimbursement landscape, navigating the…

Beatrice Suero
Associate Director, HEOR

Beatrice has experience in all aspects of HEOR, including indirect treatment comparisons, economic modelling, systematic literature reviews, and RWE. In her four years with EVERSANA, Beatrice has established herself as an expert in reimbursement strategies…

Imtiaz Samjoo
Senior Director, Value & Evidence

As Senior Director of the Value & Evidence team at EVERSANA, Imtiaz leads evidence synthesis projects that support global HEOR initiatives involving systematic literature reviews, indirect treatment comparisons, and health economic modeling,  to support reimbursement…