Effectiveness of crizotinib in patients with ROS1-positive non-small-cell lung cancer: real-world evidence in Japan

Abstract

Aim: Crizotinib, approved in Japan (2017) for ROS1-positive NSCLC, has limited real-world data. Materials & methods: Crizotinib monotherapy real-world effectiveness and treatment status were analyzed from claims data (June 2017–March 2021; Japanese Medical Data Vision; 58 patients tested for ROS1NSCLC). Results: Median duration of treatment ([DoT]; primary end point), any line: 12.9 months; 22 patients on crizotinib, 23 discontinued, 13 receiving post-crizotinib treatment. 1L (n = 27) median DoT: 13.0 months (95% CI, 4.4–32.0 months); 13 patients on crizotinib; seven discontinued; seven receiving post-crizotinib treatment. 2L (n = 13) median DoT: 14.0 months (95% CI, 4.6–22.2 months); 2L+ (n = 31): nine patients on crizotinib; 16 discontinued; six receiving post-crizotinib treatment. Post-crizotinib treatments (chemotherapy, cancer immunotherapy, anti–VEGF/R) did not affect crizotinib DoT. Conclusion: Data supplement crizotinib’s effectiveness in ROS1-positive NSCLC previously seen in clinical trials/real-world. Plain language summary: Non-small-cell lung cancer (NSCLC) is a common type of cancer in the lung that is often caused by mutations in specific genes in the DNA. One type of NSCLC occurs when you have mutations in a gene called ROS1, whose normal function is not well understood. Crizotinib, an oral medicine, was approved in Japan for the treatment of NSCLC with mutations in ROS1 in 2017; however, this was based upon data from controlled clinical trials. This study was looking at crizotinib use in Japan based upon claims data from the Japanese Medical Data Vision database, which captures all use of medications provided in Japan. Data was collected from June 2017 to March 2021 for 58 Japanese patients who had NSCLC, tested positive for ROS1 mutations, and received crizotinib. Patients took crizotinib for a median of 13.0 months as a first treatment option and 14.0 months as a second treatment option for their NSCLC. The type of and duration of anticancer treatments given before crizotinib did not have an effect on the length of time crizotinib was used. Other treatments outside of crizotinib were given before or after crizotinib and include chemotherapy, therapy that modifies the immune system to treat cancer, or treatments that inhibit the growth of blood vessels that help the cancer grow/spread. Together, these real-world data provide evidence supporting the use of crizotinib in the treatment of patients with NSCLC and ROS1 mutations. Tweetable abstract: For ROS1-positive NSCLC patients, duration of treatment (DOT) with crizotinib in real world was identified by using claims database in Japan. DOT of crizotinib for any line was 391 days (N=58). Details are here: (link of manuscript) #ROS1, #NSCLC, #RealWorldData