P45.01 Therapeutic effectiveness of Lorlatinib After Alectinib in Japanese Patients With ALK-Positive NSCLC in Real-World

Abstract

Three anaplastic lymphoma kinase (ALK)-TKIs (crizotinib, alectinib and ceritinib) are available as 1st line setting in clinical practice in Japan. In the 2020 clinical practice guideline for lung cancer in Japan, lorlatinib is recommended as a subsequent therapy option for the patients with ALK-positive (ALK+) NSCLC whose disease has progressed after any ALK-TKI treatment. Alectinib, brigatinib and ceritinib are also recommended in the guideline. In addition, chemotherapy may be used after alectinib. However, there are no data to demonstrate the ALK TKI sequence treatment of loratinib as 2nd/3rd line after alectinib in clinical practice in Japan. Therefore, it is important to understand the post-marketing use of lorlatinib in Japanese patients with ALK+ NSCLC in real-world clinical practice to evaluate clinical effectiveness of lorlatinib. Main objective for this study was to reveal the real-world clinical effectiveness of lorlatinib in second /later line setting as ALK TKI sequence treatment after failure of alectinib in Japanese ALK+ NSCLC patients. The claims data from diagnosis procedure combination (DPC) hospitals provided by Medical Data Vision Co., Ltd. (MDV) were used for this study. Patients in this MDV had been identified from the following criteria; (1) ICD10 diagnosis of lung cancer (C34) and (2) patients who received alectinib and with prescription order for lorlatinib directly after alectinib therapy. In this review, patients with loraltinib in 2nd line or 3rd + line were defined based on the absence or presence of prescription of other drugs before the start of alectinib prescription. Baseline characteristics were summarized as descriptive analysis. The median DOT was estimated using the Kaplan–Meier (KM) method and individual DOT and treatment patterns were visualized as swimmer’s plot for DOT including lorlatinib. From the MDV data, 319 patients were identified as who received alectinib and with prescription order for an ALK-TKI (lorlatinib or ceritinib) or chemotherapy (pemetrexed(PEM) or PEM+ cisplatin(CDDP) or bevacizumab(BEV)+PEM+CDDP) directly after alectinib treatment. The gender (female; 59.9 %) was similar to that in clinical trials, however, the mean age of patients prescribed with alectinb was 61years and higher than that of previous report in clinical trials. 174 patients were prescribed lorlatinib after alectinib. Of the 174 patients who were prescribed lorlatinib after alectinib, median DOT estimated from KM was 149 days (95% CI; 109-200). 136 and 38 patients were prescribed lorlatinib in 2nd line and 3rd + line setting, respectively. ALK-TKIs including lorlatinib and chemotherapy treatment sequences after alectinib were observed nationwide in Japan. About half of the patients who were prescribed alectinib were prescribed lorlatinib as the next treatment following alectinib. The median duration of lorlatinib treatment in patients with ALK+NSCLC as the next treatment for alectinib was around 5 months.