RESUMO
INTRODUCTION: The comparative efficacy and safety of lorlatinib, a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), versus second-generation ALK TKIs as a first-line treatment for ALK+ advanced/metastatic nonsmall cell lung cancer (NSCLC) remains uncertain as there are no head-to-head clinical trials. METHODS: Matching-adjusted indirect comparisons (MAICs) were conducted using phase III trial data demonstrating superior efficacy over crizotinib, a first-generation ALK TKI. MAICs were conducted to compare lorlatinib (CROWN) versus alectinib (ALEX and ALESIA) and brigatinib (ALTA-1L) with matching based on prespecified effect modifiers. Efficacy outcomes included progression-free survival (PFS), objective response (OR), and time to progression in the central nervous system (TTP-CNS). Safety outcomes included Grade ≥3 adverse events (AEs) and AEs leading to treatment discontinuation, dose reduction, or dose interruption. RESULTS: Lorlatinib was estimated to improve PFS compared to alectinib (ALEX) (HR: 0.54 [95% CI: 0.33, 0.88]) and brigatinib (ALTA-1L) (HR: 0.51 [95% CI: 0.31, 0.82]). Lorlatinib was estimated to improve TTP-CNS compared with brigatinib (HR: 0.19 [95% CI: 0.05, 0.71]). The estimated Grade ≥3 AE rate was higher with lorlatinib than with alectinib (RR: 1.48 [95% CI: 1.13, 1.94]); however, no differences were observed in other safety endpoints (ie, AEs leading to discontinuation, dose reduction, or interruption) or compared to brigatinib. CONCLUSION: Lorlatinib was estimated to have superior efficacy over first- and second-generation ALK-TKIs, but a higher rate of Grade ≥3 AEs compared to alectinib. These data support the use of lorlatinib as a first-line treatment for ALK+ advanced/metastatic NSCLC.
RESUMO
OBJECTIVES: Bevacizumab is commonly used to treat solid tumors. However, little is known about the manner and the extent to which bevacizumab biosimilars are utilized in real-world oncology practice in the United States. The objective of this study was to describe patient and provider characteristics and treatment patterns associated with the recently introduced bevacizumab-bvzr biosimilar. STUDY DESIGN: Retrospective cohort study. METHODS: A retrospective analysis of medical and pharmacy claims between January 24, 2019, and July 31, 2020, was performed. Adult patients with at least 1 claim indicating usage of bevacizumab-bvzr were included. Patients who could not be assigned to an applicable diagnosis group were excluded. Index treatment date was defined as the date of the first claim for bevacizumab-bvzr. Descriptive analysis was conducted for all study variables. RESULTS: A total of 206 patients were included; patients most often were 65 years or older (49.5%), were female (62.6%), and resided in the West (45.1%). The most common indications observed for bevacizumab-bvzr were metastatic colorectal cancer (mCRC; 51.0%), cancer of the female genital organs (CFGO; 27.2%), glioblastoma (11.2%), and non-small cell lung cancer (8.7%). Overall, 72.4% and 48.2% of patients with mCRC and CFGO, respectively, had switched to bevacizumab-bvzr from the reference drug or another bevacizumab biosimilar. Bevacizumab-bvzr was used in chemotherapy combination regimens for patients with mCRC and CFGO. CONCLUSIONS: Utilization was observed in extrapolated indications. Findings suggest that both switching between reference product and bevacizumab biosimilars and using bevacizumab-bvzr as part of chemotherapy combination regimens have been adopted in US oncology practice.