medwireNews: Crizotinib provides durable clinical benefit to patients with ROS1-rearranged advanced non-small-cell lung cancer (NSCLC), show updated PROFILE 1001 data.
Alice Shaw (Massachusetts General Hospital Cancer Center, Boston, USA) and co-investigators say their study “provides a new benchmark for OS [overall survival] in patients with ROS1-rearranged advanced NSCLC, and supports the continued use of crizotinib in the treatment of these patients.”
Initial results from the PROFILE 1001 study, published after approximately 16 months of follow-up, showed that patients receiving crizotinib at a starting dose of 250 mg twice daily (n=50) responded well to treatment, with an objective response rate (ORR) of 72% and a median response duration of 17.6 months.
After a further 46.2 months of follow-up, giving a median of 62.6 months in total, and the addition of a further three patients, the ORR remained at 72% but the median response duration increased to 24.7 months, the researchers report.
There were six confirmed complete responses to the oral tyrosine kinase inhibitor, which targets the ALK, ROS1, and MET receptor tyrosine kinases, along with 32 partial responses. In addition, 10 patients had stable disease while receiving treatment.
Shaw and team found that patients responded rapidly to treatment, with a median time to first tumor response of 7.9 weeks. They note that this corresponded to the approximate time of the first on-treatment tumor scan.
During the extended follow-up period, 36 (68%) patients experienced disease progression or died, giving median progression-free and OS times of 19.3 and 51.4 months, respectively.
The likelihoods of survival at 12, 24, 36, and 48 months were 79%, 67%, 53%, and 51%, respectively.
The researchers observed no correlation between OS and specific ROS1 fusion partners; there was also no difference in treatment response according to baseline disease and demographic characteristics.
During a median treatment duration of 22.4 months, all patients experienced at least one treatment-related adverse event (AE), typically of grade 1 or 2 in severity (64%).
There were no grade 4 or 5 treatment-related AEs and Shaw and colleagues say that their “findings support the favorable safety profile of crizotinib, even with long-term treatment.”
Writing in the Annals of Oncology, the authors conclude: “While efficacy data with other ROS1 TKIs are still emerging, our findings show that treatment with crizotinib is associated with impressive OS in ROS1-rearranged advanced NSCLC.”
By Laura Cowen
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group
Ann Oncol 2019; doi:10.1093/annonc/mdz131
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