Blueprint Medicines Posts Data From NSCLC Study On Pralsetinib
Zacks Investment Research | Jan 08, 2020 10:31PM ET
Blueprint Medicines Corporation (NASDAQ:BPMC) announced top-line data from a phase I/II study on its investigational precision therapy pralsetinib, which is being developed for addressing previously-treated patients with receptor tyrosine RET-fusion non-small cell lung cancer (NSCLC). The ARROW study evaluated once-daily oral, pralsetinib in 80 patients with RET fusion-positive NSCLC who received prior treatment with platinum-based chemotherapy.
Data from the study showed that treatment with pralsetinib led to an objective response rate (ORR) of 61% and prolonged durability in the given patient population. 95% of patients had tumor shrinkage with 14% experiencing complete regression of target tumors. However, the median duration of response (DOR) was not reached.
The study evaluated 26 patients with treatment-naïve RET fusion-positive NSCLC. Per independent central review, the ORR was 73% with 12% patients achieving a complete response. Importantly, all the patients showed tumor shrinkage.
Along with announcing the top-line data from the ARROW study, Blueprint Medicines initiated the rolling submission of new drug application (NDA) to the FDA for pralsetinib to address the RET fusion-positive NSCLC indication. Notably, pralsetinib is also being studied for RET-mutant medullary thyroid carcinoma (MTC). The company plans to complete the NDA submission for pralsetinib in the first quarter of 2020 to treat NSCLC while the same for the MTC indication is expected to be filed in the second quarter.
Additionally, Blueprint Medicines plans to begin a phase III AcceleRET Lung study on pralsetinib for treating patients with first-line RET fusion-positive NSCLC later this month. The study will evaluate the potential of pralsetinib to extend progression free survival (PFS) compared to the platinum-based chemotherapy with or without Merck’s (NYSE:MRK) anti-PD-1 therapy Keytruda (pembrolizumab).
Shares of Blueprint Medicines have rallied 24.9% in the past year against the Zacks Investment Research
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