Blueprint Medicines Corporation 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 MRK anti-PD-1 therapy Keytruda (pembrolizumab).
Shares of Blueprint Medicines have rallied 24.9% in the past year against the industry’s decline of 4.2%.
We remind investors that Blueprint Medicines’ lead pipeline candidate avapritinib, an inhibitor of KIT and PDGFRA proteins, is being evaluated in several late-stage studies for cancer indications.
In August 2019, the FDA accepted the new drug application (NDA) for avapritinib to treat patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST) regardless of any earlier therapy, and the fourth-line GIST. The FDA has set an action date of Feb 14, 2020 for both indications.
Currently, Blueprint Medicines has no approved product in its portfolio. Revenues generated by the company are drawn from its partnerships with Roche RHHBY and CStone Pharmaceuticals for the development of its pipeline candidates. Therefore, a potential nod to avapritinib will lower the company’s excessive dependence on its partners for revenues and help boost its growth prospects.
Zacks Rank & Key Pick
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Emergent Biosolutions Inc. EBS, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have moved 5.6% north for 2020 over the past 60 days.
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