Roche and Blueprint Medicines on Tuesday signed a licensing and collaboration agreement worth potentially up to $1.7 billion for the once-daily oral precision therapy pralsetinib, which is in late-stage development for patients with RET-altered non-small-cell lung cancer (NSCLC), medullary and other types of thyroid cancer, as well as other solid tumours. Under the deal, Roche will pay $675 million upfront in cash, in addition to making a $100-million equity investment in Blueprint, with the latter also eligible to receive up to $927 million in potential milestones, plus royalties on net product sales outside the US.
James Sabry, head of Roche Pharma Partnering, said the "collaboration with Blueprint, a partner we have already been working with for four years, [has] the goal of bringing a potentially transformative treatment option to patients with rare RET-altered cancers as quickly as possible." He added that "in bringing pralsetinib to patients, we will leverage our global reach and expertise in oncology, as well as our capabilities in diagnostics and the use of real-world data."
Filings submitted in RET-driven lung, thyroid cancers
Blueprint has submitted regulatory filings for pralsetinib in the US and Europe for the treatment of RET fusion-positive NSCLC, with an FDA decision slated for November 23. In January, the company reported top-line data from the Phase I/II ARROW study showing a 61% objective response rate, with the median duration of response not reached, in patients with RET fusion-positive NSCLC previously treated with platinum-based chemotherapy.
Beyond lung cancer, Blueprint also recently submitted an FDA filing for pralsetinib as a potential treatment for RET mutation-positive medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.
As part of the collaboration agreement, Roche and Blueprint will work on the development of pralsetinib, and also co-market the treatment in the US, while Roche will be responsible for commercial activities outside the US, excluding Mainland China, Hong Kong, Macau and Taiwan. According to the companies, "pralsetinib has demonstrated tumour-agnostic potential." They said they also plan to expand development of pralsetinib in multiple treatment settings and explore development of a next-generation RET inhibitor under their partnership.
Lilly's Retevmo approval
In May, the FDA approved Eli Lilly's Retevmo (selpercatinib) for patients with advanced RET-driven lung and thyroid cancers. The agency noted at the time that Retevmo was the first therapy approved specifically for this patient population.
For related analysis, see KOL Views Results: Leading oncologist says Eli Lilly’s key rival for Retevmo is testing not Blueprint's pralsetinib, as well as KOL Views: Sizing up clash of RET inhibitors in light of approved label for Eli Lilly's Retevmo. See also ViewPoints: Blueprint makes running start with first approval.
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