Tanja Obradovic: Jaypirca vs Imbruvica – Promising Phase 3 Data in CLL/SLL
Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:
“Few days ago Eli Lilly and Company announced positive topline results from the Phase 3 BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL /SLL).
Trial had met its primary endpoint of overall response rate showing non-inferiority with nominal superiority. The key secondary progression-free survival endpoint was immature, but was trending in favor of Jaypirca and no negative impact upon overall survival was observed.
Head-to-head trials between drugs of the same class is a risky endeavor but it provides clarity so much needed by regulators, patients, oncologists, and reimbursement bodies. Very informative article is just out summarizing experiences from 2009-2020. Less than 25% of next-in-class cancer drugs demonstrated a survival benefit and 52% in other non OS end point over existing in-class agents in head-to-head trials, according to findings published in JAMA Internal Medicine.
As for Jaypirca, plans of the company are obviously taking into account need for OS benefit and filing plans to FDA are focused on results from the 1st line CLL Bruin CLL-313 trial.”
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