Lilly's Blood Cancer Drug Clears Late-Stage Study, Boosting Oncology Portfolio

Eli Lilly's blood cancer drug has met its main goal in a late-stage study. The drug, which is used to treat acute myeloid leukemia, showed an overall response rate of 60.1% in patients with relapsed or refractory disease. Lilly plans to submit the results to regulatory agencies for potential approval.

Eli Lilly and Company (NYSE: LLY) has reported positive topline results from the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor. The study, which compared pirtobrutinib to bendamustine plus rituximab (chemoimmunotherapy), demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions [1].

The primary endpoint of the study was met, showing a substantial improvement in PFS compared to the standard chemoimmunotherapy regimen. This marks the third positive Phase 3 study from the pirtobrutinib development program in CLL. Overall survival (OS), a key secondary endpoint, was not yet mature but trended strongly in favor of pirtobrutinib. The overall safety profile of pirtobrutinib was generally consistent with previous trials [1].

Eli Lilly plans to use the results from BRUIN CLL-313 and BRUIN CLL-314 to seek label expansions in earlier lines of therapy, with global regulatory submissions beginning later this year. The company expects to present detailed results at a medical congress and submit them to a peer-reviewed journal. Jacob Van Naarden, executive vice president and president of Lilly Oncology, commented that the results further demonstrate pirtobrutinib's potential as a meaningful treatment option for people with untreated CLL/SLL [1].

These results follow the FDA's Breakthrough Therapy designation for olomorasib in combination with KEYTRUDA (pembrolizumab) for the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression 50% [2]. Lilly's focus on innovative clinical trials and the development of targeted therapies highlights its commitment to addressing significant health challenges and improving patient outcomes.

References:
[1] https://sg.finance.yahoo.com/news/lillys-jaypirca-pirtobrutinib-first-only-104500259.html
[2] https://www.marketscreener.com/news/eli-lilly-and-company-receives-u-s-fda-s-breakthrough-therapy-designation-for-the-treatment-of-cert-ce7d59d8d88cf724