Eli Lilly's Jaypirca Shows Promising Results in CLL Phase 3 Trial, Shares Rise 16%

Eli Lilly announced positive results from its Phase 3 BRUIN CLL-313 trial, revealing significant progression-free survival improvements for its drug Jaypirca in treatment-naive CLL/SLL patients. The FDA's Breakthrough Therapy designation for olomorasib, targeting NSCLC in combination with KEYTRUDA, supports the company's innovative momentum. These developments have bolstered confidence in Eli Lilly's growth prospects, leading to a 16% share price rise over the past month.

Eli Lilly and Company (NYSE: LLY) has announced positive topline results from its Phase 3 BRUIN CLL-313 clinical trial, demonstrating significant improvements in progression-free survival (PFS) for Jaypirca (pirtobrutinib) in treatment-naïve chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) patients. The trial, which compared pirtobrutinib to the standard chemoimmunotherapy regimen of bendamustine plus rituximab, showed a highly statistically significant and clinically meaningful improvement in PFS, indicating one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study [1].

The study enrolled 282 patients who were randomized 1:1 to receive pirtobrutinib or bendamustine plus rituximab. The primary endpoint was PFS, which was assessed by an independent review committee (IRC). The overall safety profile of pirtobrutinib in this trial was generally consistent with previously reported trials across treatment settings [1].

These results build on Lilly's previous positive Phase 3 studies, including BRUIN CLL-321 and BRUIN CLL-314, which further solidify the potential of pirtobrutinib as a meaningful treatment option for CLL/SLL patients. The company plans to use the data from BRUIN CLL-313 and BRUIN CLL-314 to seek label expansions in earlier lines of therapy and submit global regulatory submissions later this year [1].

Eli Lilly's progress in CLL/SLL treatment coincides with the FDA's Breakthrough Therapy designation for olomorasib in combination with KEYTRUDA for the treatment of non-small cell lung cancer (NSCLC), underscoring the company's innovative momentum in oncology [2]. This positive momentum has contributed to a 16% share price rise for Eli Lilly over the past month, reflecting investor confidence in the company's growth prospects.

References:
[1] https://www.prnewswire.com/news-releases/lillys-jaypirca-pirtobrutinib-the-first-and-only-approved-non-covalent-reversible-btk-inhibitor-significantly-improved-progression-free-survival-in-patients-with-treatment-naive-cllsll-302548399.html
[2] FDA Breakthrough Therapy Designation for Olomorasib in Combination with KEYTRUDA for NSCLC