Lilly’s Jaypirca shows improved survival in CLL trial

INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY) announced today that its Phase 3 BRUIN CLL-322 trial met its primary endpoint, showing Jaypirca (pirtobrutinib) combined with venetoclax and rituximab improved progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. The pharmaceutical giant, with a market capitalization of $841 billion, posted revenue of $65.2 billion over the last twelve months with impressive 45% growth, according to InvestingPro data.

The trial enrolled 639 patients who were randomized to receive either pirtobrutinib plus venetoclax and rituximab or venetoclax and rituximab alone. Treatment was administered for up to two years, after which patients do not take any CLL therapy until disease progression.

The study demonstrated a statistically significant improvement in progression-free survival as assessed by an independent review committee. Results were consistent across clinically relevant subgroups and regardless of prior treatment with a covalent BTK inhibitor.InvestingPro analysis indicates the stock is currently undervalued relative to its Fair Value, presenting a potential opportunity for investors. The company maintains a "GREAT" financial health score and stands as a prominent player in the Pharmaceuticals industry, according to InvestingPro Tips. Subscribers can access 13 additional ProTips and comprehensive Pro Research Reports covering LLY and 1,400+ other US equities.

Overall survival, a key secondary endpoint, was not yet mature at this analysis but was trending in favor of the pirtobrutinib combination regimen, according to the press release statement. The safety profile was consistent with the known safety profile of each medicine, with adverse event rates similar across study arms and low rates of treatment discontinuations.

Lilly plans to submit the results to regulators later this year for a label expansion. Detailed results will be presented at a medical congress and submitted to a peer-reviewed journal.

This marks the fourth positive Phase 3 study of pirtobrutinib in CLL, following the BRUIN Phase 1/2 trial, BRUIN CLL-321, BRUIN CLL-314, and BRUIN CLL-313 trials.

Jaypirca is currently FDA-approved for treating adult patients with relapsed or refractory CLL/SLL who have previously been treated with a covalent BTK inhibitor, and for relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy.

In other recent news, Eli Lilly and Company announced the availability of its new weight loss medication, Foundayo, following approval by the U.S. Food and Drug Administration on April 1, 2026. The once-daily oral pill is designed for adults with obesity or weight-related medical problems and can be taken without food or water restrictions. Foundayo is now part of the offerings at Amazon Pharmacy, which will provide same-day delivery for customers with valid prescriptions, marking a competitive move in the weight management medication market. Weight Watchers has also integrated Foundayo into its Med+ program, offering members an injection-free option for weight management. Analyst firms RBC Capital and Cantor Fitzgerald have reiterated their positive outlooks on Eli Lilly, with RBC Capital setting a price target of $1,250 and Cantor Fitzgerald targeting $1,205. RBC Capital anticipates that Eli Lilly’s first-quarter 2026 sales will meet consensus estimates, with particular strength in sales of Zepbound and Mounjaro. These developments come as Eli Lilly prepares to report its earnings for the first quarter of 2026, drawing significant attention to its product launches and market strategies.

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