Loxo posts Phase 3 pirtobrutinib results; five more Lilly-linked trials update

Six clinical trial records tied to Eli Lilly updated this week, led by newly posted Phase 3 leukemia results.

• Loxo Oncology, with Eli Lilly as collaborator, posted results for "BRUIN-CLL-313," a Phase 3 trial comparing pirtobrutinib to bendamustine plus rituximab in untreated chronic lymphocytic leukemia and small lymphocytic lymphoma. The purpose of the study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated.¹ The trial enrollment reached 282 participants (actual)¹ and its primary endpoint is progression-free survival assessed by independent review committee.
• Memorial Sloan Kettering, with Eli Lilly as collaborator, posted results for a completed Phase 2 trial of abemaciclib plus fulvestrant in recurrent endometrial cancer. The purpose of this study is to determine the effectiveness of the combination of abemaciclib and fulvestrant in treating this type of cancer and to determine the types and severity of side effects caused by treatment with abemaciclib and fulvestrant.² Enrollment reached 27 participants (actual)², and the primary outcome is objective response rate.
• Eli Lilly posted results for a Phase 2 study of LY3549492 in older adults with a healthy BMI after the trial was terminated. The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in adult participants with a healthy body max index (BMI) of 22 to 25 kilograms per square meter (kg/m2).³ The study was terminated for strategic business reasons³, with final enrollment of 1 participants (actual)³ across the 15 mg, 60 mg, and placebo arms, and no participants in any arm reported serious adverse events considered by the investigator to be related to study drug administration³.
• Eli Lilly is recruiting for a Phase 2 study of brenipatide (LY3537031) in moderate-to-severe COPD, called "RENEW-COPD." The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo.⁴ The study plans to enroll 606 participants (estimated)⁴, with change in pre-bronchodilator FEV₁ as the primary outcome.
• Dana-Farber Cancer Institute, with Eli Lilly and Karyopharm Therapeutics as collaborators, registered a not-yet-recruiting Phase 2 trial called "SIERRA," combining imlunestrant, abemaciclib, and selinexor in low-grade serous ovarian cancer and endometrioid endometrial cancer. This is a phase 2, interventional treatment trial evaluating imlunestrant, abemaciclib, and selinexor in two separate patient cohorts: low grade serous ovarian cancer and endometrioid endometrial cancer.⁵ Planned enrollment: 60 participants (estimated)⁵.
• Eli Lilly registered a not-yet-recruiting Phase 4 study of donanemab in Indian participants with early symptomatic Alzheimer's disease. The main purpose of this study is to assess how well Donanemab is tolerated and what side effects may occur in Indian participants with early symptoms of Alzheimer's Disease (AD).⁶ The study plans to enroll 50 participants (estimated)⁶, with amyloid-related imaging abnormalities as a primary outcome.