INDIANAPOLIS, March 14, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from its oncology portfolio will be presented at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, April 14 – 19, 2023. The presentations include the first clinical data from the Phase 1 studies of LY3537982 (KRAS G12C inhibitor) and LY3410738 (IDH inhibitor) and the Phase 2 study of Verzenio® (abemaciclib; CDK4/6 inhibitor) in metastatic treatment refractory castration-resistant prostate cancer. In addition, preclinical characterization data on Jaypirca's™ (pirtobrutinib; BTK inhibitor) binding mechanism will also be presented.
A list of the presentations, along with their viewing details, are shared below.
Medicine | Abstract Title | Presentation Details |
LY3537982 | A first-in-human phase 1 study of LY3537982, a highly selective and potent KRAS G12C inhibitor in patients with KRAS G12C-mutant advanced solid tumors | Abstract Number: CT028 Session Title: Targeting the KRAS Pathway in the Clinic Session Type: Oral Session Date / Time:April 17 at 2:30 PM – 4:30 PM ET |
LY3410738 | A first-in-human phase 1 study of LY3410738, a covalent inhibitor of mutant IDH, in advanced myeloid malignancies | Abstract Number: CT026 Session Title: Novel Clinical Trials for Hematological Malignancies Session Type: Oral Session Date / Time: April 16 at 3:00 PM – 5:00 PM ET |
LY3410738 | A first-in-human phase 1 study of LY3410738, a covalent inhibitor of mutant IDH, in advanced IDH-mutant cholangiocarcinoma and other solid tumors | Abstract Number: CT098 Session Title: First-in-Human Phase I Clinical Trials 1 Session Type: Poster Session Date / Time:April 17 at 1:30 PM – 5:00 PM ET Location: Poster Section 45 |
Verzenio®(abemaciclib) | CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated with a Novel Hormonal Agent and Taxane-based Chemotherapy | Abstract Number: CT159 Session Title: Phase II Clinical Trials 1 Session Type: Poster Session Date / Time:April 17 at 1:30 PM – 5:00 PM ET Location: Poster Section 47 |
Jaypirca™ (pirtobrutinib) | Unique pharmacodynamic properties conferred by differential binding to BTK, pirtobrutinib vs covalent inhibitors | Abstract Number: 2780 Session Title: Pharmacokinetics, Pharmacodynamics, and Molecular Pharmacology Session Type: Poster Session Date / Time: April 17 at 1:30 PM – 5:00 PM ET Location: Poster Section 18 |
INDICATIONS FOR VERZENIO® VERZENIO® is a kinase inhibitor indicated:
IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib) Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, diarrhea occurred in 81 to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8 to 20% of patients receiving Verzenio. Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of the first diarrhea event ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19 to 26% of patients with diarrhea required a Verzenio dose interruption and 13 to 23% required a dose reduction.
Instruct patients to start antidiarrheal therapy, such as loperamide, at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.
Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio. Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 to 33 days, and the median duration of Grade ≥3 neutropenia ranged from 11 to 16 days. Febrile neutropenia has been reported in