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Lilly Announces Details of Presentations at 2023 American Association for Cancer Research (AACR) Annual Meeting

Published: 2023-03-14 20:30:00 ET
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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 PM4:30 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 PM5:00 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 PM5:00 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 PM5:00 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 PM5:00 PM ET

Location: Poster Section 18

INDICATIONS FOR VERZENIO®  VERZENIO® is a kinase inhibitor indicated: 

  • in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. 
  • in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. 
  • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. 
  • as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. 

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