Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 3

MONARCH 2; NCT02107703

Breast Cancer

CDK4 & 6 Inhibitor


A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4 & 6 Inhibitor, for Women With Hormone-Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer*

NCT02107703
Key Inclusion Criteria
  • Hormone-receptor-positive, HER2-negative breast cancer
  • Locally advanced disease not amenable to curative treatment by surgery or metastatic disease, and must meet one of the following criteria:
    • Relapsed with radiologic evidence of progression while receiving neoadjuvant/adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
    • Relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
    • Relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than one line of endocrine therapy or any prior chemotherapy for metastatic disease
    • Presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than one line of endocrine therapy or any prior chemotherapy for metastatic disease
  • Postmenopausal status due to either surgical/natural menopause or ovarian suppression with a gonadotropin-releasing hormone agonist (initiated ≥28 days prior to randomization)
  • Measurable disease or nonmeasurable bone-only disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Discontinued prior cancer therapies for at least 21 or 14 days for myelosuppressive or nonmyelosuppressive agents, respectively, and recovered from acute effects of therapy
Key Exclusion Criteria
  • Currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
  • Clinical evidence or history of central nervous system metastasis
  • Prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4 & 6 inhibitor. For the endocrine-naïve cohort: Treatment with any prior endocrine therapy
  • Yellow fever vaccination within 28 days prior to randomization
  • Major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)
  • Syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest within the last 12 months
  • Inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission with no therapy for a minimum of 3 years
  • Received an autologous or allogeneic stem-cell transplant
  • Active bacterial, fungal, or viral infection
  • Initiation of bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization
*
This clinical trial is being conducted globally.
Abemaciclib 150 mg or placebo equivalent is administered PO Q12H.
Fulvestrant 500 mg is administered intramuscularly on days 1 and 15 of a 28-day cycle for cycle 1, then on day 1 for all subsequent cycles.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.