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 plus; NCT02763566

Breast Cancer

CDK4 & 6 Inhibitor


A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 & 6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone-Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer*

NCT02763566
Key Inclusion Criteria
  • Hormone-receptor-positive, HER2-negative breast cancer
  • Locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
  • Cohort A must exhibit one of the following:
    • Relapsed with progression >1 year from completion with no adjuvant endocrine therapy (ET) and has received no prior ET for locoregionally recurrent or metastatic disease
    • Relapsed with progression <1 year from completion of or while receiving adjuvant ET (except for letrozole or anastrozole) and has received no prior ET for locoregionally recurrent or metastatic disease
    • Presented with de novo metastatic breast cancer and has not received any prior ET
  • Cohort B must exhibit one of the following:
    • Relapsed with progression while receiving neoadjuvant/adjuvant letrozole or anastrozole, with no subsequent ET received following progression
    • Relapsed with progression within 1 year from completion of adjuvant letrozole or anastrozole, with no subsequent ET received following progression
    • Relapsed with radiologic evidence of progression >1 year from completion of adjuvant ET and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line ET for metastatic disease. Patients may not have received more than one line of ET or any prior chemotherapy for metastatic disease
    • Presented with de novo with metastatic disease and then relapsed with progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line ET for metastatic disease. Patients may not have received more than one line of ET or any prior chemotherapy for metastatic disease
  • Postmenopausal status
  • Measurable disease or nonmeasurable bone-only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Discontinuation of localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least grade 1) except for residual alopecia or peripheral neuropathy
Key Exclusion Criteria
  • Visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
  • Inflammatory breast cancer
  • Evidence or history of central nervous system metastasis
  • Currently receiving or has previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
  • Prior treatment with everolimus or fulvestrant (for cohort B only)
  • Prior therapy with a CDK4 & 6 inhibitor
  • Prior treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
  • Serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (eg, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis)
  • Syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest within the last 12 months
  • 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
  • Active bacterial, fungal, and/or known viral infection
*
This clinical trial is being conducted outside the United States.
Abemaciclib or placebo equivalent is administered PO Q12H on days 1-28 of a 28-day cycle.
Anastrozole or letrozole is administered PO Q24H on days 1-28 of a 28-day cycle.
§
Fulvestrant is administered intramuscularly on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
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.