Lilly's Breast Cancer Drug Verzenio® (Abemaciclib) Approved in China for HR+/HER2- Advanced Breast Cancer

Eli Lilly and Company recently announced its new anti-tumor drug, Verzenio®(Abeciclib Tablets) were approved by the National Medical Products Administration (NMPA) on December 29, 2020, for use in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:

Chinese Scholars Lead International Multicenter Clinical Study, Validating Verzenio®(Efficacy and Safety of Abemaciclib Tablets Combined with Endocrine Therapy in Chinese Patients with Advanced Breast Cancer)[1],[2]

Verzenio®The approval of (abemaciclib tablets) is based on the results of the pivotal Phase III clinical study, MONARCH plus. The study was led by principal investigators Professor Jiang Zefei from the Fifth Medical Center of the Chinese PLA General Hospital and Professor Hu Xichun from Fudan University Shanghai Cancer Center, with participation from 45 centers across China, India, Brazil, and South Africa, including 28 centers in China.

 
MONARCH plus met the stringent threshold for demonstrating efficacy at the prespecified interim analysis. Cohort A confirmed a statistically and clinically significant improvement in progression-free survival (PFS) with abemaciclib combined with nonsteroidal aromatase inhibitors (NSAIs) (median PFS not reached vs. 14.73 months in the placebo plus NSAI group; HR: 0.499; 95% CI, 0.346–0.719; p=0.0001). Cohort B confirmed that abemaciclib plus fulvestrant extended median PFS by 5.88 months compared with fulvestrant monotherapy, representing a significant clinical benefit (11.47 months vs. 5.59 months in the placebo plus fulvestrant group; HR = 0.376; 95% CI, 0.240–0.588; P<0.0001). The benefits of abemaciclib were generally consistent across prespecified subgroups in both cohorts. Abemaciclib combined with endocrine therapy demonstrated a safety profile consistent with previous studies and was well tolerated in the study population, including Chinese patients with advanced breast cancer; common adverse events were monitorable and manageable. The results of this interim analysis were first presented at the 2019 European Society for Medical Oncology (ESMO) Congress and published in Therapeutic Advances in Medical Oncology in October 2020.
 
MONARCH plus is the first and only international, multicenter, Phase III clinical trial to demonstrate the clinical benefit of CDK4/6 inhibitors in women with HR+, HER2- advanced breast cancer, predominantly comprising Chinese patients. We extend our gratitude for the significant contributions made by the investigators, healthcare professionals, patients, and their families in China and the other three participating countries.
 
Verzenio®(Abeciclib Tablets) Poised to Become a New Treatment Option for the Broad Population of HR+, HER2- Advanced Breast Cancer Patients in China
Breast cancer is the leading malignant tumor threatening the health of Chinese women. According to statistics from the International Agency for Research on Cancer, there were approximately 416,000 new cases of breast cancer and about 117,000 deaths in China in 2020, accounting for approximately 17.1% of global breast cancer deaths.[3] Among the various subtypes of advanced breast cancer, HR+/HER2− is the most common, accounting for approximately 60%.[4]However, the complexity of the disease poses significant challenges to the treatment of HR+, HER2- advanced breast cancer, urgently necessitating novel therapeutic regimens to improve efficacy and prolong patient survival.
 
 

 
About Advanced Breast Cancer
Breast cancer is the most prevalent malignant tumor in terms of incidence and mortality among women worldwide. Approximately 3–8% of breast cancer patients are diagnosed with advanced-stage disease at initial presentation.[5]30-40% of patients with early-stage breast cancer still progress to advanced breast cancer despite undergoing surgery and postoperative treatment. Once the disease progresses to advanced breast cancer, it is often incurable, with a 5-year survival rate of only about 20% and a median overall survival time of just 2–3 years.[6]
 
About the MONARCH plus Study
MONARCH plus is a randomized, double-blind, international, multicenter Phase 3 clinical study conducted in postmenopausal women with HR+, HER2− advanced breast cancer, predominantly comprising Chinese patients. The study evaluated the efficacy and safety of abemaciclib combined with a nonsteroidal aromatase inhibitor (letrozole or anastrozole) versus placebo combined with a nonsteroidal aromatase inhibitor as initial therapy, as well as abemaciclib combined with fulvestrant versus placebo combined with fulvestrant following disease progression on prior endocrine therapy.
 
About Verzenio®(Abeciclib Tablets)
Verzenio® (abemaciclib tablets) is an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, which are activated by binding to cyclin D. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote the phosphorylation of the retinoblastoma protein (Rb), thereby accelerating cell cycle progression and cellular proliferation. In vitro, continuous exposure to abemaciclib inhibits Rb phosphorylation and blocks cell cycle progression from the G1 phase to the S phase, leading to cellular senescence and apoptosis (cell death).
 
Verzenio®(Abeciclib Tablets) is the first solid oral drug produced by Eli Lilly using a faster and more efficient “continuous manufacturing” model. “Continuous manufacturing” is an advanced, novel production model in the pharmaceutical industry, and Eli Lilly is one of the earliest companies to adopt this technology.
 
About Eli Lilly and Company
Eli Lilly and Company is a global leader in the pharmaceutical industry, dedicated to improving human health through innovation. Founded more than a century ago, the company was established with a commitment to producing high-quality medicines that meet real medical needs. Today, we remain steadfast in this mission and guide our work by it. Around the world, our employees strive to discover and develop transformative medicines and deliver them to patients who truly need them. Furthermore, we are committed to enhancing public understanding of diseases and improving disease management, while giving back to society through philanthropy and volunteerism. For more information about Eli Lilly and Company, please visit www.lilly.com.
 
References:
[1] Jiang Z, et al.2019 ESMO Abstract LBA25.
[2] Zhang QY, et al. Ther Adv Med Oncol. 2020;12:1-14
[3] Global Cancer. IARC.2020. https://gco.larc.fr
[4] Deluche E, et al. Eur J Cancer. 2020; 129:60-70
[5] Expert consensus on maintenance therapy for advanced breast cancer in China. Chinese Medical Journal. 2018;98(2):87-90
[6] Expert Committee on Breast Cancer of the National Cancer Quality Control Center, Breast Cancer Professional Committee of the China Anti-Cancer Association, Professional Committee on Clinical Research of Oncology Drugs of the China Anti-Cancer Association. Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer in China (2020 Edition) [J]. Chinese Journal of Oncology, 2020, 42(10):781-797