VERZENIO® (abemaciclib) Receives Positive Reimbursement Recommendation from Canadian Agency for Drugs and Technologies in Health (CADTH) for Early Breast Cancer

TORONTO, Oct. 31, 2022 /CNW/ - Lilly Canada announced today that the Canadian Agency for Drugs and Technologies in Health (CADTH) has issued their final reimbursement recommendation for VERZENIO® (abemaciclib) in early breast cancer.

CADTH recommends that VERZENIO in combination with endocrine therapy be reimbursed 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 disease recurrence based on clinicopathological features and a Ki-67 score ≥20%.  VERZENIO received a Notice of Compliance from Health Canada on January 12, 2022.

"This positive CADTH recommendation is an important step forward. Our organization supports many patients diagnosed at a younger age, who often have aggressive disease with a greater risk of recurrence. They want more effective tools in their toolbox that will help improve their chances against this challenging disease that's turned their life-plans upside-down, says MJ DeCoteau, Executive Director, ReThink Breast Cancer. "Verzenio as an option for those with HR+ HER2- breast cancer that is at a high risk of recurrence will give patients a tangible way to help treat their disease and maintain hope."

"This recommendation is an important step forward for the breast cancer community," says Cathy Ammendolea, Chair of the Board of Directors for the Canadian Breast Cancer Network. "It represents hope for so many who have been diagnosed with early breast cancers, living in fear of recurrence."

The CADTH recommendation is based on an evaluation of existing evidence from the phase III monarchE trial within the Ki-67 high patient population, as is aligned with the Health Canada approved indication.

Lilly Canada is pleased that the clinical evidence and benefit of VERZENIO have been recognized by CADTH for use in Canadians with high-risk early breast cancer, and looks forward to working with the provinces and all stakeholders to ensure timely access for those who need it.

Full details on the recommendation, including conditions for reimbursement, are available on the CADTH website.ⁱ

About the monarchE Study The efficacy of VERZENIO plus physician's choice of standard endocrine therapy was evaluated in monarchE is a global, randomized, open-label, two cohort, multicenter Phase 3 study in adult women and men with HR+ HER2-, node-positive resected EBC with clinical and pathological features consistent with a high risk of disease recurrence. A total of 5,637 patients were randomized (1:1) to receive two years of Verzenio 150 mg twice daily plus physician's choice of standard endocrine therapy, or standard endocrine therapy alone. Patients in both treatment arms were instructed to continue to receive adjuvant endocrine therapy for up to 5-10 years as recommended by their clinician. Cohort 1 enrolled patients with ≥4 positive axillary lymph nodes (ALN), or 1-3 positive ALN and either Grade 3 disease or tumor size ≥5 cm. Cohort 2 enrolled patients with 1-3 positive ALN and centrally determined Ki-67 score of ≥20%. The primary endpoint was IDFS in the ITT population (Cohorts 1 & 2). Secondary endpoints were IDFS in patients with high Ki-67 score (in the ITT population and in the Cohort 1 population), DRFS, overall survival, and safety.^{ii, iii}

About Breast Cancer
Breast cancer has now surpassed lung cancer as the most commonly diagnosed cancer worldwide, according to GLOBOCAN. The estimated 2.3 million new cases indicate that 1 in every 8 cancers diagnosed in 2020 is breast cancer. With approximately 685,000 deaths in 2020, breast cancer is the fifth-leading cause of cancer death worldwide.^iv In 2021, 27,700 women were diagnosed with breast cancer in Canada. Breast Cancer represents 14% of all cancer deaths in Canada, and will account for 25% of all new cancer cases in women in 2022.^v

About Early Breast Cancer and Risk of Recurrence 
It is estimated that 90 per cent of all breast cancers are detected at an early stage and that approximately 70 per cent of all breast cancers are of the HR+ HER2- subtype.^vi Although the prognosis for HR+ HER2- EBC is generally positive, 20 per cent of patients will experience recurrence potentially to incurable metastatic disease.^vii Risk of recurrence is greatest within the initial two to three years post-diagnosis, particularly in patients with axillary lymph node-positive, high risk EBC.vⁱⁱⁱ Factors associated with high risk of recurrence include: positive axillary lymph node status, large tumour size (≥5 cm), high tumour grade (Grade 3), and high rate of cellular proliferation [Ki-67 score (≥20%)].ⁱⁱⁱ

Axillary lymph node-positivity means that cancer cells from the tumour in the breast have been found in the lymph nodes in the armpit area. Although the cancerous tumour located in the breast tissue may be removed through surgery, the presence of cancer cells in the lymph nodes signifies that there is a higher chance of the cancer returning and spreading because it shows that the cancerous cells have spread beyond the breast tissue.

About Verzenio^® (abemaciclib)
VERZENIO is a targeted treatment known as a cyclin-dependent kinase (CDK) 4/6 inhibitor, which is a non-chemotherapy oral tablet. Cyclin-dependent kinases (CDK) 4/6 are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation. VERZENIO works inside the cell to block CDK4/6 activity to help stop the growth of cancer cells, so that they may eventually die (based on preclinical studies).  In vitro, continuous exposure to VERZENIO inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death).

The full Canadian VERZENIO Product Monograph is available here.

About Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.

For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA.  

Lilly Forward-Looking Statement 
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Verzenio® (abemaciclib) as a treatment for patients with early breast cancer and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that VERZENIO will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

VERZENIO® is a registered trademark owned or licenced to Eli Lilly and Company, its subsidiaries, or affiliates.

References

ⁱ CADTH: abemaciciclib. Accessed October 26, 2022.

ⁱⁱ Johnston SRD, Harbeck N, Hegg R, et al; monarchE Committee Members and Investigators. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE) [published online ahead of print, September 20, 2020]. J Clin Oncol. doi:10.1200/JCO.20.02514.

ⁱⁱⁱ Verzenio® (abemaciclib) Canadian Product Monograph, January 10, 2022.

^iv Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-249

^v Canadian Cancer Society: Breast Cancer statistics – Last accessed, October 17, 2022.

^vi National Cancer Institute, SEER. Cancer Stat Facts: Female Breast Cancer. https://seer.cancer.gov/statfacts/html/breast.html. Accessed September 14, 2021.

^vii Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005;365(9472):1687-1717. doi:10.1016/S0140-6736(05)66544-0.

^viii Cheng L, Swartz MD, Zhao H, et al. Hazard of recurrence among women after primary breast cancer treatment--a 10-year follow-up using data from SEER-Medicare. Cancer Epidemiol Biomarkers Prev. 2012;21:800-809.

SOURCE Eli Lilly Canada Inc.

Amanda Meek, Eli Lilly Canada, [email protected], [phone]