TORONTO, Aug. 8, 2019 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada) is pleased to announce the availability of VERZENIO™ (abemaciclib). VERZENIO is indicated for the treatment of estrogen and/or progesterone hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) metastatic breast cancer (mBC): in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy; in combination with fulvestrant for women with disease progression following endocrine therapy; and as a single agent for women with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
VERZENIO is a cyclin-dependent kinase (CDK) 4 & 6 inhibitor1. The recommended dose of VERZENIO in combination with endocrine therapy (i.e. anastrozole, letrozole, fulvestrant) is 150 mg orally twice daily, and as monotherapy is 200 mg, continued until disease progression or unacceptable toxicity. VERZENIO is available in four tablet strengths (200 mg, 150 mg, 100 mg, and 50 mg)2.
"When a new medication is approved to effectively treat breast cancer, it brings additional options to Canadian women living with metastatic breast cancer", says Cathy Ammendolea, Chair of the Board of Directors for the Canadian Breast Cancer Network (CBCN). "Having more treatment options for women living with advanced breast cancer means we continue to move in a direction that may enable these women to live their lives to the fullest."
"Targeted therapies like abemaciclib, may help patients whose breast cancer presents with certain disease characteristics that confer a less favorable prognosis," says Dr. Christine Brezden-Masley, Medical Oncologist, Medical Director of Cancer Services, Mount Sinai Hospital in Toronto, Ontario. "Because breast cancers are as diverse as the women who have them, and advanced disease can be a labyrinth of tumour sites and presentation, mBC remains a challenging disease to treat. By disrupting the pathway that leads cancer cells to grow and divide, abemaciclib either alone, or in combination with endocrine therapy, can manage metastatic disease for some by delaying disease progression."
The research behind VERZENIO - MONARCH 3, MONARCH 2 and MONARCH 13
The approval of VERZENIO is based on the efficacy and safety demonstrated in the pivotal MONARCH 3, MONARCH 2 and MONARCH 1 clinical trials.
About MONARCH 3
MONARCH 3 is a Phase 3, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of VERZENIO, a CDK4 & 6 inhibitor, in combination with an AI (anastrozole or letrozole), as initial endocrine-based therapy for postmenopausal women with HR+, HER2- advanced (locoregionally recurrent or metastatic) breast cancer who have had no prior systemic treatment for advanced disease.
If neoadjuvant/adjuvant endocrine therapy was administered, a disease-free interval of more than 12 months since completion of endocrine therapy was required. A total of 493 patients were randomized 2:1 to receive 150 mg of VERZENIO or placebo orally twice a day, without interruption, given in combination with either 1 mg of anastrozole or 2.5 mg of letrozole once daily until disease progression or unacceptable toxicity. The primary endpoint of the study was progression-free survival (PFS), with key secondary endpoints of overall response rates (ORR), duration of response (DoR), overall survival (OS) and safety4.
About MONARCH 2
MONARCH 2 was a Phase 3, randomized, double blind placebo-controlled trial that enrolled 669 patients with HR+, HER2- mBC who progressed on endocrine therapy. Patients were randomized 2:1 to VERZENIO plus fulvestrant or placebo plus fulvestrant. VERZENIO was dosed on a continuous dosing schedule until disease progression or unacceptable toxicity. The primary endpoint was PFS. Key secondary endpoints were ORR, OS and DoR. Patients enrolled in the study had experienced disease progression on or within 12 months of receiving endocrine therapy for metastatic disease. Patients could not have received chemotherapy or more than one line of endocrine therapy for mBC5.
About MONARCH 1
MONARCH 1, a Phase 2, single arm trial, enrolled 132 patients with HR+, HER2- mBC who were given VERZENIO (200 mg) dosed orally twice daily. Patients enrolled in the study had measurable disease, progressed during or after endocrine therapy, and received one or two prior chemotherapy regimens in the metastatic setting. The primary endpoint was ORR and the secondary endpoint was DoR. VERZENIO demonstrated single-agent efficacy in this heavily pretreated patient population. In the study, per investigator assessment, VERZENIO achieved an ORR of 19.7 per cent (95% CI: 13.3-27.5). VERZENIO demonstrated an 8.6 month median DoR (95% CI: 5.8-10.2). Assessments by independent review yielded comparable rates and estimates5.
The most frequently reported (>5%) Grade 3 or Grade 4 adverse reactions across the three studies were: neutropenia, diarrhea, leukopenia, anemia and increases in alanine aminotransferase (ALT).
Metastatic breast cancer (mBC), also referred to as advanced breast cancer, is breast cancer that has spread beyond the breast to other areas in the body, most commonly the bones, lungs liver or brain6. Although metastatic cancers present themselves in different areas of the body, the disease still has the same type of cells shown in the original cancer and is still breast cancer7.
The tumour's HR and HER2 status determine sub-types of mBC8. The most common type is HR+ and HER2-, which occurs in about 70 per cent of breast cancer cases9. Despite improvements made with early detection and treatment, there is currently no cure for mBC. The five-year relative survival rate is 22 per cent for women with advanced breast cancer or mBC in Canada10.
About VERZENIO™ (abemaciclib)
VERZENIO (abemaciclib) is an inhibitor of cyclin-dependent kinases (CDK) 4 & 6, which 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.
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). Preclinically, VERZENIO dosed daily without interruption resulted in reduction of tumor size. Inhibiting CDK4 & 6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that VERZENIO crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of VERZENIO and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations3.
VERZENIO is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.
VERZENIO is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer:
- in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy
- in combination with fulvestrant for women with disease progression following endocrine therapy
- as a single agent for adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Clinical effectiveness of VERZENIO in combination with an aromatase inhibitor is based on the benefit observed in patients treated with VERZENIO in combination with letrozole or anastrozole for the treatment of postmenopausal women with advanced breast cancer.
The full VERZENIO Product Monograph is available here.
About Eli Lilly Canada Inc.
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. Across the globe, 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 Eli Lilly Canada, please visit us at www.lilly.ca.
VERZENIOTM registered trademark owned by Eli Lilly and Company; used under license.
1 About Verzenio. (n.d.). Retrieved from https://www.verzenio.ca/about
2 Verzenio by Itself. Dosing.(n.d.). Retrieved from https://www.verzenio.com/verzenio-by-itself/dosing
3 Yurtoğlu, N. (2018). Http://www.historystudies.net/dergi//birinci-dunya-savasinda-bir-asayis-sorunu-sebinkarahisar-ermeni-isyani20181092a4a8f.pdf. History Studies International Journal of History, 10(7), 30-42. doi:10.9737/hist.2018.658
4 Lilly Recieves Additional FDA Approval for Verzenio™ (abemaciclib), as Initial Treatment for Advanced Breast Cancer. Eli Lilly and Company. February 2018.
5 Lilly Recieves U.S. FDA Approval of Verzenio ™ (abemaciclib). Eli Lilly and Company. October 2017.
6 What is Metastatic Breast Cancer? (n.d.). Retrieved from https://cbcn.ca/en/what_is_mbc
7 What is metastatic cancer? - Canadian Cancer Society. (n.d.). Retrieved from http://www.cancer.ca/en/cancer-information/cancer-type/metastatic-cancer/metastatic-cancer/?region=nu
8 Metastatic Breast Cancer: Know Your Type. (n.d.). Retrieved from https://cbcn.ca/web/default/files/public/Living Legacy_Postcard_HR HER2-_Final_ENG.pdf
9 Canadian Partnership Against Cancer. Breast Cancer Control in Canada: A System Performance Special Focus Report. September 2012
10 Canadian Cancer Society. www.cancer.ca . [Online] 2012http://www.cancer.ca/en/cancer-information/cancer-type/breast/prognosis-and-survival/survival-statistics/?region=nu.
SOURCE Eli Lilly Canada Inc.
For further information: Alyssa Acorn, Cohn & Wolfe, firstname.lastname@example.org, (647) 259-3304; Madelyn Boelhouwer, Cohn & Wolfe, email@example.com, (647) 259-3283