Taking Hope Further in Hormone Receptor (HR)+, Human Epidermal Growth Factor Receptor 2 (HER2)- Breast Cancer: The Abemaciclib (Yulareb®) Philippine Launch

In the year 2020, 27,163 new cases of breast cancer were diagnosed in the Philippines and breast cancer accounted for 17.7% of all cancer cases, making it the most common type of cancer in the country.¹

On April 15, 2023, ZP Therapeutics held a scientific symposium entitled Taking Hope Further in HR+, HER2- Breast Cancer at the EDSA Shangri-La Hotel in response to this alarming trend, and to formally launch a new treatment option for breast cancer: Abemaciclib (Yulareb®). The event gathered over 100 industry experts and oncologists from across the country.



In his opening remarks, Jeff Folland, ZP Therapeutics General Manager, noted that the goal of the launch was to increase awareness of the current healthcare burden of breast cancer and the availability of the latest treatment options like abemaciclib.

Dr. Honey Sarita J. Abarquez, Vice President of the Philippine Society of Medical Oncology lauded the event and how it complemented the society’s efforts to always stay up to date with the latest treatment options.

Current Trends in Advanced/Metastatic Breast Cancer and Updates from Abemaciclib (Yulareb®) Monarch Studies

Dr. Lee Guek Eng, Senior Consultant Oncologist at the Icon Cancer Center in Singapore recalled the emergence of endocrine therapy (ET) as the initial treatment option for HR+, HER2- disease as recommended by different guidelines from all over the world.^2-4 However, a high rate of endocrine resistance has led to the development of selective inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6),  which have been found to prolong  cancer cell cycle arrest leading to apoptosis or senescence.^5,6

In her review of the MONARCH 2 study – which examined abemaciclib in pre-, peri- or post-menopausal women with HR+/HER2- advanced breast cancer whose disease progressed during neoadjuvant or adjuvant ET – Dr. Lee pointed out that progression free survival (PFS), the study’s primary outcome measure was noted to be significantly better in the abemaciclib group compared to placebo. This effect was stronger in patients with primary resistance, progesterone receptor (PR) disease and visceral metastasis.⁷

The final survival analysis of MONARCH 2 showed significantly higher overall survival rates in abemaciclib patients with a hazard ratio (HR) of 0.78 (95% CI), and an HR of 0.54 (95% CI) for persistent progression free survival compared to the placebo (See Figure 1). These survival rates highlight the efficacy of abemaciclib.⁸




Dr. Lee also discussed the MONARCH 3 trial which studied the use of abemaciclib or placebo plus a non-steroidal aromatase inhibitor in post-menopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. The study found that PFS was improved in the abemaciclib group compared to the placebo group (HR 0.54), with better results noted among Asians, PR- cases and those with metastatic sites other than visceral or bone involvement.⁹

Dr. Lee noted that the results of both studies indicate that abemaciclib could work better in more aggressive disease.Safety data from MONARCH 2 showed that majority of adverse events were grade 1 or 2 diarrhea, neutropenia, nausea, fatigue and abdominal pain.  Diarrhea affected 86.4% of patients, setting in early at 6 to 8 days after starting treatment, but improved as treatment progressed. Antidiarrheal medication was effective, and treatment discontinuation rates were low.⁷

Changing Treatment Outcomes of High-Risk eBC patients with Abemaciclib

Fusing evidence from research into real-world practice, Dr. Shaheenah Dawood, Consultant Medical Oncologist at Mediclinic City Hospital, Dubai emphasized the importance of risk stratification to help identify patients who need further treatment and avoid overtreatment in those who don’t.

She underscored the value of genetic testing and the use of online genomic platforms – like PREDICT for short term recurrence risk and the CTS5 calculator for predicting the risk of distant relapse – in conjunction with the classic clinicopathologic risk indicators.^10,11 After reiterating key points in the analysis of risk of recurrence, Dr. Dawood insisted that the rate of high risk cases is likely much higher than the 14% cited in studies¹² and that risk reduction obviously needs to improve.

The results of earlier Monarch studies showing abemaciclib improve overall survival in endocrine sensitive and resistant metastatic breast cancer and has an ability to overcome primary endocrine resistance, have generated a lot of interest in the adjuvant setting for high-risk breast cancer.^7,9

The monarchE trial studied abemaciclib in the treatment of HR+, HER2-, advanced breast cancer patients   who have had surgery and as indicated, radiotherapy and/or adjuvant or neoadjuvant chemotherapy. Abemaciclib showed a 33.6% reduction in the risk of an IDFS event with an absolute benefit in 4-year rates of 6.4%, with the trend suggesting continued reduction with additional follow up (See Figure 2). This data indicates that abemaciclib can help decrease the risk of early and delayed recurrence in the adjuvant setting.^13-15



A 34.1% reduction in the risk of distant relapse-free survival (DRFS) with an absolute benefit of 5.9% at 4 years between the Abemaciclib arm and the placebo arm was also reported (See Figure 3).^13-15



Dr. Dawood said serious side effects from abemaciclib can be expected in the adjuvant setting making counselling and appropriate consent very important. Diarrhea and neutropenia are still the most reported side effect at comparable rates from previous MONARCH studies. Adverse effect outcomes showed dose reduction at 43%, dose withheld in 61% and treatment discontinued in 18.5% but only 8.9% after dose reduction.^15-17

Abemaciclib may be given 14 days after completion of   radiotherapy, within 16 months of definitive cancer surgery and up to 12 weeks of receiving ET.13 Recently, US Food and Drug Administration (FDA) recommended that all who fit the criteria be given abemaciclib irrespective of Ki67 levels.¹⁸  

Abemaciclib in local clinical practice

Local experts shared case presentations to showcase local experiences with the use of abemaciclib. The presenters were Dr. Jerry Tan Chun Bing, Head of the Section of Medical Oncology, University of Cebu Medical Center; Dr. Marcelo Imasa, Training Officer, Department of Medicine, St. Luke’s Medical Center; and Dr. Rubi Khaw Li, head of Research Unit, Cancer Institute and St. Luke’s Human Cancer Biobank Research and Biotechnology Group.

An interactive discussion between the resource persons and the participants followed, facilitated by Dr. Roselle de Guzman, Associate Professor and Head, Oncology and Pain Management section, Manila Central University.

To cap off the event, the participants signed a virtual commitment wall promising to take hope further for HR+, HER2- early and metastatic breast cancer patients.

With emerging effective treatments like abemaciclib and the commitment and expertise of local and international experts, hope for breast cancer patients can go further than ever.



References: 1. World Health Organization. International Agency for Research on Cancer. Available at https://gco.iarc.fr/today/data/factsheets/populations/608-philippines-fact-sheets.pdf Accessed 3 May 2023. 2. Cardoso F, et al.  Ann Oncol 2012;23:vii11–vii19. 3. Cardoso F, et al. Ann Oncol 2014;25:1871–1888. 4. American Society of Clinical Oncology (ASCO) 2016. Available at https://old-prod.asco.arg/sites/new-www.asco.org/files/content-files/practice-and-guidelines/documents/2016-adv-endocrine-breast-summary-table.pdf.  Accessed 27 Apr 2023. 5. Dizdar O, et al. Expert Opin Emerg Drugs 2009;14(1):85-98. 6. Ahn SG, et al. NPJ Breast Cancer. 2022 May 2;8(1):58. Erratum in: NPJ Breast Cancer. 2022 May 18;8(1):67. 7. Sledge GW Jr, et al. MONARCH 2:  J Clin Oncol. 2017;35(25):2875-2884. 8. Sledge GW, et al. Final overall survival analysis of Monarch 2: A phase 3 trial of Abemaciclib plus Fulvestrant in patients with hormone receptor-positive, HER2-negative advanced breast cancer. Presented at: San Antonio Breast Cancer Symposium 2022; 6-10 December 2022; San Antonio, Texas, USA. Abstract PD13-11. 9. Johnston S, et al. MONARCH 3 final PFS NPJ Breast Cancer. 2019;5:5. 10. UK National Health Service. PREDICT breast cancer tool. Available at https://breast.predict.nhs.uk/tool Accessed 4 May 2023. 11. CTS5 Calculator Available at https://cts5-calculator.com/ Accessed 4 May 2023. 12. Sheffield KM, et al. Future Oncol. 2022;18(21):2667–2682. 13. Johnston SRD, et al. J Clin Oncol 2020;38(34):3987–3998. 14. Harbeck N, et al. Ann Oncol. 2021;32(12):1571–1581. 15. Johnston S, et al. Abemaciclib plus endocrine therapy for HR+, HER2-, node-positive, high-risk early breast cancer: results from a pre-planned monarchE overall survival interim analysis, including 4-year efficacy outcomes. Presented at: San Antonio Breast Cancer Symposium 2022; 6-10 December 2022; San Antonio, Texas, USA. Abstract GS1-09. 9. 16. Johnston S, et a. Lancet Oncol. In press. 17. Rugo HS, et al. Ann Oncol 2022;33(6):616-627. 18. US food and Drug Administration. FDA expands early breast cancer indication for abemaciclib with endocrine therapy. Available at https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-early-breast-cancer-indication-abemaciclib-endocrine-therapy. Accessed 4 May 2023.

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