Impact of two years of adjuvant Verzenio treatment is observed well beyond the treatment period, reducing the risk of long-term recurrence by 32% and improving invasive disease-free survival by 7.6% at 5 years
These data reinforce two years of Verzenio plus endocrine therapy as the standard of care for these patients in this curative setting
Use of Verzenio as a treatment option in this setting is supported by an NCCN® Category 1 designation
INDIANAPOLIS, IN, USA I October 20, 2023 I Eli Lilly and Company (NYSE: LLY) today announced five-year outcomes from a pre-planned analysis of the Phase 3 monarchE study evaluating two years of adjuvant Verzenio® (abemaciclib) in combination with endocrine therapy (ET) compared with ET alone in patients with HR+, HER2-, node-positive early breast cancer (EBC) at a high risk of recurrence. These data were shared in a late-breaking presentation at the 2023 European Society for Medical Oncology (ESMO) Congress.
“The five-year time period is an established landmark for adjuvant breast cancer clinical trials and is an important milestone for patients and physicians in this curative setting,” said Nadia Harbeck, M.D., Ph.D, Director of the Breast Center and Chair for Conservative Oncology, Department of OB&GYN, LMU University Hospital (Munich, Germany), monarchE investigator, and presenter of the results at the 2023 ESMO Congress. “These five-year monarchE data clearly demonstrate a carryover effect beyond the completion of two years of abemaciclib treatment, with the IDFS and DRFS curves continuing to separate, reinforcing confidence in the role of abemaciclib added to endocrine therapy in the adjuvant setting for those with a high risk of recurrence.”
The data presented include results from a pre-specified analysis reflecting a median follow-up of 4.5 years. All patients have completed the Verzenio treatment course, with more than 80% of patients having been followed for at least two years after completion. In the intent-to-treat (ITT) population, the risk of developing invasive disease was reduced by 32% (HR=0.680, 95% CI: 0.599, 0.772; nominal p<0.001). The absolute increase in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) continued to deepen in magnitude at five years, to 7.6% and 6.7%, respectively, reflecting improvements from the two-, three-, and four-year rates. With the majority of the IDFS events being DRFS events, the DRFS benefit was also maintained with Verzenio reducing the risk of developing distant recurrence or death by 32.5% (HR=0.675, 95% CI: 0.588, 0.774; nominal p<0.001). In this five-year outcome analysis, the Kaplan-Meier curves continued to separate, confirming a sustained benefit beyond the two-year treatment period. IDFS and DRFS results for Cohort 1 were consistent with those for the ITT population. As reported previously, IDFS and DRFS benefit was seen across subgroups.
While overall survival (OS) data remain immature, fewer deaths were observed in the Verzenio arm (208 [7.4%] of 2,808 patients) compared to the control arm (234 [8.3%] of 2,829 patients) (HR=0.903, 95% CI: 0.749, 1.088; p = 0.284). Nearly twice as many patients receiving ET alone (n=269) developed and are living with metastatic disease compared to those receiving Verzenio (n=138).
There were no new safety findings, and overall results are consistent with the well-established safety profile for Verzenio. The most frequent adverse events (AEs) were diarrhea, neutropenia, and fatigue in the Verzenio-plus-ET arm, and arthralgia, hot flush, and fatigue in the ET-alone arm. The most common Grade 3-4 AEs were neutropenia, leucopenia, and diarrhea in the Verzenio arm and arthralgia, neutropenia, and ALT increased in the control arm.
Additionally, Lilly presented analyses showing that dose reductions did not compromise the efficacy of Verzenio in monarchE, which is consistent with published results of Verzenio in the metastatic setting. Dose reductions, when needed, can be an effective strategy in managing side effects and support the goal of maximizing treatment adherence for the two years of Verzenio treatment in high-risk early breast cancer.
“The mature recurrence efficacy benefit demonstrated in monarchE, achieved with a two-year treatment duration, reinforce Verzenio as the standard of care in this curative setting, where Verzenio is the only CDK4/6 inhibitor approved to treat people with HR+, HER2-, node-positive, high risk early breast cancer,” said David Hyman, M.D., chief medical officer, Lilly. “Reaching the 5-year outcomes benchmark with adjuvant Verzenio should provide further confidence for those patients where treatment intensification is needed to help them achieve their goal of remaining cancer-free.”
Updates from the Imlunestrant Clinical Development Program
In a separate mini oral presentation on Sunday, October 22, Lilly will share data from the Phase 1a/b EMBER study, evaluating imlunestrant – an investigational, oral selective estrogen receptor degrader (SERD) – as a monotherapy and in combination with everolimus or alpelisib for people with estrogen receptor positive (ER+), HER2- advanced breast cancer. These are the first clinical data on these combinations. Results demonstrated that single agent imlunestrant had a clinical benefit rate of 42% and this increased to 62% when given in combination with everolimus or alpelisib (both approved agents in the second-line setting). Side effects were mostly low grade for single agent imlunestrant, and the combination regimens had a similar side effect profile to everolimus or alpelisib given in combination with standard endocrine therapy.
About the monarchE Study
monarchE was a global, randomized, open-label, two cohort, multicenter Phase 3 clinical trial that enrolled 5,637 adults with HR+, HER2-, node-positive EBC at high risk of recurrence. The study enrolled patients across more than 600 sites in 38 countries and is the only adjuvant study designed to investigate a CDK4/6 inhibitor specifically in a node-positive, high risk EBC population. To be enrolled in Cohort 1 (n=5,120), which is the FDA-approved population, patients had to have 4+ positive nodes or 1-3 positive nodes and at least one of the following: tumors that were ≥5 cm or Grade 3. Patients enrolled in Cohort 2 could not have met the eligibility criteria for Cohort 1. To be enrolled in Cohort 2 (n=517), patients had to have 1-3 positive nodes and Ki-67 score ≥20%. Patients in each cohort were randomized 1:1 to receive either Verzenio 150 mg twice daily plus standard-of-care adjuvant ET (Cohort 1, n=2,555; Cohort 2, n=253) or standard-of-care adjuvant ET alone (Cohort 1, n=2,565; Cohort 2, n=264) for 2 years. ET continued for at least 5 years if deemed medically appropriate. The primary endpoint was IDFS. Consistent with expert guidelines, IDFS was defined as the length of time before breast cancer comes back, any new cancer develops, or death.
About Early Breast Cancer and Risk of Recurrence
It is estimated that 90% of all breast cancers are detected at an early stage.1 Approximately 70% of all breast cancer cases are the HR+, HER2- subtype.2 Although the prognosis for HR+, HER2- EBC is generally favorable, high risk patients are three times more likely than those with low risk characteristics to experience recurrence – with the majority being incurable metastatic disease.3 These patients have an increased risk of recurrence during the first two years of endocrine therapy.
Factors associated with high risk of recurrence in HR+, HER2- early breast cancer include: positive nodal status, the number of positive nodes, large tumor size (≥5 cm), and high tumor grade (Grade 3). Node-positive means that cancer cells from the tumor in the breast have been found in the lymph nodes near the breast. Although breast cancer is removed through surgery, the presence of cancer cells in the lymph nodes signifies that there is a higher chance of developing recurrence and distant metastatic disease.
About Breast Cancer
Breast cancer has 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.4 In the U.S., it is estimated that there will be more than 300,000 new cases of breast cancer diagnosed in 2023. Breast cancer is the second leading cause of cancer death in women in the U.S.5
About Verzenio® (abemaciclib)
Verzenio® (abemaciclib) is approved to treat people with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic setting. Verzenio is the first and only CDK4/6 inhibitor approved to treat node-positive, high risk early breast cancer (EBC) patients.6 The National Comprehensive Cancer Network® (NCCN®) recommends consideration of two years of abemaciclib (Verzenio) added to endocrine therapy as a Category 1 treatment option in the adjuvant setting.7 NCCN® also includes Verzenio plus endocrine therapy as a preferred treatment option for metastatic breast cancer.7
The collective results of Lilly’s clinical development program continue to differentiate Verzenio as a CDK4/6 inhibitor. In high risk EBC, Verzenio has shown a persistent and deepening benefit beyond the two-year treatment period in the monarchE trial, the only adjuvant study designed to investigate a CDK4/6 inhibitor specifically in a node-positive, high risk EBC population.8 In metastatic breast cancer, Verzenio has demonstrated statistically significant overall survival in the Phase 3 MONARCH 2 study.9 Verzenio has shown a consistent and generally manageable safety profile across clinical trials. In addition to breast cancer, Lilly is studying Verzenio in different forms of difficult-to-treat prostate cancer.
Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is currently authorized for use in more than 90 counties around the world. For full details on indicated uses of Verzenio in HR+, HER2- breast cancer, please see full Prescribing Information, available at www.Verzenio.com.
INDICATIONS FOR VERZENIO®
VERZENIO® is a kinase inhibitor indicated:
- in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) 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 recurrence.
- in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
- in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
- as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Please see full Prescribing Information and Patient Information for Verzenio.
AL HCP ISI 12OCT2021
About Imlunestrant
Imlunestrant (LY3484356) is an investigational, next-generation oral selective estrogen receptor degrader (SERD) designed to deliver continuous ER target inhibition, including ESR1-mutant breast cancer. The estrogen receptor (ER) is the key therapeutic target for patients with ER+, HER2- breast cancer. Novel degraders of ER may overcome endocrine therapy resistance while providing consistent oral pharmacology and convenience of administration. Imlunestrant was specifically designed to deliver continuous estrogen receptor target inhibition throughout the dosing period and regardless of ESR1 mutational status. Imlunestrant is currently being studied in several clinical studies.
About Lilly
Lilly unites caring with discovery to create medicines that make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer’s disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news or follow us on Facebook, Instagram and LinkedIn. P-LLY
Verzenio® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
Other company names mentioned herein are the trademarks of their respective owners.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
©Lilly USA, LLC 2023. ALL RIGHTS RESERVED.
1 National Cancer Institute, SEER. Cancer Stat Facts: Female Breast Cancer. https://seer.cancer.gov/statfacts/html/breast.html. Accessed October 18, 2023.
2 National Cancer Institute, SEER. Cancer Stat Facts: Female Breast Cancer Subtypes. https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed October 18, 2023.
3 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.
4 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.
5 American Cancer Society. Cancer Statistics Center. http://cancerstatisticscenter.cancer.org. Accessed October 18, 2023.
6 Verzenio. Prescribing information. Lilly USA, LLC.
7 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed October 18, 2023. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
8 Johnston SRD, Toi M, O’Shaughnessy J, Rastogi P, et al. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023 Jan;24(1):77-90.
9 Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2–negative breast cancer that progressed on endocrine therapy—MONARCH 2: a randomized clinical trial. JAMA Oncol. 2020;6(1):116-124. doi:10.1001/jamaoncol. 2019.4782.
SOURCE: Eli Lilly and Company
Post Views: 194
Impact of two years of adjuvant Verzenio treatment is observed well beyond the treatment period, reducing the risk of long-term recurrence by 32% and improving invasive disease-free survival by 7.6% at 5 years
These data reinforce two years of Verzenio plus endocrine therapy as the standard of care for these patients in this curative setting
Use of Verzenio as a treatment option in this setting is supported by an NCCN® Category 1 designation
INDIANAPOLIS, IN, USA I October 20, 2023 I Eli Lilly and Company (NYSE: LLY) today announced five-year outcomes from a pre-planned analysis of the Phase 3 monarchE study evaluating two years of adjuvant Verzenio® (abemaciclib) in combination with endocrine therapy (ET) compared with ET alone in patients with HR+, HER2-, node-positive early breast cancer (EBC) at a high risk of recurrence. These data were shared in a late-breaking presentation at the 2023 European Society for Medical Oncology (ESMO) Congress.
“The five-year time period is an established landmark for adjuvant breast cancer clinical trials and is an important milestone for patients and physicians in this curative setting,” said Nadia Harbeck, M.D., Ph.D, Director of the Breast Center and Chair for Conservative Oncology, Department of OB&GYN, LMU University Hospital (Munich, Germany), monarchE investigator, and presenter of the results at the 2023 ESMO Congress. “These five-year monarchE data clearly demonstrate a carryover effect beyond the completion of two years of abemaciclib treatment, with the IDFS and DRFS curves continuing to separate, reinforcing confidence in the role of abemaciclib added to endocrine therapy in the adjuvant setting for those with a high risk of recurrence.”
The data presented include results from a pre-specified analysis reflecting a median follow-up of 4.5 years. All patients have completed the Verzenio treatment course, with more than 80% of patients having been followed for at least two years after completion. In the intent-to-treat (ITT) population, the risk of developing invasive disease was reduced by 32% (HR=0.680, 95% CI: 0.599, 0.772; nominal p<0.001). The absolute increase in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) continued to deepen in magnitude at five years, to 7.6% and 6.7%, respectively, reflecting improvements from the two-, three-, and four-year rates. With the majority of the IDFS events being DRFS events, the DRFS benefit was also maintained with Verzenio reducing the risk of developing distant recurrence or death by 32.5% (HR=0.675, 95% CI: 0.588, 0.774; nominal p<0.001). In this five-year outcome analysis, the Kaplan-Meier curves continued to separate, confirming a sustained benefit beyond the two-year treatment period. IDFS and DRFS results for Cohort 1 were consistent with those for the ITT population. As reported previously, IDFS and DRFS benefit was seen across subgroups.
While overall survival (OS) data remain immature, fewer deaths were observed in the Verzenio arm (208 [7.4%] of 2,808 patients) compared to the control arm (234 [8.3%] of 2,829 patients) (HR=0.903, 95% CI: 0.749, 1.088; p = 0.284). Nearly twice as many patients receiving ET alone (n=269) developed and are living with metastatic disease compared to those receiving Verzenio (n=138).
There were no new safety findings, and overall results are consistent with the well-established safety profile for Verzenio. The most frequent adverse events (AEs) were diarrhea, neutropenia, and fatigue in the Verzenio-plus-ET arm, and arthralgia, hot flush, and fatigue in the ET-alone arm. The most common Grade 3-4 AEs were neutropenia, leucopenia, and diarrhea in the Verzenio arm and arthralgia, neutropenia, and ALT increased in the control arm.
Additionally, Lilly presented analyses showing that dose reductions did not compromise the efficacy of Verzenio in monarchE, which is consistent with published results of Verzenio in the metastatic setting. Dose reductions, when needed, can be an effective strategy in managing side effects and support the goal of maximizing treatment adherence for the two years of Verzenio treatment in high-risk early breast cancer.
“The mature recurrence efficacy benefit demonstrated in monarchE, achieved with a two-year treatment duration, reinforce Verzenio as the standard of care in this curative setting, where Verzenio is the only CDK4/6 inhibitor approved to treat people with HR+, HER2-, node-positive, high risk early breast cancer,” said David Hyman, M.D., chief medical officer, Lilly. “Reaching the 5-year outcomes benchmark with adjuvant Verzenio should provide further confidence for those patients where treatment intensification is needed to help them achieve their goal of remaining cancer-free.”
Updates from the Imlunestrant Clinical Development Program
In a separate mini oral presentation on Sunday, October 22, Lilly will share data from the Phase 1a/b EMBER study, evaluating imlunestrant – an investigational, oral selective estrogen receptor degrader (SERD) – as a monotherapy and in combination with everolimus or alpelisib for people with estrogen receptor positive (ER+), HER2- advanced breast cancer. These are the first clinical data on these combinations. Results demonstrated that single agent imlunestrant had a clinical benefit rate of 42% and this increased to 62% when given in combination with everolimus or alpelisib (both approved agents in the second-line setting). Side effects were mostly low grade for single agent imlunestrant, and the combination regimens had a similar side effect profile to everolimus or alpelisib given in combination with standard endocrine therapy.
About the monarchE Study
monarchE was a global, randomized, open-label, two cohort, multicenter Phase 3 clinical trial that enrolled 5,637 adults with HR+, HER2-, node-positive EBC at high risk of recurrence. The study enrolled patients across more than 600 sites in 38 countries and is the only adjuvant study designed to investigate a CDK4/6 inhibitor specifically in a node-positive, high risk EBC population. To be enrolled in Cohort 1 (n=5,120), which is the FDA-approved population, patients had to have 4+ positive nodes or 1-3 positive nodes and at least one of the following: tumors that were ≥5 cm or Grade 3. Patients enrolled in Cohort 2 could not have met the eligibility criteria for Cohort 1. To be enrolled in Cohort 2 (n=517), patients had to have 1-3 positive nodes and Ki-67 score ≥20%. Patients in each cohort were randomized 1:1 to receive either Verzenio 150 mg twice daily plus standard-of-care adjuvant ET (Cohort 1, n=2,555; Cohort 2, n=253) or standard-of-care adjuvant ET alone (Cohort 1, n=2,565; Cohort 2, n=264) for 2 years. ET continued for at least 5 years if deemed medically appropriate. The primary endpoint was IDFS. Consistent with expert guidelines, IDFS was defined as the length of time before breast cancer comes back, any new cancer develops, or death.
About Early Breast Cancer and Risk of Recurrence
It is estimated that 90% of all breast cancers are detected at an early stage.1 Approximately 70% of all breast cancer cases are the HR+, HER2- subtype.2 Although the prognosis for HR+, HER2- EBC is generally favorable, high risk patients are three times more likely than those with low risk characteristics to experience recurrence – with the majority being incurable metastatic disease.3 These patients have an increased risk of recurrence during the first two years of endocrine therapy.
Factors associated with high risk of recurrence in HR+, HER2- early breast cancer include: positive nodal status, the number of positive nodes, large tumor size (≥5 cm), and high tumor grade (Grade 3). Node-positive means that cancer cells from the tumor in the breast have been found in the lymph nodes near the breast. Although breast cancer is removed through surgery, the presence of cancer cells in the lymph nodes signifies that there is a higher chance of developing recurrence and distant metastatic disease.
About Breast Cancer
Breast cancer has 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.4 In the U.S., it is estimated that there will be more than 300,000 new cases of breast cancer diagnosed in 2023. Breast cancer is the second leading cause of cancer death in women in the U.S.5
About Verzenio® (abemaciclib)
Verzenio® (abemaciclib) is approved to treat people with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic setting. Verzenio is the first and only CDK4/6 inhibitor approved to treat node-positive, high risk early breast cancer (EBC) patients.6 The National Comprehensive Cancer Network® (NCCN®) recommends consideration of two years of abemaciclib (Verzenio) added to endocrine therapy as a Category 1 treatment option in the adjuvant setting.7 NCCN® also includes Verzenio plus endocrine therapy as a preferred treatment option for metastatic breast cancer.7
The collective results of Lilly’s clinical development program continue to differentiate Verzenio as a CDK4/6 inhibitor. In high risk EBC, Verzenio has shown a persistent and deepening benefit beyond the two-year treatment period in the monarchE trial, the only adjuvant study designed to investigate a CDK4/6 inhibitor specifically in a node-positive, high risk EBC population.8 In metastatic breast cancer, Verzenio has demonstrated statistically significant overall survival in the Phase 3 MONARCH 2 study.9 Verzenio has shown a consistent and generally manageable safety profile across clinical trials. In addition to breast cancer, Lilly is studying Verzenio in different forms of difficult-to-treat prostate cancer.
Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is currently authorized for use in more than 90 counties around the world. For full details on indicated uses of Verzenio in HR+, HER2- breast cancer, please see full Prescribing Information, available at www.Verzenio.com.
INDICATIONS FOR VERZENIO®
VERZENIO® is a kinase inhibitor indicated:
- in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) 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 recurrence.
- in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
- in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
- as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Please see full Prescribing Information and Patient Information for Verzenio.
AL HCP ISI 12OCT2021
About Imlunestrant
Imlunestrant (LY3484356) is an investigational, next-generation oral selective estrogen receptor degrader (SERD) designed to deliver continuous ER target inhibition, including ESR1-mutant breast cancer. The estrogen receptor (ER) is the key therapeutic target for patients with ER+, HER2- breast cancer. Novel degraders of ER may overcome endocrine therapy resistance while providing consistent oral pharmacology and convenience of administration. Imlunestrant was specifically designed to deliver continuous estrogen receptor target inhibition throughout the dosing period and regardless of ESR1 mutational status. Imlunestrant is currently being studied in several clinical studies.
About Lilly
Lilly unites caring with discovery to create medicines that make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer’s disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news or follow us on Facebook, Instagram and LinkedIn. P-LLY
Verzenio® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
Other company names mentioned herein are the trademarks of their respective owners.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
©Lilly USA, LLC 2023. ALL RIGHTS RESERVED.
1 National Cancer Institute, SEER. Cancer Stat Facts: Female Breast Cancer. https://seer.cancer.gov/statfacts/html/breast.html. Accessed October 18, 2023.
2 National Cancer Institute, SEER. Cancer Stat Facts: Female Breast Cancer Subtypes. https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed October 18, 2023.
3 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.
4 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.
5 American Cancer Society. Cancer Statistics Center. http://cancerstatisticscenter.cancer.org. Accessed October 18, 2023.
6 Verzenio. Prescribing information. Lilly USA, LLC.
7 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed October 18, 2023. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
8 Johnston SRD, Toi M, O’Shaughnessy J, Rastogi P, et al. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023 Jan;24(1):77-90.
9 Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2–negative breast cancer that progressed on endocrine therapy—MONARCH 2: a randomized clinical trial. JAMA Oncol. 2020;6(1):116-124. doi:10.1001/jamaoncol. 2019.4782.
SOURCE: Eli Lilly and Company
Post Views: 194
