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Association details:

Evidence:

Evidence Level:
Sensitive: A1 - Approval
New
Title:
VERZENIO (abemaciclib) available in Canada for metastatic breast cancer
Published date:
08/08/2019
Excerpt:
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.
Secondary therapy:
Aromatase inhibitor; fulvestrant
Evidence Level:
Sensitive: A1 - Approval
Title:
Abemaciclib (Verzenios) is accepted for use within NHSScotland
Published date:
04/05/2019
Excerpt:
Abemaciclib (Verzenios) is accepted for use within NHSScotland...for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor* as initial endocrine-based therapy, or in women who have received prior endocrine therapy...
Secondary therapy:
Aromatase inhibitor
Evidence Level:
Sensitive: A1 - Approval
Published date:
09/26/2018
Excerpt:
Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Secondary therapy:
Aromatase inhibitor; fulvestrant
Evidence Level:
Sensitive: A1 - Approval
Source:
Excerpt:
VERZENIO in combination with an aromatase inhibitor as initial endocrine based therapy for the treatment of postmenopausal women 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 women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
Secondary therapy:
Aromatase inhibitor; fulvestrant
Evidence Level:
Sensitive: A1 - Approval
Source:
Excerpt:
VERZENIO as monotherapy for the treatment of adult patients with HRpositive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
HER2 Negative Breast Cancer: Invasive Breast Cancer…SYSTEMIC THERAPY FOR ER - AND/OR PR - POSITIVE RECURRENT OR STAGE IV (M1) DISEASE…HER2-Negative and Postmenopausal or Premenopausal Receiving Ovarian Ablation or Suppression…Preferred Regimens...Fulvestrant+ CDK4/6 inhibhitor ( Abemaciclib, palbociclib or ribociclib) (Category 1)
Secondary therapy:
fulvestrant
Evidence Level:
Sensitive: B - Late Trials
Title:
Lilly Presents Positive Primary Outcome Data from monarchE that Builds on Previous Definitive Analysis for Verzenio
Published date:
12/09/2020
Excerpt:
Eli Lilly and Company...today announced additional data from a pre-planned primary outcome analysis from the Phase 3 monarchE trial that showed Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) decreased the risk of breast cancer recurrence by 28.7 percent compared to standard adjuvant ET alone for people with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009)...
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
MONARCH 3: Updated time to chemotherapy and disease progression following abemaciclib plus aromatase inhibitor (AI) in HR+, HER2- advanced breast cancer (ABC)
Published date:
10/10/2020
Excerpt:
ITT population, updated PFS was 28.2 vs 14.8 months (HR [95% CI]: 0.525 [0.415, 0.665]; p< .0001) in the abemaciclib vs placebo arms...Addition of abemaciclib to AI prolonged PFS2 and TCT in the ITT population and all prognostic subgroups...
Secondary therapy:
anastrozole; letrozole
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
Safety and efficacy of abemaciclib plus endocrine therapy (ET) in elderly patients (pts) with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+, HER2-) advanced breast cancer (ABC): an age-specific subgroup analysis of the phase 3, MONARCH 2 and 3 trials
Published date:
10/10/2020
Excerpt:
We report age-specific outcomes from exploratory subgroup analyses of the MONARCH 2 and 3 trials in HR+, HER2- ABC...A consistent PFS benefit was observed with abemaciclib+ET vs PBO+ET across all subgroups in both studies...
Secondary therapy:
letrozole
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:
Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE)
Published date:
09/20/2020
Excerpt:
Abemaciclib plus ET demonstrated superior IDFS versus ET alone (P = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively….Abemaciclib when combined with ET is the first CDK4/6 inhibitor to demonstrate a significant improvement in IDFS in patients with HR+, HER2− node-positive EBC at high risk of early recurrence.
DOI:
10.1200/JCO.20.02514
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
LBA5_PR - Abemaciclib in high risk early breast cancer
Published date:
09/19/2020
Excerpt:
...Abemaciclib plus ET demonstrated a statistically significant improvement in IDFS versus ET alone (p=.0096, HR: 0.747, 95% CI: 0.598, 0.932), corresponding to a 25.3% reduction in the risk of an IDFS event. The 2-year IDFS rates were 92.2% vs 88.7%, respectively....Abemaciclib when combined with ET is the first CDK4 & 6 inhibitor to demonstrate a statistically significant improvement in IDFS in patients with HR+, HER2-, high risk EBC.
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:
Efficacy and Safety of Cyclin-Dependent Kinases 4 and 6 Inhibitors in HR+/HER2- Advanced Breast Cancer
Published date:
06/04/2020
Excerpt:
Subgroup analyses showed no statistically significant difference of PFS among three CDKi: palbociclib vs ribociclib (HR 0.55, 95% CI 0.49-0.60, P = 0.34), palbociclib vs abemaciclib (HR 0.53, 95% CI, 0.47-0.59, P = 0.61), and ribociclib vs abemaciclib (HR 0.56, 95% CI, 0.51-0.62, P = 0.72). CDKi combined with ET can significantly prolong PFS and improve the ORR, CBR and OS in patients with HR+/HER2- ABC. However, the advantage of different CDKi has not been established.
DOI:
10.2147/CMAR.S254365
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
A review of phase 3 clinical trials of CDK4/6 inhibitor combination therapy in premenopausal women.
Published date:
05/16/2018
Excerpt:
In the MONARCH 2 trial (NCT02107703), 669 women without prior chemotherapy for ABC received abemaciclib (or placebo) + fulvestrant + goserelin. Among all patients, 59% and 38% had 0 and 1 prior lines of ET for metastatic disease. In premenopausal women (abemaciclib, n = 72; placebo, n = 42), abemaciclib prolonged PFS...safety and efficacy established in the MONALEESA-7 trial of premenopausal women and premenopausal subsets of the PALOMA-3 and MONARCH 2 trials support using CDK4/6 inhibitor combination therapy in these patients.
Secondary therapy:
fulvestrant + Goserelin
DOI:
10.1200/JCO.2018.36.15_suppl.e13057
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer
Excerpt:
The ORR was 61.0% in the abemaciclib arm versus 45.5% in the placebo arm (measurable disease, p = .003). The median duration of response was longer in the abemaciclib arm (27.39 months) compared to the placebo arm (17.46 months).
DOI:
10.18632/oncotarget.17778
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor–Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy—MONARCH 2
Excerpt:
Treatment with abemaciclib plus fulvestrant resulted in a statistically significant and clinically meaningful median OS improvement of 9.4 months for patients with HR-positive, ERBB2-negative ABC who progressed after prior ET regardless of menopausal status.
Secondary therapy:
fulvestrant; fulvestrant
DOI:
10.1001/jamaoncol.2019.4782
Evidence Level:
Sensitive: B - Late Trials
Title:
MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer
Excerpt:
Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy, significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive, HER2-negative advanced breast cancer.
Secondary therapy:
anastrozole; letrozole
DOI:
10.1200/JCO.2017.75.6155
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (monarchE)
Excerpt:
...The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (MONARCH 2)
Excerpt:
...Have a diagnosis of HR+, HER2- breast cancer...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:
122P - Abemaciclib in HR+/HER2- metastatic breast cancer: a real-world experience
Published date:
05/03/2021
Excerpt:
Patients with HR+/HER2- metastatic breast cancer treated with abemaciclib in combination with ET...were identified.... In patients with measurable disease, ORR was 55.7%, significantly higher in first line compared to second line (70.5% vs 17.7%, p<0.001)....abemaciclib was associated with a meaningful rate of objective response, with a favourable safety profile.
Evidence Level:
Sensitive: C3 – Early Trials
Title:
48P - Abemaciclib combined with adjuvant endocrine therapy in patients from Asia with high risk early breast cancer: monarchE
Published date:
05/03/2021
Excerpt:
There was also a numerical improvement in distant relapse free survival (DRFS) [HR (95% CI) = 0.758 (0.455, 1.264)], with 2-year DRFS rates of 94.4% vs 91.7%. The median txt duration of abemaciclib was 17.7 months. In the abemaciclib arm, the most frequent adverse event (AE) was diarrhea (89.5%), most were G1/2 (55.8%/28.7%). More G≥3 AEs and serious AEs were observed with abemaciclib+ET vs ET (53.5% vs 10.5% and 12.1% vs 6.3%), with neutropenia (31.5%) being the most frequent G≥3 AE. Interstitial lung disease occurred in 6.6% pts, G≥3 in 0.3% pts. G≥3 ALT and AST increases occurred in 4.2% and 3.1% pts, respectively.14.5% of abemaciclib-treated pts discontinued abemaciclib or all txt due to AEs.In pts from Asia with HR+, HER2-, high-risk EBC, abemaciclib plus standard adjuvant ET led to a clinically meaningful improvement in IDFS and DRFS, consistent with benefits demonstrated in the ITT population. Safety was consistent with the known safety profile of abemaciclib. Abemaciclib is the first CDK4 & 6 inhibitor to demonstrate effective and tolerable txt in pts with high-risk EBC
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
Patient-reported outcomes predict progression-free survival of patients with advanced breast cancer treated with abemaciclib
Published date:
04/29/2021
Excerpt:
....the PFS treatment benefit [HR (95% CI)] of abemaciclib (vs comparators) was 0.75 (0.57-1.0)...patients diagnosed with HR+/HER2- advanced breast cancer treated with abemaciclib...had a smaller PFS benefit from abemaciclib (vs comparator) than patients with intermediate/high physical function.
DOI:
10.1002/onco.13806
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Efficacy and Safety of CDK4/6 Inhibitors Combined with Endocrine Therapy in HR+/HER-2- ABC Patients: A Systematic Review and Meta-Analysis
Published date:
04/22/2021
Excerpt:
HR+/HER-2- ABC patients treated with CDK4/6 inhibitors combined with ET had significantly prolonged progression-free survival (PFS) and improved objective response rate (ORR) and clinical benefit rate (CBR)....the patients in experimental intervention groups were treated with CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib)...groups treated with CDK4/6 inhibitors (palbociclib, ribociclib or abemaciclib) combined with ET had a prolonged PFS compared with the endocrine monotherapy groups (HR = 0.55, 95% CI: 0.50–0.60, p < 0.001...
DOI:
https://doi.org/10.1080/07357907.2021.1910705
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Clinical Outcomes With Abemaciclib After Prior CDK4/6 Inhibitor Progression in Breast Cancer: A Multicenter Experience
Published date:
03/24/2021
Excerpt:
We identified 87 patients with HR+ MBC from 6 medical centers in the United States who received abemaciclib after prior progression on a palbociclib- or ribociclib-containing regimen in the metastatic setting….Median PFS on abemaciclib-based therapy in the 87 patients was 5.3 months (95% CI, 3.5–7.8 months; Figure 1A).
DOI:
10.6004/jnccn.2020.7662
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
273O - nextMONARCH: Final overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with HR+, HER2- metastatic breast cancer
Published date:
09/19/2020
Excerpt:
nextMONARCH was a multicenter, randomized, open-label phase II trial of abemaciclib in women with heavily pretreated HR+, HER2- MBC whose disease progressed on or after ET and chemotherapy. Patients were randomized 1:1:1 to abemaciclib 150 mg + tamoxifen 20 mg (A+T), or abemaciclib 150 mg (A-150) or abemaciclib 200 mg plus prophylactic loperamide (A-200)....Median OS was 24.2 months in the A+T arm, compared to 20.8 months in A-150, and 17.0 months in A-200 (A+T vs. A-150: HR 0.620 (95% CI [0.397, 0.969] p=0.034); A-150 vs. A-200: HR 0.956 (95% CI [0.635, 1.438] p=0.832))....Addition of tamoxifen to abemaciclib provided a statistically significant median OS improvement compared to abemaciclib monotherapy in this heavily pretreated HR+, HER2- MBC patient population.
Secondary therapy:
tamoxifen
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:
A Phase 2 Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer
Published date:
06/21/2020
Excerpt:
Abemaciclib was associated with an iCBR of 24% in patients with heavily pretreated HR+, HER2- MBC.
DOI:
10.1158/1078-0432.CCR-20-1764
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
CDK inhibitors in advanced HR+ Her 2- breast cancer: A systematic review and meta-analysis of randomized trials.
Published date:
05/16/2018
Excerpt:
Adding abemaciclib/palbociclib/ribociclib to AI (HR: 0.55, 95% CI 0.48-0.64) or abemaciclib/palbociclib to fulvestrant (HR: 0.49, 95% CI 0.37-0.63) improved significantly the PFS of metastatic HR+ Her 2- breast cancers regardless menopausal status and site of metastasis.
Secondary therapy:
fulvestrant; Aromatase inhibitor
Evidence Level:
Sensitive: C3 – Early Trials
Title:
MONARCH 1, A Phase II Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, as a Single Agent, in Patients with Refractory HR+/HER2- Metastatic Breast Cancer
Excerpt:
A total of 132 patients with HR+/HER2− MBC were enrolled….Abemaciclib demonstrated single-agent activity with 26 of 132 patients achieving a confirmed PR for an ORR of 19.7% (95% CI, 13.3–27.5; 15% not excluded)...
DOI:
10.1158/1078-0432.CCR-17-0754
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:
A phase Ib study of abemaciclib with therapies for metastatic breast cancer.
Excerpt:
Patients (pts) in 6 cohorts received abemaciclib 150-200 mg every 12 hours (Q12H) with letrozole 2.5 mg/d (Part A), anastrozole 1 mg/d (Part B), tamoxifen 20 mg/d (Part C), exemestane 25 mg/d (Part D), exemestane 25 mg/d + everolimus 5 mg/d (Part E)...Combinations of abemaciclib with endocrine therapies demonstrate manageable safety and early clinical evidence of antitumor activity.
Secondary therapy:
anastrozole; tamoxifen; exemestane
DOI:
10.1200/jco.2015.33.15_suppl.522
Evidence Level:
Sensitive: C4 – Case Studies
Source:
Title:
Response to Abemaciclib After 10 Lines of Therapy Including Palbociclib in Metastatic Breast Cancer: A Case Report With Literature Review
Published date:
09/02/2020
Excerpt:
We report a case of a postmenopausal woman with HR-positive and HER2-negative advanced BC...We then tried abemaciclib in the 11th-line setting, where it induced a response that lasted 16 months.
DOI:
10.1007/s40487-020-00126-0
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