The benefit of adjuvant Verzenio in
combination with endocrine therapy continues to deepen with
additional follow-up, now demonstrating an absolute improvement in
invasive disease-free survival (IDFS) and distance relapse-free
survival (DRFS) rates of 6.4% and 5.9% at four years, respectively,
in patients with HR+, HER2-, node-positive, high risk early breast
cancer
INDIANAPOLIS, Dec. 6, 2022
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today
announced updated results from the pivotal Phase 3 monarchE trial
of adjuvant Verzenio® (abemaciclib) in combination with
standard endocrine therapy (ET) for the treatment of hormone
receptor-positive (HR+), human epidermal growth factor receptor
2-negative (HER2-), node-positive, high risk early breast cancer
(EBC). These data, which include results for investigational uses
in the intent-to-treat (ITT) and Cohort 1 populations, were
presented today as an oral presentation at the 2022 San Antonio
Breast Cancer Symposium (SABCS) and simultaneously published in
The Lancet Oncology.
Data include updated results from a prespecified analysis
reflecting a median follow-up of 3.5 years, with all patients
having now discontinued or completed the two-year Verzenio
treatment period. The absolute increase in invasive disease-free
survival (IDFS) and distance relapse-free survival (DRFS) continued
to deepen in magnitude at four years, to 6.4% and 5.9%,
respectively, reflecting improvements from the two- and three-year
rates. This IDFS and DRFS benefit was seen across all prespecified
subgroups, regardless of Ki-67 score. While overall survival (OS)
data remain immature at this time, fewer deaths were observed in
the Verzenio-plus-ET arm compared to the ET monotherapy arm
(HR=0.929, 95% CI: 0.748, 1.153). There were no new safety
findings, and overall results are consistent with the
well-established safety profile for Verzenio.
"These results from the monarchE trial provide further evidence
of the clinically meaningful benefit that adjuvant Verzenio adds to
standard endocrine therapy in patients with high risk early breast
cancer, a population with an urgent need to intensify therapy.
Moreover, this benefit continues to deepen at four years, well
beyond the two-year treatment course with adjuvant Verzenio," said
Stephen Johnston, M.D., Ph.D.,
Professor of Breast Cancer Medicine and Consultant Medical
Oncologist at The Royal Marsden NHS Foundation Trust (London, U.K.) and lead investigator for the
monarchE trial.
The monarchE trial (N=5,637) included women and men with HR+,
HER2-, node-positive EBC with a high risk of disease recurrence.
The ITT population included patients enrolled to both Cohort 1 and
Cohort 2, with Cohort 1 (N=5,120) representing 91% of all enrolled
patients. Cohort 1 enrolled patients based on high risk clinical
pathological factors (≥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% (defined in the study as "Ki-67
high"). Ki-67 is a marker of cellular proliferation. Ki-67 score
was also determined centrally in Cohort 1 patients with a suitable
sample, but Ki-67 determination was not required for enrollment in
this cohort.
At the July 1, 2022 data cutoff,
in the ITT population, the risk of developing invasive disease was
reduced by 33.6% (HR=0.664, 95% CI: 0.578, 0.762; nominal
p<0.0001). The four-year IDFS rate was 85.8% for patients
treated with Verzenio plus ET compared to 79.4% for patients
treated with ET alone, reflecting an absolute difference of 6.4%
(compared to 2.8% at two years). The majority of the IDFS events
were distant metastatic disease. Adjuvant Verzenio also reduced the
risk of developing metastatic disease by 34.1% (HR=0.659, 95% CI:
0.567, 0.767; nominal p<0.0001). The four-year DRFS rate was
88.4% for patients treated with Verzenio plus ET compared to 82.5%
for patients treated with ET alone, an absolute difference of 5.9%
(compared to 2.5% at two years). Consistent with the findings of
previous analyses, a high Ki-67 score correlated with increased
risk of recurrence, but IDFS and DRFS results showed a similar
benefit regardless of Ki-67 status. Data presented at SABCS also
included efficacy outcomes in the FDA-approved population, as well
as the Cohort 1 population.
OS data remain immature. Fewer deaths were observed in the
Verzenio-plus-ET arm (157 [5.6%] of 2,808 patients) compared to the
ET monotherapy arm (173 [6.1%] of 2,829 patients) (HR=0.929, 95%
CI: 0.748, 1.153; p = 0.50). Fewer deaths due to breast cancer
occurred in the Verzenio-plus-ET arm compared to the ET alone arm
(117 [4.2%] of 2,791 patients vs. 138 [4.9%] of 2,800 patients).
Nearly twice as many patients in the control arm have developed and
are living with metastatic disease compared to those receiving
Verzenio. Continued follow-up is ongoing until final assessment of
OS.
The most frequent adverse events (AEs) were diarrhea,
neutropenia, and fatigue in the Verzenio arm, and arthralgia, hot
flush, and fatigue in the control 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 ET alone
arm.
"The continued strengthening of the adjuvant Verzenio benefit
seen at four years further underscores the potential importance of
these data for women and men with HR+, HER2-, node-positive, high
risk early breast cancer," said David
Hyman, M.D., chief medical officer, Loxo@Lilly. "We are
pleased with these results and have submitted an application with
the FDA to expand our adjuvant indication in the U.S. based on
these data."
As previously published in the Journal of Clinical
Oncology,1 and subsequently updated in the Annals
of Oncology,2 monarchE met its primary endpoint of a
statistically significant improvement in IDFS in the ITT population
for patients treated with adjuvant Verzenio plus ET
compared to those treated with ET alone. Consistent with
expert guidelines, IDFS was defined as the length of time
before breast cancer comes back, any new cancer
develops, or death. On October 12, 2021, the FDA
approved Verzenio in combination with endocrine therapy (tamoxifen
or an aromatase inhibitor) for the adjuvant treatment of adult
patients with HR+, HER2-, node-positive, early breast cancer at
high risk of recurrence and a Ki-67 score of ≥20% as determined by
an FDA-approved test.3
About the monarchE Study
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).
Consistent with expert guidelines, IDFS was defined as the
length of time before breast cancer comes back,
any new cancer develops, or death. 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.2,3
About Early Breast Cancer and Risk of Recurrence
It is
estimated that 90 percent of all breast cancers are detected at an
early stage. Although the prognosis for HR+, HER2- EBC is generally
positive, 20 percent of patients will experience recurrence
potentially to incurable metastatic disease.4 Risk of
recurrence is greatest within the initial two to three years
post-diagnosis, particularly in patients with node-positive, high
risk EBC.5 Factors associated with high risk of
recurrence include: positive nodal status, large tumor size (≥5
cm), high tumor grade (Grade 3), and high rate of cellular
proliferation [Ki-67 score (≥20%)].3
Node-positive means that cancer cells from the tumor in the
breast have been found in the lymph nodes in the armpit area.
Although the breast cancer is 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.
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.6 In the
U.S., it is estimated that there will be 290,560 new cases of
breast cancer in 2022.7
Approximately 70 percent of all breast cancers are of the HR+,
HER2- subtype.8
INDICATIONS FOR
VERZENIO®
Verzenio® (abemaciclib) in
combination with endocrine therapy (ET) is indicated for the
adjuvant treatment of adult patients with hormone receptor-positive
(HR+), human epidermal growth factor receptor 2-negative (HER2-),
node-positive, early breast cancer (EBC) at high risk of recurrence
and a Ki-67 score of ≥20%, as determined by a U.S. Food and Drug
Administration (FDA)-approved test.
Verzenio is also indicated for the treatment of HR+, HER2-
advanced or metastatic breast cancer:
- In combination with ET (tamoxifen or an aromatase inhibitor)
for the adjuvant treatment of adult patients with HR+, HER2-,
node-positive, EBC at high risk of recurrence and a Ki-67 score
≥20% as determined by an FDA-approved test
- In combination with an aromatase inhibitor as initial ET for
the treatment of postmenopausal women, and men, with HR+, HER2-
advanced or metastatic breast cancer
- In combination with fulvestrant for the treatment of adult
patients with HR+, HER2- advanced or metastatic breast cancer with
disease progression following ET
- As monotherapy for the treatment of adult patients with HR+,
HER2- advanced or metastatic breast cancer with disease progression
following ET and prior chemotherapy in the metastatic setting
IMPORTANT SAFETY INFORMATION FOR VERZENIO
(abemaciclib)
Severe diarrhea associated
with dehydration and infection occurred in patients treated with
Verzenio. Across four clinical trials in 3691 patients, diarrhea
occurred in 81 to 90% of patients who received Verzenio. Grade 3
diarrhea occurred in 8 to 20% of patients receiving Verzenio. Most
patients experienced diarrhea during the first month of Verzenio
treatment. The median time to onset of the first diarrhea event
ranged from 6 to 8 days; and the median duration of Grade 2 and
Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days,
respectively. Across trials, 19 to 26% of patients with diarrhea
required a Verzenio dose interruption and 13 to 23% required a dose
reduction.
Instruct patients to start antidiarrheal therapy, such as
loperamide, at the first sign of loose stools, increase oral
fluids, and notify their healthcare provider for further
instructions and appropriate follow-up. For Grade 3 or 4 diarrhea,
or diarrhea that requires hospitalization, discontinue Verzenio
until toxicity resolves to ≤Grade 1, and then resume Verzenio at
the next lower dose.
Neutropenia, including febrile neutropenia and fatal
neutropenic sepsis, occurred in patients treated with Verzenio.
Across four clinical trials in 3691 patients, neutropenia occurred
in 37 to 46% of patients receiving Verzenio. A Grade ≥3 decrease in
neutrophil count (based on laboratory findings) occurred in 19 to
32% of patients receiving Verzenio. Across trials, the median time
to first episode of Grade ≥3 neutropenia ranged from 29 to 33 days,
and the median duration of Grade ≥3 neutropenia ranged from 11 to
16 days. Febrile neutropenia has been reported in <1% of
patients exposed to Verzenio across trials. Two deaths due to
neutropenic sepsis were observed in MONARCH 2. Inform patients to
promptly report any episodes of fever to their healthcare
provider.
Monitor complete blood counts prior to the start of Verzenio
therapy, every 2 weeks for the first 2 months, monthly for the next
2 months, and as clinically indicated. Dose interruption, dose
reduction, or delay in starting treatment cycles is recommended for
patients who develop Grade 3 or 4 neutropenia.
Severe, life-threatening, or fatal interstitial lung
disease (ILD) or pneumonitis can occur in patients treated
with Verzenio and other CDK4/6 inhibitors. In Verzenio-treated
patients in EBC (monarchE), 3% of patients experienced ILD or
pneumonitis of any grade: 0.4% were Grade 3 or 4 and there was one
fatality (0.1%). In Verzenio-treated patients in MBC (MONARCH 1,
MONARCH 2, MONARCH 3), 3.3% of Verzenio-treated patients had ILD or
pneumonitis of any grade: 0.6% had Grade 3 or 4, and 0.4% had fatal
outcomes. Additional cases of ILD or pneumonitis have been observed
in the postmarketing setting, with fatalities reported.
Monitor patients for pulmonary symptoms indicative of ILD or
pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or
interstitial infiltrates on radiologic exams. Infectious,
neoplastic, and other causes for such symptoms should be excluded
by means of appropriate investigations. Dose interruption or dose
reduction is recommended in patients who develop persistent or
recurrent Grade 2 ILD or pneumonitis. Permanently discontinue
Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis.
Grade ≥3 increases in alanine aminotransferase
(ALT) (2 to 6%) and aspartate aminotransferase
(AST) (2 to 3%) were reported in patients receiving
Verzenio. Across three clinical trials in 3559 patients (monarchE,
MONARCH 2, MONARCH 3), the median time to onset of Grade ≥3 ALT
increases ranged from 57 to 87 days and the median time to
resolution to Grade <3 was 13 to 14 days. The median time to
onset of Grade ≥3 AST increases ranged from 71 to 185 days and the
median time to resolution to Grade <3 ranged from 11 to 15
days.
Monitor liver function tests (LFTs) prior to the start of
Verzenio therapy, every 2 weeks for the first 2 months, monthly for
the next 2 months, and as clinically indicated. Dose interruption,
dose reduction, dose discontinuation, or delay in starting
treatment cycles is recommended for patients who develop persistent
or recurrent Grade 2, or any Grade 3 or 4 hepatic transaminase
elevation.
Venous thromboembolic events (VTE) were reported in
2 to 5% of patients across three clinical trials in 3559 patients
treated with Verzenio (monarchE, MONARCH 2, MONARCH 3). VTE
included deep vein thrombosis, pulmonary embolism, pelvic venous
thrombosis, cerebral venous sinus thrombosis, subclavian and
axillary vein thrombosis, and inferior vena cava thrombosis. In
clinical trials, deaths due to VTE have been reported in patients
treated with Verzenio.
Verzenio has not been studied in patients with early breast
cancer who had a history of VTE. Monitor patients for signs and
symptoms of venous thrombosis and pulmonary embolism and treat as
medically appropriate. Dose interruption is recommended for EBC
patients with any grade VTE and for MBC patients with a Grade 3 or
4 VTE.
Verzenio can cause fetal harm when administered
to a pregnant woman, based on findings from animal studies and the
mechanism of action. In animal reproduction studies, administration
of abemaciclib to pregnant rats during the period of organogenesis
caused teratogenicity and decreased fetal weight at maternal
exposures that were similar to the human clinical exposure based on
area under the curve (AUC) at the maximum recommended human dose.
Advise pregnant women of the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception
during treatment with Verzenio and for 3 weeks after the last dose.
Based on findings in animals, Verzenio may impair fertility in
males of reproductive potential. There are no data on the presence
of Verzenio in human milk or its effects on the breastfed child or
on milk production. Advise lactating women not to breastfeed during
Verzenio treatment and for at least 3 weeks after the last dose
because of the potential for serious adverse reactions in breastfed
infants.
The most common adverse reactions (all grades,
≥10%) observed in monarchE for Verzenio plus
tamoxifen or an aromatase inhibitor vs tamoxifen or an aromatase
inhibitor, with a difference between arms of ≥2%, were
diarrhea (84% vs 9%), infections (51% vs 39%), neutropenia (46% vs
6%), fatigue (41% vs 18%), leukopenia (38% vs 7%), nausea (30% vs
9%), anemia (24% vs 4%), headache (20% vs 15%), vomiting (18% vs
4.6%), stomatitis (14% vs 5%), lymphopenia (14% vs 3%),
thrombocytopenia (13% vs 2%), decreased appetite (12% vs 2.4%), ALT
increased (12% vs 6%), AST increased (12% vs 5%), dizziness (11% vs
7%), rash (11% vs 4.5%), and alopecia (11% vs 2.7 %).
The most frequently reported ≥5% Grade 3 or 4 adverse
reaction that occurred in the Verzenio arm vs the
tamoxifen or an aromatase inhibitor arm of monarchE were
neutropenia (19.6% vs 1%), leukopenia (11% vs <1%), diarrhea (8%
vs 0.2%), and lymphopenia (5% vs <1%).
Lab abnormalities (all grades; Grade 3 or
4) for monarchE in ≥10% for Verzenio plus
tamoxifen or an aromatase inhibitor with a difference between arms
of ≥2% were increased serum creatinine (99% vs 91%; .5% vs
<.1%), decreased white blood cells (89% vs 28%; 19.1% vs 1.1%),
decreased neutrophil count (84% vs 23%; 18.7% vs 1.9%), anemia (68%
vs 17%; 1% vs .1%), decreased lymphocyte count (59% vs 24%; 13.2 %
vs 2.5%), decreased platelet count (37% vs 10%; .9% vs .2%),
increased ALT (37% vs 24%; 2.6% vs 1.2%), increased AST (31% vs
18%; 1.6% vs .9%), and hypokalemia (11% vs 3.8%; 1.3% vs 0.2%).
The most common adverse reactions (all grades,
≥10%) observed in MONARCH 3 for Verzenio plus
anastrozole or letrozole vs anastrozole or letrozole, with a
difference between arms of ≥2%, were diarrhea (81% vs
30%), fatigue (40% vs 32%), neutropenia (41% vs 2%), infections
(39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%),
vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%),
decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine
increased (19% vs 4%), constipation (16% vs 12%), ALT increased
(16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus
(13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11%
vs 9%), weight decreased (10% vs 3.1%), influenza-like illness (10%
vs 8%), and thrombocytopenia (10% vs 2%).
The most frequently reported ≥5% Grade 3 or 4 adverse
reactions that occurred in the Verzenio arm vs the placebo
arm of MONARCH 3 were neutropenia (22% vs 1%),
diarrhea (9% vs 1.2%), leukopenia (7% vs <1%)), increased ALT
(6% vs 2%), and anemia (6% vs 1%).
Lab abnormalities (all grades; Grade 3 or
4) for MONARCH 3 in ≥10% for Verzenio plus
anastrozole or letrozole with a difference between arms of
≥2% were increased serum creatinine (98% vs 84%; 2.2% vs
0%), decreased white blood cells (82% vs 27%; 13% vs 0.6%), anemia
(82% vs 28%; 1.6% vs 0%), decreased neutrophil count (80% vs 21%;
21.9% vs 2.6%), decreased lymphocyte count (53% vs 26%; 7.6% vs
1.9%), decreased platelet count (36% vs 12%; 1.9% vs 0.6%),
increased ALT (48% vs 25%; 6.6% vs 1.9%), and increased AST (37% vs
23%; 3.8% vs 0.6%).
The most common adverse reactions (all grades,
≥10%) observed in MONARCH 2 for Verzenio plus
fulvestrant vs fulvestrant, with a difference between arms of
≥2%, were diarrhea (86% vs 25%), neutropenia (46% vs 4%),
fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%),
abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs
2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%),
headache (20% vs 15%), dysgeusia (18% vs 2.7%), thrombocytopenia
(16% vs 3%), alopecia (16% vs 1.8%), stomatitis (15% vs 10%), ALT
increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%),
dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema
(12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs
4.5%), pyrexia (11% vs 6%), and weight decreased (10% vs 2.2%).
The most frequently reported ≥5% Grade 3 or 4 adverse
reactions that occurred in the Verzenio arm vs the placebo
arm of MONARCH 2 were neutropenia (25% vs 1%),
diarrhea (13% vs 0.4%), leukopenia (9% vs 0%), anemia (7% vs 1%),
and infections (5.7% vs 3.5%).
Lab abnormalities (all grades; Grade 3 or
4) for MONARCH 2 in ≥10% for Verzenio plus
fulvestrant with a difference between arms of ≥2% were
increased serum creatinine (98% vs 74%; 1.2% vs 0%), decreased
white blood cells (90% vs 33%; 23.7% vs .9%), decreased neutrophil
count (87% vs 30%; 32.5% vs 4.2%), anemia (84% vs 34%; 2.6% vs
.5%), decreased lymphocyte count (63% vs 32%; 12.2% vs 1.8%),
decreased platelet count (53% vs 15%; 2.1% vs 0%), increased ALT
(41% vs 32%; 4.6% vs 1.4%), and increased AST (37% vs 25%; 3.9% vs
4.2%).
The most common adverse reactions (all grades,
≥10%) observed in MONARCH 1 with Verzenio
were diarrhea (90%), fatigue (65%), nausea (64%), decreased
appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting
(35%), infections (31%), anemia (25%), thrombocytopenia (20%),
headache (20%), cough (19%), constipation (17%), leukopenia (17%),
arthralgia (15%), dry mouth (14%), weight decreased (14%),
stomatitis (14%), creatinine increased (13%), alopecia (12%),
dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration
(10%).
The most frequently reported ≥5% Grade 3 or 4 adverse
reactions from MONARCH 1 with Verzenio
were diarrhea (20%), neutropenia (24%), fatigue (13%), and
leukopenia (5%).
Lab abnormalities (all grades; Grade 3 or 4) for MONARCH
1 with Verzenio were increased serum creatinine (99%;
.8%), decreased white blood cells (91%; 28%), decreased neutrophil
count (88%; 26.6%), anemia (69%; 0%), decreased lymphocyte count
(42%; 13.8%), decreased platelet count (41%; 2.3%), increased ALT
(31%; 3.1%), and increased AST (30%; 3.8%).
Strong and moderate CYP3A inhibitors increased the
exposure of abemaciclib plus its active metabolites to a clinically
meaningful extent and may lead to increased toxicity. Avoid
concomitant use of ketoconazole. Ketoconazole is predicted to
increase the AUC of abemaciclib by up to 16-fold. In patients with
recommended starting doses of 200 mg twice daily or 150 mg twice
daily, reduce the Verzenio dose to 100 mg twice daily with
concomitant use of strong CYP3A inhibitors other than ketoconazole.
In patients who have had a dose reduction to 100 mg twice daily due
to adverse reactions, further reduce the Verzenio dose to 50 mg
twice daily with concomitant use of strong CYP3A inhibitors. If a
patient taking Verzenio discontinues a strong CYP3A inhibitor,
increase the Verzenio dose (after 3 to 5 half-lives of the
inhibitor) to the dose that was used before starting the inhibitor.
With concomitant use of moderate CYP3A inhibitors, monitor for
adverse reactions and consider reducing the Verzenio dose in 50 mg
decrements. Patients should avoid grapefruit products.
Avoid concomitant use of strong or moderate CYP3A inducers
and consider alternative agents. Coadministration of
strong or moderate CYP3A inducers decreased the plasma
concentrations of abemaciclib plus its active metabolites and may
lead to reduced activity.
With severe hepatic impairment (Child-Pugh C),
reduce the Verzenio dosing frequency to once daily. The
pharmacokinetics of Verzenio in patients with severe renal
impairment (CLcr <30 mL/min), end stage renal disease,
or in patients on dialysis is unknown. No dosage adjustments are
necessary in patients with mild or moderate hepatic (Child-Pugh A
or B) and/or renal impairment (CLcr ≥30-89 mL/min).
Please see full Prescribing Information for
Verzenio.
AL HCP ISI 12OCT2021
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 47 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/newsroom or
follow us on Facebook, Instagram and LinkedIn. P-LLY
© Lilly USA,
LLC 2022. ALL RIGHTS RESERVED.
Verzenio® is a trademark owned by or licensed
to Eli Lilly and Company, its subsidiaries, or affiliates.
Cautionary Statement Regarding Forward-Looking
Statements
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 people with early breast cancer and the timeline for
future readouts, presentations, and other milestones relating to
Verzenio its clinical trials, and reflects Lilly's current
beliefs and expectations. However, as with any pharmaceutical
product, there are substantial risks and uncertainties in the
process of drug research, development, and commercialization. Among
other things, there is no guarantee that planned or ongoing studies
will be completed as planned, that future study results will be
consistent with study results to date, that Verzenio will receive
additional regulatory approvals, or that Lilly will
execute its strategy as expected. For further discussion of these
and other risks and uncertainties that could cause actual results
to differ from Lilly's expectations, see Lilly's 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.
1 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.
2 Harbeck N, Rastogi P, Martin M, et al; monarchE
Committee Members. Adjuvant abemaciclib combined with endocrine
therapy for high-risk early breast cancer: updated efficacy and
Ki-67 analysis from the monarchE study. Ann Oncol. 2021
Dec;32(12):1571-1581. doi: 10.1016/j.annonc.2021.09.015.
3 Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company.
4 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.
5 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.
6 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
7 American Cancer Society. Cancer Statistics Center.
http://cancerstatisticscenter.cancer.org. Accessed December 4, 2022.
8 National Cancer Institute, SEER. Cancer Stat Facts:
Female Breast Cancer.
https://seer.cancer.gov/statfacts/html/breast.html.
Accessed December 4, 2022.
Refer
to:
|
Tracy Henrikson;
tracy.henrikson@lilly.com; 609-454-7116 – media
Joe Fletcher; jfletcher@lilly.com; 317-296-2884 –
investors
|
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