INDIANAPOLIS, Nov. 21,
2022 /PRNewswire/ -- Eli Lilly and Company (NYSE:
LLY) today announced that study investigators will present
data from its breast cancer portfolio and pipeline at the 2022 San
Antonio Breast Cancer Symposium (SABCS), to be held December 6-10, 2022, in San Antonio, Texas, and virtually. These
presentations include new results from studies of
Verzenio® (abemaciclib; a CDK4/6 inhibitor),
imlunestrant (an investigational oral selective estrogen receptor
degrader [SERD]), and LOXO-783 (an investigational mutant-selective
allosteric PI3Kα H1047R inhibitor).
The Verzenio oral and poster presentations will provide updated
clinical data from ongoing studies in early and advanced forms of
hormone receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-) breast cancer. An oral presentation
will provide results from a pre-planned overall survival (OS)
analysis from the Phase 3 monarchE study in HR+, HER2-,
node-positive, high risk early breast cancer, including four-year
efficacy outcomes. Updated results at the final OS from the Phase 3
MONARCH 2 trial of Verzenio plus fulvestrant in patients with HR+,
HER2- advanced breast cancer will be presented in a spotlight
poster discussion. Additional analyses include real-world evidence
in early breast cancer with a high risk of recurrence.
In a spotlight poster discussion, combination therapy results
with imlunestrant will be presented from the Phase 1 EMBER
trial of imlunestrant in combination with Verzenio, with or without
an aromatase inhibitor, in patients with estrogen receptor
positive (ER+), HER2- advanced breast cancer. In addition,
pharmacodynamic data from the preoperative EMBER-2 trial evaluating
imlunestrant in ER+, HER2- early breast cancer will be provided.
Preclinical data with LOXO-783 in combination with standard-of-care
breast cancer agents will also be presented at the meeting.
A list of the presentations, along with their viewing details,
is shared below.
Presentation Title
|
Details
|
Verzenio
(abemaciclib)
|
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
|
Presentation
#GS1-09
General Session
#1
Date: Tuesday, December
6, 2022
Presentation Time: 4:00
– 4:15 PM CT
Location: Hall
3
Presenter: Johnston
S
|
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
|
Presentation
#PD13-11
Spotlight Poster
Discussion Session #13: Therapeutic Approaches for HR+/Her2- Breast
Cancer
Date: Thursday,
December 8, 2022
Presentation Time: 5:00
– 6:15 PM CT
Location: Stars at
Night Ballroom 1&2
Presenter:
Llombart-Cussac A
|
Persistence with
adjuvant endocrine therapy in patients with early breast cancer at
high risk of recurrence: a US-based real-world study
|
Presentation
#P4-03-01
Poster Session 4:
Epidemiology, Risk, and Prevention: Epidemiology - Population
Studies
Date: Thursday,
December 8, 2022
Presentation Time: 7:00
– 8:15 PM CT
Location: Hall
1
Presenter: Vikto
AS
|
Association of
neutrophil-to-lymphocyte ratio and absolute lymphocyte count with
clinical outcomes for patients with advanced breast cancer in the
MONARCH 2 trial
|
Presentation
#P5-02-23
Poster Session
5: Prognostic and Predictive
Factors: Biomarkers Predicting Tx Response: For Targeted
Therapies
Date: Thursday,
December 8, 2022
Presentation Time: 5:00
– 6:15 PM CT
Location: Hall
1
Presenter: Tokunaga
E
|
Costs of breast cancer
recurrence after initial treatment for high risk early breast
cancer using SEER-Medicare linked data
|
Presentation
#P6-07-01
Poster Session
6: Psychosocial, QOL, and
Educational Aspects: Social and Education Issues -
Cost-Effectiveness
Date: Friday, December
9, 2022
Presentation Time: 7:00
– 8:15 AM CT
Location: Hall
1
Presenter: Vitko
AS
|
Imlunestrant
|
Imlunestrant, an oral
selective estrogen receptor degrader, in combination with
abemaciclib with or without an aromatase inhibitor, in estrogen
receptor-positive advanced breast cancer: Results from the phase
1a/b EMBER study
|
Presentation
#PD13-12
Spotlight Poster
Session 13: Therapeutic Approaches for HR+/HER2- Breast
Cancer
Date: Thursday,
December 8, 2022
Presentation Time: 5:00
– 6:15 PM CT
Location: Stars at
Night Ballroom 1&2
Presenter: Jhaveri
K
|
A preoperative
window-of-opportunity study of imlunestrant in estrogen
receptor-positive, HER2-negative early breast cancer: Results from
the EMBER-2 study
|
Presentation
#P6-10-06
Poster Session
6: Treatment: Therapeutic
Strategies - Novel Targets and Targeted Agents
Date: Friday, December
9, 2022
Presentation Time: 7:00
– 8:15 AM CT
Location: Hall
1
Presenter: Neven
P
|
LOXO-783
|
A potent, highly mutant
selective and brain-penetrant allosteric PI3Kα H1047R inhibitor in
combination with standard of care (SOC) treatments in preclinical
PI3Kα H1047R-mutant breast cancer models
|
Presentation
#P4-08-02
Poster Session
4: Tumor Cell and Molecular
Biology: Novel/Emerging Therapeutic Targets
Date: Thursday,
December 8, 2022
Presentation Time: 7:00
– 8:15 AM CT
Location: Hall
1
Presenter: Puca
L
|
About Verzenio® (abemaciclib)
Verzenio® (abemaciclib) is a targeted treatment known as
a CDK4/6 inhibitor. Verzenio is a nonchemotherapy oral tablet.
Verzenio works inside the cell to block CDK4/6 activity and help
stop the growth of cancer cells so that they may eventually die
(based on preclinical studies). Cyclin-dependent kinases (CDK)4/6
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
concentrations.
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.
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
About Imlunestrant
Imlunestrant (LY3484356) is an
investigational, oral selective estrogen receptor degrader (SERD)
with pure antagonistic properties. 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.
For information about imlunestrant clinical trials, please refer
to www.clinicaltrials.gov. Interested patients and physicians can
contact the Loxo@Lilly clinical trial team by e-mailing
clinicaltrials@loxooncology.com.
About LOXO-783
LOXO-783 is an
investigational potent, highly mutant-selective and
brain-penetrant allosteric PI3Kα H1047R inhibitor that is designed
to spare wild-type PI3Kα, other PI3K isoforms, and other kinases.
Phosphoinositide 3-kinase alpha (PI3Kα) H1047R mutations are
activating oncogenic events that occur in approximately 15 percent
of breast cancers and less commonly in other cancers. LOXO-783 has
shown preclinical activity without on-target wild-type PI3Kα
mediated toxicity. LOXO-783 is being investigated in an open-label,
multicenter, Phase 1a/1b study in
patients with PIK3CA H1047R-mutant advanced breast cancer and other
solid tumors.
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, imlunestrant, and LOXO-783 as potential
treatments for people with various types of cancer and the timeline
for future readouts, presentations, and other milestones relating
to Verzenio, imlunestrant, and LOXO-783 and their 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, imlunestrant, and LOXO-783 will
prove to be safe and effective treatments for certain types of
cancer, that Verzenio will receive additional regulatory approvals,
that imlunestrant or LOXO-783 will receive 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.
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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SOURCE Eli Lilly and Company