INDIANAPOLIS, May 16, 2018 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced that new results from a number
of studies across the company's oncology product and pipeline
portfolio will be presented at the 54th Annual Meeting
of the American Society of Clinical Oncology (ASCO) in Chicago, June 1-5,
2018. Data from 30 oral presentations, poster presentations
and e-publications underscore Lilly Oncology's focus on making a
meaningful difference in the lives of people living with cancer
through clinical development and collaboration.
Highlights include the late-breaking oral presentation of the
Phase 3 REACH-2 trial results for ramucirumab as a single agent in
the second-line treatment of people with hepatocellular carcinoma
(HCC), also known as liver cancer. Key abemaciclib data include
findings from the MONARCH 2 study evaluating abemaciclib plus
fulvestrant in pre- and peri-menopausal women with hormone
receptor-positive (HR+), human epidermal growth factor receptor
2-negative (HER2-) advanced breast cancer, as well as data from the
MONARCH 2 and 3 studies investigating the impact of the addition of
abemaciclib to fulvestrant or a nonsteroidal aromatase inhibitor
(NSAI) on the start of subsequent chemotherapy. Additionally, data
will be presented from Lilly's ongoing immuno-oncology clinical
collaborations with Merck (known as MSD outside the U.S. and
Canada). These include additional
results from the KEYNOTE-021 (Cohort G) and KEYNOTE-189 trials
evaluating pemetrexed plus platinum chemotherapy in combination
with pembrolizumab in the first-line treatment of metastatic
nonsquamous non-small cell lung cancer (NSCLC), as well as results
from the study of ramucirumab and pembrolizumab in multiple tumor
types and the study of abemaciclib and pembrolizumab in HR+, HER-
metastatic breast cancer.
"The data presented at ASCO demonstrate Lilly's steadfast
commitment to advancing medicines in areas where patients
experience the greatest need," said Levi
Garraway, M.D., Ph.D., senior vice president, global
development and medical affairs, Lilly Oncology. "We look forward
to the first presentation of the REACH-2 trial results. Advanced
liver cancer is an aggressive disease, and ramucirumab has now
demonstrated a survival benefit in a group of patients associated
with particularly poor prognosis in two randomized clinical
studies. We are also sharing several other study findings aimed to
leverage our understanding of biomarkers and new therapeutic
applications to benefit patients with hard-to-treat cancers."
Ramucirumab REACH-2 Data at ASCO
REACH-2 is the
first positive Phase 3 HCC trial in a biomarker-selected patient
population, and confirms the results of the first REACH study in
patients who had a high alpha-fetoprotein (AFP-High). The REACH-2
study evaluated the benefit of ramucirumab treatment in HCC
patients who were intolerant to, or had disease progression while
on or following treatment with, sorafenib and AFP-High, defined as
an AFP of ≥400 ng/mL. Approximately half of all advanced HCC
patients are AFP-High and these patients are among those with the
poorest prognosis relative to the general HCC patient population.
While there have been some recent advances in treating HCC, there
remains a very high unmet need for patients in this treatment
setting.
Select studies, along with the dates, times and locations of
their data sessions, are highlighted below.
Ramucirumab
Abstract #4003: REACH-2: A randomized, double-blind,
placebo-controlled Phase 3 study of ramucirumab versus placebo as
second-line treatment in patients with advanced hepatocellular
carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP)
following first-line sorafenib. (Andrew X.
Zhu)
- Oral Abstract Session; Gastrointestinal (Noncolorectal)
Cancer
- Monday, June 4; 4:00 –
4:12 p.m. CDT; Arie Crown
Theater
Abstract #4036: Randomized, double-blind, Phase 2 study of
S-1 plus oxaliplatin (SOX) with or without ramucirumab (RAM) as
first-line therapy followed by paclitaxel plus RAM as second-line
therapy in patients with advanced gastric or gastroesophageal
junction adenocarcinoma (AGC). (Kei
Muro)
- Poster Session: Poster Board #225; Gastrointestinal
(Noncolorectal) Cancer
- Sunday, June 3; 8:00 –
11:30 a.m. CDT; Hall A
Abstract #4044: Effect of post-discontinuation therapy (PDT)
on survival in metastatic gastric-gastroesophageal junction (G-GEJ)
adenocarcinoma patients from the RAINFALL trial: an exploratory
analysis. (Kohei Shitara)
- Poster Session: Poster Board #233; Gastrointestinal
(Noncolorectal) Cancer
- Sunday, June 3; 8:00 –
11:30 a.m. CDT; Hall A
Abstract #4526: Ramucirumab (RAM) exposure-response (ER)
relationship in RANGE, a randomized Phase 3 trial of docetaxel
(DOC) with or without RAM in advanced urothelial carcinoma (UC)
patients (pts) who progressed on or after platinum therapy. (Ronald
De Wit)
- Poster Session: Poster Board #352; Genitourinary (Nonprostate)
Cancer
- Saturday, June 2; 8:00 –
11:30 a.m. CDT; Hall A
Abstract #4542: A subgroup analysis of the East Asia population in RANGE: a randomized
Phase 3 study of docetaxel (DOC) with or without ramucirumab (RAM)
in platinum-refractory advanced or metastatic urothelial carcinoma
(UC). (Nobuaki Matsubara)
- Poster Session: Poster Board #368; Genitourinary (Nonprostate)
Cancer
- Saturday, June 2; 8:00 –
11:30 a.m. CDT; Hall A
Abstract #9053: Efficacy and safety results of
ramucirumab in combination with osimertinib in advanced
T790M-positive EGFR-mutant NSCLC. (David
Planchard)
- Poster Session: Poster Board #376; Lung Cancer—Non-Small Cell
Metastatic
- Sunday, June 3; 8:00 –
11:30 a.m. CDT; Hall A
Abemaciclib
Abstract #1002: Abemaciclib for pre/perimenopausal women with
HR+, HER2- advanced breast cancer. (Patrick Neven)
- Oral Abstract Session: Breast Cancer—Metastatic
- Sunday, June 3; 8:00 –
11:00 a.m. CDT; Presentation Time
8:24 – 8:36 a.m. CDT; Hall D2
Abstract #1048: Impact of abemaciclib on the time to
subsequent chemotherapy and the time to second disease progression
across the MONARCH 2 and 3 studies. (Sara
M. Tolaney)
- Poster Session: Poster Board #129; Breast
Cancer—Metastatic
- Saturday, June 2; 8:00 –
11:30 a.m. CDT; Hall A
Abstract #1049: Health-related quality of life (HRQoL) in
MONARCH 2: Abemaciclib plus fulvestrant in women with HR+, HER2-
advanced breast cancer (ABC) who progressed on endocrine therapy.
(Peter A. Kaufman)
- Poster Session: Poster Board #130; Breast
Cancer—Metastatic
- Saturday, June 2; 8:00 –
11:30 a.m. CDT; Hall A
Abstract #1053: The association of early toxicity and
outcomes for patients treated with abemaciclib. (Hope S. Rugo)
- Poster Session: Poster Board #134; Breast
Cancer—Metastatic
- Saturday, June 2; 8:00 –
11:30 a.m. CDT; Hall A
Olaratumab
Abstract #10541: Phase 1 study of olaratumab as monotherapy
and in combination with doxorubicin, vincristine/irinotecan, or
high-dose ifosfamide in pediatric patients with relapsed or
refractory solid tumors: Part A results. (Steven G. DuBois)
- Poster Session: Poster Board #214; Pediatric Oncology
- Saturday, June 2; 8:00 –
11:30 a.m. CDT; Hall A
Abstract #11542: Phase 1b/2
study of olaratumab plus gemcitabine and docetaxel for the
treatment of advanced soft tissue sarcoma (STS) (ANNOUNCE 2): Phase
1b results. (Victor Manuel Villalobos)
- Poster Session: Poster Board #287; Sarcoma
- Saturday, June 2; 8:00 –
11:30 a.m. CDT; Hall A
Abstract #11548: Characteristics and clinical outcomes of
French patients diagnosed with advanced soft tissue sarcoma (aSTS)
in real-life setting: Data from the European sarcoma biological and
clinical data banking (ESBCB). (Jean-Yves
Blay)
- Poster Session: Poster Board #293; Sarcoma
- Saturday, June 2; 8:00 –
11:30 a.m. CDT; Hall A
Prexasertib
Abstract #2579: A Phase 1b
dose-escalation study of prexasertib, a checkpoint kinase 1 (CHK1)
inhibitor, in combination with cisplatin in patients with advanced
cancer. (Manish R. Patel)
- Poster Session: Poster Board #405; Developmental
Therapeutics—Clinical Pharmacology and Experimental
Therapeutics
- Monday, June 4; 8:00 –
11:30 a.m. CDT; Hall A
Data from Immuno-Oncology Collaborations
Abstract #9021: Health-related quality of life (HRQoL) in the
KEYNOTE-189 study of pembrolizumab (pembro) or placebo (pbo) +
pemetrexed (pem) + platinum (plt) for metastatic NSCLC.
(Marina Chiara Garassino)
- Poster Discussion Session: Poster Board #344; Lung
Cancer—Non-Small Cell Metastatic
- Sunday, June 3; 8:00 –
11:30 a.m. CDT; Hall A
- Poster Discussion Session on Sunday,
June 3; 11:30 a.m. –
12:45 p.m. CDT, at Arie Crown
Theater
Abstract #9026: 24-month overall survival from KEYNOTE-021
cohort G: Pemetrexed-carboplatin plus pembrolizumab as first-line
therapy for advanced nonsquamous NSCLC. (Ryan D. Gentzler)
- Poster Session: Poster Board #349; Lung Cancer—Non-Small Cell
Metastatic
- Sunday, June 3; 8:00 –
11:30 a.m. CDT; Hall A
Abstract #3059: Activity of ramucirumab (R) with
pembrolizumab (P) by PD-L1 expression in advanced solid tumors:
Phase 1a/b study in later lines of therapy. (Roy S. Herbst)
- Poster Session: Poster Board #273; Developmental
Therapeutics—Immunotherapy
- Monday, June 4; 8:00 –
11:30 a.m. CDT; Hall A
Abstract #1059: Updated efficacy, safety, & PD-L1 status
of patients with HR+, HER2- metastatic breast cancer administered
abemaciclib plus pembrolizumab. (Sara M.
Tolaney)
- Poster Session: Poster Board #140; Breast
Cancer—Metastatic
- Saturday, June 2; 8:00 –
11:30 a.m. CDT; Hall A
Data from Other Collaborations
Abstract #3537: Subgroup analysis by prior anti-VEGF or
anti-EGFR target therapy in FRESCO, a randomized, double-blind,
Phase 3 trial comparing fruquintinib versus placebo plus best
supportive care in Chinese patients with metastatic colorectal
cancer (mCRC). (Ruihua Xu)
- Poster Session: Poster Board #30; Gastrointestinal (Colorectal)
Cancer
- Sunday, June 3; 8:00 –
11:30 a.m. CDT; Hall A
Abstract #3544: Quality-adjusted time without symptoms or
toxicity (Q-TWiST) of patients with metastatic colorectal cancer
(mCRC) treated with fruquintinib in the randomized Phase 3 FRESCO
trial. (Yu-Xian Bai)
- Poster Session: Poster Board #37; Gastrointestinal (Colorectal)
Cancer
- Sunday, June 3; 8:00 –
11:30 a.m. CDT; Hall A
About Lilly Oncology
For more than 50 years,
Lilly has been dedicated to delivering life-changing medicines and
support to people living with cancer and those who care for them.
Lilly is determined to build on this heritage and continue making
life better for all those affected by cancer around the world. To
learn more about Lilly's commitment to people with cancer, please
visit www.LillyOncology.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with
discovery to make life better for people around the world. We were
founded more than a century ago by a man committed to creating
high-quality medicines that meet real needs, and today we remain
true to that mission in all our work. Across the globe, Lilly
employees work to discover and bring life-changing medicines to
those who need them, improve the understanding and management of
disease, and give back to communities through philanthropy and
volunteerism. To learn more about Lilly, please visit us at
www.lilly.com and newsroom.lilly.com/social-channels. P-LLY
© Lilly USA, LLC 2018. ALL
RIGHTS RESERVED.
Lilly Forward-Looking Statement
This press release
contains forward-looking statements (as that term is defined
in the Private Securities Litigation Reform Act of 1995) regarding
Lilly's oncology portfolio and pipeline, including ramucirumab,
abemaciclib, olaratumab, prexasertib, pemetrexed and fruquintinib.
This press release reflects Lilly's current beliefs. However, as
with any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
Among other risks, there can be no guarantee that these treatment
options will receive regulatory approval, or, if approved, that it
will achieve intended benefits or become a commercially successful
product. For further discussion of these and other risks and
uncertainties, see Lilly's most recent 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; 609-240-3902 (media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838
(investors)
|
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SOURCE Eli Lilly and Company