THOUSAND OAKS, Calif.,
Sept. 16, 2021 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced the first combination study results
from the Phase 1b/2 CodeBreaK 101
study, the most comprehensive global clinical development program
in patients with KRAS G12C-mutated advanced colorectal
cancer (CRC). These new data show that combining LUMAKRAS™
(sotorasib) with Vectibix® (panitumumab), Amgen's
monoclonal antibody epidermal growth factor receptor (EGFR)
inhibitor, demonstrated encouraging efficacy and safety. Overall,
the objective response rate (ORR) was 27% (confirmed and
unconfirmed) among 26 patients in the efficacy analysis set (which
included 5 patients who had progressed with prior sotorasib
monotherapy). The disease control rate (DCR) was 81%. ORR and DCR
were secondary endpoints. In the expansion cohort of
sotorasib-naïve patients with refractory CRC (n=18), 33% of
patients experienced a response (confirmed and unconfirmed). These
data are being featured during the European Society of Medical
Oncology 2021 (ESMO21) Virtual Congress.
"We are excited by these CodeBreaK 101 data, which show
encouraging response rates that were much higher than the 9.7%
response rate observed with LUMAKRAS monotherapy and highlight the
importance of combination therapy for patients with KRAS
G12C-mutated advanced colorectal cancer," said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "Based on these results and
the urgent need for new therapies, we are pleased to announce the
initiation of a new Phase 3 trial with LUMAKRAS plus Vectibix in
the third-line setting. This new trial, along with our doublet and
triplet combination trials in colorectal cancer, demonstrates our
commitment to delivering a new treatment option for metastatic CRC
patients who harbor the KRAS G12C mutation."
In total, 31 patients with heavily pretreated (median of two
prior lines of therapy; range 1-10) KRAS G12C-mutated
metastatic CRC were enrolled in the dose exploration and dose
expansion cohorts for the combination of LUMAKRAS and Vectibix. No
patients experienced dose-limiting toxicities during the 28 days
following initial treatment. The majority of treatment-related
adverse events (TRAEs) were Grade 1-2 in severity, and no Grade 4
or fatal TRAEs were observed. The most common TRAEs (occurring in
> 10% of patients) were consistent with known adverse events for
LUMAKRAS and Vectibix and included dermatitis acneiform, dry skin,
nausea, diarrhea, hypokalemia, hypomagnesemia, pruritus and rash.
No new safety concerns were identified.
"With treatment response rates being as low as 2% in patients
with colorectal cancer who progress in advanced stages, developing
new treatment approaches for these patients is of critical
interest," said Marwan G. Fakih,
M.D., primary study investigator and co-director of the
Gastrointestinal Cancer Program, City of Hope, Duarte, Calif. "Preclinical research has
indicated that the addition of an EGFR inhibitor to
KRASG12C inhibition can be synergistic, and now we have
the first clinical data indicating the combination of sotorasib and
panitumumab has the potential to be a safe and effective treatment
for patients with KRAS G12C-mutated advanced CRC."
Advancing Tarlatamab (formerly AMG 757) and AMG 404 in Small
Cell Lung Cancer
In addition to the LUMAKRAS combination
research, a presentation will detail the design of an ongoing study
of half-life extended (HLE) bispecific T cell engager
(BiTE®) molecule tarlatamab with anti-PD-1 antibody
AMG 404 in patients with small cell lung cancer. The multicenter,
open-label, Phase 1b study will
evaluate the safety and tolerability of the combination and
determine dosing as primary objectives, as well as examine
preliminary antitumor activity and pharmacokinetics as secondary
objectives.
Amgen to Webcast Investor Call at ESMO 2021
Amgen will
host a webcast call for the investment community in conjunction
with the European Society for Medical Oncology (ESMO) 2021
Congress. On Thursday, Sept. 16, 2021, at 8:30 a.m.
ET, David M. Reese, M.D.,
executive vice president of Research and Development at Amgen,
along with other members of Amgen's management team, will
discuss clinical data being presented on the Company's
KRASG12C inhibitor LUMAKRAS™ (sotorasib) in combination
with Vectibix® (panitumumab).
Live audio of the investor call will be broadcast over the
internet simultaneously and will be available to members of the
news media, investors and the general public.
The webcast, as with other selected presentations regarding
developments in Amgen's business given at certain investor and
medical conferences, can be accessed on Amgen's website,
www.amgen.com, under Investors. Information regarding presentation
times, webcast availability and webcast links are noted on Amgen's
Investor Relations Events Calendar. The webcast will be archived
and available for replay for at least 90 days after the
event.
About LUMAKRASTM (sotorasib)
Amgen took on
one of the toughest challenges of the last 40 years in cancer
research by developing LUMAKRAS, a
KRASG12C inhibitor.1 LUMAKRAS has
demonstrated a positive benefit-risk profile with rapid, deep and
durable anticancer activity in patients with locally advanced or
metastatic non-small cell lung cancer (NSCLC) harboring the
KRAS G12C mutation with a once daily oral
formulation.2
In May 2021, LUMAKRAS was the
first KRASG12C inhibitor to receive regulatory approval
anywhere in the world with its approval in the U.S., under
accelerated approval. LUMAKRAS is also approved in the United Arab Emirates, and in Great Britain and Canada under Project Orbis.
Amgen is progressing the largest and broadest global
KRASG12C inhibitor development program with unparalleled
speed and exploring more than 10 sotorasib combination regimens,
including triplets, with clinical trial sites spanning five
continents. To date, LUMAKRAS has treated almost 3,000 patients
around the world through the clinical development program and
commercial use.
In the U.S., LUMAKRAS was reviewed by the FDA under its
Real-Time Oncology Review (RTOR), a pilot program that aims to
explore a more efficient review process that ensures safe and
effective treatments are made available to patients as early as
possible. Amgen is participating in the FDA's Project Orbis
initiative and through the initiative, has Marketing Authorization
Applications (MAAs) for sotorasib in review in Australia and Brazil. Additionally, Amgen has submitted an
MAA in the European Union, Japan,
Switzerland, South Korea, Singapore, Israel, Turkey, Taiwan, Colombia, Thailand, Mexico and Hong
Kong.
LUMAKRAS is also being studied in multiple other solid
tumors.1
About CodeBreaK
The CodeBreaK clinical development
program for Amgen's drug sotorasib is designed to treat
patients with an advanced solid tumor with the KRAS
G12C mutation and address the longstanding unmet medical need
for these cancers. As the most advanced KRASG12C
inhibitor clinical development program, CodeBreaK has enrolled more
than 800 patients across 13 tumor types since its inception.
CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label
multicenter study, enrolled patients with KRAS
G12C-mutant solid tumors. Eligible patients must have received a
prior line of systemic anticancer therapy, consistent with their
tumor type and stage of disease. The primary endpoint for the Phase
2 study was centrally assessed objective response rate. The Phase 2
trial in NSCLC enrolled 126 patients, 124 of whom had centrally
evaluable lesions by RECIST at baseline. The Phase 2 trial in
colorectal cancer (CRC) is fully enrolled and results have been
submitted for publication.
A global Phase 3 randomized active-controlled study comparing
sotorasib to docetaxel in patients with KRAS G12C-mutated
NSCLC (CodeBreaK 200) has completed enrollment. Amgen also has
several Phase 1b studies
investigating sotorasib monotherapy and sotorasib combination
therapy across various advanced solid tumors (CodeBreaK 101) open
for enrollment. A Phase 2 randomized study will evaluate sotorasib
in patients with stage IV KRAS G12C-mutated NSCLC in need of
first-line treatment (CodeBreaK 201).
For information, please visit www.hcp.codebreaktrials.com.
About Advanced Colorectal Cancer and the KRAS G12C
Mutation
Colorectal cancer (CRC) is the second leading cause
of cancer deaths worldwide, comprising 10% of all cancer
diagnoses.3 It is also the third most commonly diagnosed
cancer globally.4
Patients with previously treated metastatic CRC need more
effective treatment options, as standard therapies yield median PFS
times of about two months and patients' response rates are less
than 2%. 5,6
KRAS mutations are among the most common genetic alterations in
colorectal cancers, with the KRAS G12C mutation present in
approximately 3-5% of colorectal cancers.7,8,9
About BiTE® Technology
BiTE®
(bispecific T cell engager) technology is a targeted
immuno-oncology platform that is designed to engage a patient's own
T cells to any tumor-specific antigen, activating the cytotoxic
potential of T cells to eliminate detectable cancer. The BiTE
immuno-oncology platform has the potential to treat different tumor
types through tumor-specific antigens. The BiTE platform has a goal
of leading to off-the-shelf solutions, which have the potential to
make innovative T cell treatment available to all providers when
their patients need it. Amgen is advancing BiTE molecules across a
broad range of hematologic malignancies and solid tumors and
further investigating BiTE technology with the goal of enhancing
patient experience and therapeutic potential.
LUMAKRASTM (sotorasib) U.S.
Indication
LUMAKRASTM is indicated for the
treatment of adult patients with KRAS G12C-mutated locally
advanced or metastatic non-small cell lung cancer (NSCLC), as
determined by an FDA-approved test, who have received at least one
prior systemic therapy.
This indication is approved under accelerated approval based on
overall response rate (ORR) and duration of response (DOR).
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s).
LUMAKRAS™ (sotorasib) Important Safety Information
Hepatotoxicity
- LUMAKRAS™ can cause hepatotoxicity, which may lead to
drug-induced liver injury and hepatitis.
- Among 357 patients who received LUMAKRAS™ in CodeBreaK 100,
hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A
total of 18% of patients who received LUMAKRAS™ had increased
alanine aminotransferase (ALT)/increased aspartate aminotransferase
(AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose
interruption or reduction, 5% of patients received corticosteroids
for the treatment of hepatotoxicity.
- Monitor liver function tests (ALT, AST and total bilirubin)
prior to the start of LUMAKRAS™, every 3 weeks for the first 3
months of treatment, then once a month or as clinically indicated,
with more frequent testing in patients who develop transaminase
and/or bilirubin elevations.
- Withhold, dose reduce or permanently discontinue LUMAKRAS™
based on severity of adverse reaction.
Interstitial Lung Disease (ILD)/Pneumonitis
- LUMAKRAS™ can cause ILD/pneumonitis that can be fatal. Among
357 patients who received LUMAKRAS™ in CodeBreaK 100,
ILD/pneumonitis occurred in 0.8% of patients, all cases were Grade
3 or 4 at onset, and 1 case was fatal. LUMAKRAS™ was discontinued
due to ILD/pneumonitis in 0.6% of patients.
- Monitor patients for new or worsening pulmonary symptoms
indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever).
Immediately withhold LUMAKRAS™ in patients with suspected
ILD/pneumonitis and permanently discontinue LUMAKRAS™ if no other
potential causes of ILD/pneumonitis are identified.
Most Common Adverse Reactions
- The most common adverse reactions ≥ 20% were diarrhea,
musculoskeletal pain, nausea, fatigue, hepatotoxicity and
cough.
Drug Interactions
- Advise patients to inform their healthcare provider of all
concomitant medications, including prescription medicines,
over-the-counter drugs, vitamins, dietary and herbal products.
- Inform patients to avoid proton pump inhibitors and
H2 receptor antagonists while taking LUMAKRAS™.
- If coadministration with an acid-reducing agent cannot be
avoided, inform patients to take LUMAKRAS™ 4 hours before or 10
hours after a locally acting antacid.
Please see LUMAKRASTM full Prescribing
Information.
About Vectibix® (panitumumab)
Vectibix is the first fully human monoclonal anti-EGFR antibody
approved by the FDA for the treatment of mCRC. Vectibix
was approved in the U.S. in September 2006 as a
monotherapy for the treatment of patients with EGFR-expressing mCRC
after disease progression after prior treatment with
fluoropyrimidine-, oxaliplatin-, and irinotecan-containing
chemotherapy.
In May 2014, the FDA approved Vectibix for use in
combination with FOLFOX, as first-line treatment in patients with
wild-type KRAS (exon 2) mCRC. With this approval,
Vectibix became the first-and-only biologic therapy indicated for
use with FOLFOX, one of the most commonly used chemotherapy
regimens, in the first-line treatment of mCRC for patients with
wild-type KRAS mCRC.
In June 2017, the FDA approved a refined
indication for Vectibix for use in in patients with
wild-type RAS (defined as wild-type in
both KRAS and NRAS as determined
by an FDA-approved test for this use) mCRC.
INDICATION AND LIMITATION OF USE
Vectibix® is indicated for the treatment of
patients with wild-type RAS (defined as wild-type
in both KRAS and NRAS as
determined by an FDA-approved test for this use) metastatic
colorectal cancer (mCRC): as first-line therapy in combination
with FOLFOX, and as monotherapy following disease progression after
prior treatment with fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy.
Limitation of Use: Vectibix® is not indicated
for the treatment of patients with RAS mutant mCRC or
for whom RAS mutation status is unknown.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities
occurred in 90% of patients and were severe (NCI-CTC grade 3 and
higher) in 15% of patients receiving Vectibix
monotherapy [see Dosage and Administration (2.3),
Warnings and Precautions (5.1), and Adverse Reactions
(6.1)].
- In Study 20020408, dermatologic toxicities occurred in 90% of
patients and were severe (NCI-CTC grade 3 and higher) in 15% of
patients with mCRC receiving Vectibix®. The clinical
manifestations included, but were not limited to, acneiform
dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia,
dry skin, and skin fissures.
- Monitor patients who develop dermatologic or soft tissue
toxicities while receiving Vectibix® for the
development of inflammatory or infectious sequelae.
Life-threatening and fatal infectious complications including
necrotizing fasciitis, abscesses, and sepsis have been observed in
patients treated with Vectibix®. Life-threatening and
fatal bullous mucocutaneous disease with blisters, erosions, and
skin sloughing has also been observed in patients treated with
Vectibix®. It could not be determined whether these
mucocutaneous adverse reactions were directly related to EGFR
inhibition or to idiosyncratic immune- related effects
(e.g., Stevens Johnson syndrome or toxic epidermal
necrolysis). Withhold or discontinue Vectibix® for
dermatologic or soft tissue toxicity associated with severe or
life-threatening inflammatory or infectious complications. Dose
modifications for Vectibix® concerning dermatologic
toxicity are provided in the product labeling.
- Vectibix® is not indicated for the treatment of
patients with colorectal cancer that harbor
somatic RAS mutations in exon 2 (codons 12 and
13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of
either KRAS or NRAS and hereafter
is referred to as "RAS."
- Retrospective subset analyses across several randomized
clinical trials were conducted to investigate the role
of RAS mutations on the clinical effects of
anti-EGFR-directed monoclonal antibodies (panitumumab or
cetuximab). Anti-EGFR antibodies in patients with tumors
containing RAS mutations resulted in exposing
those patients to anti-EGFR related adverse reactions without
clinical benefit from these agents. Additionally, in Study
20050203, 272 patients with RAS-mutant mCRC tumors
received Vectibix® in combination with FOLFOX and
276 patients received FOLFOX alone. In an exploratory subgroup
analysis, OS was shorter (HR = 1.21, 95% CI: 1.01-1.45)
in patients with RAS-mutant mCRC who received
Vectibix® and FOLFOX versus FOLFOX alone.
- Progressively decreasing serum magnesium levels leading to
severe (grade 3-4) hypomagnesemia occurred in up to 7% (in Study
20080763) of patients across clinical trials. Monitor patients for
hypomagnesemia and hypocalcemia prior to initiating
Vectibix® treatment, periodically during
Vectibix® treatment, and for up to 8 weeks after
the completion of treatment. Other electrolyte disturbances,
including hypokalemia, have also been observed. Replete magnesium
and other electrolytes as appropriate.
- In Study 20020408, 4% of patients experienced infusion
reactions and 1% of patients experienced severe infusion reactions
(NCI-CTC grade 3-4). Infusion reactions, manifesting as fever,
chills, dyspnea, bronchospasm, and hypotension, can occur following
Vectibix® administration. Fatal infusion reactions
occurred in postmarketing experience. Terminate the infusion for
severe infusion reactions.
- Severe diarrhea and dehydration, leading to acute renal failure
and other complications, have been observed in patients treated
with Vectibix® in combination with
chemotherapy.
- Fatal and nonfatal cases of interstitial lung disease (ILD)
(1%) and pulmonary fibrosis have been observed in patients treated
with Vectibix®. Pulmonary fibrosis occurred in less than
1% (2/1467) of patients enrolled in clinical studies of
Vectibix®. In the event of acute onset or worsening of
pulmonary symptoms interrupt Vectibix® therapy.
Discontinue Vectibix® therapy if ILD is
confirmed.
- In patients with a history of interstitial pneumonitis or
pulmonary fibrosis, or evidence of interstitial pneumonitis or
pulmonary fibrosis, the benefits of therapy with
Vectibix® versus the risk of pulmonary
complications must be carefully considered.
- Exposure to sunlight can exacerbate dermatologic toxicity.
Advise patients to wear sunscreen and hats and limit sun exposure
while receiving Vectibix®.
- Keratitis and serious cases of keratitis, ulcerative keratitis,
known risk factors for and corneal perforation, have occurrred with
Vectibix use. Monitor for evidence of keratitis , ulcerative
keratitis, or corneal perforation. Interrupt or discontinue
Vectibix therapy for acute or worsening keratitis, ulcerative
keratitis, or corneal perforation.
- In an interim analysis of an open-label, multicenter,
randomized clinical trial in the first-line setting in patients
with mCRC, the addition of Vectibix® to the
combination of bevacizumab and chemotherapy resulted in decreased
OS and increased incidence of NCI-CTC grade 3-5 (87% vs 72%)
adverse reactions. NCI-CTC grade 3-4 adverse reactions occurring at
a higher rate in Vectibix®-treated patients included
rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs 12%),
dehydration (16% vs 5%), primarily occurring in patients with
diarrhea, hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs <
1%), and hypomagnesemia (4% vs 0).
- NCI-CTC grade 3-5 pulmonary embolism occurred at a higher rate
in Vectibix®-treated patients (7% vs 3%) and included
fatal events in three (< 1%) Vectibix®-treated
patients. As a result of the toxicities experienced, patients
randomized to Vectibix®, bevacizumab, and chemotherapy
received a lower mean relative dose intensity of each
chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or
infusional 5-FU) over the first 24 weeks on study compared with
those randomized to bevacizumab and chemotherapy.
- Vectibix® can cause fetal harm when
administered to a pregnant woman. Advise pregnant women and females
of reproductive potential of the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception
during treatment, and for at least 2 months after the last dose of
Vectibix®.
- In monotherapy, the most commonly reported adverse reactions (≥
20%) in patients with Vectibix® were skin rash with
variable presentations, paronychia, fatigue, nausea, and
diarrhea.
- The most commonly reported adverse reactions (≥ 20%) with
Vectibix® + FOLFOX were diarrhea, stomatitis,
mucosal inflammation, asthenia, paronychia, anorexia,
hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus,
and dry skin. The most common serious adverse reactions (≥ 2%
difference between treatment arms) were diarrhea and
dehydration.
To see the Vectibix® Prescribing Information,
including Boxed Warning visit www.vectibix.com.
About Amgen Oncology
At Amgen Oncology, our mission to
serve patients drives all that we do. That's why we're relentlessly
focused on accelerating the delivery of medicines that have the
potential to empower all angles of care and transform lives of
people with cancer.
For the last four decades, we have been dedicated to discovering
the firsts that matter in oncology and to finding ways to reduce
the burden of cancer. Building on our heritage, Amgen continues to
advance the largest pipeline in the Company's history, moving with
great speed to advance those innovations for the patients who need
them.
At Amgen, we're advancing oncology at the speed of life™.
For more information, follow us on
www.twitter.com/amgenoncology.
About Amgen
Amgen is committed to unlocking
the potential of biology for patients suffering from serious
illnesses by discovering, developing, manufacturing and delivering
innovative human therapeutics. This approach begins by using tools
like advanced human genetics to unravel the complexities of disease
and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
Forward-Looking Statements
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forward-looking statements that are based on the current
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outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company (including BeiGene, Ltd.,
Kyowa-Kirin Co., Ltd., or any collaboration to manufacture
therapeutic antibodies against COVID-19), the performance of
Otezla® (apremilast) (including anticipated Otezla sales
growth and the timing of non-GAAP EPS accretion), or the Five Prime
Therapeutics, Inc. acquisition, as well as estimates of revenues,
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results. Forward-looking statements involve significant risks
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Our results may be affected by our ability to successfully
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The scientific information discussed in this news release
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CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631
(media)
Megan Fox, 805-447-1423 (media)
Arvind Sood, 805-447-1060
(investors)
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