First Global Phase 3 Study in Patients with
Chemorefractory KRAS G12C-Mutated Metastatic
Colorectal Cancer
Results Featured in a Presidential Symposium
at ESMO and Simultaneously Published in the New England Journal
of Medicine (NEJM)
THOUSAND
OAKS, Calif., Oct. 22,
2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced data from the global Phase 3 CodeBreaK 300 trial
evaluating two doses of LUMAKRAS® (sotorasib) (960 mg or
240 mg) in combination with Vectibix®
(panitumumab). Both doses demonstrated a statistically
significant superiority in progression-free survival (PFS) over the
investigator's choice of therapy in patients with chemorefractory
KRAS G12C-mutated metastatic colorectal cancer (mCRC). The
results are being presented today at the Presidential Symposium 2
session as a late-breaking oral presentation (LBA10) during the
European Society for Medical Oncology (ESMO) 2023 Congress in
Madrid, Spain, with simultaneous
publication in the New England Journal of Medicine.
"The CodeBreaK 300 trial demonstrated the benefit of LUMAKRAS
plus Vectibix to deliver statistically significant PFS outcomes for
patients compared to the investigator's choice of therapy, offering
new hope to this population with historically poor outcomes," said
David M. Reese, M.D., executive vice
president, Research and Development at Amgen.
After a median follow-up of 7.8 months, the median PFS was 5.6
months and 3.9 months with LUMAKRAS 960 mg plus Vectibix and
LUMAKRAS 240 mg plus Vectibix respectively, versus 2.2 months with
investigator's choice of therapy (trifluridine and tipiracil, or
regorafenib). The improvement in PFS for patients treated with
LUMAKRAS plus Vectibix was seen across key subgroups, including
tumor sidedness, primary tumor location, prior lines of
therapy and presence or absence of liver metastases. Among
secondary endpoints, higher objective response rate (ORR) and
disease control rate (DCR) were observed in patients treated with
LUMAKRAS plus Vectibix at both doses versus investigator's choice
of care. Patients at both dose regimens of LUMAKRAS
plus Vectibix experienced a longer duration of treatment than
those treated with investigator's choice therapy.
"With these new data, sotorasib plus panitumumab showed
consistent efficacy across key subgroups at both doses
and supports the biologic rationale of combining these two
biomarker-directed therapies," said Filippo
Pietrantonio, M.D., Fondazione IRCCS Istituto Nazionale dei
Tumori. "Fewer than 20% of people diagnosed with mCRC survive
beyond five years, and additional treatment options are clearly
needed, particularly for the patients with KRAS mutations
for whom evidence-based targeted options were not yet
available."
The most common Grade ≥3 treatment-related
adverse events (TRAEs) with LUMAKRAS plus Vectibix were
dermatitis acneiform (960 mg: 11%; 240 mg: 4%), hypomagnesemia (960
mg: 6%; 240 mg: 8%), rash (960 mg: 6%; 240 mg: 2%), and diarrhea
(960 mg: 4%; 240 mg: 6%).
Based on the CodeBreaK 300 primary analysis results, Amgen is
planning to submit these data to regulatory authorities.
About CodeBreaK 300
The CodeBreaK 300 trial enrolled
160 participants and compared LUMAKRAS at doses of 960 mg and 240
mg in combination with Vectibix to investigator's choice of
standard of care (trifluridine and tipiracil, or regorafenib) in
patients with chemorefractory KRAS G12C-mutated metastatic
colorectal cancer (mCRC).
The primary endpoint was PFS, and key secondary endpoints were
overall survival (OS) and objective response rate (ORR).
- The median PFS for patients treated with the 960 mg dose of
LUMAKRAS plus Vectibix (n=53) was 5.6 months (Hazard Ratio (HR)
0.49 (95% Confidence Interval (CI): 0.30, 0.80)).
- The median PFS for patients treated with the 240 mg dose of
LUMAKRAS plus Vectibix (n=53) was 3.9 months (HR 0.58 (95% CI:
0.36, 0.93)).
- The median PFS for patients treated with investigator's choice
(n=54) was 2.2 months.
LUMAKRAS plus Vectibix combination regimens demonstrated higher
ORR compared with investigator's choice (95% CI; 960 mg: 26%
[15.3–40.3]; 240 mg: 6% [1.2–15.7]; investigator's choice of care:
0% [0–6.6]). Similarly, consistent improvement in DCR was observed
in patients treated with LUMAKRAS plus Vectibix (95% CI; 960 mg:
72% [57.7–83.2]; 240 mg: 68% [53.7–80.1]; investigator's choice:
46% [32.6–60.4]). Tumor shrinkage of any level from baseline was
observed in 81%, 57% and 20% of patients in the 960 mg dose, 240 mg
dose and investigator's choice cohorts, respectively. The OS was
immature at the time of the data cutoff.
About
LUMAKRAS®/LUMYKRAS® (sotorasib)
LUMAKRAS
received accelerated approval from the U.S. Food and Drug
Administration on May 28, 2021. The
supplemental New Drug Application (sNDA) for full approval of
LUMAKRAS was accepted by the FDA for standard review and a
Prescription Drug User Fee Act (PDUFA) target action date of
December 24, 2023, has been set.
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.1 It is also the third most commonly diagnosed
cancer globally.2 Patients with previously treated
metastatic CRC need more effective treatment options.
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.3,4,5
LUMAKRAS® (sotorasib) U.S. Indication
LUMAKRAS 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 U.S. 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 occurring in ≥ 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 LUMAKRAS 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 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 ulcerative keratitis, known risk factors for
corneal perforation, have been reported with
Vectibix® use. Monitor for evidence of keratitis or
ulcerative keratitis. Interrupt or discontinue
Vectibix® for acute or worsening keratitis.
- 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
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1 Rawla, P, et al. Gastroenterology Review.
2019;14(2):89-103.
2 World Health Organization. 2022 Statistics. Available
at: https://www.who.int/en/news-room/fact-sheets/detail/cancer.
Accessed on June 2, 2023.
3 Neumann J, et al. Pathol Res Pract.
2009;205(12):858-862. doi:10.1016/j.prp.2009.07.010.
4 Jones RP, et al. Br J Cancer.
2017;116(7):923-929. doi:10.1038/bjc.2017.37.
5 Wiesweg M, et al. Oncogene.
2019;38(16):2953-2966. doi:10.1038/s41388-018-0634-0.
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