Approval is based on results from the Phase 3 PAPILLON
study, which demonstrated RYBREVANT® plus chemotherapy
reduced the risk of disease progression or death by 61 percent
versus chemotherapy alone in patients with previously untreated
NSCLC with EGFR exon 20 insertion mutations
National Comprehensive Cancer Network ® (NCCN
®) updated its NCCN Clinical Practice Guidelines in
Oncology (NCCN Guidelines ®) to recommend
amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a
preferred first-line regimen for patients with NSCLC with EGFR exon
20 insertion mutations
RARITAN,
N.J., March 1, 2024 /PRNewswire/ -- Johnson
& Johnson (NYSE: JNJ) announced today that following a
priority review, the U.S. Food and Drug Administration (FDA) has
approved RYBREVANT® (amivantamab-vmjw) in combination
with chemotherapy (carboplatin-pemetrexed) for the first-line
treatment of patients with locally advanced or metastatic non-small
cell lung cancer (NSCLC) with epidermal growth factor receptor
(EGFR) exon 20 insertion mutations as detected by an FDA-approved
test.1 This FDA action converts the May 2021 accelerated approval of
RYBREVANT® to a full approval based on the confirmatory
Phase 3 PAPILLON study.
"When aiming for the best possible treatment outcomes, a
targeted approach should be used in the first line for patients
with EGFR exon 20 insertion mutations, as this is a commonly
applied practice for patients with NSCLC harboring other molecular
driver alterations," said Joshua K.
Sabari, M.D.*, an oncologist at NYU Langone's Perlmutter
Cancer Center and study investigator.* "The results
observed in the PAPILLON study showed significant improvement in
progression-free survival, supporting the use of this regimen as
the potential standard-of-care in the first-line treatment of these
patients."
Worldwide, lung cancer is one of the most common cancers, with
NSCLC making up 80 to 85 percent of all lung cancer
cases.2,3 Alterations in EGFR are the most common
actionable driver mutations in NSCLC.4 Clinical data
show patients with EGFR exon 20 insertion mutations generally
experience limited benefits with currently approved
third-generation EGFR tyrosine kinase inhibitors and
chemotherapy.5,6 NSCLC driven by EGFR exon 20 insertion
mutations carries a worse prognosis and shorter survival rates
compared with lung cancer driven by other EGFR driver
mutations.7
"For patients with lung cancer and their families, each
breakthrough in treatment provides not only a new option, but a
potential lifeline. The approval of RYBREVANT plus chemotherapy
heralds a promising new first-line treatment option for patients
newly diagnosed with non-small cell lung cancer where their driver
mutation is an EGFR exon 20 insertion," said Marcia Horn**, Executive Director of the Exon 20
Group and CEO of ICAN, International Cancer Advocacy Network. "This
new regimen is a major advance over chemotherapy alone. We've seen
first-hand the extended survival that Exon 20 Group patients
experienced on RYBREVANT plus chemotherapy in the PAPILLON study,
and we're delighted that this historic treatment option, which
specifically targets the EGFR exon 20 insertion mutation, has been
approved."
The FDA approval is based on positive results from the
randomized, open-label Phase 3 PAPILLON study, which showed
RYBREVANT® plus chemotherapy resulted in a 61 percent
reduction in the risk of disease progression or death compared to
chemotherapy alone.1 Results also showed treatment with
RYBREVANT® plus chemotherapy improved objective response
rate (ORR) and progression-free survival (PFS).1 Based
on PAPILLON data, the National Comprehensive Cancer Network
® (NCCN ®) updated its' NCCN
Clinical Practice Guidelines (NCCN Guidelines®) to
include a category 1 recommendation for amivantamab-vmjw
(RYBREVANT®) plus chemotherapy as a preferred first-line
therapy for patients with NSCLC with EGFR exon 20 insertion
mutations.8 †‡
"We are redefining care for patients with non-small cell lung
cancer by advancing innovative regimens that can be used early,
with the goal of extending survival," said Kiran Patel, M.D., Vice President, Clinical
Development, Solid Tumors, Johnson & Johnson Innovative
Medicine. "RYBREVANT plus chemotherapy is the first targeted
approach approved for the first-line treatment of patients with
NSCLC with EGFR exon 20 insertion mutations. We look forward to
building on this latest milestone as we continue to accelerate our
transformative lung cancer portfolio."
Warnings and Precautions include Infusion Related Reactions
(IRR), Interstitial Lung Disease (ILD)/Pneumonitis, Dermatologic
Adverse Reactions, Ocular Toxicity and Embryo-fetal Toxicity. The
most common adverse reactions (≥20 percent) were rash, nail
toxicity, stomatitis, IRR, fatigue, edema, constipation, decreased
appetite, nausea, COVID-19, diarrhea and vomiting. The most common
Grade 3 or 4 laboratory abnormalities (≥2 percent) were decreased
albumin, increased alanine aminotransferase, increased
gamma-glutamyl transferase, decreased sodium, decreased potassium,
decreased magnesium, and decreases in white blood cells,
hemoglobin, neutrophils, platelets, and
lymphocytes.1
About the PAPILLON Study
PAPILLON (NCT04538664) is a randomized, open-label Phase 3 study
evaluating the efficacy and safety of RYBREVANT® in
combination with chemotherapy, compared with chemotherapy alone, in
newly diagnosed patients with advanced or metastatic NSCLC
characterized by EGFR exon 20 insertion mutations. The primary
endpoint of the study is PFS (using RECIST v1.1
guidelines§) as assessed by blinded independent central
review (BICR). Secondary endpoints include ORR, PFS after first
subsequent therapy, time to symptomatic progression and overall
survival (OS). Patients who received chemotherapy alone were
allowed to receive RYBREVANT® monotherapy in the
second-line setting after confirmation of disease
progression.10
About RYBREVANT®
RYBREVANT® (amivantamab-vmjw), a fully-human
bispecific antibody targeting EGFR and MET with immune
cell-directing activity is approved in the U.S., Europe and in other markets around the world
as monotherapy for the treatment of adult patients with locally
advanced or metastatic NSCLC with EGFR exon 20 insertion mutations,
as detected by an FDA-approved test, whose disease has progressed
on or after platinum-based chemotherapy.[1]
This indication is approved under accelerated approval based on ORR
and duration of response (DOR). Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials. RYBREVANT®
is also approved in the U.S. in combination with chemotherapy
(carboplatin and pemetrexed) for the first-line treatment of adult
patients with locally advanced or metastatic NSCLC with EGFR exon
20 insertion mutations, as detected by an FDA-approved test. In
October 2023, a type II extension of
indication application was submitted to the European Medicines
Agency (EMA) seeking approval of RYBREVANT® for this
indication. In December 2023, Johnson
& Johnson submitted an sBLA together with a New Drug
Application (NDA) to the U.S. FDA for RYBREVANT® in combination
with lazertinib for the first-line treatment of adult patients with
locally advanced or metastatic NSCLC with EGFR exon 19 deletions or
L858R substitution mutations, as detected by an FDA-approved test.
This submission is based on the Phase 3 MARIPOSA study and was
granted Priority Review in February 2024. A marketing
authorization application (MAA) and type II extension of indication
application were also submitted to the EMA seeking approval of
lazertinib in combination with RYBREVANT® based on the MARIPOSA
study. In November 2023, Johnson
& Johnson submitted an sBLA to the U.S. FDA for RYBREVANT® in
combination with chemotherapy for the treatment of patients with
EGFR-mutated NSCLC who progressed on or after osimertinib based on
the MARIPOSA-2 study. A type II extension of indication application
was also submitted to the EMA seeking the approval of RYBREVANT®
for this indication.
The NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for NSCLC∥ prefer
next-generation sequencing-based strategies over polymerase chain
reaction-based approaches for the detection of EGFR exon 20
insertion variants. The NCCN Guidelines® include:
- Amivantamab-vmjw (RYBREVANT®) plus carboplatin and
pemetrexed as a preferred (Category 1 recommendation) first-line
therapy in treatment-naive patients with newly diagnosed advanced
or metastatic EGFR exon 20 insertion mutation-positive
advanced NSCLC, or as a subsequent therapy option (Category 2A
recommendation) for patients that have progressed on or after
platinum-based chemotherapy with or without immunotherapy and have
EGFR exon 20 insertion mutation-positive advanced NSCLC.8
†‡
- Amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a
preferred (Category 1 recommendation) subsequent therapy for
patients with locally advanced or metastatic NSCLC with EGFR exon
19 deletions or exon 21 L858R mutations who experienced disease
progression after treatment with osimertinib.8 †‡
- Amivantamab-vmjw (RYBREVANT®) as a subsequent
therapy option (Category 2A recommendation) for patients that have
progressed on or after platinum-based chemotherapy with or without
an immunotherapy and have EGFR exon 20 insertion mutation-positive
NSCLC.8 †‡
In addition to the Phase 3 PAPILLON study,
RYBREVANT® is being studied in multiple clinical
trials in NSCLC, including:
- The Phase 3 MARIPOSA-2 (NCT04988295) study evaluating the
efficacy and safety of RYBREVANT® and chemotherapy
in patients with locally advanced or metastatic EGFR ex19del or
L858R substitution NSCLC who had disease progression on or after
treatment with osimertinib. Data for this randomized Phase 3 study
presented at the ESMO 2023 Congress demonstrated statistically
significant and clinically meaningful improvement in PFS in
patients receiving RYBREVANT® plus chemotherapy with and
without lazertinib versus chemotherapy.11,12
- The Phase 3 MARIPOSA (NCT04487080) study assessing
RYBREVANT® in combination with lazertinib, a novel
third-generation EGFR TKI, versus osimertinib and versus lazertinib
alone in the first-line treatment of patients with locally advanced
or metastatic NSCLC with EGFR exon 19 deletions (ex19del) or L858R
substitution mutations. Data for this randomized Phase 3 study
presented at the ESMO 2023 Congress showed statistically
significant and clinically meaningful improvement in
progression-free survival in patients with EGFR-mutated advanced
NSCLC treated with RYBREVANT® plus lazertinib versus
osimertinib.13,14
- The Phase 1 CHRYSALIS (NCT02609776) study evaluating
RYBREVANT® in participants with advanced
NSCLC.15
- The Phase 1/1b CHRYSALIS-2
(NCT04077463) study evaluating RYBREVANT® in combination
with lazertinib and lazertinib as a monotherapy in patients with
advanced NSCLC with EGFR mutations.16
- The Phase 1 PALOMA (NCT04606381) study assessing the
feasibility of subcutaneous (SC) administration of amivantamab
based on safety and pharmacokinetics and to determine a dose, dose
regimen and formulation for amivantamab SC
delivery.17
- The Phase 2 PALOMA-2 (NCT05498428) study assessing subcutaneous
amivantamab in participants with advanced or metastatic solid
tumors including EGFR-mutated NSCLC.18
- The Phase 3 PALOMA-3 (NCT05388669) study assessing lazertinib
with subcutaneous amivantamab compared to intravenous amivantamab
in participants with EGFR-mutated advanced or metastatic
NSCLC.19
- The Phase 1/2 METalmark (NCT05488314) study assessing
RYBREVANT® and capmatinib combination therapy in locally
advanced or metastatic NSCLC.20
- The Phase 1/2 PolyDamas (NCT05908734) study assessing
RYBREVANT® and cetrelimab combination therapy in locally
advanced or metastatic NSCLC.21
- The Phase 2 SKIPPirr study (NCT05663866) exploring how to
decrease the incidence and/or severity of first-dose
infusion-related reactions with RYBREVANT® in
combination with lazertinib in relapsed or refractory EGFR-mutated
advanced or metastatic NSCLC.22
- The Phase 2 COCOON study (NCT06120140) will evaluate enhanced
dermatological care to reduce rash and paronychia in patients with
EGFR-mutated NSCLC treated first-line with amivantamab plus
lazertinib.23
For more information, visit: https://www.RYBREVANT.com.
About Non-Small Cell Lung Cancer
Worldwide, lung cancer is one of the most common cancers, with
NSCLC making up 80 to 85 percent of all lung cancer
cases.2,3 The main subtypes of NSCLC are adenocarcinoma,
squamous cell carcinoma, and large cell carcinoma.24
Among the most common driver mutations in NSCLC are alterations in
EGFR, which is a receptor tyrosine kinase controlling
cell growth and division.4 EGFR mutations are
present in 10 to 15 percent of Western patients with NSCLC with
adenocarcinoma histology and occur in 40 to 50 percent of Asian
patients.4,24,25,26,27,28 EGFR ex19del or EGFR L858R
mutations are the most common EGFR mutations.29 The
five-year survival rate for all people with advanced NSCLC and EGFR
mutations treated with EGFR TKIs is less than 20
percent.30,31 Patients with EGFR ex19del or L858R
mutations have a real-world five-year OS of 19
percent.32
RYBREVANT® IMPORTANT SAFETY
INFORMATION2
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
RYBREVANT® can cause infusion-related reactions (IRR); signs and
symptoms of IRR include dyspnea, flushing, fever, chills, nausea,
chest discomfort, hypotension, and vomiting.
RYBREVANT® with Carboplatin and Pemetrexed
RYBREVANT in combination with carboplatin and
pemetrexed can cause infusion-related reactions. Based on the
safety population, infusion-related reactions occurred in 42% of
patients treated with RYBREVANT® in combination with carboplatin
and pemetrexed, including Grade 3 (1.3%) adverse reactions. The
incidence of infusion modifications due to IRR was 40%, and 0.7% of
patients permanently discontinued RYBREVANT.
RYBREVANT® as a Single Agent
Based on the safety population, IRR occurred in
66% of patients treated with RYBREVANT®. Among patients receiving
treatment on Week 1 Day 1, 65% experienced an IRR, while the
incidence of IRR was 3.4% with the Day 2 infusion, 0.4% with
the Week 2 infusion, and cumulatively 1.1% with subsequent
infusions. Of the reported IRRs, 97% were Grade 1-2, 2.2% were
Grade 3, and 0.4% were Grade 4. The median time to onset
was 1 hour (range 0.1 to 18 hours) after start of infusion. The
incidence of infusion modifications due to IRR was 62% and 1.3% of
patients permanently discontinued RYBREVANT® due to IRR.
Premedicate with antihistamines, antipyretics, and
glucocorticoids and infuse RYBREVANT® as recommended. Administer
RYBREVANT® via a peripheral line on Week 1 and Week 2.
Monitor patients for any signs and symptoms of infusion reactions
during RYBREVANT® infusion in a setting where cardiopulmonary
resuscitation medication and equipment are available. Interrupt
infusion if IRR is suspected. Reduce the infusion rate or
permanently discontinue RYBREVANT® based on severity.
Interstitial Lung Disease/Pneumonitis
RYBREVANT® can cause interstitial lung disease
(ILD)/pneumonitis.
RYBREVANT® with Carboplatin and Pemetrexed
Based on the safety population, Grade 3
ILD/pneumonitis occurred in 2.6% of patients treated with
RYBREVANT® in combination with carboplatin and pemetrexed, all
patients required permanent discontinuation.
RYBREVANT® as a Single Agent
Based on the safety population, ILD/pneumonitis
occurred in 3.3% of patients treated with RYBREVANT®, with 0.7% of
patients experiencing Grade 3 ILD/pneumonitis. Three patients
(1%) discontinued RYBREVANT® due to ILD/pneumonitis.
Monitor patients for new or worsening symptoms indicative of
ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold
RYBREVANT® in patients with suspected ILD/pneumonitis and
permanently discontinue if ILD/pneumonitis is confirmed.
Dermatologic Adverse Reactions
RYBREVANT® can cause rash (including dermatitis acneiform),
pruritus and dry skin.
RYBREVANT® with Carboplatin and Pemetrexed
RYBREVANT in combination with carboplatin and
pemetrexed can cause dermatologic adverse reactions. Based on the
safety population, rash occurred in 89% of patients treated with
RYBREVANT® in combination with carboplatin and pemetrexed,
including Grade 3 (19%) adverse reactions. Rash leading to dose
reductions occurred in 19% of patients, and 2% permanently
discontinued RYBREVANT® and 1.3% discontinued pemetrexed.
RYBREVANT® as a Single Agent
Based on the safety population, rash occurred in
74% of patients treated with RYBREVANT®, including Grade 3
rash in 3.3% of patients. The median time to onset of rash was
14 days (range: 1 to 276 days). Rash leading to dose
reduction occurred in 5% of patients, and RYBREVANT® was
permanently discontinued due to rash in 0.7% of patients.
Toxic epidermal necrolysis occurred in one
patient (0.3%) treated with RYBREVANT® as a single agent.
Instruct patients to limit sun exposure during and for
2 months after treatment with RYBREVANT®. Advise patients to
wear protective clothing and use broad-spectrum UVA/UVB sunscreen.
Alcohol‑free emollient cream is recommended for dry skin.
If skin reactions develop, start topical corticosteroids and
topical and/or oral antibiotics. For Grade 3 reactions, add
oral steroids and consider dermatologic consultation. Promptly
refer patients presenting with severe rash, atypical appearance or
distribution, or lack of improvement within 2 weeks to a
dermatologist. Withhold, dose reduce or permanently discontinue
RYBREVANT® based on severity.
Ocular Toxicity
RYBREVANT® can cause ocular toxicity including keratitis, dry
eye symptoms, conjunctival redness, blurred vision, visual
impairment, ocular itching, and uveitis.
RYBREVANT® with Carboplatin and Pemetrexed
Based on the safety population, RYBREVANT® in
combination with carboplatin and pemetrexed can cause ocular
toxicity including blepharitis, dry eye, conjunctival redness,
blurred vision, and eye pruritus. All events were Grade 1-2.
RYBREVANT® as a Single Agent
Based on the safety population, keratitis
occurred in 0.7% and uveitis occurred in 0.3% of patients treated
with RYBREVANT®. All events were Grade 1-2. Promptly refer patients
presenting with eye symptoms to an ophthalmologist. Withhold, dose
reduce or permanently discontinue RYBREVANT® based on severity.
Embryo-Fetal Toxicity
Based on its mechanism of action and findings from animal
models, RYBREVANT® can cause fetal harm when administered to a
pregnant woman. Advise females of reproductive potential of the
potential risk to the fetus. Advise female patients of reproductive
potential to use effective contraception during treatment and for
3 months after the last dose of RYBREVANT®.
Adverse Reactions
RYBREVANT® with Carboplatin and Pemetrexed
For the 151 patients in the PAPILLON clinical trial who received
RYBREVANT® in combination with carboplatin and pemetrexed the most
common adverse reactions (≥ 20%) were rash (90%), nail
toxicity (62%), stomatitis (43%), infusion-related reaction (42%),
fatigue (42%), edema (40%), constipation (40%), decreased appetite
(36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting
(21%). The most common Grade 3 to 4 laboratory abnormalities
(≥ 2%) were decreased albumin (7%), increased alanine
aminotransferase (4%), increased gamma‑glutamyl transferase (4%),
decreased sodium (7%), decreased potassium (11%), decreased
magnesium (2%), and decreases in white blood cells (17%),
hemoglobin (11%), neutrophils (36%), platelets (10%), and
lymphocytes (11%).
Serious adverse reactions occurred in 37% of patients who
received RYBREVANT® in combination with carboplatin and pemetrexed.
Serious adverse reactions in ≥ 2% of patients included rash,
pneumonia, ILD, pulmonary embolism, vomiting and COVID-19. Fatal
adverse reactions occurred in 7 patients (4.6%) due to pneumonia,
cerebrovascular accident, cardio-respiratory arrest, COVID-19,
sepsis, and death not otherwise specified.
RYBREVANT® as a Single Agent
For the 129 patients in the CHRYSALIS clinical trial who
received RYBREVANT® as a single agent the most common adverse
reactions (≥20%) were rash (84%), IRR (64%), paronychia (50%),
musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue
(33%), edema (27%), stomatitis (26%), cough (25%), constipation
(23%), and vomiting (22%). The most common Grade 3 to 4
laboratory abnormalities (≥2%) were decreased lymphocytes (8%),
decreased albumin (8%), decreased phosphate (8%), decreased
potassium (6%), increased alkaline phosphatase (4.8%), increased
glucose (4%), increased gamma-glutamyl transferase (4%), and
decreased sodium (4%).
Serious adverse reactions occurred in 30% of patients who
received RYBREVANT®. Serious adverse reactions in ≥ 2% of patients
included pulmonary embolism, pneumonitis/ILD, dyspnea,
musculoskeletal pain, pneumonia, and muscular weakness. Fatal
adverse reactions occurred in 2 patients (1.5%) due to pneumonia
and 1 patient (0.8%) due to sudden death.
Please read the full Prescribing Information for
RYBREVANT®.
About Johnson & Johnson
At Johnson & Johnson, we believe health is
everything. Our strength in healthcare innovation empowers us to
build a world where complex diseases are prevented, treated,
and cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in
Innovative Medicine and MedTech, we are uniquely positioned to
innovate across the full spectrum of healthcare solutions today to
deliver the breakthroughs of tomorrow, and profoundly impact health
for humanity. Learn more at https://www.jnj.com/ or at
www.janssen.com/johnson-johnson-innovative-medicine. Follow us
at @JanssenUS and @JNJInnovMed. Janssen Research &
Development, LLC, and Janssen Biotech, Inc., are both Johnson &
Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development and the potential benefits and
treatment impact of RYBREVANT® (amivantamab-vmjw) and
lazertinib. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of Janssen Research & Development, LLC, Janssen
Biotech, Inc., and Johnson & Johnson. Risks and
uncertainties include, but are not limited to: challenges and
uncertainties inherent in product research and development,
including the uncertainty of clinical success and of obtaining
regulatory approvals; uncertainty of commercial success;
competition, including technological advances, new products and
patents attained by competitors; challenges to patents; changes in
behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
January 1, 2023, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in Johnson &
Johnson's subsequent Quarterly Reports on Form 10-Q and other
filings with the Securities and Exchange Commission. Copies of
these filings are available online at www.sec.gov, www.jnj.com or
on request from Johnson & Johnson. None of Janssen Research
& Development, LLC, Janssen Biotech, Inc., and Johnson &
Johnson undertakes to update any forward-looking statement as a
result of new information or future events or developments.
*Dr. Sabari has served as a consultant to Johnson & Johnson;
he has not been paid for any media work.
**Ms. Horn has not been paid for any media work.
†See the NCCN Guidelines for detailed recommendations, including
other treatment options.
‡The NCCN Guidelines for NSCLC provide recommendations for
certain individual biomarkers that should be tested and recommend
testing techniques but do not endorse any specific commercially
available biomarker assays or commercial laboratories.
§RECIST (v1.1) refers to Response Evaluation Criteria in Solid
Tumors, which is a standard way to measure how well solid tumors
respond to treatment and is based on whether tumors shrink, stay
the same or get bigger.
∥The NCCN Content does not constitute medical advice and should
not be used in place of seeking professional medical advice,
diagnosis or treatment by licensed practitioners. NCCN makes no
warranties of any kind whatsoever regarding their content, use or
application and disclaims any responsibility for their application
or use in any way.
- RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
- The World Health Organization. Cancer.
https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed
September 2023.
- American Cancer Society. What is Lung Cancer?
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Accessed September 2023.
- Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion
Mutation Variants: Estimates from NGS-based Real World Datasets.
Abstract presented at: World Conference on Lung Cancer Annual
Meeting; January 29, 2021;
Singapore.
- Yasuda H, et al. Structural, biochemical, and clinical
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PMCID: PMC3954775. Accessed January
2024.
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Accessed December 2023.
- Vyse S, Huang PH. Targeting EGFR exon 20
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Inc. All rights reserved. To view the most recent and complete
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- Girard N, et al. Amivantamab Plus Carboplatin/Pemetrexed vs
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- ClinicalTrials.gov. A Study of Combination Amivantamab and
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Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic
Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor
Receptor (EGFR) Exon 20 Insertions (PAPILLON).
https://clinicaltrials.gov/ct2/show/NCT04538664. Accessed
July 2023.
- ClinicalTrials.gov. A Study of Amivantamab and Lazertinib in
Combination With Platinum-Based Chemotherapy Compared With
Platinum-Based Chemotherapy in Patients With Epidermal Growth
Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic
Non-Small Cell Lung Cancer After Osimertinib Failure (MARIPOSA-2).
https://clinicaltrials.gov/ct2/show/NCT04988295. Accessed
October 2023.
- Passaro P, et al. Amivantamab Plus Chemotherapy (With or
Without Lazertinib) vs Chemotherapy Alone in EGFR-mutated, Advanced
Non-small Cell Lung Cancer (NSCLC) After Progression on
Osimertinib: MARIPOSA-2, a Phase 3, Global, Randomized, Controlled
Trial. 2023 European Society for Medical Oncology. October 23,
2023.
- ClinicalTrials.gov. A Study of Amivantamab and Lazertinib
Combination Therapy Versus Osimertinib in Locally Advanced or
Metastatic Non-Small Cell Lung Cancer (MARIPOSA).
https://classic.clinicaltrials.gov/ct2/show/NCT04487080. Accessed
October 2023.
- Cho BC, et al. Amivantamab Plus Lazertinib vs Osimertinib as
First-line Treatment in Patients With EGFR-mutated, Advanced
Non-small Cell Lung Cancer (NSCLC): Primary Results From MARIPOSA,
a Phase 3, Global, Randomized, Controlled Trial. 2023 European
Society for Medical Oncology. October 23, 2023.
- ClinicalTrials.gov. A Study of Amivantamab, a Human Bispecific
EGFR and cMet Antibody, in Participants With Advanced Non-Small
Cell Lung Cancer (CHRYSALIS).
https://clinicaltrials.gov/ct2/show/NCT02609776. Accessed
September 2023.
- ClinicalTrials.gov. A Study of Lazertinib as Monotherapy or in
Combination With Amivantamab in Participants With Advanced
Non-small Cell Lung Cancer (CHRYSALIS-2).
https://clinicaltrials.gov/ct2/show/NCT04077463. Accessed
September 2023.
- ClinicalTrials.gov. A Study of Amivantamab Subcutaneous (SC)
Administration for the Treatment of Advanced Solid Malignancies
(PALOMA). https://clinicaltrials.gov/ct2/show/NCT04606381. Accessed
September 2023.
- ClinicalTrials.gov. A Study of Amivantamab in Participants With
Advanced or Metastatic Solid Tumors Including Epidermal Growth
Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
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