Further analyses from the Phase 1/1b CHRYSALIS-2 study showed patients with
osimertinib pre-treated EGFR-mutated lung cancer who have a
MET positive biomarker had an overall response rate of 61 percent
and a median PFS of 12.2 months when treated with the
chemotherapy-free combination of RYBREVANT® and
lazertinib
Updated safety analysis from the Phase 1
PALOMA study evaluating subcutaneous delivery of
RYBREVANT® showed shorter administration time and a
marked reduction in the incidence and severity of infusion-related
reactions
CHICAGO, June 4, 2023
/PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson
& Johnson today announced long-term results from the
CHRYSALIS study, which showed the combination of
RYBREVANT® (amivantamab-vmjw) and lazertinib*, a
third-generation epidermal growth factor receptor (EGFR) tyrosine
kinase inhibitor (TKI), was associated with sustained antitumor
activity as a first-line treatment in patients with EGFR-mutated
non-small cell lung cancer (NSCLC) (Abstract #9134).1
These findings and additional data, including an analysis of
predictive biomarkers from Cohort D of the Phase 1/1b CHRYSALIS-2 study evaluating a
chemotherapy-free regimen of RYBREVANT® in combination
with lazertinib (Abstract #9013)2 and updated safety
results from the Phase 1 PALOMA study evaluating the subcutaneous
(SC) administration of RYBREVANT® as a monotherapy
(Abstract #9126)3 were presented at the 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting.
Patients enrolled in the treatment-naïve cohort from the ongoing
CHRYSALIS (NCT02609776) study had NSCLC characterized by either an
EGFR exon 19 deletion (ex19del) (n=11) or L858R mutation
(n=9).1,4 After a median follow-up of nearly three years
(33.6 months), the median duration of response (DOR), median
progression-free survival (PFS) and overall survival (OS) were not
yet reached. The estimated PFS rate was 85 percent after one year,
65 percent at two years and 51 percent at three years. The longest
ongoing duration of treatment is over three years (37.2 months),
and longest DOR is nearly three years (35.7
months).1
Safety among patients in this cohort was consistent with
previous reports and no new safety signals were identified.
Treatment-related dose interruptions, reductions and
discontinuations of either RYBREVANT® or lazertinib
occurred in seven patients (35 percent), eight patients (40
percent) and one patient (5 percent), respectively.1
"Advanced NSCLC and EGFR-mutated lung cancer has a five-year
survival rate of less than 20 percent, underscoring an urgent need
for more targeted treatment options, especially in earlier lines of
therapy," said Se-Hoon Lee**, M.D., Ph.D., professor of medicine at
the Samsung Medical Center and Sungkyunkwan University School of
Medicine, and presenting author. "These long-term data for
amivantamab and lazertinib introduce the potential for this
combination therapy to be used as first-line treatment for this
patient population."
New Analyses on Predictive Biomarkers for Response to
RYBREVANT® and Lazertinib Combination Therapy
Patients with advanced NSCLC harboring common EGFR mutations
including ex19del or L858R who have experienced disease
progression on or after osimertinib are a population with
substantial unmet medical need. There are no approved targeted
therapies, and the standard of care is platinum-doublet
chemotherapy. Data from Cohort D of the Phase 1/1b CHRYSALIS-2 study, which enrolled
such patients, were highlighted in an oral presentation at
ASCO this year. CHRYSALIS-2 (NCT04077463) is an open-label study to
evaluate the safety and pharmacokinetics of lazertinib as
monotherapy or in combination with
RYBREVANT®.5 Consistent with a prior
presentation at ASCO 2021, these data indicate that
immunohistochemical (IHC) staining (a testing method using
antibodies to determine the relative level of certain antigens or
markers in cancer tissue samples) for MET may identify patients
more likely to benefit from treatment with the combination
of RYBREVANT® and lazertinib.2,6 Among
patients with MET overexpression as identified by
immunohistochemistry, the response rate was 61 percent with a
median PFS of 12.2 months. In contrast, patients with low MET
expression had a response rate of 14 percent with a median PFS of
4.2 months.2
Updated Safety Data from the Phase 1 PALOMA Study Evaluating
the Investigational Use of Subcutaneous
RYBREVANT®
Results from the Phase 1 PALOMA study were featured in a poster
presentation and showed RYBREVANT® SC dose was
administered on the first day in less than seven minutes, removing
the need for split dosing.3 The current approved
RYBREVANT® intravenous (IV) infusion dosing is split
over two days, with infusion times of approximately 4 to 6 hours
for the RYBREVANT® 1050 mg and 1400 mg dose,
respectively.8 PALOMA (NCT04606381) is an
ongoing, open-label, multicenter study assessing the
investigational SC administration of RYBREVANT® as a
potential treatment for patients with advanced NSCLC.7
Meaningful reductions in the incidence and severity of infusion
related reactions (IRRs) were also observed (16 percent [no grade 3
or higher IRR] with SC as compared to 67 percent [two percent grade
3 or higher IRR] previously reported with IV).3
"These data provide further evidence of the potential efficacy
and safety profile of RYBREVANT as both monotherapy and combination
therapy for the treatment of patients with EGFR-mutated NSCLC and
support our commitment to advance personalized treatment regimens
in areas of continued unmet need," said Kiran Patel, M.D., Vice President, Clinical
Development, Solid Tumors, Janssen Research & Development, LLC.
"We look forward to continuing to evaluate the full potential of
RYBREVANT in our ambition to make this novel therapy available
earlier in the treatment paradigm for these patients and improve
cancer care."
About the CHRYSALIS Study
CHRYSALIS (NCT02609776) is a Phase 1 open-label, multicenter,
first-in-human study to evaluate the safety, pharmacokinetics and
preliminary efficacy of RYBREVANT® as a monotherapy
and in combinations including with lazertinib, a novel
third-generation EGFR TKI, in adults with advanced NSCLC. The study
consists of two parts: RYBREVANT® monotherapy and
combination dose escalations (Part 1) and
RYBREVANT® monotherapy and combination dose
expansions (Part 2). The study enrolled 780 patients with
advanced NSCLC.4
The treatment-naive cohort of the ongoing CHRYSALIS study
enrolled patients with EGFR ex19del or L858R-mutated advanced
NSCLC. All patients received 1050 mg of RYBREVANT®
intravenously (1400 mg if weighing at least 80 kg or more) and 240
mg of lazertinib orally. Disease response using overall response
rate (ORR), per Response Evaluation Criteria in Solid Tumors
Version 1.1♦ (RECIST v1.1) as evaluated by Blinded
Independent Central Review (BICR), was the primary endpoint.
Circulating tumor DNA was analyzed from plasma samples prior to
initiation of treatment, at Cycle 3 Day 1, and at end of
treatment.1
About the CHRYSALIS-2 Study5
CHRYSALIS-2 (NCT04077463) is an open-label Phase 1/1b study to evaluate the safety and
pharmacokinetics of lazertinib, a third generation EGFR-TKI, as
monotherapy or in combinations with RYBREVANT®, a human
bispecific EGFR and cMet antibody in participants with advanced
NSCLC. The study enrolled 460 patients with advanced NSCLC.
Cohort D of the ongoing CHRYSALIS-2 study seeks to validate one
or both potential biomarker strategies (NGS and IHC), previously
identified in Cohort E, in patients with osimertinib-relapsed
and chemotherapy-naïve, EGFR ex19del or L858R-mutated NSCLC.
Patients receive the recommended Phase 2 dose of lazertinib orally
once daily and RYBREVANT® every seven days for the first
28-day cycle and every two weeks thereafter.
About the PALOMA Study7
PALOMA (NCT04606381) is a Phase 1, open-label, multicenter
study assessing the feasibility of the SC administration of
RYBREVANT® based on safety and pharmacokinetics, and to
determine a dose, dose regimen and formulation for
RYBREVANT® SC delivery.
In the ongoing PALOMA study, patients with various advanced
solid tumors must have progressed after standard-of-care therapy
for metastatic disease, be ineligible for, or have declined current
standard therapies. In Part 1, the feasibility of SC administration
of RYBREVANT® using the available intravenous (IV)
formulation (50 mg/mL) at the recommended Phase 2 dose for IV
administration, with and without recombinant human hyaluronidase
(rHuPH20), will be assessed. In Part 2, dose escalation will be
evaluated using a high-concentration formulation (160 mg/mL) of
RYBREVANT®, with and without rHuPH20. This study is also
evaluating administration of the full dose of RYBREVANT®
on the first day.
About RYBREVANT®
RYBREVANT® (amivantamab-vmjw) received accelerated
approval by the U.S. Food and Drug Administration (FDA) in
May 2021 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.8 This indication is approved under
accelerated approval based on overall response rate and duration of
response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the
confirmatory trials. RYBREVANT® has also received
approval from health authorities in Europe, as well as other markets around the
world.
The NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for Non-Small Cell Lung
Cancer◊ prefer NGS-based strategies over PCR-based
approaches for the detection of EGFR exon 20 insertion variants and
include amivantamab-vmjw (RYBREVANT®) as a subsequent
therapy option with a 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.9†^
RYBREVANT® is being studied in multiple clinical
trials in NSCLC, including:
- As first-line therapy in 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 untreated advanced EGFR-mutated
NSCLC.10
- The Phase 3 MARIPOSA-2 (NCT04988295) study assessing the
efficacy of RYBREVANT® (with or without lazertinib) and
carboplatin-pemetrexed versus carboplatin-pemetrexed in patients
with locally advanced or metastatic EGFR ex19del or exon 21 L858R
substitution NSCLC after osimertinib failure.11
- The Phase 1 CHRYSALIS (NCT02609776) study evaluating
RYBREVANT® in participants with advanced
NSCLC.4
- 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.5
- The Phase 3 PAPILLON (NCT04538664) study assessing
RYBREVANT® in combination with carboplatin-pemetrexed
versus chemotherapy alone in patients with advanced or metastatic
EGFR-mutated NSCLC and exon 20 insertion
mutations.12
- The Phase 1 PALOMA (NCT04606381) study assessing the
feasibility of subcutaneous (SC) administration of
RYBREVANT® based on safety and pharmacokinetics and to
determine a dose, dose regimen and formulation for
RYBREVANT® SC delivery.7
- The Phase 2 PALOMA-2 (NCT05498428) study assessing subcutaneous
RYBREVANT® in participants with advanced or metastatic
solid tumors including EGFR-mutated NSCLC.13
- The Phase 3 PALOMA-3 (NCT05388669) study assessing lazertinib
with subcutaneous RYBREVANT® as compared to intravenous
RYBREVANT® in participants with EGFR-mutated advanced or
metastatic NSCLC.14
- The Phase 1/2 METalmark (NCT05488314) study assessing
RYBREVANT® and capmatinib combination therapy in
unresectable metastatic NSCLC.15
For more information, visit: https://www.RYBREVANT.com.
About Lazertinib
Lazertinib is an oral, third-generation, brain-penetrant EGFR
TKI that targets both the T790M mutation and activating EGFR
mutations while sparing wild type-EGFR. Integrated analysis of
the efficacy and safety of lazertinib from the Phase 1/2 study were
published in The Journal of Thoracic Oncology in
2022.16 In 2018, Janssen Biotech, Inc. entered into a
license and collaboration agreement with Yuhan Corporation for the
development of lazertinib.
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.17,18 The main subtypes of NSCLC are
adenocarcinoma, squamous cell carcinoma and large cell
carcinoma.19 Among the most common driver mutations in
NSCLC are alterations in EGFR, which is a receptor tyrosine
kinase supporting cell growth and division.20 EGFR
mutations are present in 10 to 15 percent of people with NSCLC
adenocarcinoma and occur in 40 to 50 percent of
Asians.19-25 EGFR ex19del or EGFR L858R mutations are
the most common EGFR mutations.26 The five-year survival
rate for all people with advanced NSCLC and EGFR mutations treated
with EGFR TKIs is less than 20 percent.27,28
RYBREVANT® IMPORTANT SAFETY
INFORMATION8
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.
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. 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. 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®.
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.
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 final dose of
RYBREVANT®.
Adverse Reactions
The most common adverse reactions (≥20%) were rash, IRR,
paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema,
stomatitis, cough, constipation, and vomiting. The most common
Grade 3 or 4 laboratory abnormalities (≥2%) were decreased
lymphocytes, decreased albumin, decreased phosphate, decreased
potassium, increased alkaline phosphatase, increased glucose,
increased gamma-glutamyl transferase, and decreased
sodium.
Please read full Prescribing Information for
RYBREVANT®.
About the Janssen Pharmaceutical Companies of Johnson &
Johnson
At Janssen, we're creating a future where disease is a thing of
the past. We're the Pharmaceutical Companies of Johnson &
Johnson, working tirelessly to make that future a reality for
patients everywhere by fighting sickness with science, improving
access with ingenuity, and healing hopelessness with heart. We
focus on areas of medicine where we can make the biggest
difference: Cardiovascular, Metabolism & Retina; Immunology;
Infectious Diseases & Vaccines; Neuroscience; Oncology; and
Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at @JanssenGlobal
and @JanssenUS. Janssen Research & Development, LLC and
Janssen Biotech, Inc. belong to the Janssen Pharmaceutical
Companies of Johnson & Johnson.
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 and RYBREVANT® SC. 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 and
Development, LLC, Janssen Biotech, Inc., any of the
other Janssen Pharmaceutical Companies and/or 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 and
Development, LLC, Janssen Biotech, Inc., the Janssen Pharmaceutical
Companies nor Johnson & Johnson undertakes to update any
forward-looking statement as a result of new information or future
events or developments.
*In 2018, Janssen Biotech, Inc. entered into a
license and collaboration agreement with Yuhan Corporation for the
development of lazertinib.
**Dr. Lee has served as a consultant to the Janssen
Pharmaceutical Companies; he has not been paid for any media
work.
♦RECIST (version 1.1) 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 representations or warranties and explicitly disclaims the
appropriateness or applicability of the NCCN Content to any
specific patient's care or treatment.
†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.
_____________________
1 Lee S, et al. Amivantamab and lazertinib in
treatment-naïve EGFR-mutated advanced non-small cell lung cancer
(NSCLC): Long-term follow-up and ctDNA results from CHRYSALIS. 2023
American Society for Clinical Oncology Annual Meeting. June 4, 2023.
2 Besse B, et al. Predictive biomarkers for treatment
with amivantamab plus lazertinib among EGFR-mutated NSCLC in the
post-osimertinib setting: Analysis of tissue IHC and ctDNA NGS.
2023 American Society for Clinical Oncology Annual Meeting.
June 2, 2023.
3 Minchom A, et al. Subcutaneous amivantamab (ami) in
patients (pts) with advanced solid malignancies: The PALOMA
study—Updated safety and identification of the recommended phase 2
dose. 2023 American Society for Clinical Oncology Annual Meeting.
June 4, 2023.
4 ClinicalTrials.gov. A Study of Amivantamab, a
Human Bispecific EGFR and cMet Antibody, in Participants With
Advanced Non-Small Cell Lung Cancer (CHRYSALIS). Available at:
https://clinicaltrials.gov/ct2/show/NCT02609776. Accessed
May 2023.
5 ClinicalTrials.gov. A Study of Lazertinib as
Monotherapy or in Combination With Amivantamab in Participants With
Advanced Non-small Cell Lung Cancer (CHRYSALIS-2). Available at:
https://clinicaltrials.gov/ct2/show/NCT04077463. Accessed
May 2023.
6 NCI Dictionary of Cancer Terms. (n.d.). National
Cancer Institute.
https://www.cancer.gov/publications/dictionaries/cancer-terms/def/immunohistochemistry
7 ClinicalTrials.gov. A Study of Amivantamab
Subcutaneous (SC) Administration for the Treatment of Advanced
Solid Malignancies (PALOMA). Available at:
https://clinicaltrials.gov/ct2/show/NCT04606381. Accessed
May 2023.
8 RYBREVANT® Prescribing Information.
Horsham, PA: Janssen Biotech,
Inc.
9 Referenced with permission from the NCCN
Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for
Non-Small Cell Lung Cancer V.3.2022. © National Comprehensive
Cancer Network, Inc. 2022. All rights reserved. Accessed March
22, 2023. To view the most recent and complete version of the
guideline, go online to NCCN.org.
10 ClinicalTrials.gov. A Study of Amivantamab
and Lazertinib Combination Therapy Versus Osimertinib in
Locally
Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA).
Available at: https://clinicaltrials.gov/ct2/show/NCT04487080.
Accessed May 2023.
11 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). Available at:
https://clinicaltrials.gov/ct2/show/NCT04988295. Accessed
May 2023.
12 ClinicalTrials.gov. A Study of Combination
Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With
Carboplatin-Pemetrexed, in Participants With Advanced or
Metastatic Non-Small Cell Lung Cancer Characterized by
Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
(PAPILLON). Available at:
https://clinicaltrials.gov/ct2/show/NCT04538664. Accessed
May 2023.
13 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 (PALOMA-2). Available at:
https://clinicaltrials.gov/ct2/show/NCT05498428. Accessed
May 2023.
14 ClinicalTrials.gov. A Study of Lazertinib
With Subcutaneous Amivantamab Compared With Intravenous Amivantamab
in Participants With Epidermal Growth Factor Receptor
(EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
(PALOMA-3). Available at:
https://clinicaltrials.gov/ct2/show/NCT05388669. Accessed
May 2023.
15 ClinicalTrials.gov. A Study of Amivantamab and
Capmatinib Combination Therapy in Unresectable Metastatic Non-small
Cell Lung Cancer (METalmark). Available at:
https://clinicaltrials.gov/ct2/show/NCT05488314. Accessed
May 2023.
16 Cho BC, et al. A Phase 1/2 Study of
Lazertinib 240 mg in Patients With Advanced EGFR T790M-Positive
NSCLC After Previous EGFR Tyrosine Kinase Inhibitors. J Thorac
Oncol. 2022 Apr;17(4):558-567. doi: 10.1016/j.jtho.2021.11.025.
Epub 2021 Dec 24. Erratum in: J Thorac Oncol. 2022 Oct 22;:
PMID: 34958928.
17 The World Health Organization. Cancer.
https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed
May 2023.
18 American Cancer Society. What is Lung Cancer?
https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html.
Accessed May 2023.
19 Oxnard JR, et al. Natural history and molecular
characteristics of lung cancers harboring EGFR exon 20 insertions.
J Thorac Oncol. 2013 Feb;8(2):179-84. doi:
10.1097/JTO.0b013e3182779d18.
20 Bauml JM, et al. Underdiagnosis of EGFR Exon 20
Insertion Mutation Variants: Estimates from NGS-based Real World
Datasets. WCLC Poster #3399. January
2021.
21 Riess JW, et al. Diverse EGFR exon 20
insertions and co-occurring molecular alterations identified by
comprehensive genomic profiling of NSCLC. J Thorac Oncol.
2018;13(10):1560-1568. doi:10.1016/j.jtho.2018.06.019
22 Pennell NA, et al. A phase II trial pf
adjuvant erlotinib in patients with resected epidermal growth
factor receptor-mutant non-small cell lung cancer. J Clin
Oncol. 37:97-104.
23 Burnett H, et al. Epidemiological and clinical
burden of EGFR exon 20 insertion in advanced non-small cell lung
cancer: a systematic literature review. Abstract presented at:
World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
24 Zhang YL, et al. The prevalence of EGFR
mutation in patients with non-small cell lung cancer: a systematic
review and meta-analysis. Oncotarget.
2016;7(48):78985-78993
25 Midha A, et al. EGFR mutation incidence in
non-small-cell lung cancer of adenocarcinoma histology: a
systematic review and global map by ethnicity. Am J Cancer
Res. 2015;5(9):2892-2911
26 American Lung Association. EGFR and Lung
Cancer.
https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr.
Accessed May 2023.
27 Howlader N, et al. SEER Cancer Statistics
Review, 1975-2016, National Cancer Institute. Bethesda, MD,
https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the
SEER web site.
28 Lin JJ, et al. Five-Year Survival in
EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs.
J Thorac Oncol. 2016 Apr;11(4):556-65.
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SOURCE Janssen Pharmaceutical Companies of Johnson &
Johnson