Phase 3 PAPILLON study showed RYBREVANT® in
combination with carboplatin and pemetrexed significantly
improved progression-free survival, reducing the risk of disease
progression or death by 60 per cent versus carboplatin and
pemetrexed alone in patients with previously untreated NSCLC with
EGFR exon 20 insertion mutations.1
TORONTO, July 3, 2024
/CNW/ - Johnson & Johnson (NYSE: JNJ) announced today that
Health Canada, through a Priority Review, has issued a Notice of
Compliance (NOC) for RYBREVANT® (amivantamab) in
combination with platinum-based chemotherapy (carboplatin and
pemetrexed) for the first-line treatment of adult patients with
locally advanced (not amenable to curative therapy) or metastatic
non-small cell lung cancer (NSCLC) with activating epidermal growth
factor receptor (EGFR) Exon 20 insertion
mutations.1
![(CNW Group/Janssen Inc.) (CNW Group/Janssen Inc.)](https://mma.prnewswire.com/media/2453068/Janssen_Inc__Health_Canada_Authorizes_RYBREVANT_%C2%A0_amivantamab__i.jpg)
"Patients with EGFR Exon 20 mutated non-small cell lung
cancer face an aggressive disease with a worse prognosis than those
with other EGFR mutations. There is a significant unmet need
to improve the effectiveness of treatment for patients with this
type of lung cancer," says Dr. Susanna
Cheng*, Medical Oncologist, Sunnybrook Health Sciences
Centre. "The approval of novel targeted therapies like
RYBREVANT® can bring hope for improved outcomes and
quality of life for patients with this rare mutation. The data from
the PAPILLON study supports the use of this regimen as the
standard-of-care in the first-line treatment of patients with NSCLC
harbouring EGFR Exon 20 insertion mutations."
"The treatment of lung cancer has been strongly influenced by an
improved understanding of the underlying biology behind this
disease. Understanding the mechanism of action of certain genetic
alterations such as EGFR mutations has allowed exciting new
anti-cancer therapies to improve survival in patients touched with
these diseases. However, there are still significant treatment gaps
to bridge, in particular, in relation to EGFR Exon 20
insertion mutations," says Dr. Kevin
Jao**, Medical Oncologist, Hôpital du
Sacré-Cœur-de-Montréal. "The emergence of a first line combination
therapy with amivantamab and chemotherapy represents a particularly
exciting breakthrough for patients diagnosed with this difficult
genetic alteration. This represents the first truly meaningful
therapy in this setting that gives patients diagnosed with NSCLC
with EGFR Exon 20 insertion mutations new hope for a meaningful
outcome."
In Canada, lung cancer is the
most commonly diagnosed cancer, with an estimated 31,000 new cases
in 2023.2 It is also responsible for 24 per cent of all
cancer deaths among Canadians.2 An estimated 15 per cent
of Canadians with non-squamous NSCLC have an activating EGFR
mutation.3 The frequency of EGFR mutations is
even greater in patients of Asian descent (~39 per cent) and in
Asia-Pacific countries (~47 per
cent).4,5 Those with the third most prevalent
variant, EGFR Exon 20 insertion mutations, tend to have a
worse prognosis and shorter survival rates compared with
individuals with more common EGFR
mutations.6,7,8 In fact, patients newly diagnosed
with locally advanced or metastatic NSCLC with EGFR Exon 20
insertion mutations have a real-world median overall survival (OS)
of 16.2 months, about nine months less than those with the more
common EGFR Exon 19 deletions/L858R mutations (25.5
months).9
"The approval of RYBREVANT® offers a promising
and urgently needed new first-line treatment option and represents
significant advancement for those battling this rare mutation,"
says Nina Devito***, Co-chair,
Exon20 group-Canada. "The positive
study results underscore the importance of ongoing research and
innovation in the fight against lung cancer, bringing new
possibilities and renewed hope to patients and their loved
ones."
The Health Canada NOC is based on results from the Phase 3,
randomized, open-label, multicenter PAPILLON study.1 The
study compared treatment with RYBREVANT® in
combination with platinum-based chemotherapy to treatment with
platinum-based chemotherapy alone in patients with treatment-naïve,
locally advanced or metastatic NSCLC with EGFR Exon 20
insertion mutations, as identified by local testing.1 A
total of 308 patients were randomized (1:1) to receive
RYBREVANT® in combination with platinum-based
chemotherapy (N=153) or platinum-based chemotherapy alone
(N=155).1 The results
demonstrated RYBREVANT® in combination
with platinum-based chemotherapy provides a clinically meaningful
and statistically significant improvement in progression-free
survival (PFS) and a 60 per cent reduction in the risk of disease
progression or death compared to platinum-based chemotherapy
alone.1
Among 151 patients who received RYBREVANT® in
combination with platinum-based chemotherapy, the median duration
of treatment was 9.7 months (range: 0.1 to 26.9 months), with 76%
were exposed for 6 months or longer and 38% were exposed for
greater than one year.1 Serious adverse events occurred
in 37.1 per cent of patients who received RYBREVANT® in
combination with platinum-based chemotherapy.1 Fatal
adverse events, irrespective of relatedness to treatment, occurred
in 7 patients (4.6 per cent) who received RYBREVANT® in
combination with platinum-based chemotherapy.1 The most
common treatment-emergent adverse events (≥ 20 per cent) were rash,
neutropenia, paronychia, anaemia, stomatitis, infusion-related
reactions, hypoalbuminaemia, edema, constipation, leukopenia,
nausea, thrombocytopenia, decreased appetite, fatigue, alanine
aminotransferase (ALT) increased, aspartate aminotransferase (AST)
increased, COVID-19, hypokalaemia, vomiting, and
diarrhea.1 The most common Grade 3 to 4 laboratory
abnormalities (≥ 2 per cent) were decreased albumin, increased ALT,
increased gamma-glutamyltransferase, decreased sodium, decreased
potassium, decreased magnesium and decreases in white blood cells,
hemoglobin, neutrophils, platelets, and
lymphocytes.1
"This approval reinforces our commitment to developing novel
therapies, particularly for underserved patient populations with
significant unmet needs," says Berkeley Vincent, President,
Janssen Inc., a Johnson &
Johnson Company. "With RYBREVANT® in combination with
carboplatin and pemetrexed, we are redefining care for patients
with newly diagnosed NSCLC with EGFR exon 20 insertion
mutations by offering a targeted treatment that may delay
progression of their disease versus carboplatin and pemetrexed
alone. This milestone takes us one step closer to our aim of
getting in front of cancer."
About RYBREVANT®
RYBREVANT® is a fully-human EGFR-MET
bispecific antibody that acts by targeting tumours with activating
and resistance EGFR mutations and MET mutations and
amplifications, and by harnessing the immune system.1 It
binds extracellularly, or to the outside of the cell, slowing or
inhibiting tumour growth and leading to tumour cell
death.1 RYBREVANT®, indicated as a
monotherapy for the treatment of adult patients with locally
advanced or metastatic NSCLC with activating EGFR Exon 20
insertion mutations whose disease has progressed on or after
platinum-based chemotherapy, has been issued a marketing
authorization with conditions.1
RYBREVANT®, indicated in combination with
platinum-based chemotherapy (carboplatin and pemetrexed) for the
first-line treatment of adult patients with locally advanced (not
amenable to curative therapy) or metastatic NSCLC with activating
EGFR Exon 20 insertion mutations, has been issued a market
authorization without conditions.1 A validated test is
required to identify EGFR Exon 20 insertions
mutation-positive status prior to treatment.1
About the PAPILLON Study
PAPILLON (NCT04538664) is a Phase 3 randomized, open-label study
evaluating the efficacy and safety of RYBREVANT® in
combination with platinum-based chemotherapy (carboplatin and
pemetrexed), compared with platinum-based 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 overall response rate
(ORR) and overall survival (OS). Patients who received
platinum-based chemotherapy alone were allowed to receive
RYBREVANT® monotherapy in the second-line setting after
confirmation of disease progression.10
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 and
https://www.janssen.com/canada. Follow us at
@JNJInnovMedCAN.
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). 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 Inc. 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 December 31, 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 Inc. nor Johnson & Johnson undertakes to update any
forward-looking statement as a result of new information or future
events or developments.
* Dr. Susanna Cheng was not
compensated for this media work. She has been compensated
previously by J&J for other professional engagements.
** Dr. Kevin Jao was not
compensated for this media work. He has been compensated previously
by J&J for other professional engagements.
*** Nina Devito was not
compensated for this media work. Exon20 group-Canada has been compensated previously by
J&J for other professional engagements.
© Janssen Inc. 2024. All rights reserved.
_____________________________________
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RYBREVANT® Product
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2023 Faces of Lung
Cancer Report. Lung Cancer Canada. p.11.
https://www.lungcancercanada.ca/getattachment/Resources/Faces-of-Lung-Cancer-Reports/LCC1010ENG_FOLCR_Report_2023_v8-digital.pdf.aspx
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Cheema PK, Gomes M,
Banerji S, et al. Consensus recommendations for optimizing
biomarker testing to identify and treat advanced EGFR-mutated
non-small-cell lung cancer. Curr Oncol. 2020;27(6):321-329.
doi:10.3747/co.27.7297
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KF, et al. The prevalence of EGFR mutation in patients with
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Oncotarget. 2016;7(48):78985-78993.
doi:10.18632/oncotarget.12587
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of adenocarcinoma histology: a systematic review and global map by
ethnicity (mutMapII). Am J Cancer Res. 2015;5(9):2892-2911.
Published 2015 Aug 15.
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Arcila ME, Nafa K,
Chaft JE, et al. EGFR exon 20 insertion mutations in lung
adenocarcinomas: prevalence, molecular heterogeneity, and
clinicopathologic characteristics. Mol Cancer Ther.
2013;12(2):220-229. doi:10.1158/1535-7163.MCT-12-0620
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Oxnard GR, Lo PC,
Nishino M, et al. Natural history and molecular characteristics of
lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol.
2013;8(2):179-184. doi:10.1097/JTO.0b013e3182779d18
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Vyse S, Huang PH.
Targeting EGFR exon 20 insertion mutations in non-small cell lung
cancer. Signal Transduct Target Ther. 2019;4:5. Published 2019 Mar
8. doi:10.1038/s41392-019-0038-9
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Bazhenova L, Minchom A,
Viteri S, et al. Comparative clinical outcomes for patients with
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common EGFR mutations. Lung Cancer. 2021;162:154-161.
doi:10.1016/j.lungcan.2021.10.020
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ClinicalTrials.gov. A
Study of Combination Amivantamab and Carboplatin-Pemetrexed
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Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by
Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
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SOURCE Janssen Inc.