Application based on Phase 3 PALOMA-3 results showing
five-fold reduction in infusion-related reactions with five-minute
administration of subcutaneous amivantamab
Longer overall survival, progression-free survival and
duration of response also observed with subcutaneous
amivantamab
RARATIN, N.J., June 17,
2024 /PRNewswire/ -- Johnson & Johnson
(NYSE: JNJ) announced today the submission of a Biologics
License Application (BLA) to the U.S. Food and Drug Administration
(FDA) for a fixed combination of amivantamab and recombinant human
hyaluronidase for subcutaneous administration (SC amivantamab) for
all currently approved or submitted indications of intravenous (IV)
RYBREVANT® (amivantamab-vmjw) in certain patients with
non-small cell lung cancer (NSCLC).
Data from the Phase 3 PALOMA-3 study (NCT05388669) presented at
the 2024 American Society of Clinical Oncology (ASCO) Annual
Meeting and published in the Journal of Clinical Oncology
showed SC amivantamab had comparable overall response rates to IV
administration in patients with NSCLC with epidermal growth factor
receptor (EGFR) exon 19 deletion or L858R mutations. SC amivantamab
also demonstrated significantly shorter administration time and a
five-fold reduction in infusion-related reactions, alongside longer
overall survival, progression-free survival and duration of
response.1 Efficacy results like these have not been
seen before in a study assessing IV and SC comparability. The BLA
submission includes data from the Phase 2 PALOMA-2 (NCT05498428)
study evaluating SC amivantamab in settings where IV amivantamab
has been previously submitted for approval and is intended to
support dosing schedules of every two and every three
weeks.2
"RYBREVANT administered intravenously is a foundational
treatment for patients with EGFR-mutated NSCLC," said Kiran Patel, M.D., Vice President, Clinical
Development, Solid Tumors, Johnson & Johnson Innovative
Medicine. "This subcutaneous option, administered in approximately
five minutes, is a clinically important advancement that could
transform the treatment experience for patients, oncologists and
nursing staff. We look forward to working with the FDA and global
regulators in the review of these applications."
Today's submission follows two recent milestones for the
RYBREVANT® IV formulation, including the
approval of RYBREVANT® in combination with
chemotherapy as the first FDA-approved therapy for first-line
treatment of patients with NSCLC with EGFR exon 20 insertion
mutations supported by the Phase 3 PAPILLON study and a
CHMP positive opinion for RYBREVANT® in combination
with chemotherapy for this indication in Europe.
About PALOMA-3
PALOMA-3 (NCT05388669), which enrolled 418 patients, is a
randomized, open-label Phase 3 study evaluating the
pharmacokinetics (PK), efficacy and safety of subcutaneous
amivantamab (administered via manual injection) combined with
lazertinib compared to IV amivantamab and lazertinib in patients
with EGFR-mutated advanced or metastatic NSCLC after progression on
osimertinib and chemotherapy. The co-primary PK endpoints of the
study were trough concentration (Ctrough on Cycle [C] 2 Day [D] 1
or C4D1) and C2 area under the curve (AUCD1-D15). Key secondary
endpoints were objective response rate and progression-free
survival. Overall survival was a predefined exploratory endpoint.
Prophylactic anticoagulation was recommended for the first four
months of treatment.1
About the PALOMA-2 Study
PALOMA-2 (NCT05498428) is an open-label Phase 2 study evaluating
the efficacy, safety, and PK of first-line SC amivantamab
(administered via manual injection) combined with lazertinib and/or
chemotherapy in patients with EGFR-mutated advanced or metastatic
NSCLC. Sixty-eight and 58 patients were enrolled in Cohorts 1 and
6, respectively. Prophylactic anticoagulation for the first four
months of treatment was recommended in Cohort 1 and mandatory in
Cohort 6. The primary endpoint was objective response rate (ORR) as
assessed by the investigator per RECIST v1.1.2
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.3 In the subcutaneous formulation,
amivantamab is co-formulated with recombinant human hyaluronidase
PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery
technology.
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 a supplemental Biologics License
Application (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 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.4 †‡
- Amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a
preferred (Category 1 recommendation) subsequent therapy for
patients with locally advanced or metastatic NCSLC with EGFR exon
19 deletions or exon 21 L858R mutations who experienced disease
progression after treatment with
osimertinib.4 †‡
- 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.4 †‡
RYBREVANT® is being studied in multiple clinical
trials in NSCLC, including:
- The Phase 1 PALOMA (NCT04606381) study assessing the
feasibility of subcutaneous administration of amivantamab based on
safety and pharmacokinetics and to determine a dose, dose regimen
and formulation for amivantamab subcutaneous delivery.5
- The Phase 2 PALOMA-2 (NCT05498428) study assessing subcutaneous
amivantamab in patients with advanced or metastatic solid tumors
including EGFR-mutated NSCLC.2
- The Phase 3 PALOMA-3 (NCT05388669) study assessing lazertinib
with subcutaneous amivantamab compared to intravenous amivantamab
in patients with EGFR-mutated advanced or metastatic
NSCLC.1
- The Phase 3 PAPILLON (NCT04538664) study assessing
RYBREVANT® in combination with
carboplatin-pemetrexed versus chemotherapy alone in the first-line
treatment of patients with advanced or metastatic NSCLC with EGFR
exon 20 insertion mutations.6
- The Phase 3 MARIPOSA-2 (NCT04988295) study assessing the
efficacy of RYBREVANT® (with or without lazertinib)
and carboplatin-pemetrexed versus carboplatin-pemetrexed alone in
patients with locally advanced or metastatic EGFR ex19del or L858R
substitution NSCLC after disease progression on or after
osimertinib.7
- The Phase 3 MARIPOSA (NCT04487080) study assessing
RYBREVANT® in combination with lazertinib versus
osimertinib and versus lazertinib alone in the first-line treatment
of patients with locally advanced or metastatic NSCLC with EGFR
ex19del or L858R substitution mutations.8
- The Phase 1 CHRYSALIS (NCT02609776) study evaluating
RYBREVANT® in patients with advanced
NSCLC.9
- 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.10
- The Phase 1/2 METalmark (NCT05488314) study assessing
RYBREVANT® and capmatinib combination therapy in
locally advanced or metastatic NSCLC.11
- The Phase 1/2 PolyDamas (NCT05908734) study assessing
RYBREVANT® and cetrelimab combination therapy in
locally advanced or metastatic NSCLC.12
- 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.13
For more information,
visit: https://www.RYBREVANT.com.
About Lazertinib
Lazertinib is an oral, third-generation, brain-penetrant EGFR
tyrosine kinase inhibitor (TKI) that targets both the T790M
mutation and activating EGFR mutations while sparing wild
type-EGFR. An analysis of the efficacy and safety of lazertinib
from the Phase 3 study was published in The Journal of Clinical
Oncology in 2023. In 2018, Janssen Biotech, Inc., entered into a
license and collaboration agreement with Yuhan Corporation for the
development of lazertinib.14
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.15,16 The main subtypes of NSCLC
are adenocarcinoma, squamous cell carcinoma, and large cell
carcinoma.17 Among the most common driver mutations
in NSCLC are alterations in EGFR, which is a receptor tyrosine
kinase controlling cell growth and division.18 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.17, 18, 19, 20, 21,
22 EGFR ex19del or EGFR L858R mutations are the most
common EGFR mutations.23 The five year survival
rate for all people with advanced NSCLC and EGFR mutations treated
with EGFR tyrosine kinase inhibitors (TKIs) is less than 20
percent.24, 25 EGFR exon 20 insertion
mutations are the third most prevalent activating EGFR
mutation.26 Patients with EGFR exon 20 insertion
mutations have a real-world five-year overall survival (OS) of
eight percent in the frontline setting, which is worse than
patients with EGFR ex19del or L858R mutations, who have a
real-world five-year OS of 19 percent.27
RYBREVANT® IMPORTANT SAFETY
INFORMATION3
WARNINGS AND PRECAUTIONS
The safety population of RYBREVANT® with carboplatin
and pemetrexed described in Warnings and Precautions was based on
151 patients in the PAPILLON study.
The safety population of RYBREVANT® as a single agent
described in Warnings and Precautions was based on 129 patients in
the CHRYSALIS study.
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® as a single agent. 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 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 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/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; manufacturing
difficulties and delays; competition, including technological
advances, new products and patents attained by competitors;
challenges to patents; product efficacy or safety concerns
resulting in product recalls or regulatory action; 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 Research
& Development, LLC, Janssen Biotech, Inc. nor Johnson &
Johnson undertakes to update any forward-looking statement as a
result of new information or future events or developments.
†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.
§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.
1 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).
https://clinicaltrials.gov/ct2/show/NCT05388669. Accessed
May 2024.
2 ClinicalTrials.gov. A Study of Amivantamab in
Participants With Advanced or Metastatic Solid Tumors Including
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3 RYBREVANT® Prescribing
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4 Referenced with permission from the NCCN Clinical
Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small
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Inc. All rights reserved. To view the most recent and complete
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https://clinicaltrials.gov/ct2/show/NCT04077463. Accessed
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https://clinicaltrials.gov/ct2/show/NCT05488314. Accessed
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in patients with non-small cell lung cancer: a systematic review
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24 Howlader N, et al. SEER Cancer Statistics
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