New longer-term knowledge from the
Outcomes from an interim evaluation featured in late-breaker oral presentation at WCLC
At three years (a median follow-up of 31.1 months), 61 p.c of sufferers receiving RYBREVANT ® plus LACLUZE™ had been alive in comparison with 53 p.c of these handled with osimertinib based mostly on an evaluation carried out on the request of a well being authority (Median OS not estimable vs 37.3 months; hazard ratio [HR], 0.77; [95 percent confidence interval [CI], 0.61-0.96]; nominal P=0.019). General survival will proceed to be assessed with long run follow-up as a key secondary endpoint. The first efficacy consequence measure was progression-free survival (PFS) as assessed by blinded unbiased central evaluation (BICR).1
“By combining the multi-targeted mechanism of RYBREVANT with LAZCLUZE, a central nervous system-penetrant third-generation tyrosine kinase inhibitor, we are advancing a chemotherapy-free regimen for the first-line treatment of patients with EGFR-mutant NSCLC. This approach blocks EGFR and MET pathways and leverages the immune system, offering patients an opportunity for prolonged benefits,” stated Shirish M. Gadgeel, M.D., Chief of Division of Hematology and Oncology, Affiliate Director at Henry Ford (NYSE:) Most cancers Institute and presenting creator. “Even more encouraging is the marked improvement in the hazard ratio and the ongoing separation of survival curves, showing an eight percent improvement at three years for RYBREVANT plus LAZCLUZE compared to osimertinib. This supports the long-term benefit of the combination as a first-line treatment option in this setting.”
Outcomes additional confirmed RYBREVANT ® plus LAZCLUZE™ demonstrated a pattern towards improved central nervous system illness management in comparison with osimertinib at three years (HR, 0.82; [95 percent CI, 0.62-1.09]; nominal P=0.165). On the three-year landmark, intracranial PFS was double for RYBREVANT ® plus LAZCLUZE™ versus osimertinib (38 p.c vs 18 p.c, respectively). Extra sufferers remained on therapy at three years with the RYBREVANT ® mixture in comparison with osimertinib (40 p.c vs 29 p.c, respectively; HR, 0.80; [95 percent CI, 0.68-0.96]; nominal P=0.014). Moreover, extra sufferers receiving RYBREVANT ® and LAZCLUZE™ on the three-year follow-up had not began a subsequent remedy versus osimertinib (45 p.c vs 32 p.c, respectively; HR, 0.77; [95 percent CI, 0.65-0.93]; nominal P=0.005). Development-free survival after first subsequent remedy was 57 p.c for the RYBREVANT ® mixture in comparison with 49 p.c for osimertinib (HR, 0.73; [95 percent CI, 0.59-0.91]; nominal P=0.004).1
“Promising results like these presented at WCLC reinforce our mission to improve the lives of patients diagnosed with lung cancer,” stated
As beforehand reported within the
In
In regards to the
About RYBREVANT ®
RYBREVANT ® (amivantamab-vmjw), a fully-human bispecific antibody concentrating on EGFR and MET with immune cell-directing exercise, is accepted within the
RYBREVANT ® is accepted within the
RYBREVANT ® is accepted within the
In November 2023, Johnson & Johnson submitted a supplemental Biologics License Utility (sBLA) to the
In
The NCCN Medical Observe Tips in Oncology (NCCN Tips ®) for NSCLC § choose next-generation sequencing“based mostly methods over polymerase chain response“based mostly approaches for the detection of EGFR exon 20 insertion variants. The NCCN Tips embody:
- Amivantamab-vmjw (RYBREVANT ®) plus chemotherapy as a most popular (Class 1 most popular advice) subsequent remedy for sufferers with regionally superior or metastatic NCSLC with EGFR exon 19 deletions or exon 21 L858R mutations who skilled illness development after therapy with Osimertinib.5 ¡
- Amivantamab-vmjw (RYBREVANT ®) plus carboplatin and pemetrexed as a most popular (Class 1 most popular advice) first-line remedy in treatment-naive sufferers with newly recognized superior or metastatic EGFR exon 20 insertion mutation-positive superior NSCLC, or as a subsequent remedy possibility (Class 2A advice) for sufferers which have progressed on or after platinum-based chemotherapy with or with out immunotherapy and have EGFR exon 20 insertion mutation-positive superior NSCLC.5 ¡
- Amivantamab-vmjw (RYBREVANT ®) as a subsequent remedy possibility (Class 2A advice) for sufferers which have progressed on or after platinum-based chemotherapy with or with out an immunotherapy and have EGFR exon 20 insertion mutation-positive NSCLC.5 ¡
Along with the Part 3 MARIPOSA examine, RYBREVANT ® is being studied in a number of medical trials in NSCLC, together with:
- The Part 3 MARIPOSA-2 (NCT04988295) examine assessing the efficacy of RYBREVANT ® (with or with out LAZCLUZE™) and carboplatin-pemetrexed versus carboplatin-pemetrexed alone in sufferers with regionally superior or metastatic EGFR ex19del or L858R substitution NSCLC after illness development on or after osimertinib.6
- The Part 3 PAPILLON (NCT04538664) examine assessing RYBREVANT ® together with carboplatin-pemetrexed versus chemotherapy alone within the first-line therapy of sufferers with superior or metastatic NSCLC with EGFR exon 20 insertion mutations.7
- The Part 3 PALOMA-3 (NCT05388669) examine assessing LAZCLUZE™ with subcutaneous amivantamab in comparison with intravenous amivantamab in sufferers with EGFR-mutated superior or metastatic NSCLC.8
- The Part 2 PALOMA-2 (NCT05498428) examine assessing subcutaneous amivantamab in sufferers with superior or metastatic stable tumors together with EGFR-mutated NSCLC.9
- The Part 1 PALOMA (NCT04606381) examine assessing the feasibility of subcutaneous administration of amivantamab based mostly on security and pharmacokinetics and to find out a dose, dose routine and formulation for amivantamab subcutaneous supply.10
- The Part 1 CHRYSALIS (NCT02609776) examine evaluating RYBREVANT ® in sufferers with superior NSCLC.11
- The Part 1/1b CHRYSALIS-2 (NCT04077463) examine evaluating RYBREVANT ® together with LAZCLUZE™ and LAZCLUZE™ as a monotherapy in sufferers with superior NSCLC with EGFR.12
- The Part 1/2 METalmark (NCT05488314) examine assessing RYBREVANT ® and capmatinib mixture remedy in regionally superior or metastatic NSCLC.13
- The Part 1/2 PolyDamas (NCT05908734) examine assessing RYBREVANT ® and cetrelimab mixture remedy in regionally superior or metastatic NSCLC.14
- The Part 2 SKIPPirr examine (NCT05663866) exploring lower the incidence and/or severity of first-dose infusion-related reactions with RYBREVANT ® together with LAZCLUZE™ in relapsed or refractory EGFR-mutated superior or metastatic NSCLC.15
- The Part 1/2 swalloWTail (NCT06532032) examine assessing RYBREVANT ® and docetaxel mixture remedy in sufferers with metastatic NSCLC.16
- The Part 1b/2 OrigAMI-1 (NCT05379595) examine assessing RYBREVANT ® monotherapy and along with standard-of-care chemotherapy in sufferers with superior or metastatic colorectal most cancers.17
- The Part 1b/2 OrigAMI-4 (NCT06385080) examine assessing RYBREVANT ® monotherapy and along with standard-of-care therapeutic brokers in sufferers with recurrent/metastatic head and neck squamous cell carcinoma.18
For extra data, go to: https://www.RYBREVANT.com.
About LAZCLUZE™
In 2018, Janssen Biotech, Inc., entered right into a license and collaboration settlement with Yuhan Company for the event of LAZCLUZE™ (marketed as LACLAZA in
About Non-Small Cell Lung Most cancers
Worldwide, lung most cancers is among the commonest cancers, with NSCLC making up 80 to 85 p.c of all lung most cancers instances.19,20 The principle subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and huge cell carcinoma.21 Among the many commonest driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell development and division.22EGFR mutations are current in 10 to fifteen p.c of Western sufferers with NSCLC with adenocarcinoma histology and happen in 40 to 50 p.c of Asian sufferers.21,22,23,24,25,26EGFR ex19del or EGFR L858R mutations are the most typical EGFR mutations.27 The five- yr survival charge for all folks with superior NSCLC and EGFR mutations handled with EGFR tyrosine kinase inhibitors (TKIs) is lower than 20 p.c.28,29 EGFR exon 20 insertion mutations are the third most prevalent activating EGFR mutation.30 Sufferers with EGFR exon 20 insertion mutations have a real-world five-year total survival (OS) of eight p.c within the frontline setting, which is worse than sufferers with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 p.c.31
IMPORTANT SAFETY INFORMATION4,32
WARNINGS AND PRECAUTIONS
Infusion-Associated Reactions
RYBREVANT ® may cause infusion-related reactions (IRR); indicators and signs of IRR embody dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is roughly 1 hour.
RYBREVANT ® with LAZCLUZE™
RYBREVANT ® together with LAZCLUZE™ may cause infusion-related reactions. In
RYBREVANT ® with Carboplatin and Pemetrexed
In PAPILLON (n=151), infusion-related reactions occurred in 42% of sufferers handled with RYBREVANT ® together with carboplatin and pemetrexed, together with Grade 3 (1.3%) hostile reactions. The incidence of infusion modifications on account of IRR was 40%, and 0.7% of sufferers completely discontinued RYBREVANT ®.
RYBREVANT ® as a Single Agent
In CHRYSALIS (n=302), IRR occurred in 66% of sufferers handled with RYBREVANT ®. Amongst sufferers receiving therapy on Week 1 Day 1, 65% skilled an IRR, whereas 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% had been Grade 1-2, 2.2% had been Grade 3, and 0.4% had been Grade 4. The median time to onset was 1 hour (vary 0.1 to 18 hours) after begin of infusion. The incidence of infusion modifications on account of IRR was 62% and 1.3% of sufferers completely discontinued RYBREVANT ® on account of IRR.
Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT ® as advisable. Administer RYBREVANT ® by way of a peripheral line on Week 1 and Week 2 to cut back the chance of infusion-related reactions. Monitor sufferers for indicators and signs of infusion reactions throughout RYBREVANT ® infusion in a setting the place cardiopulmonary resuscitation treatment and gear can be found. Interrupt infusion if IRR is suspected. Scale back the infusion charge or completely discontinue RYBREVANT ® based mostly on severity.
Interstitial Lung Illness/Pneumonitis
RYBREVANT ® may cause extreme and deadly interstitial lung illness (ILD)/pneumonitis.
RYBREVANT ® with LAZCLUZE™
In
RYBREVANT ® with Carboplatin and Pemetrexed
In PAPILLON, Grade 3 ILD/pneumonitis occurred in 2.6% of sufferers handled with RYBREVANT ® together with carboplatin and pemetrexed, all sufferers required everlasting discontinuation.
RYBREVANT ® as a Single Agent
In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of sufferers handled with RYBREVANT ®, with 0.7% of sufferers experiencing Grade 3 ILD/pneumonitis. Three sufferers (1%) discontinued RYBREVANT ® on account of ILD/pneumonitis.
Monitor sufferers for brand spanking new or worsening signs indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). For sufferers receiving RYBREVANT ® together with LAZCLUZE™, instantly withhold each medicine in sufferers with suspected ILD/pneumonitis and completely discontinue if ILD/pneumonitis is confirmed. For sufferers receiving RYBREVANT ® as a single agent or together with carboplatin and pemetrexed, instantly withhold RYBREVANT ® in sufferers with suspected ILD/pneumonitis and completely discontinue if ILD/pneumonitis is confirmed.
Venous Thromboembolic (VTE) Occasions with Concomitant Use of RYBREVANT ® and LAZCLUZE™
RYBREVANT ® together with LAZCLUZE™ may cause severe and deadly venous thromboembolic (VTEs) occasions, together with deep vein thrombosis and pulmonary embolism. Nearly all of these occasions occurred throughout the first 4 months of remedy.
In
Administer prophylactic anticoagulation for the primary 4 months of therapy. The usage of Vitamin Ok antagonists shouldn’t be advisable. Monitor for indicators and signs of VTE occasions and deal with as medically applicable.
Withhold RYBREVANT ® and LAZCLUZE™ based mostly on severity. As soon as anticoagulant therapy has been initiated, resume RYBREVANT ® and LAZCLUZE™ on the similar dose degree on the discretion of the healthcare supplier. Within the occasion of VTE recurrence regardless of therapeutic anticoagulation, completely discontinue RYBREVANT ® and proceed therapy with LAZCLUZE™ on the similar dose degree on the discretion of the healthcare supplier.
Dermatologic Opposed Reactions
RYBREVANT ® may cause extreme rash together with poisonous epidermal necrolysis (TEN), dermatitis acneiform, pruritus, and dry pores and skin.
RYBREVANT ® with LAZCLUZE™
In
RYBREVANT ® with Carboplatin and Pemetrexed
In PAPILLON, rash occurred in 89% of sufferers handled with RYBREVANT ® together with carboplatin and pemetrexed, together with Grade 3 (19%) hostile reactions. Rash resulting in dose reductions occurred in 19% of sufferers, and a pair of% completely discontinued RYBREVANT ® and 1.3% discontinued pemetrexed.
RYBREVANT ® as a Single Agent
In CHRYSALIS, rash occurred in 74% of sufferers handled with RYBREVANT ® as a single agent, together with Grade 3 rash in 3.3% of sufferers. The median time to onset of rash was 14 days (vary: 1 to 276 days). Rash resulting in dose discount occurred in 5% of sufferers, and RYBREVANT ® was completely discontinued on account of rash in 0.7% of sufferers.
Poisonous epidermal necrolysis occurred in a single affected person (0.3%) handled with RYBREVANT ® as a single agent.
Instruct sufferers to restrict solar publicity throughout and for two months after therapy with RYBREVANT ® or LAZCLUZE™ together with RYBREVANT ®. Advise sufferers to put on protecting clothes and use broad-spectrum UVA/UVB sunscreen. Alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream is advisable for dry pores and skin.
When initiating RYBREVANT ® therapy with or with out LAZCLUZE™, administer alcohol-free emollient cream to cut back the chance of dermatologic hostile reactions. Contemplate prophylactic measures (e.g. use of oral antibiotics) to cut back the chance of dermatologic reactions. If pores and skin reactions develop, begin topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and contemplate dermatologic session. Promptly refer sufferers presenting with extreme rash, atypical look or distribution, or lack of enchancment inside 2 weeks to a dermatologist. For sufferers receiving RYBREVANT ® together with LAZCLUZE™, withhold, dose cut back or completely discontinue each medicine based mostly on severity. For sufferers receiving RYBREVANT ® as a single agent or together with carboplatin and pemetrexed, withhold, dose cut back or completely discontinue RYBREVANT ® based mostly on severity.
Ocular Toxicity
RYBREVANT ® may cause ocular toxicity together with keratitis, blepharitis, dry eye signs, conjunctival redness, blurred imaginative and prescient, visible impairment, ocular itching, eye pruritus, and uveitis.
RYBREVANT ® with LAZCLUZE™
In
RYBREVANT ® with Carboplatin and Pemetrexed
In PAPILLON, ocular toxicity together with blepharitis, dry eye, conjunctival redness, blurred imaginative and prescient, and eye pruritus occurred in 9%. All occasions had been Grade 1-2.
RYBREVANT ® as a Single Agent
In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of sufferers handled with RYBREVANT ®. All occasions had been Grade 1-2.
Promptly refer sufferers with new or worsening eye signs to an ophthalmologist. Withhold, dose cut back or completely discontinue RYBREVANT ® based mostly on severity.
Embryo-Fetal Toxicity
Primarily based on its mechanism of motion and findings from animal fashions, RYBREVANT ® and LAZCLUZE™ may cause fetal hurt when administered to a pregnant lady. Advise females of reproductive potential of the potential threat to the fetus.
Advise feminine sufferers of reproductive potential to make use of efficient contraception throughout therapy and for 3 months after the final dose of RYBREVANT ®.
Advise females of reproductive potential to make use of efficient contraception throughout therapy with LAZCLUZE™ and for 3 weeks after the final dose. Advise male sufferers with feminine companions of reproductive potential to make use of efficient contraception throughout therapy with LAZCLUZE™ and for 3 weeks after the final dose.
Opposed Reactions
RYBREVANT ® with LAZCLUZE™
For the 421 sufferers within the
Severe hostile reactions occurred in 49% of sufferers who obtained RYBREVANT ® together with LAZCLUZE™. Severe hostile reactions occurring in ‰¥2% of sufferers included VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% every), COVID-19 (2.4%), and pleural effusion and infusion-related response (RYBREVANT ®) (2.1% every). Deadly hostile reactions occurred in 7% of sufferers who obtained RYBREVANT ® together with LAZCLUZE™ on account of demise not in any other case specified (1.2%); sepsis and respiratory failure (1% every); pneumonia, myocardial infarction, and sudden demise (0.7% every); cerebral infarction, pulmonary embolism (PE), and COVID-19 an infection (0.5% every); and ILD/pneumonitis, acute respiratory misery syndrome (ARDS), and cardiopulmonary arrest (0.2% every).
RYBREVANT ® with Carboplatin and Pemetrexed
For the 151 sufferers within the PAPILLON medical trial who obtained RYBREVANT ® together with carboplatin and pemetrexed, the most typical hostile reactions ( ‰¥20%) had been rash (90%), nail toxicity (62%), stomatitis (43%), infusion-related response (42%), fatigue (42%), edema (40%), constipation (40%), decreased urge for food (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The commonest Grade 3 to 4 laboratory abnormalities ( ‰¥2%) had been decreased albumin (7%), elevated alanine aminotransferase (4%), elevated gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and reduces in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).
Severe hostile reactions occurred in 37% of sufferers who obtained RYBREVANT ® together with carboplatin and pemetrexed. Severe hostile reactions in ‰¥2% of sufferers included rash, pneumonia, ILD, pulmonary embolism, vomiting, and COVID-19. Deadly hostile reactions occurred in 7 sufferers (4.6%) on account of pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and demise not in any other case specified.
RYBREVANT ® as a Single Agent
For the 129 sufferers within the CHRYSALIS medical trial who obtained RYBREVANT ® as a single agent, the most typical hostile reactions ( ‰¥20%) had been rash (84%), IRR (64%), paronychia (50%), musculoskeletal ache (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The commonest Grade 3 to 4 laboratory abnormalities ( ‰¥2%) had been decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), elevated alkaline phosphatase (4.8%), elevated glucose (4%), elevated gamma-glutamyl transferase (4%), and decreased sodium (4%).
Severe hostile reactions occurred in 30% of sufferers who obtained RYBREVANT ®. Severe hostile reactions in ‰¥2% of sufferers included pulmonary embolism, pneumonitis/ILD, dyspnea, musculoskeletal ache, pneumonia, and muscular weak point. Deadly hostile reactions occurred in 2 sufferers (1.5%) on account of pneumonia and 1 affected person (0.8%) on account of sudden demise.
LAZCLUZE™ Drug Interactions
Keep away from concomitant use of LAZCLUZE™ with robust and average CYP3A4 inducers. Contemplate an alternate concomitant treatment with no potential to induce CYP3A4.
Monitor for hostile reactions related to a CYP3A4 or BCRP substrate the place minimal focus modifications could result in severe hostile reactions, as advisable within the accepted product labeling for the CYP3A4 or BCRP substrate.
Please learn full Prescribing Data for RYBREVANT ®.
Please learn full Prescribing Data for LAZCLUZE™.
About Johnson & Johnson
At Johnson & Johnson, we consider well being is all the things. Our energy in healthcare innovation empowers us to construct a world the place advanced illnesses are prevented, handled, and cured, the place remedies are smarter and fewer invasive, and options are private. Via our experience in Progressive Drugs and MedTech, we’re uniquely positioned to innovate throughout the complete spectrum of healthcare options immediately to ship the breakthroughs of tomorrow, and profoundly affect well being for humanity. Study extra at https://www.jnj.com/ or at www.janssen.com/johnson-johnson-innovative-medicine. Observe us at @JanssenUS and @JNJInnovMed. Janssen Analysis & Improvement, LLC, and Janssen Biotech, Inc. are Johnson & Johnson firms.
Cautions Regarding Ahead-Trying Statements
This press launch comprises “forward-looking statements” as outlined within the Personal Securities Litigation Reform Act of 1995 relating to product growth and the potential advantages and therapy affect of RYBREVANT ® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib). The reader is cautioned to not depend on these forward-looking statements. These statements are based mostly on present expectations of future occasions. If underlying assumptions show inaccurate or recognized or unknown dangers or uncertainties materialize, precise outcomes may range materially from the expectations and projections Janssen Analysis & Improvement, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Dangers and uncertainties embody, however should not restricted to: challenges and uncertainties inherent in product analysis and growth, together with the uncertainty of medical success and of acquiring regulatory approvals; uncertainty of economic success; manufacturing difficulties and delays; competitors, together with technological advances, new merchandise and patents attained by opponents; challenges to patents; product efficacy or security issues leading to product remembers or regulatory motion; modifications in habits and spending patterns of purchasers of well being care services and products; modifications to relevant legal guidelines and laws, together with international well being care reforms; and tendencies towards well being care value containment. An extra record and descriptions of those dangers, uncertainties and different elements could be present in Johnson & Johnson’s Annual Report on Type 10-Ok for the fiscal yr ended
Dr.
See the NCCN Tips for detailed suggestions, together with different therapy choices.
¡The NCCN Tips for NSCLC present suggestions for sure particular person biomarkers that needs to be examined and advocate testing strategies however don’t endorse any particular commercially obtainable biomarker assays or industrial laboratories.
§The NCCN Content material doesn’t represent medical recommendation and shouldn’t be used instead of in search of skilled medical recommendation, prognosis or therapy by licensed practitioners. NCCN makes no warranties of any type in any way relating to their content material, use or software and disclaims any duty for his or her software or use in any method.
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1 Gadgeel SM, et al. Amivantamab Plus LAZCLUZE™ vs Osimertinib in First-line EGFR-mutant Superior NSCLC: Longer Observe-up of the |
2Cho BC, et al. Amivantamab Plus LAZCLUZE™ vs Osimertinib as First-line Remedy in Sufferers With EGFR-mutated, Superior Non-small Cell Lung Most cancers (NSCLC): Major Outcomes From |
3 ClinicalTrials.gov. A Examine of Amivantamab and LAZCLUZE™ Mixture Remedy Versus Osimertinib in Domestically Superior or Metastatic Non-Small Cell Lung Most cancers ( |
4 RYBREVANT ® Prescribing Data. |
5 Referenced with permission from the NCCN Medical Observe Tips in Oncology (NCCN Tips ®) for Non-Small Cell |
6 ClinicalTrials.gov. A Examine of Amivantamab and LAZCLUZE™ in Mixture With Platinum-Primarily based Chemotherapy In contrast With Platinum-Primarily based Chemotherapy in Sufferers With Epidermal Progress Issue Receptor (EGFR)-Mutated Domestically Superior or Metastatic Non-Small Cell Lung Most cancers After Osimertinib Failure ( |
7 ClinicalTrials.gov. A Examine of Mixture Amivantamab and Carboplatin-Pemetrexed Remedy, In contrast With Carboplatin-Pemetrexed, in Individuals With Superior or Metastatic Non-Small Cell Lung Most cancers Characterised by Epidermal Progress Issue Receptor (EGFR) Exon 20 Insertions (PAPILLON). Out there at: https://clinicaltrials.gov/ct2/present/NCT04538664. Accessed September 2024. |
8 ClinicalTrials.gov. A Examine of LAZCLUZE™ With Subcutaneous Amivantamab In contrast With Intravenous Amivantamab in Individuals With Epidermal Progress Issue Receptor (EGFR)-Mutated Superior or Metastatic Non-small Cell Lung Most cancers (PALOMA-3). https://clinicaltrials.gov/ct2/present/NCT05388669. Accessed September 2024. |
9 ClinicalTrials.gov. A Examine of Amivantamab in Individuals With Superior or Metastatic Strong Tumors Together with Epidermal Progress Issue Receptor (EGFR)-Mutated Non-Small Cell Lung Most cancers (PALOMA-2). https://clinicaltrials.gov/ct2/present/NCT05498428. Accessed September 2024. |
10 ClinicalTrials.gov. A Examine of Amivantamab Subcutaneous (SC) Administration for the Remedy of Superior Strong Malignancies (PALOMA). Out there at: https://clinicaltrials.gov/examine/NCT04606381. Accessed September 2024. |
11 ClinicalTrials.gov. A Examine of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Individuals With Superior Non-Small Cell Lung Most cancers (CHRYSALIS). https://clinicaltrials.gov/ct2/present/NCT02609776. Accessed September 2024. |
12 ClinicalTrials.gov. A Examine of LAZCLUZE™ as Monotherapy or in Mixture With Amivantamab in Individuals With Superior Non-small Cell Lung Most cancers (CHRYSALIS-2). https://clinicaltrials.gov/ct2/present/NCT04077463. Accessed September 2024. |
13 ClinicalTrials.gov. A Examine of Amivantamab and Capmatinib Mixture Remedy in Unresectable Metastatic Non-small Cell Lung Most cancers (METalmark). https://clinicaltrials.gov/ct2/present/NCT05488314. Accessed September 2024. |
14 ClinicalTrials.gov. A Examine of Mixture Remedy With Amivantamab and Cetrelimab in Individuals With Metastatic Non-small Cell Lung Most cancers (PolyDamas). https://www.clinicaltrials.gov/examine/NCT05908734?time period=polydamas&rank=1. Accessed September 2024. |
15 ClinicalTrials.gov. Premedication to Scale back Amivantamab Related Infusion Associated Reactions (SKIPPirr). https://basic.clinicaltrials.gov/ct2/present/NCT05663866. Accessed September 2024. |
16 ClinicalTrials.gov. A Examine of Mixture Remedy With Amivantamab and Docetaxel in Individuals With Metastatic Non-small Cell Lung Most cancers (swalloWTail). https://www.clinicaltrials.gov/examine/NCT06532032?time period=Swallowtail&intr=amivantamab&rank=1. Accessed |
17 ClinicalTrials.gov. A Examine of Amivantamab Monotherapy and in Addition to Normal-of-Care Chemotherapy in Individuals With Superior or Metastatic Colorectal Most cancers (OrigAMI-1). https://clinicaltrials.gov/examine/NCT05379595?time period=NCT05379595&rank=1. Accessed |
18 ClinicalTrials.gov. A Examine of Amivantamab Alone or in Addition to Different Remedy Brokers in Individuals With Recurrent/ Metastatic Head and Neck Most cancers (OrigAMI-4). https://clinicaltrials.gov/examine/NCT06385080?time period=OrigAMI-4&restrict=10&rank=1. Accessed |
19 The World Well being Group. Most cancers. https://www.who.int/news-room/fact-sheets/element/most cancers. Accessed September 2024. |
20American Most cancers Society. What’s Lung Most cancers? https://www.most cancers.org/content material/most cancers/en/most cancers/lung-cancer/about/what-is.html. Accessed September 2024. |
21 Oxnard JR, et al. Pure historical past and molecular traits of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18. |
22 Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Actual World Datasets. Summary introduced at: World Convention on Lung Most cancers Annual Assembly; January 29, 2021; Singapore. |
23 Pennell NA, et al. A part II trial of adjuvant erlotinib in sufferers with resected epidermal development issue receptor-mutant non-small cell lung most cancers. J Clin Oncol. 37:97-104. |
24 Burnett H, et al. Epidemiological and medical burden of EGFR exon 20 insertion in superior non-small cell lung most cancers: a scientific literature evaluation. Summary introduced at: World Convention on Lung Most cancers Annual Assembly; January 29, 2021; Singapore. |
25 Zhang YL, et al. The prevalence of EGFR mutation in sufferers with non-small cell lung most cancers: a scientific evaluation and meta-analysis. Oncotarget. 2016;7(48):78985-78993. |
26 Midha A, et al. EGFR mutation incidence in non-small-cell lung most cancers of adenocarcinoma histology: a scientific evaluation and international map by ethnicity. Am J Most cancers Res. 2015;5(9):2892-2911. |
27American Lung Affiliation. EGFR and Lung Most cancers. https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr. Accessed |
28 Howlader N, et al. SEER Most cancers Statistics Evaluation, 1975-2016, Nationwide Most cancers Institute. |
29 Lin JJ, et al. 5-Yr Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Handled with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65. |
30 Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic traits. Mol Most cancers Ther. 2013 Feb; 12(2):220-9. |
31 Girard N, et al. Comparative medical outcomes for sufferers with NSCLC harboring EGFR exon 20 insertion mutations and customary EGFR mutations. Summary introduced at: World Convention on Lung Most cancers Annual Assembly; January 29, 2021; Singapore. |
32 LAZCLUZE™ Prescribing Data. |
Media contact: |
Investor contact: |
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sfrost@its.jnj.com |
investor-relations@its.jnj.com |
Jackie Zima-Evans |
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jzimaev@ITS.JNJ.com |
+1 800 526-7736 |