New longer-term information from the MARIPOSA examine verify superior outcomes of chemotherapy-free RYBREVANT ^® plus LAZCLUZE™ routine in comparison with osimertinib monotherapy as first-line remedy

Outcomes from an interim analysis featured in late-breaker oral presentation at WCLC

SAN DIEGO, Sept. 8, 2024 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) at the moment introduced longer follow-up information from the landmark Section 3 MARIPOSA examine which confirmed first-line therapy with RYBREVANT ^® (amivantamab-vmjw) mixed with LAZCLUZE™ (lazertinib) supplied constant profit throughout long-term outcomes in comparison with osimertinib monotherapy in grownup sufferers with superior non-small cell lung most cancers (NSCLC) with epidermal progress issue receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. The information present a powerful and bettering total survival (OS) pattern favoring RYBREVANT ^® plus LAZCLUZE™ at roughly three years of follow-up. These outcomes have been introduced in a late-breaking oral presentation on the Worldwide Affiliation for the Research of Lung Most cancers (IASLC) 2024 World Convention on Lung Most cancers (WCLC) (Summary #1146).¹

At three years (a median follow-up of 31.1 months), 61 % of sufferers receiving RYBREVANT ^® plus LACLUZE™ have been alive in comparison with 53 % of these handled with osimertinib primarily based on an analysis 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 term follow-up as a key secondary endpoint. The first efficacy final result measure was progression-free survival (PFS) as assessed by blinded impartial central assessment (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,” mentioned Shirish M. Gadgeel, M.D., Chief of Division of Hematology and Oncology, Affiliate Director at Henry Ford (NYSE:) Most cancers Institute and presenting writer. “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 % vs 18 %, respectively). Extra sufferers remained on therapy at three years with the RYBREVANT ^® mixture in comparison with osimertinib (40 % vs 29 %, 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 % vs 32 %, respectively; HR, 0.77; [95 percent CI, 0.65-0.93]; nominal P=0.005). Development-free survival after first subsequent remedy was 57 % for the RYBREVANT ^® mixture in comparison with 49 % 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,” mentioned Joshua Bauml, M.D., Vice President, Lung Most cancers Illness Space Stronghold Chief, Johnson & Johnson Modern Drugs. “We are encouraged by the favorable overall survival trend observed with RYBREVANT plus LAZCLUZE and are eager to see how these data evolve as we continue to follow patients over time.”

As beforehand reported within the MARIPOSA examine, the security profile was in keeping with the security profiles of the person therapies. The speed of discontinuation of all examine therapies resulting from treatment-related antagonistic occasions for RYBREVANT ^® plus LAZCLUZE™ was 10 %. The speed of interstitial lung illness (together with pneumonitis) was lower than three % in each arms.²

In August 2024, RYBREVANT ^® mixed with LAZCLUZE™ was authorized following a Precedence Assessment by the U.S. Meals and Drug Administration as a first-line remedy for sufferers with EGFR-mutated NSCLC primarily based on the favorable efficacy and security profile demonstrated on this examine.

In regards to the MARIPOSA Research

MARIPOSA (NCT04487080), which enrolled 1,074 sufferers, is a randomized, Section 3 examine evaluating RYBREVANT ^® together with LAZCLUZE™ versus osimertinib and versus LAZCLUZE™ alone in first-line therapy of sufferers with regionally superior or metastatic NSCLC with EGFR ex19del or L858R substitution mutations. The first endpoint of the examine is PFS (utilizing RECIST v1.1 tips) as assessed by BICR. Secondary endpoints embrace OS, total response fee (ORR), period of response (DOR), second progression-free survival (PFS2) and intracranial PFS.³

About RYBREVANT ^®

RYBREVANT ^® (amivantamab-vmjw), a fully-human bispecific antibody concentrating on EGFR and MET with immune cell-directing exercise, is authorized within the U.S., Europe, and in different markets around the globe as monotherapy for the therapy of grownup sufferers with regionally superior or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved take a look at, whose illness has progressed on or after platinum-based chemotherapy.⁴

RYBREVANT ^® is authorized within the U.S., Europe and in markets around the globe together with chemotherapy (carboplatin and pemetrexed) for the first-line therapy of grownup sufferers with regionally superior or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved take a look at.

RYBREVANT ^® is authorized within the U.S. together with LAZCLUZE™ (lazertinib) for the first-line therapy of grownup sufferers with regionally superior or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved take a look at. A advertising and marketing authorization software (MAA) and sort II extension of indication software have been submitted to the European Medicines Company (EMA) searching for approval of LAZCLUZE™ together with RYBREVANT ^® primarily based on the MARIPOSA examine.

In November 2023, Johnson & Johnson submitted a supplemental Biologics License Utility (sBLA) to the U.S. FDA for RYBREVANT ^® together with chemotherapy for the therapy of sufferers with EGFR-mutated NSCLC who progressed on or after osimertinib primarily based on the MARIPOSA-2 examine. This indication was authorized in Europe in August 2024.

In June 2024, Johnson & Johnson submitted a BLA to the U.S. FDA for the subcutaneous formulation of RYBREVANT ^® together with LAZCLUZE™ for all at present authorized or submitted indications of intravenous (IV) RYBREVANT ^® in sure sufferers with NSCLC. A submission for the extension of the RYBREVANT ^® advertising and marketing authorization (line extension) was additionally submitted to the EMA searching for approval for this indication.

The NCCN Medical Observe Pointers in Oncology (NCCN Pointers ^®) for NSCLC ^§ want next-generation sequencing“primarily based methods over polymerase chain response“primarily based approaches for the detection of EGFR exon 20 insertion variants. The NCCN Pointers embrace:

• Amivantamab-vmjw (RYBREVANT ^®) plus chemotherapy as a most popular (Class 1 most popular suggestion) 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 suggestion) 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 choice (Class 2A suggestion) 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 choice (Class 2A suggestion) 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 Section 3 MARIPOSA examine, RYBREVANT ^® is being studied in a number of scientific trials in NSCLC, together with:

• The Section 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 Section 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 Section 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 Section 2 PALOMA-2 (NCT05498428) examine assessing subcutaneous amivantamab in sufferers with superior or metastatic strong tumors together with EGFR-mutated NSCLC.⁹
• The Section 1 PALOMA (NCT04606381) examine assessing the feasibility of subcutaneous administration of amivantamab primarily based on security and pharmacokinetics and to find out a dose, dose routine and formulation for amivantamab subcutaneous supply.¹⁰
• The Section 1 CHRYSALIS (NCT02609776) examine evaluating RYBREVANT ^® in sufferers with superior NSCLC.¹¹
• The Section 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 Section 1/2 METalmark (NCT05488314) examine assessing RYBREVANT ^® and capmatinib mixture remedy in regionally superior or metastatic NSCLC.¹³
• The Section 1/2 PolyDamas (NCT05908734) examine assessing RYBREVANT ^® and cetrelimab mixture remedy in regionally superior or metastatic NSCLC.¹⁴
• The Section 2 SKIPPirr examine (NCT05663866) exploring how to 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 Section 1/2 swalloWTail (NCT06532032) examine assessing RYBREVANT ^® and docetaxel mixture remedy in sufferers with metastatic NSCLC.¹⁶
• The Section 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 Section 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 Korea). LAZCLUZE™ is an oral, third-generation, brain-penetrant EGFR TKI that targets each the T790M mutation and activating EGFR mutations whereas sparing wild-type EGFR. An analysis of the efficacy and security of LAZCLUZE™ from the Section 3 LASER301 examine was revealed in The Journal of Medical Oncology in 2023.

About Non-Small Cell Lung Most cancers

Worldwide, lung most cancers is without doubt one of the commonest cancers, with NSCLC making up 80 to 85 % of all lung most cancers circumstances.^19,20 The principle subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and enormous cell carcinoma.²¹ Among the many commonest driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell progress and division.²²EGFR mutations are current in 10 to fifteen % of Western sufferers with NSCLC with adenocarcinoma histology and happen in 40 to 50 % of Asian sufferers.^{21,22,23,24,25,26}EGFR ex19del or EGFR L858R mutations are the most typical EGFR mutations.²⁷ The five- yr survival fee for all folks with superior NSCLC and EGFR mutations handled with EGFR tyrosine kinase inhibitors (TKIs) is lower than 20 %.^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 % 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 %.³¹

IMPORTANT SAFETY INFORMATION^4,32

WARNINGS AND PRECAUTIONS

Infusion-Associated Reactions

RYBREVANT ^® may cause infusion-related reactions (IRR); indicators and signs of IRR embrace 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 MARIPOSA (n=421), IRRs occurred in 63% of sufferers handled with RYBREVANT ^® together with LAZCLUZE™, together with Grade 3 in 5% and Grade 4 in 1% of sufferers. The incidence of infusion modifications resulting from IRR was 54% of sufferers, and IRRs resulting in dose discount of RYBREVANT ^® occurred in 0.7% of sufferers. Infusion-related reactions resulting in everlasting discontinuation of RYBREVANT ^® occurred in 4.5% of sufferers receiving RYBREVANT ^® together with LAZCLUZE™.

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%) antagonistic reactions. The incidence of infusion modifications resulting from 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% have been Grade 1-2, 2.2% have been Grade 3, and 0.4% have 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 resulting from IRR was 62% and 1.3% of sufferers completely discontinued RYBREVANT ^® resulting from IRR.

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT ^® as beneficial. 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 medicine and tools can be found. Interrupt infusion if IRR is suspected. Scale back the infusion fee or completely discontinue RYBREVANT ^® primarily based on severity.

Interstitial Lung Illness/Pneumonitis

RYBREVANT ^® may cause extreme and deadly interstitial lung illness (ILD)/pneumonitis.

RYBREVANT ^® with LAZCLUZE™

In MARIPOSA, ILD/pneumonitis occurred in 3.1% of sufferers handled with RYBREVANT ^® together with LAZCLUZE™, together with Grade 3 in 1.0% and Grade 4 in 0.2% of sufferers. There was one deadly case (0.2%) of ILD/pneumonitis and a couple of.9% of sufferers completely discontinued RYBREVANT ^® and LAZCLUZE™ resulting from ILD/pneumonitis.

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 ^® resulting from 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 critical and deadly venous thromboembolic (VTEs) occasions, together with deep vein thrombosis and pulmonary embolism. Nearly all of these occasions occurred through the first 4 months of remedy.

In MARIPOSA, VTEs occurred in 36% of sufferers receiving RYBREVANT ^® together with LAZCLUZE™, together with Grade 3 in 10% and Grade 4 in 0.5% of sufferers. On-study VTEs occurred in 1.2% of sufferers (n=5) whereas receiving anticoagulation remedy. There have been two deadly circumstances of VTE (0.5%), 9% of sufferers had VTE resulting in dose interruptions of RYBREVANT ^®, and seven% of sufferers had VTE resulting in dose interruptions of LAZCLUZE™; 1% of sufferers had VTE resulting in dose reductions of RYBREVANT ^®, and 0.5% of sufferers had VTE resulting in dose reductions of LAZCLUZE™; 3.1% of sufferers had VTE resulting in everlasting discontinuation of RYBREVANT ^®, and 1.9% of sufferers had VTE resulting in everlasting discontinuation of LAZCLUZE™. The median time to onset of VTEs was 84 days (vary: 6 to 777).

Administer prophylactic anticoagulation for the primary 4 months of therapy. Using Vitamin Okay antagonists is just not beneficial. Monitor for indicators and signs of VTE occasions and deal with as medically applicable.

Withhold RYBREVANT ^® and LAZCLUZE™ primarily based on severity. As soon as anticoagulant therapy has been initiated, resume RYBREVANT ^® and LAZCLUZE™ on the similar dose stage 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 stage on the discretion of the healthcare supplier.

Dermatologic Adversarial Reactions

RYBREVANT ^® may cause extreme rash together with poisonous epidermal necrolysis (TEN), dermatitis acneiform, pruritus, and dry pores and skin.

RYBREVANT ^® with LAZCLUZE™

In MARIPOSA, rash occurred in 86% of sufferers handled with RYBREVANT ^® together with LAZCLUZE™, together with Grade 3 in 26% of sufferers. The median time to onset of rash was 14 days (vary: 1 to 556 days). Rash resulting in dose interruptions occurred in 37% of sufferers for RYBREVANT ^® and 30% for LAZCLUZE™, rash resulting in dose reductions occurred in 23% of sufferers for RYBREVANT ^® and 19% for LAZCLUZE™, and rash resulting in everlasting discontinuation occurred in 5% of sufferers for RYBREVANT ^® and 1.7% for LAZCLUZE™.

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%) antagonistic reactions. Rash resulting in dose reductions occurred in 19% of sufferers, and a couple 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 resulting from 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 beneficial 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 antagonistic reactions. Take into account 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 think about 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 scale back or completely discontinue each medicine primarily based on severity. For sufferers receiving RYBREVANT ^® as a single agent or together with carboplatin and pemetrexed, withhold, dose scale back or completely discontinue RYBREVANT ^® primarily based 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 MARIPOSA, ocular toxicity occurred in 16% of sufferers handled with RYBREVANT ^® together with LAZCLUZE™, together with Grade 3 or 4 ocular toxicity in 0.7% of sufferers. Withhold, scale back the dose, or completely discontinue RYBREVANT ^® and proceed LAZCLUZE™ primarily based on severity.

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 have 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 have been Grade 1-2.

Promptly refer sufferers with new or worsening eye signs to an ophthalmologist. Withhold, dose scale back or completely discontinue RYBREVANT ^® primarily based 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 danger 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.

Adversarial Reactions

RYBREVANT ^® with LAZCLUZE™

For the 421 sufferers within the MARIPOSA scientific trial who obtained RYBREVANT ^® together with LAZCLUZE™, the most typical antagonistic reactions ( ‰¥20%) have been rash (86%), nail toxicity (71%), infusion-related reactions (RYBREVANT ^®, 63%), musculoskeletal ache (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry pores and skin (25%), decreased urge for food (24%), pruritus (24%), nausea (21%), and ocular toxicity (16%). The commonest Grade 3 or 4 laboratory abnormalities ( ‰¥2%) have been decreased albumin (8%), decreased sodium (7%), elevated ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), elevated AST (3.8%), elevated GGT (2.6%), and elevated magnesium (2.6%).

Severe antagonistic reactions occurred in 49% of sufferers who obtained RYBREVANT ^® together with LAZCLUZE™. Severe antagonistic 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 antagonistic reactions occurred in 7% of sufferers who obtained RYBREVANT ^® together with LAZCLUZE™ resulting from dying not in any other case specified (1.2%); sepsis and respiratory failure (1% every); pneumonia, myocardial infarction, and sudden dying (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 scientific trial who obtained RYBREVANT ^® together with carboplatin and pemetrexed, the most typical antagonistic reactions ( ‰¥20%) have 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%) have 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 antagonistic reactions occurred in 37% of sufferers who obtained RYBREVANT ^® together with carboplatin and pemetrexed. Severe antagonistic reactions in ‰¥2% of sufferers included rash, pneumonia, ILD, pulmonary embolism, vomiting, and COVID-19. Deadly antagonistic reactions occurred in 7 sufferers (4.6%) resulting from pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and dying not in any other case specified.

RYBREVANT ^® as a Single Agent

For the 129 sufferers within the CHRYSALIS scientific trial who obtained RYBREVANT ^® as a single agent, the most typical antagonistic reactions ( ‰¥20%) have 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%) have 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 antagonistic reactions occurred in 30% of sufferers who obtained RYBREVANT ^®. Severe antagonistic reactions in ‰¥2% of sufferers included pulmonary embolism, pneumonitis/ILD, dyspnea, musculoskeletal ache, pneumonia, and muscular weak point. Deadly antagonistic reactions occurred in 2 sufferers (1.5%) resulting from pneumonia and 1 affected person (0.8%) resulting from sudden dying.

LAZCLUZE™ Drug Interactions

Keep away from concomitant use of LAZCLUZE™ with robust and reasonable CYP3A4 inducers. Take into account an alternate concomitant medicine with no potential to induce CYP3A4.

Monitor for antagonistic reactions related to a CYP3A4 or BCRP substrate the place minimal focus modifications might result in critical antagonistic reactions, as beneficial within the authorized product labeling for the CYP3A4 or BCRP substrate.

Please learn full Prescribing Info for RYBREVANT ^®.

Please learn full Prescribing Info 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 therapies are smarter and fewer invasive, and options are private. By means of our experience in Modern Drugs and MedTech, we’re uniquely positioned to innovate throughout the complete spectrum of healthcare options at the moment to ship the breakthroughs of tomorrow, and profoundly influence well being for humanity. Be taught extra at https://www.jnj.com/ or at www.janssen.com/johnson-johnson-innovative-medicine. Comply with us at @JanssenUS and @JNJInnovMed. Janssen Analysis & Growth, LLC, and Janssen Biotech, Inc. are Johnson & Johnson firms.

Cautions Regarding Ahead-Wanting Statements

This press release comprises “forward-looking statements” as outlined within the Non-public Securities Litigation Reform Act of 1995 relating to product growth and the potential advantages and therapy influence of RYBREVANT ^® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib). The reader is cautioned to not depend on these forward-looking statements. These statements are primarily based on present expectations of future occasions. If underlying assumptions show inaccurate or identified or unknown dangers or uncertainties materialize, precise outcomes might fluctuate materially from the expectations and projections Janssen Analysis & Growth, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Dangers and uncertainties embrace, however should not restricted to: challenges and uncertainties inherent in product research and growth, together with the uncertainty of scientific 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; modifications to relevant legal guidelines and rules, together with world well being care reforms; and tendencies towards well being care value containment. An additional listing and descriptions of those dangers, uncertainties and different elements will be present in Johnson & Johnson’s Annual Report on Type 10-Okay for the fiscal yr ended December 31, 2023, together with within the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Stories on Type 10-Q and different filings with the Securities and Alternate Fee. Copies of those filings can be found on-line at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Analysis & Growth, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to replace any forward-looking assertion on account of new data or future occasions or developments.

Dr. Shirish M. Gadgeel has supplied consulting, advisory, and talking providers to Johnson & Johnson; he has not been paid for any media work.

See the NCCN Pointers for detailed suggestions, together with different therapy choices.

^¡The NCCN Pointers for NSCLC present suggestions for sure particular person biomarkers that must be examined and suggest testing methods however don’t endorse any particular commercially out there biomarker assays or business laboratories.

^§The NCCN Content material doesn’t represent medical recommendation and shouldn’t be used rather than searching for skilled medical recommendation, analysis or therapy by licensed practitioners. NCCN makes no warranties of any sort in any way relating to their content material, use or software and disclaims any accountability for his or her software or use in any means.