Johnson & Johnson : advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA

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Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA

PALOMA-3 presentation of subcutaneous amivantamab and lazertinib selected to showcase cutting-edge approaches in lung cancer during prestigious "Best of ASCO" program

New data showcase first- and -best-in-class, complementary multiple myeloma therapies, including DARZALEX® (daratumumab), CARVYKTI® (ciltacabtagene autoleucel; cilta-cel), TECVAYLI® (teclistamab-cqyv) and TALVEY® (talquetamab-tgvs)

RARITAN, N.J., May 23, 2024 - Johnson & Johnson announced today that the 2024 American Society of Clinical Oncology (ASCO)Annual Meeting will feature 34 clinical study and real-world evidence presentations from the Company's hematologic malignancies and solid tumor oncology product portfolio and pipeline. Additionally, 43 abstracts will be presented at the European Hematology Association (EHA) 2024 Congressthe following week. Eighteen oral presentations across both meetings include new data from pivotal trials and updated clinical data in lung cancer, prostate cancer, bladder cancer, multiple myeloma, and B-cell and myeloid malignancies.

"Our data at ASCO and EHA this year demonstrate our long-standing commitment to advance the treatment of solid tumors and blood cancers with the goal of transforming outcomes for those who battle with these complex diseases," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Innovative Medicine. "With a legacy in oncology innovation spanning three decades, our mission to redefine the standard of care in hematologic malignancies and solid tumors has never been stronger as we work every day to get in front of cancer."

"With nearly 20 million people diagnosed annually worldwide, we innovate with purpose to lead where medicine is going and ultimately transform outcomes for people living with cancer," said Biljana Naumovic, U.S. President, Oncology, Solid Tumor, Johnson & Johnson Innovative Medicine. "This year, we look forward to presenting data that represent our commitment to unlocking the value of innovation in treatment across a range of difficult-to-treat cancers, disease stages and risk factors for patients who have limited options."

Key Data Presentations

Lung Cancer at ASCO

• Late-breakingresults from the Phase 3 PALOMA-3 study evaluating subcutaneous amivantamab combined with lazertinib in patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R mutations (Oral Abstract #LBA8505)
• Data from the Phase 2 PALOMA-2 study evaluating subcutaneous amivantamab combined with lazertinib as first- line treatment in patients with advanced NSCLC with EGFR ex19del or L858R mutations (Poster Abstract #LBA8612)

• Subgroup analysis from the landmark Phase 3 MARIPOSA study evaluating first-line treatment with RYBREVANT® (amivantamab-vmjw) and lazertinib in patients exhibiting high-risk clinical and biological features commonly observed in EGFR-mutant advanced NSCLC, who typically experience poorer outcomes (Oral Abstract #8504)
• Results from Cohort C of the CHRYSALIS-2 study evaluating RYBREVANT® plus lazertinib in patients with atypical EGFR-mutant advanced NSCLC who were treatment-naïve or received two or fewer prior lines of treatment (Oral Abstract #8516)

Prostate Cancer at ASCO

• First presentation of data from the first-in-human Phase 1 study evaluating JNJ-69086420, a first-in-class radioligand therapy, targeting human kallikrein 2 (hK2) with an actinium-225(225Ac)-labeled antibody to treat patients with metastatic castration-resistant prostate cancer (Oral Abstract #5010)

Bladder Cancer at ASCO

• An analysis of fibroblast growth factor receptor (FGFR) alterations in patients who develop locally advanced metastatic urothelial cancer (mUC) and their association with tumor subtype and clinical outcomes in patients treated with BALVERSA® (erdafitinib) versus pembrolizumab (Poster Abstract #4578)

Multiple Myeloma at ASCO and EHA

ASCO Highlights

• Additional analyses from the Phase 3 PERSEUS study assessing the impact of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for induction and consolidation treatment and maintenance therapy on deepening minimal residual disease (MRD) response, sustained MRD and progression-free survival based on reaching MRD in patients who are transplant-eligible with newly diagnosed multiple myeloma (Oral Abstract #7502)
• Analysis of data from the Phase 3 CARTITUDE-4 study of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) investigating the subgroup of patients with functional high-risk multiple myeloma treated with CARVYKTI® as second- line therapy (Oral Abstract #7504)
• Results from the Phase 2 CARTITUDE-2 Cohort D study of CARVYKTI® investigating the efficacy and safety of CARVYKTI® with lenalidomide maintenance in patients with suboptimal response to frontline autologous stem cell transplant (Oral Abstract #7505)
• Updated analysis with longer-termfollow-up from the Phase 1/2 MajesTEC-1 study of TECVAYLI® in patients with relapsed or refractory multiple myeloma receiving prophylactic tocilizumab for the reduction of cytokine release syndrome (Oral Abstract #7517)
• Long-termfollow-up data from the Phase 1/2 MajesTEC-1 study of TECVAYLI® in patients with relapsed or refractory multiple myeloma (Poster Abstract #7540)
• First data from safety run in from the Phase 3 MajesTEC-7 study of TECVAYLI® in patients with transplant ineligible/not intended newly diagnosed multiple myeloma (Oral Abstract #7506)
• First data from the Phase 2 OPTec study evaluating outpatient step-up administration of TECVAYLI® using prophylactic tocilizumab in patients with relapsed or refractory multiple myeloma (Poster Abstract #7528)

EHA Highlights

• Data from the Phase 3 PERSEUS study assessing the impact of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for induction and consolidation treatment and maintenance therapy on deepening minimal residual disease (MRD) response, sustained MRD and progression-free survival based on reaching MRD in patients who are transplant-eligible with newly diagnosed multiple myeloma (Oral Abstract #S201)

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• Final overall survival analysis from the Phase 3 MAIA study evaluating DARZALEX® plus lenalidomide and dexamethasone compared to lenalidomide and dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma (Poster Abstract #P968)
• Six-yearfollow-up data from the Phase 3 CASSIOPEIA study evaluating DARZALEX® in combination with bortezomib, thalidomide and dexamethasone (D-VTd) followed by an every 8 week DARZALEX® maintenance regimen in transplant-eligible, newly diagnosed multiple myeloma (Oral Abstract #S204)
• Long-termefficacy and safety results from the Phase 1/2 MonumenTAL-1 study of TALVEY® (talquetamab-tgvs) in patients with relapsed/refractory multiple myeloma (Poster Abstract #P915)
• Safety and efficacy results from the Phase 1b MonumenTAL-2 study evaluating TALVEY® in combination with pomalidomide in patients with relapsed/refractory multiple myeloma (Poster Abstract #P911)
• Results from the MajesTEC-1 study evaluating TECVAYLI® in patients with high-risk relapsed or refractory multiple myeloma, and the clinical benefit and durability of TECVAYLI® (Poster Abstract #P923)

B-Cell Malignancies at ASCO and EHA

ASCO Highlights

• Outcomes in high-risk subgroups after 5.5 years of follow-up from the Phase 2 CAPTIVATE study evaluating fixed- duration IMBRUVICA® (ibrutinib) plus venetoclax in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) (Oral Abstract #7009)
• Efficacy and safety results from the Phase 3 SYMPATICO study of IMBRUVICA® plus venetoclax in patients with mantle cell lymphoma (MCL) and TP53 mutations (Oral Abstract #7007)

EHA Highlights

• Ten-yearfollow-up data from the Phase 3 RESONATE-2 study evaluating first-lineIMBRUVICA® treatment in patients with CLL/SLL (Poster Abstract #P670)
• Presentation of outcomes in high-risk subgroups after 5.5 years of follow-up from the Phase 2 CAPTIVATE study evaluating fixed-durationIMBRUVICA® plus venetoclax in patients with CLL/SLL (Poster Abstract #P675)
• Comparison of overall survival between patients with CLL treated with first-lineIMBRUVICA® to an age-matched European population (Poster Abstract #P664)
• Presentation of efficacy and safety results from the Phase 3 SYMPATICO study of IMBRUVICA® plus venetoclax in patients with MCL and TP53 mutations (Poster Abstract #P1128)

Myeloid Malignancies at EHA

• Data from the Phase 1b study of the Menin-KMT2a inhibitor JNJ-75276617 in combination with venetoclax and azacitidine in patients with relapsed or refractory acute myeloid leukemia harboring certain genetic alterations (Oral Abstract #S133)

Warm Autoimmune Hemolytic Anemia at EHA

• Data from a real-world longitudinal population-based study reporting on overall survival and the use of conventional treatments, including corticosteroids and immunosuppressants, in Swedish patients with primary or secondary warm Autoimmune Hemolytic Anemia (wAIHA) (Poster Abstract # P1545)

Johnson & Johnson presentations at ASCO 2024 Annual Meeting:

Lung Cancer

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Oral Presentations

Abstract #8504		Amivantamab plus lazertinib vs osimertinib in first-lineEGFR-mutant
		advanced non-small cell lung cancer (NSCLC) with biomarkers of high-risk
		disease: A secondary analysis from the Phase 3 MARIPOSA study
Abstract #LBA8505		Subcutaneous amivantamab vs intravenous amivantamab, both in
		combination with lazertinib, in refractory EGFR-mutated, advanced NSCLC:
		Primary results, including overall survival (OS), from the global, Phase 3,
		randomized controlled PALOMA-3 trial
Abstract #8516		Amivantamab plus lazertinib in atypical EGFR-mutated advanced NSCLC:
		Results from CHRYSALIS-2
Poster Presentations
Abstract #LBA8612		Subcutaneous amivantamab and lazertinib as first-line treatment in patients
		with EGFR-mutated, advanced NSCLC: Results from the Phase 2 PALOMA-2
		study
Abstract #8619		Amivantamab plus capmatinib in advanced NSCLC harboring MET
		alterations: Identification of the recommended Phase 2 combination dose and
		preliminary dose-escalation results from the Phase 1/2 METalmark study
Abstract #8606		Amivantamab plus chemotherapy vs. chemotherapy as first-line treatment
		among patients with EGFR exon 20 insertion-mutated advanced NSCLC:
		PAPILLON Chinese subgroup analysis
Prostate Cancer
Oral Presentations
Abstract #5010		A Phase 1 study of JNJ-69086420(JNJ-6420), an actinium-225 (225Ac)-
		labeled antibody targeting human kallikrein 2 (hk2) to treat metastatic
		castration-resistant prostate cancer (mCRPC)
Poster Presentations
Abstract #5076		Rapid and deep prostate-specific antigen (PSA) response to apalutamide plus
		androgen deprivation therapy (ADT) and survival in metastatic castration-
		sensitive prostate cancer (mCSPC) in real-world practice in the US (OASIS
		Project)
Abstract #5095		Clinical characteristics and treatment patterns of patients with high-risk
		localized prostate cancer (HR LPC) treated with radical prostatectomy (RP)
		and perioperative hormonal therapy (HT) in Japan, South Korea, and Taiwan
Abstract #5065		Development of a machine learning model to predict OS results from
		randomized clinical trials of patients with metastatic prostate cancer
Abstract #5027		PHAROS, a real-worldmulti-country European study on patients with high-
		risk localized and locally advanced prostate cancer receiving radical treatment
Abstract #11061		Prospective iterative data visualization study to enhance health literacy in
		prostate cancer (PC)
Abstract #TPS5119		LIBERTAS: A degendered and transgender-inclusive Phase 3 study of
		apalutamide (APA) plus intermittent vs continuous ADT in participants (pts)
		with metastatic hormone-sensitive prostate cancer (mHSPC)
Bladder Cancer
Poster Presentation
Abstract #4578		FGFR3 alterations in patients who develop locally advanced or mUC, and
		their association with tumor subtype and clinical outcomes in patients treated
		with erdafitinib vs. pembrolizumab
Tumor Agnostic Disease
Oral Presentations
Abstract #8515		Efficacy and safety of erdafitinib in adults with NSCLC and prespecified FGFR
		alterations in the Phase 2 open-label,single-arm RAGNAR trial
Abstract #10002		Efficacy and safety of erdafitinib in pediatric patients with advanced solid
		tumors and FGFR alterations in the Phase 2 RAGNAR trial
Poster Presentations
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Abstract #1088	Efficacy and safety of erdafitinib in adults with breast cancer and prespecified
	FGFR alterations in the Phase 2 open-label,single-arm RAGNAR Trial
Abstract #3119	Efficacy of erdafitinib in adults with advanced solid tumors and non-
	prespecified FGFR mutations in the Phase 2 RAGNAR trial: Exploratory
	cohort
Abstract #4121	Efficacy and safety of erdafitinib in patients with advanced or metastatic
	cholangiocarcinoma and FGFR alterations: Pooled analysis of RAGNAR and
	LUC2001 studies
Other Solid
Oral Presentation
Abstract #1020	ACE-Breast-02: A pivotal Phase 2/3 trial of ARX788, a novel anti-HER2
	antibody-drug conjugate (ADC), versus lapatinib plus capecitabine for HER2+
	advanced breast cancer (ABC)
Poster Presentations
Abstract #TPS1123	ACE-BREAST-03: A Phase 2 trial evaluating ARX788, an anti-HER2 antibody
	drug conjugate (ADC), for the treatment of HER2+ metastatic breast cancer
	(MBC) in patients who have been previously treated with trastuzumab
	deruxtecan (T-DXd)
Multiple Myeloma
Oral Presentations
Abstract #7502	Daratumumab plus bortezomib/lenalidomide/dexamethasone (VRD)
	in transplant-eligible patients with NDMM: analysis of minimal residual
	disease (MRD) in the PERSEUS trial
Abstract #7504	Ciltacabtagene autoleucel vs. standard of care in patients with functional
	high-risk multiple myeloma: CARTITUDE-4 subgroup analysis
Abstract #7505	Efficacy and safety of ciltacabtagene autoleucel ± lenalidomide maintenance
	in newly diagnosed multiple myeloma with suboptimal response to frontline
	autologous stem cell transplant: CARTITUDE-2 cohort D
Abstract #7506	Safety results from the Phase 3 MajesTEC-7 study in patients with transplant-
	ineligible/not intended NDMM
Abstract #7517	Longer-termfollow-up of patients receiving prophylactic tocilizumab (toci) for
	the reduction of cytokine release syndrome (CRS) in the Phase
	1/2 MajesTEC-1 study of teclistamab in relapsed/refractory multiple
	myeloma (RRMM)
Poster Presentations
Abstract #7528	OPTec: A Phase 2 study to evaluate outpatient (OP) step-up administration
	of teclistamab, a B-cell maturation antigen (BCMA)-targeting bispecific
	antibody, in patients with RRMM
Abstract #7535	Ciltacabtagene autoleucel in patients with lenalidomide-refractory multiple
	myeloma: CARTITUDE-2 cohort A expansion subgroup
Abstract #7536	Real-world schedule de-escalation of teclistamab in patients with
	relapsed/refractory multiple myeloma
Abstract #7540	Long-termfollow-up from the Phase 1/2 MajesTEC-1 trial
	of teclistamab in patients with RRMM
Abstract #7570	Clinical outcomes of retreatment with daratumumab-based regimens in anti-
	CD38 refractory multiple myeloma
Abstract #TPS7575	A Phase III, randomized study of daratumumab, cyclophosphamide,
	bortezomib and dexamethasone (DARA-VCD) induction followed by
	autologous stem cell transplant or DARA-VCD consolidation and
	daratumumab maintenance in patients with newly diagnosed AL amyloidosis
B-Cell Malignancies
Oral Presentations
Abstract #7007	Efficacy and safety of ibrutinib plus venetoclax in patients with mantle cell
	lymphoma (MCL) and TP53 mutations in the SYMPATICO study
Abstract #7009	Outcomes in high-risk subgroups after fixed-duration ibrutinib plus venetoclax
	for CLL/SLL: up to 5.5 years of follow-up in the Phase 2 CAPTIVATE study
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Johnson & Johnson presentations at EHA 2024 Congress:

Multiple Myeloma

Oral Presentations

Abstract #S201	Daratumumab plus bortezomib/lenalidomide/dexamethasone in transplant-
	eligible patients with NDMM: analysis of MRD in the PERSEUS trial
Abstract #S204	Daratumumab (DARA) plus bortezomib/thalidomide/dexamethasone (D-VTd)
	followed by DARA maintenance in transplant-eligible NDMM: >6-year update
	of CASSIOPEIA
Abstract #S205	Ciltacabtagene autoleucel ± lenalidomide maintenance in NDMM with
	suboptimal response to frontline autologous stem cell transplant:
	CARTITUDE-2 cohort D
Poster Presentations
Abstract #P902	Real-world schedule de-escalation of teclistamab in patients with RRMM
Abstract #P911	Talquetamab, a GPRC5D×CD3 Bispecific Antibody, in combination with
	pomalidomide in patients with RRMM: safety and efficacy results from the
	hase 1b MonumenTAL-2 study
Abstract #P913	Real-life outcomes in patients with BCMA-exposed RRMM treated with
	standard of care in the LocoMMotion and MoMMent studies
Abstract #P915	Long-term efficacy and safety results from the Phase 1/2 MonumenTAL-1
	study of talquetamab, a GPRC5D×CD3 Bispecific Antibody, in patients with
	RRMM
Abstract #P920	Safety results from the Phase 3 MajesTEC-7 study in patients with transplant-
	ineligible/not intended NDMM
Abstract #P922	Outcomes of patients with extramedullary disease and RRMM from historical
	clinical trials
Abstract #P923	Efficacy and safety of teclistamab in patients with RRMM with high-risk
	features: a subgroup analysis from the Phase 1/2 MajesTEC-1 study
Abstract #P934	Longer-termfollow-up of patients receiving prophylactic tocilizumab for
	reduction of cytokine release syndrome in the Phase 1/2 MajesTEC-1 study of
	teclistamab in RRMM
Abstract #942	Long-termfollow-up from the Phase 1/2 MajesTEC-1 trial of teclistamab in
	patients with RRMM
Abstract #P953	Efficacy and safety of daratumumab monotherapy in newly diagnosed
	patients with stage 3B light-chain amyloidosis: A Phase 2 study by the
	European Myeloma Network
Abstract #P959	Ciltacabtagene autoleucel vs standard of care in patients with functional high-
	risk multiple myeloma: CARTITUDE-4 subgroup analysis
Abstract #P863	Clinical biomarkers associated with progression free survival to
	ciltacabtagene autoleucel in Chinese patients with RRMM from CARTIFAN-1
Abstract #P967	Comparative effectiveness of ciltacabtagene autoleucel from the
	CARTITUDE-4 trial vs real-world physician's choice of therapy from the
	flatiron registry in lenalidomide-refractory multiple myeloma
Abstract #P968	Final survival analysis of daratumumab plus lenalidomide and
	dexamethasone versus lenalidomide and dexamethasone in transplant-
	ineligible patients with NDMM: MAIA study
Abstract #P974	Daratumumab plus bortezomib/lenalidomide/dexamethasone (D-VRd) with d-r
	maintenance in transplant-eligible NDMM: Analysis of PERSEUS based on
	cytogenetic risk
Abstract #P978	Ciltacabtagene autoleucel vs standard of care in lenalidomide-refractory
	multiple myeloma: Phase 3 CARTITUDE-4 subgroup analysis by cytogenetic
	risk
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Abstract #P990	Real-World Schedule De-Escalation of Teclistamab in Patients With Relapsed
	or Refractory Multiple Myeloma - A US National Healthcare Claims Analysis
Abstract #P992	Teclistamab step-up dosing (SUD) and treatment dose schedule de-
	escalation in the real-world (rw) setting - an analysis of multicenter electronic
	medical records
Abstract #P1940	Exploratory analysis to identify response-related biomarkers in the China
	cohort of the Phase 1/2 MajesTEC-1 trial of teclistamab for triple-class
	exposed RRMM
Abstract #P1960	Efficacy and safety of talquetamab, a GPRC5D×CD3 bispecific antibody, in
	Chinese patients with RRMM from the Phase 1/2 MonumenTAL-1 study
Abstract #1970	Indirect treatment comparisons of daratumumab-pomalidomide-
	dexamethasone (DPd) and pomalidomide-bortezomib-dexamethasone (PVd)
	in RRMM
Abstract #1973	Real-world observations on the evolving treatment landscape and improved
	survival outcomes for multiple myeloma patients in Finland
Abstract #P1981	Real-world treatment patterns, efficacy, and safety of daratumumab-based
	regimens in Chinese patients with multiple myeloma: an updated analysis of
	the MMY4032 study
Abstract #P1987	Epidemiology and real-world management of monoclonal gammopathies
	patients in Spain by based natural language and artificial intelligence,
	the CIMMA study
B-Cell Malignancies
Poster Presentations
Abstract #P632	CLL and SLL patient demographics and patient-reported burden in ibrutinib
	and non-ibrutinib receivers in the US: a real-world study
Abstract #P664	First-line (1L) ibrutinib in patients with CLL demonstrates OS comparable to
	an age-matched European population
Abstract #P670	Final analysis of the RESONATE-2 study: up to 10 years of follow-up of first-
	line ibrutinib treatment in patients with CLL/SLL
Abstract #P675	Outcomes in high-risk subgroups after fixed-duration ibrutinib plus venetoclax
	for CLL/SLL: up to 5.5 years of follow-up in the Phase 2 CAPTIVATE study
Abstract #P694	Comparative effectiveness of ibrutinib flexible dosing treatment strategies on
	time to next treatment in a largely community-based claims database: a target
	trial emulation study
Abstract #P696	Comparison of time to next treatment between patients with CLL initiating
	first-line ibrutinib or acalabrutinib overall and in a subgroup with high-risk
	characteristics
Abstract #P699	6-Year time to next treatment (TTNT) extrapolation curve for GLOW study:
	first-line ibrutinib plus venetoclax offers long treatment-free period for
	elderly/unfit CLL patients
Abstract #P704	IBROMICS: a real-world study of clinical and biological parameters
	determining response in patients with CLL treated in first line with single agent
	ibrutinib
Abstract #P1128	Efficacy and safety of ibrutinib plus venetoclax in patients with MCL and TP53
	mutations in the SYMPATICO study
Abstract #P1835	Cross-study comparison of ibrutinib in combination with venetoclax versus
	venetoclax in combination with obinutuzumab in subjects with previously
	untreated CLL with comorbidities
Abstract #P1846	Real-world clinical outcomes of first-line ibrutinib dose reduction versus
	acalabrutinib among patients with CLL or SLL
Abstract #P2070	Dose adjustment outcomes in patients with Waldenström's macroglobulinemia
	treated with ibrutinib
Myeloid Malignancies
Oral Presentations
	7

Abstract #S133	A Phase 1b study of the Menin-KMT2A Inhibitor
	JNJ-75276617 in combination with venetoclax and azacitidine in
	relapsed/refractory acute myeloid leukemia (AML) with alterations in KMT2A
	or NPM1
Poster Presentations
Abstract #P1017	T-cell phenotyping supports the use of T-cell engaging antibodies for
	treatment of calreticulin mutated myeloproliferative neoplasms
Abstract #P1545	OS of patients with warm autoimmune hemolytic anemia in Sweden: a
	nationwide population-based study
Abstract #P1806	Treatment patterns and molecular testing across the patient journey: a real-
	world analysis in a US-based cohort of newly diagnosed and
	relapsed/refractory AML patients

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.1

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 submittedto the European Medicines Agency (EMA) seeking approval of RYBREVANT® for this indication.

In December 2023, Johnson & Johnson submitteda 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 submittedan 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 submittedto the EMA seeking approval of RYBREVANT® for this indication.

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC§ prefer next-generationsequencing-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.2 †‡
• 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.2 †‡
• 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.2 †‡

RYBREVANT® is being studied in multiple clinical trials in NSCLC, including:

• 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. Topline data for this randomized Phase 3 study demonstratedstatistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients receiving RYBREVANT®.3

8

• 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. Topline data for this randomized Phase 3 study demonstratedstatistically significant and clinically meaningful improvement in PFS in these patients receiving RYBREVANT® plus chemotherapy with and without lazertinib versus chemotherapy.4
• 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. Topline data for this randomized Phase 3 study demonstratedstatistically significant and clinically meaningful improvement in PFS in patients receiving RYBREVANT® plus lazertinib versus osimertinib.5
• The Phase 1 CHRYSALIS (NCT02609776) study evaluating RYBREVANT® in patients with advanced NSCLC.6
• 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.7
• 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.8
• The Phase 2 PALOMA-2(NCT05498428) study assessing subcutaneous amivantamab in patients with advanced or metastatic solid tumors including EGFR-mutated NSCLC.9
• 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.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-doseinfusion-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 ERLEADA®

ERLEADA® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastaticcastration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).14 ERLEADA®receivedU.S. Food and Administration (FDA) approval for nmCRPC in February 2018 and receivedU.S. FDA approval for mCSPC in September 2019. To date, more than 200,000 patients worldwide have been treated with ERLEADA®. Additional studies are ongoing in the evaluation of ERLEADA® for the treatment of localized high-risk or locally advanced prostate cancer including the Phase 3 ATLAS 15 (NCT02531516) and PROTEUS (NCT03767244) studies.

For more information, visit www.ERLEADA.com.

About BALVERSA®

BALVERSA® (erdafitinib) is a once-daily, oral FGFR kinase inhibitor indicated for the treatment of adult patients with locally advanced or mUC with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA ® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-(L)1 inhibitor therapy.15 Patients are selected for therapy based on an FDA-approved companion diagnostic for BALVERSA®. Information on FDA-approved tests for the detection of FGFR genetic alterations in urothelial cancer is available at: http://www.fda.gov/CompanionDiagnostics.

BALVERSA® received Breakthrough Therapy Designation from the U.S. FDA in 2018 and received full approvalin 2024 for the treatment of adults with locally advanced or mUC that has susceptible FGFR3 or fibroblast growth factor receptor 2 (FGFR2) genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing

chemotherapy.16 Full approval was based on the clinical and overall survival benefited in the Phase 3 THOR study.

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The Company submitted a marketing authorization application to the European Medicines Agency in September 2023 for BALVERSA ® as a treatment for adult patients with FGFR3-altered, locally advanced unresectable or mUC that has progressed following therapy with a PD-L1 inhibitor.

In 2008, Janssen Pharmaceuticals entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize BALVERSA®.

For more information, visit www.BALVERSA.com.

About CARVYKTI® (ciltacabtagene autoleucel; cilta-cel)

CARVYKTI® (cilta-cel) received U.S. Food and Drug Administration approvalin February 2022 for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.17 CARVYKTI® is now approved in the U.S. for the treatment of adult patients with relapsed or refractory myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and who are refractory to lenalidomide. In addition to a unanimous (11 to 0) FDA Oncologic Drugs Advisory Committee (ODAC) recommendation in support of this new indication, in April 2024, the European Commission approved a Type

1. variation for CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. CARVYKTI® is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient's own T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR positive T cells to eliminate cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. The CARVYKTI® CAR protein features two BCMA-targeting single domains designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.

In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI®.

For more information, visit www.CARVYKTI.com.

About DARZALEX FASPRO® and DARZALEX®

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)receivedU.S. FDA approval in May 2020 and is approved for eight indications in multiple myeloma, three of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.18 It is the only subcutaneous CD38- directed antibody approved to treat patients with MM. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.

DARZALEX® (daratumumab) received U.S. FDA approval in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.19

DARZALEX® is the first CD38-directed antibody approved to treat multiple myeloma.20 DARZALEX®-based regimens have been used in the treatment of more than 518,000 patients worldwide and more than 68,000 patients in the U.S. alone.

In August 2012,Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.

Since 2020, the National Comprehensive Cancer Network® (NCCN®) has recommended daratumumab-based combination regimens for the treatment of newly diagnosed multiple myeloma and relapsed and refractory multiple myeloma.† For newly diagnosed multiple myeloma, the NCCN® guidelines recommend daratumumab in combination with lenalidomide and dexamethasone as a Category 1 preferred regimen in non-transplant candidates; daratumumab in combination with bortezomib, melphalan, and prednisone as another recommended Category 1 regimen for non-transplant candidates; and daratumumab in combination with bortezomib, thalidomide and dexamethasone as a Category 2A regimen useful in certain circumstances for transplant candidates. In relapsed/refractory myeloma, four daratumumab regimens are listed as Category 1 preferred regimens for early relapses (1-3 prior therapies): daratumumab in combination with lenalidomide and dexamethasone; daratumumab in combination with bortezomib and dexamethasone; daratumumab in combination with carfilzomib and dexamethasone; and daratumumab in combination with pomalidomide and dexamethasone [after one prior therapy including lenalidomide and a proteasome inhibitor (PI)]. The NCCN® also recommends daratumumab in combination with cyclophosphamide, bortezomib and dexamethasone as another Category 2A regimen for early relapses (1-3 prior therapies) and as monotherapy as a Category 2A regimen useful in certain circumstances for early relapse patients after at least three prior therapies, including a PI and an immunomodulatory agent, or for patients who are double refractory to a PI and an immunomodulatory agent.

For more information, visit www.DARZALEX.com.

About TECVAYLI®

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