Johnson & Johnson : Janssen Aims to Define New Standards of Care in the Treatment of Solid Tumor Cancers with Transformative Data Planned for Presentation at ESMO

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Janssen Aims to Define New Standards of Care in the Treatment of Solid Tumor

Cancers with Transformative Data Planned for Presentation at ESMO

Three Phase 3 RYBREVANT® (amivantamab-vmjw) studies (MARIPOSA, MARIPOSA-2 and PAPILLON) in EGFR-mutated lung cancer achieved statistically significant and clinically meaningful progression-free survival endpoints and will be presented in Presidential Symposium sessions

New results for investigational TAR-200 and TAR-210 novel intravesical delivery system highlight potential for transformational outcomes in the treatment of bladder cancer

RARITAN, N.J., October 16, 2023 - The Janssen Pharmaceutical Companies of Johnson

• Johnson announced today that nine oral presentations from the Company's robust solid tumor portfolio and pipeline, with three highlighted in Presidential Symposium sessions, will be featured at the European Society for Medical Oncology (ESMO) 2023 Congress. In total, 19 studies (17 company-sponsored abstracts and two investigator-initiated studies), including seven late-breaking abstracts, will feature new data and updates in lung cancer, bladder cancer, and prostate cancer, highlighting Janssen's pioneering efforts to transform the treatment of solid tumors.

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"The data and results premiering at this year's ESMO represent our determination to advance oncology science and set new innovation standards in the treatment of solid tumor malignancies," said Peter Lebowitz, M.D., PhD, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "We are uniquely positioned to build upon our legacy of innovation in oncology as we aim to improve patients' lives by transforming the treatment of non-small cell lung cancer and genitourinary cancers where massive unmet needs persist."

"This year marks Janssen's largest number of clinical presentations ever at the leading global oncology conference in Europe, highlighting our progress and commitment in bringing forward novel therapies and precision medicines," said Martin Vogel, EMEA Therapeutic Area Lead Oncology, Janssen-Cilag GmbH. "The evolution of targeted therapeutics in oncology presents a promising path forward to bring the very latest innovations to patients. We are proud to be at the forefront of advancing and delivering novel therapies as we continue our efforts to ultimately eliminate cancer."

Key ESMO Presentations

Groundbreaking research in lung cancer at ESMO reinforces Janssen's ambition to transform the trajectory of disease, including in epidermal growth factor receptor (EGFR)- mutated non-small cell lung cancer (NSCLC).

Highlights include:

• A Presidential Symposium presentation from the Phase 3 MARIPOSA study, the largest study conducted to date in EGFR-mutated NSCLC, evaluating RYBREVANT® in combination with lazertinib versus osimertinib as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC (Abstract #LBA14).
• A Presidential Symposium presentation from the Phase 3 MARIPOSA-2 study evaluating RYBREVANT® plus chemotherapy, given with or without lazertinib, versus chemotherapy alone in patients with locally advanced or metastatic EGFR-mutated NSCLC with disease progression after treatment with osimertinib (Abstract #LBA15).
• A Presidential Symposium presentation from the Phase 3 PAPILLON
  study evaluating RYBREVANT® in combination with chemotherapy as a first-

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line treatment for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations (Abstract #LBA5).

Data in bladder cancer underscore Janssen's ambition to advance new therapies and approaches to address unmet treatment needs.

Key presentations include:

• An oral presentation from the Phase 2b SunRISe-1 study evaluating TAR-200 monotherapy in patients with Bacillus Calmette-Guerin(BCG)-unresponsivehigh-risknon-muscle invasive bladder cancer (NMIBC) (Abstract #LBA105).
• An oral presentation of the first safety and efficacy results from the Phase 1 TAR-210 (erdafitinib intravesical delivery system) study investigating patients with NMIBC with select fibroblast growth factor receptor (FGFR) alterations (Abstract #LBA104).
• An oral presentation from the Phase 2 THOR-2 study evaluating BALVERSA® versus intravesical chemotherapy in patients with high-risk NMIBC with select FGFR alterations who received prior BCG treatment (Abstract #LBA102)
• Two oral presentations highlighting data from Cohort 1 and Cohort 2 of the Phase 3 THOR study. Cohort 1 includes results investigating subgroup analyses of erdafitinib versus chemotherapy in patients with prior therapy including a checkpoint inhibitor with advanced or metastatic urothelial cancer (mUC) with select FGFR alterations (Abstract #2362MO). Cohort 2 includes findings evaluating erdafitinib versus pembrolizumab in pretreated patients with mUC and select FGFR alterations (Abstract #2359O).

Building on a legacy in the treatment of prostate cancer, data at ESMO highlight precision-driven and patient-centric strategies across the disease continuum.

Key highlights include:

• An oral presentation from the final analysis of the Phase 3 MAGNITUDE study evaluating niraparib with abiraterone acetate plus prednisone in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations, especially BRCA alterations (Abstract # LBA85).

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• A poster presentation on the efficacy of niraparib with abiraterone acetate plus prednisone in HRR+ mCRPC by tissue and/or plasma assays in the Phase 3 MAGNITUDE trial (Abstract #1806P).
• A poster presentation on results from the Phase 3 TITAN study evaluating the prognostic importance of prostate-specific antigen decline (≤0.2 ng/mL) in patients with metastatic castration-sensitive prostate cancer (mCSPC) who received apalutamide plus androgen deprivation therapy (Abstract #1786P).

All Janssen-sponsored abstracts to be presented are listed below:

Lung Cancer

RYBREVANT® (amivantamab-vmjw)

Presidential Sessions

Abstract #LBA5	Amivantamab plus carboplatin/pemetrexed vs
	carboplatin/pemetrexed as first line treatment in
	EGFR exon 20 insertion-mutated advanced NSCLC:
	primary results from PAPILLON, a randomized
	Phase 3 global study
Abstract #LBA15	Amivantamab plus chemotherapy (with or without
	lazertinib) vs chemotherapy alone in EGFR-
	mutated, advanced NSCLC after progression on
	osimertinib: MARIPOSA-2, a Phase 3, global,
	randomized, controlled trial
Abstract #LBA14	Amivantamab plus lazertinib vs osimertinib as first-
	line treatment in patients with EGFR-mutated,
	advanced NSCLC: primary results from MARIPOSA,
	a Phase 3, global, randomized, controlled trial
Poster Session

Abstract #1506TiP

A single-arm, phase 2 study of amivantamab, lazertinib and pemetrexed for first-line treatment of recurrent/metastatic NSCLCs with EGFR mutations: AMIGO-1 (LACOG0821)

Bladder Cancer

BALVERSA® (erdafitinib)

Mini Oral

Abstract #2362MO	Erdafitinib (erda) vs chemotherapy (chemo) in
	patients with advanced or metastatic urothelial
	cancer with select FGFR alterations (FGFRalt):
	subgroups from the Phase 3 THOR study
Proffered Paper
Abstract #2359O	Phase 3 THOR study: results of erdafitinib (erda) vs
	pembrolizumab (pembro) in pretreated patients
	with advanced or metastatic urothelial cancer with
	select FGFRalt
Abstract #LBA102	THOR-2 cohort 1: results of erdafitinib (ERDA) vs
	intravesical chemotherapy (chemo) in patients with
	high-risk (HR) NMIBC with select FGFRalt who
	received prior BCG treatment
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Poster Session

Abstract #192P		Impact of oncogenic FGFR alterations in patients
		with advanced solid tumors in a real-world setting
Abstract #230P		FGFR co-alteration(co-alt) landscape and its impact
		on erdafitinib (erda) response in the Phase 2 open-
		label, single-arm RAGNAR trial
Abstract #1621P		Efficacy and safety of erdafitinib in adults with
		pancreatic cancer and prespecified FGFRalt in the
		Phase 2 open-label,single-arm RAGNAR trial
TAR-200
Mini Oral
Abstract #LBA105		Results from SunRISe-1 in patients with BCG
		unresponsive high-risk NMIBC receiving TAR-200
		monotherapy
Poster Session
Abstract #2407TiP		SunRISe-3:TAR-200 plus cetrelimab (CET) or TAR-
		200 versus intravesical BCG in patients with BCG-
		naïve HR NMIBC
TAR-210
Mini Oral
Abstract #LBA104		First safety and efficacy results of the TAR-210
		erdafitinib (erda) intravesical delivery system in pts
		with NMIBC with select FGFRalt
Prostate Cancer
AKEEGA™ (niraparib)
Mini Oral
Abstract #LBA85		Niraparib (NIRA) with abiraterone acetate and
		prednisone (AAP) as first-line therapy in patients
		(pts) with mCRPC and HRR gene alterations: final
		analysis of MAGNITUDE
Poster Session
Abstract #1806P		MAGNITUDE efficacy by assay: efficacy of niraparib
		and abiraterone acetate plus prednisone
		(NIRA+AAP) in HRR gene-altered mCRPC by tissue
		and/or plasma assays in the MAGNITUDE trial
Abstract #1835P		A prospective study to determine the prevalence of
		DNA repair defects in patients with advanced
		prostate cancer
ERLEADA® (apalutamide)
Poster Session

Abstract #1786P

Effect of rapid ultra-lowprostate-specific antigen decline (UL PSA) in TITAN patients with mCSPC who received apalutamide (APA) plus androgen deprivation therapy (ADT)

About RYBREVANT®

RYBREVANT® (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET with immune cell-driven activity, receivedaccelerated approval by the U.S. Food and Drug Administration (FDA) in May 2021 for the treatment of adult patients with locally

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