Johnson & Johnson : CARVYKTI® (ciltacabtagene autoleucel) Reduces Risk of Disease Progression or Death by 74 Percent in Earlier-Line Multiple Myeloma Treatment in the Landmark Phase 3 CARTITUDE-4 Study

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CARVYKTI® (ciltacabtagene autoleucel) Reduces Risk of Disease Progression or Death by 74 Percent in Earlier-Line Multiple Myeloma Treatment in the Landmark Phase 3 CARTITUDE-4 Study

At 16-months median follow-up, CARVYKTI® significantly improved progression-free survival

compared to two standard treatments1

Data presented at the 2023 ASCO and EHA Annual Meetings and published in

The New England Journal of Medicine

CHICAGO, June 5, 2023 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that results from the Phase 3 CARTITUDE-4 study showed CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) reduced the risk of disease progression or death by 74 percent compared to two standard of care treatment (SOC) regimens, pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd), in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.1 These data were featured in the press program and as an oral presentation in a special session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA106) and were simultaneously published in The New England Journal of Medicine. The results will also be presented at the European Hematology

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Association (EHA) Hybrid Congress (Abstract #S100) as part of the plenary session on Saturday, June 10, 2023. The CARTITUDE-4 study is the first randomized study investigating the efficacy of a cell therapy as early as after first relapse in multiple myeloma.2,3

"The results from the CARTITUDE-4 study highlight the potential of cilta-cel as an important treatment option for patients earlier in the disease continuum," said Binod Dhakal, M.D., M.S., Associate Professor of Medicine at the Medical College of Wisconsin, Division of Hematology, and study investigator.‡ "Cilta-cel has demonstrated a remarkably high level of efficacy in later lines of therapy, and these newest data from the CARTITUDE-4 study show its potential in earlier lines as well."

The Phase 3 CARTITUDE-4 study included patients (n=419) who received one to three prior lines of therapy, including a proteasome inhibitor (PI) and immunomodulatory agent (IMiD), and were lenalidomide-refractory.1 Patients were randomized [cilta-cel, n=208; SOC, n=211], and those in the CARVYKTI® arm then underwent apheresis.1 In the CARVYKTI® arm, 50 percent of patients were refractory to treatment with a PI and 23 percent were refractory to treatment with anti-CD38 therapies; in the SOC group, 46 percent and 21 percent of patients were refractory to PI and anti-CD38 therapies, respectively.1 Thirty-three percent of patients in the CARVYKTI® group received one prior line of treatment, compared to 32 percent of patients in the SOC group.1

At a median follow-up of 16 months, a 74 percent (Hazard Ratio [HR]=0.26; 95 percent Confidence Interval [CI], 0.18-0.38; p value p<0.0001) reduction in the risk of disease progression or death was observed in patients randomized to the CARVYKTI® arm compared to SOC treatments.1 Among patients in the CARVYKTI® arm, median progression-free survival (PFS) was not reached and in the SOC arm, median PFS was 11.8 months. PFS at 12 months for patients in the CARVYKTI® arm and SOC arm was 76 percent (95 percent CI, 69-81) and

1. percent (95 percent CI, 42-55), respectively.1 At the data cut-off, patients randomized to the CARVYKTI® arm achieved an 85 percent overall response rate (ORR) and 73 percent achieved a complete response (CR) or better.1 Among patients in the SOC arm, the ORR was

1. percent and CR or better was 22 percent.1 1In 144 patients in the CARVYKTI® arm and 101 patients in the SOC arm evaluable for minimal residual disease (MRD) status, 88 percent of patients randomized to the CARVYKTI® arm and 33 percent of patients randomized to the SOC arm achieved MRD negativity at the 10-5 threshold, respectively.1

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No new safety signals were observed in the study. Ninety-seven percent and 94 percent of patients reported grade 3 or 4 adverse events, including infections (27 percent, 25 percent) and cytopenias (94 percent, 86 percent), respectively.1 In the CARVYKTI® arm, 76 percent reported cytokine release syndrome (CRS) (1 percent grade 3, no grade 4 or 5), five percent reported immune effector cell-associated neurotoxicity syndrome (all grade 1 or 2) and one patient had a grade 1 movement and neurocognitive treatment-emergent adverse event (TEAE).1 Overall, 39 patients in the CARVYKTI® arm and 46 patients in the SOC arms died; 10 CARVYKTI® and five SOC patients passed due to TEAEs.1

"The results from the CARTITUDE-4 study clearly demonstrate the efficacy of cilta-cel when administered earlier in a patient's treatment journey," said Jordan Schecter, M.D., Vice President, Clinical Development Cellular Therapy Program, Janssen Research & Development, LLC. "At Janssen, we are committed to advancing innovative therapies to improve outcomes for patients and CARVYKTI represents an important therapy in our approach to redefine the treatment of multiple myeloma."

On May 25, 2023, Janssen submitteda Type II variation application to the European Medicines Agency (EMA) based on the CARTITUDE-4 study results seeking approval of CARVYKTI® for the earlier treatment of patients with relapsed and lenalidomide-refractory multiple myeloma.

Final Analysis of the CARTITUDE-1 Study of CARVYKTI®

Study closeout results from the Phase 1b/2 CARTITUDE-1 study (NCT03548207) of CARVYKTI® in adult patients with relapsed or refractory multiple myeloma who have received three or more prior lines of therapy including a PI, IMiD, and anti-CD38 antibody therapy showed at median follow up of 33.4 months, median PFS was 34.9 months (95 percent CI,

25.2 to not estimable [NE]), and median duration of response was 33.9 months (95 percent CI, 25.5-NE). No new safety signals or neurotoxicity events were reported since the 27.7- month median follow-up. These data were featured as a poster presentation at the 2023 ASCO Annual Meeting (Abstract #8009) and will be presented as an oral presentation at the 2023 EHA Hybrid Congress (Abstract #S202).

About CARTITUDE-4

CARTITUDE-4 (NCT04181827) is the first international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and

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dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label,multi-center study evaluating ciltacabtagene autoleucel for the treatment of patients with relapsed or refractory multiple myeloma, who previously received a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody, and who had disease progression on or after the last regimen. Patients in the study had received a median of six prior treatment regimens (range, 3-18). Of the 97 patients enrolled in the trial, 99 percent were refractory to the last line of treatment and 88 percent were triple-class refractory, meaning their cancer did not respond to, or had progressed on, an IMiD, a PI and an anti-CD38 monoclonal antibody.

About CARVYKTI® (ciltacabtagene autoleucel; cilta-cel)

CARVYKTI® 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 PI, an IMiD agent, and an anti-CD38 monoclonal antibody.4 In May 2022, the European Commission granted conditional marketing authorizationof CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an IMiD agent, a PI and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.

CARVYKTI® is a 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. entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI®.

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For more information, visit www.CARVYKTI.com.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.5 In multiple myeloma, these plasma cells change, spread rapidly and replace normal cells in the bone marrow with tumors.6 In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.7 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.8

CARVYKTI® Important Safety Information

CARVYKTI® INDICATIONS AND USAGE

CARVYKTI® (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients 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.

CARVYKTI® IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, and PROLONGED and RECURRENT CYTOPENIA

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI®. Do not administer CARVYKTI® to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of

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