Johnson & Johnson : Janssen Presents First Information from MajesTEC-2 Trial of TECVAYLI™ (teclistamab-cqyv) in Mixture with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and Lenalidomide in Relapsed or Refractory A number of Myeloma

NEW ORLEANS, December 10, 2022 – The Janssen Pharmaceutical Firms of Johnson & Johnson introduced at present new outcomes from a cohort of the Section 1b MajesTEC-2 examine of TECVAYLI™ (teclistamab-cqyv), a first-in-class, BCMAxCD3 bispecific T-cell engager antibody, together with DARZALEX FASPRO^® (daratumumab and hyaluronidase-fihj) and lenalidomide. In keeping with the outcomes, the immune-based triplet remedy routine had a manageable security profile with no sudden security indicators noticed. An excellent partial response (VGPR) or higher was achieved by 90.3 % of sufferers with relapsed or refractory a number of myeloma who had acquired one to a few prior traces of remedy, together with a proteasome inhibitor and immunomodulatory drug, with responses deepening over time.^[1] These knowledge had been offered in the course of the 2022 American Society of Hematology (ASH) Annual Assembly (Summary #160).

“These outcomes present the potential of the mixture of the bispecific BCMA-directed antibody teclistamab with the anti-CD38 antibody daratumumab and lenalidomide within the remedy of sufferers with relapsed or refractory a number of myeloma,” stated Emma Searle, M.D., Ph.D., Guide Hematologist and Honorary Senior Lecturer, The Christie Hospital and College of Manchester, England, and examine investigator.^† “That is the primary presentation of information from a teclistamab-based triplet routine and we’re keen to higher perceive how this mixture could profit sufferers by means of ongoing scientific research.”

At a median follow-up of 8.4 months (vary, 1.1 to 12.9), the general response charge (ORR) was 93.5 %.1 Amongst all sufferers within the trial, VGPRs or higher had been achieved by 90.3 % of sufferers, and 54.8 % of sufferers achieved an entire response (CR) or higher.^[1] Median time to response was one month, and responses deepened.^[1] The median time to CR or higher was three months (vary, 1 to 10.4).^[1] At knowledge cut-off, 80.6 % of sufferers remained progression-free and on remedy.^[1] Responses deepened over time, and median length of response had not been reached.^[1]

“Following the current regulatory approvals of TECVAYLI within the U.S. and EU, in addition to its inclusion within the NCCN Medical Observe Pointers in Oncology as a really useful remedy choice for sure sufferers with a number of myeloma, we’re inspired by its potential to enhance outcomes together regimens and for earlier traces of remedy,” stated Sen Zhuang, M.D., Ph.D., Vice President, Medical Analysis and Growth, Janssen Analysis & Growth, LLC. “We stay dedicated to addressing the unmet wants of sufferers with a number of myeloma by means of off-the-shelf immunotherapies like TECVAYLI and the place we will convey collectively novel therapeutic approaches within the remedy of advanced blood cancers.”

The first goal of this cohort of the MajesTEC-2 examine (NCT04722146) was to know if the immunomodulatory results of daratumumab and lenalidomide may improve the operate of TECVAYLI™, leading to enhanced antimyeloma exercise in a broader inhabitants of sufferers.^[1] The MajesTEC-7 examine (NCT05552222) will study the potential of this mixture in sufferers newly identified with a number of myeloma.

Essentially the most frequent hematological opposed occasions (AEs) noticed within the examine included neutropenia (84.4 % any grade, 78.1 % grade 3/4) and thrombocytopenia (25 % any grade, 15.6 % grade 3/4).^[1]Essentially the most frequent non-hematological AE was cytokine launch syndrome (CRS) (81.3 %, all grade 1/2); 97 % of CRS occasions occurred throughout cycle 1.^[1]

Different widespread non-hematological AEs included fatigue (46.9 % any grade, 6.3 % grade 3/4); diarrhea (46.9 % any grade, none grade 3/4); cough (40.6 % any grade, 3.1 % grade 3/4); COVID-19 (37.5 % any grade, 12.5 % grade 3/4); insomnia (37.5 % any grade, 3.1 % grade 3/4); hypophosphatemia (31.3 % any grade, 6.3 % grade 3/4); pyrexia (31.3 % any grade, 3.1 % grade 3/4); higher respiratory tract an infection (31.3 % any grade, none grade 3/4); elevated alanine aminotransferase (ALT) (28.1 % any grade, 9.4 % grade 3/4) and pneumonia (25 % any grade, 15.6 % grade 3/4).^[1] Two sufferers discontinued remedy because of an AE (COVID-19), thought-about to be unrelated to the examine by investigator evaluation.^[1]Infections had been widespread amongst sufferers within the examine and the bulk had been low grade (90.6 % any grade, 37.5 % grade 3/4).^[1]

New Information from the Section 1/2 MajesTEC-1 Research Evaluating TECVAYLI™in Relapsed or Refractory A number of Myeloma Sufferers
New correlative analyses had been additionally offered from the MajesTEC-1 examine (NCT04557098). Information from these analyses could also be used to assist higher perceive baseline immune and tumor correlatives related to outcomes in sufferers handled with TECVAYLI™.^[2] The information had been offered throughout an oral summary session (Summary #97). Extra pharmacokinetic knowledge evaluating potential drug interactions with TECVAYLI™ had been offered throughout a separate poster session (Summary #3228), in addition to analyses of serum teclistamab-cqyv concentrations after intravenous and subcutaneous administration (Summary #1911), to enhance understanding of the scientific pharmacological profile of TECVAYLI™.^[3],[4]

In regards to the MajesTEC-2 Research
MajesTEC-2 (NCT04722146); is Section 1b multicohort examine evaluating the security and efficacy of TECVAYLI™ together with different anticancer therapies in sufferers with relapsed or refractory a number of myeloma who acquired at the least one prior line of remedy.^[1] Sufferers had been eligible for remedy if they’d acquired 1-3 prior traces of remedy, together with a proteasome inhibitor and immunomodulatory drug.^[1]

Within the offered examine cohort, 32 sufferers acquired weekly doses of TECVAYLI™ (0.72 mg/kg or 1.5 mg/kg, with step-up dosing) plus the accepted schedules of DARZALEX FASPRO^® 1800 mg and lenalidomide 25 mg.^[1] Responses had been investigator assessed utilizing Worldwide Myeloma Working Group standards, and AEs had been assessed by Frequent Terminology Standards for Antagonistic Occasions (CTCAE) v5.0, apart from CRS and immune effector cell-associated neurotoxicity syndrome (ICANS), which had been graded per American Society for Transplantation and Mobile Remedy (ASTCT) pointers.^[1]

About TECVAYLI™
TECVAYLI™ (teclistamab-cqyv) acquired approval from the U.S. Meals and Drug Administration in October 2022 as an off-the-shelf (or prepared to make use of) bispecific antibody that’s administered as a subcutaneous remedy for grownup sufferers with relapsed or refractory a number of myeloma who’ve acquired at the least 4 prior traces of remedy, together with a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.^[5] In August 2022, TECVAYLI™ acquired approval from the European Fee as an off-the-shelf bispecific antibody administered as a subcutaneous remedy for grownup sufferers with relapsed or refractory a number of myeloma who’ve acquired at the least three prior traces of remedy, together with an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.^[6] Teclistamab-cqyv (TECVAYLI™) was just lately really useful by the Nationwide Complete Most cancers Community^® (NCCN^®) as a remedy choice for these sufferers. TECVAYLI™ is a first-in-class, bispecific T-cell engager antibody remedy which makes use of revolutionary science to activate the immune system by binding to the CD3 receptor expressed on the floor of T cells and to the B-cell maturation antigen (BCMA) expressed on the floor of a number of myeloma cells and a few wholesome B-lineage cells.^[7]

About DARZALEX FASPRO^®
DARZALEX FASPRO^® (daratumumab and hyaluronidase-fihj)acquired U.S. FDA approval in Might 2020 and is accepted for eight indications in a number of myeloma (MM), three of that are for frontline remedy in newly identified sufferers who’re transplant eligible or ineligible.^[8]It’s the solely subcutaneous CD38-directed antibody accepted to deal with sufferers with MM. DARZALEX FASPRO^® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE^® drug supply expertise.

About A number of Myeloma
A number of myeloma is an incurable blood most cancers that impacts a sort of white blood cell known as plasma cells, that are discovered within the bone marrow.^[9] In a number of myeloma, these plasma cells change, unfold quickly and exchange regular cells within the bone marrow with tumors.^[10] In 2022, it’s estimated that greater than 34,000 individuals will likely be identified with a number of myeloma, and greater than 12,000 individuals will die from the illness within the U.S.^[11] Whereas some individuals identified with a number of myeloma initially haven’t any signs, most sufferers are identified because of signs that may embrace bone fracture or ache, low crimson blood cell counts, tiredness, excessive calcium ranges, kidney issues or infections.^[12]

TECVAYLI™ IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY together with IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

• Cytokine launch syndrome (CRS), together with life-threatening or deadly reactions, can happen in sufferers receiving TECVAYLI™. Provoke remedy with TECVAYLI™ step-up dosing schedule to cut back threat of CRS.
• Neurologic toxicity, together with Immune Effector Cell-Related Neurotoxicity Syndrome (ICANS) and critical and life-threatening reactions, can happen in sufferers receiving TECVAYLI™. Monitor sufferers for indicators or signs of neurologic toxicity, together with ICANS, throughout remedy and deal with promptly.
• TECVAYLI™ is accessible solely by means of a restricted program known as the TECVAYLI™ Danger Analysis and Mitigation Technique (REMS).

WARNINGS AND PRECAUTIONS

Cytokine Launch Syndrome: TECVAYLI™ may cause cytokine launch syndrome (CRS), together with life-threatening or deadly reactions. Within the scientific trial, CRS occurred in 72% of sufferers who acquired TECVAYLI™ on the really useful dose, with Grade 1 CRS occurring in 50% of sufferers, Grade 2 in 21%, and Grade 3 in 0.6%. Recurrent CRS occurred in 33% of sufferers. Most sufferers skilled CRS following step-up dose 1 (42%), step-up dose 2 (35%), or the preliminary remedy dose (24%). Lower than 3% of sufferers developed first incidence of CRS following subsequent doses of TECVAYLI™. The median time to onset of CRS was 2 (vary: 1 to six) days after the latest dose with a median length of two (vary: 1 to 9) days. Medical indicators and signs of CRS included, however weren’t restricted to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation).

Provoke remedy in keeping with TECVAYLI™ step-up dosing schedule to cut back threat of CRS. Administer pretreatment drugs to cut back threat of CRS and monitor sufferers following administration of TECVAYLI™ accordingly. On the first signal of CRS, instantly consider affected person for hospitalization, handle per consensus pointers, and administer supportive care primarily based on severity; withhold or completely discontinue TECVAYLI™ primarily based on severity.

TECVAYLI™ is accessible solely by means of a restricted program beneath a REMS.

Neurologic Toxicity together with ICANS: TECVAYLI™ may cause critical or life-threatening neurologic toxicity, together with Immune Effector Cell-Related Neurotoxicity Syndrome (ICANS)

Within the scientific trial, neurologic toxicity occurred in 57% of sufferers who acquired TECVAYLI™ on the really useful dose, with Grade 3 or 4 neurologic toxicity occurring in 2.4% of sufferers. Essentially the most frequent neurologic toxicities had been headache (25%), motor dysfunction (16%), sensory neuropathy (15%), and encephalopathy (13%). With longer follow-up, Grade 4 seizure and deadly Guillain-Barré syndrome (one affected person every) occurred in sufferers who acquired TECVAYLI™.

Within the scientific trial, ICANS was reported in 6% of sufferers who acquired TECVAYLI™ on the really useful dose [see Adverse Reactions (6.1)]. Recurrent ICANS occurred in 1.8% of sufferers. Most sufferers skilled ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the preliminary remedy dose (1.8%). Lower than 3% of sufferers developed first incidence of ICANS following subsequent doses of TECVAYLI™. The median time to onset of ICANS was 4 (vary: 2 to eight) days after the latest dose with a median length of three (vary: 1 to twenty) days.Essentially the most frequent scientific manifestations of ICANS reported had been confusional state and dysgraphia. The onset of ICANS will be concurrent with CRS, following decision of CRS, or within the absence of CRS.

Monitor sufferers for indicators and signs of neurologic toxicity throughout remedy. On the first signal of neurologic toxicity, together with ICANS, instantly consider affected person and supply supportive remedy primarily based on severity; withhold or completely discontinue TECVAYLI™ primarily based on severity and observe administration suggestions.

Because of the potential for neurologic toxicity, sufferers are liable to depressed stage of consciousness. Advise sufferers to chorus from driving or working heavy or doubtlessly harmful equipment throughout and for 48 hours after completion of TECVAYLI™ step-up dosing schedule and within the occasion of latest onset of any neurologic toxicity signs till neurologic toxicity resolves.

TECVAYLI™ is accessible solely by means of a restricted program beneath a REMS.

TECVAYLI™ REMS: TECVAYLI™ is accessible solely by means of a restricted program beneath a REMS known as the TECVAYLI™ REMS due to the dangers of CRS and neurologic toxicity, together with ICANS.

Hepatotoxicity: TECVAYLI™ may cause hepatoxicity, together with fatalities. In sufferers who acquired TECVAYLI™ on the really useful dose within the scientific trial, there was one deadly case of hepatic failure. Elevated aspartate aminotransferase (AST) occurred in 34% of sufferers, with Grade 3 or 4 elevations in 1.2%. Elevated alanine aminotransferase (ALT) occurred in 28% of sufferers, with Grade 3 or 4 elevations in 1.8%. Elevated whole bilirubin occurred in 6% of sufferers with Grade 3 or 4 elevations in 0.6%. Liver enzyme elevation can happen with or with out concurrent CRS.

Monitor liver enzymes and bilirubin at baseline and through remedy as clinically indicated. Withhold TECVAYLI™ or contemplate everlasting discontinuation of TECVAYLI™ primarily based on severity.

Infections: TECVAYLI™may cause extreme, life-threatening, or deadly infections. In sufferers who acquired TECVAYLI™ on the really useful dose within the scientific trial, critical infections, together with opportunistic infections, occurred in 30% of sufferers, with Grade 3 or 4 infections in 35%, and deadly infections in 4.2%. Monitor sufferers for indicators and signs of an infection previous to and through remedy with TECVAYLI™ and deal with appropriately. Administer prophylactic antimicrobials in keeping with pointers. Withhold TECVAYLI™ or contemplate everlasting discontinuation of TECVAYLI™ primarily based on severity.

Monitor immunoglobulin ranges throughout remedy with TECVAYLI™ and deal with in keeping with pointers, together with an infection precautions and antibiotic or antiviral prophylaxis.

Neutropenia: TECVAYLI™ may cause neutropenia and febrile neutropenia. In sufferers who acquired TECVAYLI™ on the really useful dose within the scientific trial, decreased neutrophils occurred in 84% of sufferers, with Grade 3 or 4 decreased neutrophils in 56%. Febrile neutropenia occurred in 3% of sufferers.

Monitor full blood cell counts at baseline and periodically throughout remedy and supply supportive care per native institutional pointers.

Monitor sufferers with neutropenia for indicators of an infection.

Withhold TECVAYLI™ primarily based on severity [see Dosage and Administration (2.4)].

Hypersensitivity and Different Administration Reactions: TECVAYLI™ may cause each systemic administration-related and native injection-site reactions. Systemic Reactions – In sufferers who acquired TECVAYLI™ on the really useful dose within the scientific trial, 1.2% of sufferers skilled systemic-administration reactions, which included Grade 1 recurrent pyrexia and Grade 1 swollen tongue. Native Reactions – In sufferers who acquired TECVAYLI™ on the really useful dose within the scientific trial, injection-site reactions occurred in 35% of sufferers with Grade 1 injection-site reactions in 30% and Grade 2 in 4.8%. Withhold TECVAYLI™ or contemplate everlasting discontinuation of TECVAYLI™ primarily based on severity.

Embryo-Fetal Toxicity: Based mostly on its mechanism of motion, TECVAYLI™ could trigger fetal hurt when administered to a pregnant girl. Advise pregnant ladies of the potential threat to the fetus. Advise females of reproductive potential to make use of efficient contraception throughout remedy with TECVAYLI™ and for five months after the final dose.

Antagonistic Reactions: The most typical opposed reactions (≥20%) had been pyrexia, CRS, musculoskeletal ache, injection web site response, fatigue, higher respiratory tract an infection, nausea, headache, pneumonia, and diarrhea. The most typical Grade 3 to 4 laboratory abnormalities (≥20%) had been decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin and decreased platelets.

Please learn full Prescribing Data together with Boxed Warning for TECVAYLI™.

DARZALEX FASPRO^®IMPORTANT SAFETY INFORMATION

INDICATIONS

DARZALEX FASPRO^® (daratumumab and hyaluronidase-fihj) is indicated for the remedy of grownup sufferers with a number of myeloma:

• Together with bortezomib, melphalan, and prednisone in newly identified sufferers who’re ineligible for autologous stem cell transplant
• Together with lenalidomide and dexamethasone in newly identified sufferers who’re ineligible for autologous stem cell transplant and in sufferers with relapsed or refractory a number of myeloma who’ve acquired at the least one prior remedy
• Together with bortezomib, thalidomide, and dexamethasone in newly identified sufferers who’re eligible for autologous stem cell transplant
• Together with pomalidomide and dexamethasone in sufferers who’ve acquired at the least one prior line of remedy together with lenalidomide and a proteasome inhibitor
• Together with carfilzomib and dexamethasone in sufferers with relapsed or refractory a number of myeloma who’ve acquired one to a few prior traces of remedy
• Together with bortezomib and dexamethasone in sufferers who’ve acquired at the least one prior remedy
• As monotherapy in sufferers who’ve acquired at the least three prior traces of remedy together with a proteasome inhibitor (PI) and an immunomodulatory agent or who’re double-refractory to a PI and an immunomodulatory agent

CONTRAINDICATIONS
DARZALEX FASPRO^®is contraindicated in sufferers with a historical past of extreme hypersensitivity to daratumumab, hyaluronidase or any of the elements of the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Different Administration Reactions
Each systemic administration-related reactions, together with extreme or life-threatening reactions, and native injection-site reactions can happen with DARZALEX FASPRO^®. Deadly reactions have been reported with daratumumab-containing merchandise, together with DARZALEX FASPRO^®.

Systemic Reactions

In a pooled security inhabitants of 898 sufferers with a number of myeloma (N=705) or gentle chain (AL) amyloidosis (N=193) who acquired DARZALEX FASPRO^® as monotherapy or together, 9% of sufferers skilled a systemic administration-related response (Grade 2: 3.2%, Grade 3: 1%). Systemic administration-related reactions occurred in 8% of sufferers with the primary injection, 0.3% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (vary: 4 minutes to three.5 days). Of the 140 systemic administration-related reactions that occurred in 77 sufferers, 121 (86%) occurred on the day of DARZALEX FASPRO^® administration. Delayed systemic administration-related reactions have occurred in 1% of the sufferers.

Extreme reactions included hypoxia, dyspnea, hypertension and tachycardia. Different indicators and signs of systemic administration-related reactions could embrace respiratory signs, equivalent to bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, in addition to anaphylactic response, pyrexia, chest ache, pruritis, chills, vomiting, nausea, and hypotension.

Pre-medicate sufferers with histamine-1 receptor antagonist, acetaminophen and corticosteroids. Monitor sufferers for systemic administration-related reactions, particularly following the primary and second injections. For anaphylactic response or life-threatening (Grade 4) administration-related reactions, instantly and completely discontinue DARZALEX FASPRO^®. Contemplate administering corticosteroids and different drugs after the administration of DARZALEX FASPRO^®relying on dosing routine and medical historical past to reduce the chance of delayed (outlined as occurring the day after administration) systemic administration-related reactions.

Native Reactions

On this pooled security inhabitants, injection-site reactions occurred in 8% of sufferers, together with Grade 2 reactions in 0.7%. Essentially the most frequent (>1%) injection-site response was injection web site erythema. These native reactions occurred a median of 5 minutes (vary: 0 minutes to six.5 days) after beginning administration of DARZALEX FASPRO^®. Monitor for native reactions and contemplate symptomatic administration.

Cardiac Toxicity in Sufferers with Gentle Chain (AL) Amyloidosis
Critical or deadly cardiac opposed reactions occurred in sufferers with gentle chain (AL) amyloidosis who acquired DARZALEX FASPRO^® together with bortezomib, cyclophosphamide and dexamethasone. Critical cardiac problems occurred in 16% and deadly cardiac problems occurred in 10% of sufferers. Sufferers with NYHA Class IIIA or Mayo Stage IIIA illness could also be at better threat. Sufferers with NYHA Class IIIB or IV illness weren’t studied. Monitor sufferers with cardiac involvement of sunshine chain (AL) amyloidosis extra often for cardiac opposed reactions and administer supportive care as acceptable.

Neutropenia
Daratumumab could improve neutropenia induced by background remedy. Monitor full blood cell counts periodically throughout remedy in keeping with producer’s prescribing info for background therapies. Monitor sufferers with neutropenia for indicators of an infection. Contemplate withholding DARZALEX FASPRO^®till restoration of neutrophils. In decrease physique weight sufferers receiving DARZALEX FASPRO^®, increased charges of Grade 3-4 neutropenia had been noticed.

Thrombocytopenia
Daratumumab could improve thrombocytopenia induced by background remedy. Monitor full blood cell counts periodically throughout remedy in keeping with producer’s prescribing info for background therapies. Contemplate withholding DARZALEX FASPRO^® till restoration of platelets.

Embryo-Fetal Toxicity
Based mostly on the mechanism of motion, DARZALEX FASPRO^® may cause fetal hurt when administered to a pregnant girl. DARZALEX FASPRO^® could trigger depletion of fetal immune cells and decreased bone density. Advise pregnant ladies of the potential threat to a fetus. Advise females with reproductive potential to make use of efficient contraception throughout remedy with DARZALEX FASPRO^® and for 3 months after the final dose.

The mix of DARZALEX FASPRO^® with lenalidomide is contraindicated in pregnant ladies, as a result of lenalidomide could trigger delivery defects and dying of the unborn baby. Discuss with the lenalidomide prescribing info on use throughout being pregnant.

Interference with Serological Testing
Daratumumab binds to CD38 on crimson blood cells (RBCs) and ends in a optimistic Oblique Antiglobulin Check (Oblique Coombs check). Daratumumab-mediated optimistic oblique antiglobulin check could persist for as much as 6 months after the final daratumumab administration. Daratumumab certain to RBCs masks detection of antibodies to minor antigens within the affected person’s serum. The dedication of a affected person’s ABO and Rh blood sort should not impacted. Notify blood transfusion facilities of this interference with serological testing and inform blood banks {that a} affected person has acquired DARZALEX FASPRO^®. Sort and display screen sufferers previous to beginning DARZALEX FASPRO^®.

Interference with Dedication of Full Response
Daratumumab is a human IgG kappa monoclonal antibody that may be detected on each the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the scientific monitoring of endogenous M-protein. This interference can affect the dedication of full response and of illness development in some DARZALEX FASPRO^®-treated sufferers with IgG kappa myeloma protein.

ADVERSE REACTIONS
The most typical opposed response (≥20%) with DARZALEX FASPRO^® monotherapy is higher respiratory tract an infection. The most typical opposed reactions with mixture remedy (≥20% for any mixture) embrace fatigue, nausea, diarrhea, dyspnea, insomnia, pyrexia, cough, muscle spasms, again ache, vomiting, higher respiratory tract an infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema.

The most typical opposed reactions (≥20%) in sufferers with gentle chain (AL) amyloidosis who acquired DARZALEX FASPRO^® are higher respiratory tract an infection, diarrhea, peripheral edema, constipation, fatigue, peripheral sensory neuropathy, nausea, insomnia, dyspnea, and cough.

The most typical hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO^® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

Please see full Prescribing Data for DARZALEX FASPRO^®.

In regards to the Janssen Pharmaceutical Firms of Johnson & Johnson
At Janssen, we’re making a future the place illness is a factor of the previous. We are the Pharmaceutical Firms of Johnson & Johnson, working tirelessly to make that future a actuality for sufferers in every single place by combating illness with science, enhancing entry with ingenuity, and therapeutic hopelessness with coronary heart. We concentrate on areas of drugs the place we will make the largest distinction: Cardiovascular, Metabolism & Retina; Immunology; Infectious Illnesses & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

Be taught extra at www.janssen.com. Comply with us at @JanssenGlobal and @JanssenUS. Janssen Analysis & Growth, LLC and Janssen Biotech, Inc. are a part of the Janssen Pharmaceutical Firms of Johnson & Johnson.

^† Dr. Searle has served as a advisor to Janssen; she has not been paid for any media work.

Cautions Regarding Ahead-Wanting Statements
This press launch accommodates “forward-looking statements” as outlined within the Non-public Securities Litigation Reform Act of 1995 relating to product improvement and the potential advantages and remedy affect of TECVAYLI™ (teclistamab). 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 may range materially from the expectations and projections of Janssen Analysis & Growth, LLC, Janssen Biotech, Inc., any of the opposite Janssen Pharmaceutical Firms and/or Johnson & Johnson. Dangers and uncertainties embrace, however should not restricted to: challenges and uncertainties inherent in product analysis and improvement, together with the uncertainty of scientific success and of acquiring regulatory approvals; uncertainty of business success; manufacturing difficulties and delays; competitors, together with technological advances, new merchandise and patents attained by rivals; challenges to patents; product efficacy or security issues leading to product recollects or regulatory motion; modifications in habits and spending patterns of purchasers of well being care services and products; modifications to relevant legal guidelines and rules, together with international well being care reforms; and developments towards well being care value containment. An additional checklist and descriptions of those dangers, uncertainties and different components will be present in Johnson & Johnson’s Annual Report on Type 10-Okay for the fiscal 12 months ended January 2, 2022, together with within the sections captioned “Cautionary Be aware Concerning Ahead-Wanting Statements” and “Merchandise 1A. Danger Elements,” and in Johnson & Johnson’s subsequent Quarterly Reviews 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. Not one of the Janssen Pharmaceutical Firms nor Johnson & Johnson undertakes to replace any forward-looking assertion because of new info or future occasions or developments.

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[1] Searle, et. al. Teclistamab in Mixture with Subcutaneous Daratumumab and Lenalidomide in Sufferers with A number of Myeloma: Outcomes from One Cohort of MajesTEC-2, a Phase1b, Multicohort Research. American Society of Hematology Assembly 2022. December 2022.

[2] Cortes-Selva, et. al. Teclistamab, a B-cell Maturation Antigen (BCMA) x CD3 Bispecific Antibody, in Sufferers with Relapsed/Refractory A number of Myeloma (RRMM): Correlative Analyses from MajesTEC-1. American Society of Hematology Assembly 2022. December 2022.

[3] Marie-Emilie Willemin, et. al. Drug Interplay Potential As a Results of Cytokine Launch Syndrome Utilizing a Physiologically Based mostly Pharmacokinetic Mannequin: Case Research of Teclistamab. American Society of Hematology Assembly 2022. December 2022.

[4] Xin Miao, et. al. Teclistamab Inhabitants Pharmacokinetics and Publicity-Response Relationship Assist 1.5 Mg/Kg Dose Routine in Relapsed/Refractory A number of Myeloma. American Society of Hematology Assembly 2022. December 2022.

[5] TECVAYLI™ U.S. Prescribing Data. October 2022.

[6] Padala SA et al. Epidemiology, Staging, and Administration of A number of Myeloma. Med Sci (Basel). 2021;9(1):3.

[7] Frerichs KA et al. Clin Most cancers Res. 2020; doi: 10.1158/1078-0432.CCR-19-2299.

[8] DARZALEX FASPRO^® Prescribing Data, March 2021.

[9] Rajkumar SV. A number of myeloma: 2020 replace on analysis, risk-stratification and administration. Am J Hematol.2020;95(5):548-5672020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178.

[10] Nationwide Most cancers Institute. Plasma Cell Neoplasms. Accessed September 2022. https://www.most cancers.gov/sorts/myeloma/affected person/myeloma-treatment-pdq.

[11] American Most cancers Society. “Key Statistics About A number of Myeloma.” Out there at: https://www.most cancers.org/most cancers/multiple-myeloma/about/key-statistics.html#:~:textual content=Multiplepercent20myelomapercent20ispercent20apercent20relatively,menpercent20andpercent2015percent2C370percent20inpercent20women). Accessed September 2022.

[12] American Most cancers Society. “What Is A number of Myeloma?” Out there at: https://www.most cancers.org/most cancers/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed September 2022.