Lethargy

Patients, providers, and public are invited to help save lives by sharing messages and materialsPASADENA, Calif. and CELEBRATION, Fla., Oct. 09, 2024 (GLOBE NEWSWIRE) -- The National Urea Cycle Disorders Foundation (NUCDF) and Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) are teaming up to launch an awareness campaign during the month of October to improve the diagnosis of urea cycle disorders (UCDs). Their goal is to highlight the critical importance of promptly checking blood ammonia levels and using proper testing techniques. A blood ammonia test is essential to uncover elevated ammonia levels (hyperammonemia), the classic sign of a urea cycle disorder. Resources on recognizing and testing for hyperammonemia are featured on the campaign website, checkammonia.com. Quickly diagnosing UCDs is critical. Toxic ammonia levels can rise rapidly in affected individuals, which if left untreated, can cause coma and death. Newborns with severe UCDs typically become catastrophically ill within 36-48 hours after birth. It is estimated that up to 20% of sudden infant death syndrome (SIDS) cases may be attributed to an undiagnosed inborn error of metabolism such as a UCD. Adults with undiagnosed UCDs may present at emergency rooms with staggering, confusion, combativeness and disorientation that is mistaken for alcohol or drug intoxication, and many die. The campaign’s primary message is that a blood ammonia test, performed promptly and properly, can save lives. Downloadable campaign resources focus on (1) Recognizing the signs of UCDs and promptly ordering a test and (2) Following proper test procedures. About Urea Cycle Disorders A urea cycle disorder is caused by a genetic mutation—a change in a person’s genes—that leads to a deficiency of one of the enzymes needed to metabolize protein. These missing or reduced enzymes make the process less efficient, allowing ammonia to build up in the bloodstream. High ammonia levels are toxic to the brain, causing a range of physical, neurological, and behavioral symptoms. UCDs can strike at any age. Those with more severe UCDs (greater enzyme deficiency) typically become symptomatic very shortly after birth. Those with less severe UCDs (less enzyme deficiency) can develop symptoms at any time later in life. Signs of UCDs The Check Ammonia campaign website highlights the early signs of hyperammonemia in newborns and in infants, children, and adults that should prompt a blood ammonia test. Key warning signs include: Newborns from 1 to 28 days old: poor feeding or vomiting, hypotonia (poor muscle tone or floppiness), lethargy (difficult to wake up), respiratory distress, seizures, or coma.Older infants and children: inconsolable crying, agitation, or hyperactive behavior sometimes accompanied by screaming, self-injurious behavior, and refusal to eat meat or other high-protein foods. Later symptoms may include frequent episodes of vomiting, especially following high-protein meals, lethargy and delirium. Older children may be referred to child psychologists because of their behavior, developmental delays, and eating problems.Adults with high blood ammonia levels: disorientation, confusion, slurred speech, unusual and extreme combativeness or agitation, stroke-like symptoms, lethargy and delirium. Many may be seen by neurologists or psychiatrists because of psychiatric symptoms, including schizophrenia and bipolar disorder. Who should get tested? Routine ammonia checks aren’t necessary for everyone, but the test is crucial for those experiencing symptoms that could be high ammonia. How is high ammonia treated? Once identified, high ammonia levels can be managed and treated in several ways. These treatments may include medications, dietary changes including protein restriction, managing underlying conditions, or hospitalization in more severe cases, especially if neurological symptoms are present. Join the Campaign Patients, providers, and the public are invited to help share the campaign’s messages and materials widely. For electronic copies of campaign materials, visit checkammonia.com. Contact info@nucdf.org with questions or to request hard copies you can deliver to pediatricians, hospitals, emergency rooms, and other healthcare providers in your area. Follow the NUCDF’s social media sites (Facebook, LinkedIn, Instagram and YouTube) to share materials throughout the month. Learn more and hear patient stories: Watch a video on recognizing the signs of urea cycle disorders. Read about Jennings, an infant who passed away three days after he was born due to an undiagnosed UCD. Hear about Zoey, a 19-year-old girl who lost her life suddenly at age 19 from an undiagnosed urea cycle disorder. Read about Jim Stavas, a fireman who fell into a coma and died after sinus surgery due to an undiagnosed UCD (under “Why we ride”). About the National Urea Cycle Disorders Foundation: NUCDF is a nonprofit organization dedicated to saving and improving the lives of children and adults affected by urea cycle disorders (UCDs) and raising awareness since 1988. Led exclusively by patients and families affected by UCDs, we are the driving force behind critical research to improve the understanding and management of UCDs, find new treatments, and ultimately a cure. NUCDF serves as a lifeline to patients, families, and medical professionals worldwide seeking information, support, and hope. Visit www.nucdf.org or email info@nucdf.org. About Zevra Therapeutics: Zevra Therapeutics, Inc. is a commercial-stage rare disease company combining science, data, and patient needs to create transformational therapies for diseases with limited or no treatment options. Our mission is to bring life-changing therapeutics to people living with rare diseases. With unique, data-driven development and commercialization strategies, the Company is overcoming complex drug development challenges to make new therapies available to the rare disease community. For more information, please visit www.zevra.com or follow us on X (formerly Twitter) and LinkedIn. Caution Concerning Forward-Looking Statements: This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding upcoming events or Zevra’s participation at such events. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the "Risk Factors" section of Zevra’s Annual Report on Form 10-K for the year ended December 31, 2023, Zevra’s Quarterly Report for the quarter ended June 30, 2024, and Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking3 statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release. NUCDF Contact Jill Williams, 513-288-1509, jwilliams@nucdf.org Zevra Contact Nichol Ochsner, +1 (732) 754-2545, nochsner@zevra.com

SUZHOU, China, Oct. 7, 2024 /PRNewswire/ -- MediLink Therapeutics (Suzhou) Co., Ltd. ("MediLink"), a clinical-stage biotech company, today announced a global clinical trial collaboration and supply agreement with Amgen Inc. Amgen will lead a global clinical study to evaluate the therapeutic potential of the combination of MediLink's B7-H3-targeting antibody-drug conjugate (ADC) YL201 and Amgen's DLL3- and CD3-targeting bispecific T-cell engager (BiTE®) IMDELLTRA™ in extensive-stage small cell lung cancer (ES-SCLC) under the clinical trial collaboration and supply agreement. MediLink will provide the investigational drug YL201 for the combination study. This open-label, global, multi-center Phase Ib clinical study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of this combination regimen in ES-SCLC patients. Both YL201 and IMDELLTRA™ have shown potential in ES-SCLC. In May of this year, IMDELLTRA™ received accelerated approval from the FDA and is currently marketed in the US for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The efficacy of YL201 monotherapy is encouraging in ES-SCLC. MediLink has announced the data of a Phase I/II clinical trial of YL201 in patients with advanced solid tumors including SCLC as a selected oral presentation at the ESMO Congress 2024. This clinical trial collaboration aims to explore the potential of the two innovative drugs in the treatment of ES-SCLC and offer a novel and synergetic mechanism of action for clinical benefit. About ES-SCLC SCLC is an aggressive high-grade neuroendocrine carcinoma with extremely poor outcomes [1]. SCLC comprises roughly 15% (~0.36 million new cases) of the 2.4 million new lung cancer cases worldwide each year [2]. Approximately two-thirds of patients with SCLC present with extensive-stage (ES) disease at diagnosis, featuring tumors with distant metastasis or exceeding an area that can be treated within a single radiation field [3-5]. Patients with ES-SCLC, compared with patients with limited-stage (LS-SCLC), manifested with worse prognosis as the median expected overall survival is ~12 months following initial therapy and a 5-year overall survival rate of 3% [6-8]. About YL201 YL201 is an innovative ADC that specifically targets B7-H3. B7-H3 is overexpressed on different malignant cells and cancer-initiating cells of various tumor types, but has a restricted expression in normal tissue [9], indicating its potential as an ADC drug target. YL201 has been developed by utilizing MediLink's Tumor Microenvironment Activable LINker-payload (TMALIN®) conjugated with a highly specific B7-H3 antibody. Currently, YL201 is being investigated in four Phase I or II studies, including one global Phase I clinical study. About IMDELLTRA ™ IMDELLTRA™ is a first-in-class, targeted immunotherapy engineered by Amgen researchers that binds to both DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell [10-11]. DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target [12-13]. IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRATM. Initiate treatment with IMDELLTRATM using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRATM until CRS resolves or permanently discontinue based on severity. Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRATM. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRATM until ICANS resolves or permanently discontinue based on severity. WARNINGS AND PRECAUTIONS Cytokine Release Syndrome (CRS): IMDELLTRATM can cause CRS including serious or life-threatening reactions. In the pooled safety population, CRS occurred in 55% of patients who received IMDELLTRATM, including 34% Grade 1, 19% Grade 2, 1.1% Grade 3 and 0.5% Grade 4. Recurrent CRS occurred in 24% of patients, including 18% Grade 1 and 6% Grade 2. Most events (43%) of CRS occurred after the first dose, with 29% of patients experiencing any grade CRS after the second dose and 9% of patients experiencing CRS following the third dose or later. Following the Day 1, Day 8, and Day 15 infusions, 16%, 4.3% and 2.1% of patients experienced ≥ Grade 2 CRS, respectively. The median time to onset of all grade CRS from most recent dose of IMDELLTRATM was 13.5 hours (range 1 to 268 hours). The median time to onset of ≥ Grade 2 CRS from most recent dose of IMDELLTRATM was 14.6 hours (range: 2 to 566 hours). Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC). Administer IMDELLTRATM following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 IMDELLTRATM infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRATM in an appropriate health care facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRATM. Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRATM. At the first sign of CRS, immediately discontinue IMDELLTRATM infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRATM based on severity. Counsel patients to seek medical attention should signs or symptoms of CRS occur. Neurologic Toxicity, Including ICANS: IMDELLTRATM can cause serious or life-threatening neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity, including ICANS, occurred in 47% of patients who received IMDELLTRATM, including 10% Grade 3. The most frequent neurologic toxicities were headache (14%), peripheral neuropathy (7%), dizziness (7%), insomnia (6%), muscular weakness (3.7%), delirium (2.1%), syncope (1.6%), and neurotoxicity (1.1%). ICANS occurred in 9% of IMDELLTRATM-treated patients. Recurrent ICANS occurred in 1.6% of patients. Most patients experienced ICANS following Cycle 2 Day 1 (24%). Following Day 1, Day 8, and Day 15 infusions, 0.5%, 0.5% and 3.7% of patients experienced ≥ Grade 2 ICANS, respectively. The median time to onset of ICANS from the first dose of IMDELLTRATM was 29.5 days (range: 1 to 154 days). ICANS can occur several weeks following administration of IMDELLTRATM. The median time to resolution of ICANS was 33 days (range 1 to 93 days). The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia. Patients receiving IMDELLTRATM are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, in the event of any neurologic symptoms until they resolve. Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment. At the first sign of ICANS, immediately evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRATM or permanently discontinue based on severity. Cytopenias: IMDELLTRATM can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, decreased neutrophils occurred in 12% including 6% Grade 3 or 4 of IMDELLTRATM-treated patients. The median time to onset for Grade 3 or 4 neutropenia was 29.5 days (range: 2 to 213). Decreased platelets occurred in 33% including 3.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 50 days (range: 3 to 420). Decreased hemoglobin occurred in 58% including 5% Grade 3 or 4. Febrile neutropenia occurred in 0.5% of patients treated with IMDELLTRATM. Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with IMDELLTRATM, before each dose, and as clinically indicated. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRATM. Infections: IMDELLTRATM can cause serious infections, including life-threatening and fatal infections. In the pooled safety population, infections, including opportunistic infections, occurred in 41% of patients who received IMDELLTRATM. Grade 3 or 4 infections occurred in 13% of patients. The most frequent infections were COVID-19 (9%, majority during the COVID-19 pandemic), urinary tract infection (10%), pneumonia (9%), respiratory tract infection (3.2%), and candida infection (3.2%). Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRATM and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRATM based on severity. Hepatotoxicity: IMDELLTRATM can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 42%, with Grade 3 or 4 ALT elevation occurring in 2.1%. Elevated AST occurred in 44% of patients, with Grade 3 or 4 AST elevation occurring in 3.2%. Elevated bilirubin occurred in 15% of patients; Grade 3 or 4 total bilirubin elevations occurred in 1.6% of patients. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRATM, before each dose, and as clinically indicated. Withhold IMDELLTRATM or permanently discontinue based on severity. Hypersensitivity: IMDELLTRATM can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRATM and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRATM based on severity. Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRATM may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRATM and for 2 months after the last dose. ADVERSE REACTIONS The most common (> 20%) adverse reactions were CRS (55%), fatigue (51%), pyrexia (36%), dysgeusia (36%), decreased appetite (34%), musculoskeletal pain (30%), constipation (30%), anemia (27%) and nausea (22%). The most common (≥ 2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (57%), decreased sodium (16%), increased uric acid (10%), decreased total neutrophils (6%), decreased hemoglobin (5%), increased activated partial thromboplastin time (5%), decreased potassium (5%), increased aspartate aminotransferase (3.2%), decreased white blood cells (3.8%), decreased platelets (3.2%), and increased alanine aminotransferase (2.1%). Serious adverse reactions occurred in 58% of patients. Serious adverse reactions in > 3% of patients included CRS (24%), pneumonia (6%), pyrexia (3.7%), and hyponatremia (3.6%). Fatal adverse reactions occurred in 2.7% of patients including pneumonia (0.5%), aspiration (0.5%), pulmonary embolism (0.5%), respiratory acidosis (0.5%), and respiratory failure (0.5%). DOSAGE AND ADMINISTRATION: Important Dosing Information Administer IMDELLTRATM as an intravenous infusion over one hour. Administer IMDELLTRATM according to the step-up dosing schedule in the IMDELLTRATM PI (Table 1) to reduce the incidence and severity of CRS. For Cycle 1, administer recommended concomitant medications before and after Cycle 1 IMDELLTRATM infusions to reduce the risk of CRS reactions as described in the PI (Table 3). IMDELLTRATM should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS. Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRATM infusion for 22 to 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting. Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from start of the infusion with IMDELLTRATM following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. Prior to administration of IMDELLTRATM evaluate complete blood count, liver enzymes, and bilirubin before each dose, and as clinically indicated. Ensure patients are well hydrated prior to administration of IMDELLTRATM. Please see IMDELLTRA™ full Prescribing Information , including BOXED WARNINGS About MediLink Therapeutics MediLink Therapeutics, founded in 2020, is a clinical stage biotech company dedicated to developing conjugated drugs with global competitiveness. MediLink has developed its proprietary TMALIN® ADC technology platform, enabling the generation of homogeneous ADC with high drug-antibody ratio and improved therapeutic window for the treatment of solid tumors. MediLink aims to provide improved treatment options for global patients and address unmet medical needs. The company is headquartered in Suzhou, China and has established R&D sites in Shanghai, China and Boston, US. Reference: 1. Badin F. Considerations for selecting second-line treatment in patients with progressive small cell lung cancer and the use of Lurbinectedin in this setting. Cancer Treat Res. Commun., 2024, 39, 100803. 2. a. Oronsky B, Abrouk N, Caroen S, et al. A 2022 Update on Extensive Stage Small-Cell Lung Cancer (SCLC). J Cancer. 2022; 13, 2945-2953. b. World Health Organization. Lung. 2020. . Accessed on March 15, 2024. c. Sabari JK, Lok BH, Laird JH, et al. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol. 2017, 14, 549. 3. National Cancer Institute, Small cell lung cancer treatment (PDQ®) – health professional version, 2023. Available from: . Accessed 13 March 2023. 4. American Cancer Society. Lung cancer – Small cell lung cancer stages. Available from: diagnosis-staging/staging-sclc.html. Accessed 13 March 2023. 5. Cancer Research UK. Limited and extensive stage (small cell lung cancer). Available from: cancer/stages-types-grades/limited-extensive. Accessed 13 March 2023. 6. American Cancer Society. Lung Cancer Survival Rates. . Accessed on September 4, 2024. 7. Liu SV, Reck M, Mansfield AS, et al. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021, 39, 619. 8. Howlader N, Noone A, Krapcho M, Miller D, Brest A, Yu M, et al. SEER Cancer Statistics Review. National Cancer Institute. 9. Kontos F, Michelakos T, Kurokawa T, Sadagopan A, Schwab JH, Ferrone CR, Ferrone S. B7-H3: An Attractive Target for Antibody-based Immunotherapy. Clin Cancer Res., 2021, 27, 1227 10. Giffin MJ, Cooke K, Lobenhofer EK, et al. AMG 757, a Half-Life Extended, DLL3-Targeted Bispecific T-Cell Engager, Shows High Potency and Sensitivity in Preclinical Models of Small-Cell Lung Cancer. Clin Cancer Res., 2021, 27, 1526. 11. Baeuerle PA, Kufer P, Bargou R. BiTE: Teaching antibodies to engage T-cells for cancer therapy. Curr Opin Mol Ther., 2009, 11, 22. 12. Ahn MJ, Cho BC, Felip E, et al. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med., 2023, 389, 2063. 13. Rojo F, Corassa M, Mavroudis D, et al. International real-world study of DLL3 expression in patients with small cell lung cancer. Lung Cancer., 2020, 147, 237. 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Updated data show 100 percent overall response rate with 56 percent of patients achieving complete response or better with weekly dosing, supporting the combinability of the GPRC5D bispecific antibody Safety profile, including infection rates, similar to TALVEY® and DARZALEX FASPRO® monotherapies RIO DE JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced updated results from the investigational Phase 1b TRIMM-2 study evaluating the combination of TALVEY® (talquetamab-tgvs) with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and pomalidomide in patients with relapsed or refractory multiple myeloma that demonstrated an overall response rate (ORR) of 82 percent, further supporting the investigation of this combination. These data were featured in an oral presentation at the 2024 International Myeloma Society Annual Meeting (Abstract #OA – 01). The results from the Phase 1b TRIMM-2 study evaluating TALVEY®, the first bispecific T-cell engager to target GPRC5D, combined with DARZALEX FASPRO®, the first subcutaneous anti-CD38 monoclonal antibody, and pomalidomide included patients who received at least three prior lines of therapy, including a proteasome inhibitor (PI) and immunomodulatory drug (IMiD), or were double refractory to a PI and IMiD and had not received anti-CD38 therapy in the previous 90 days.1 At data cutoff, 77 patients had received TALVEY® in doses of 0.4 mg/kg weekly (QW) or 0.8 mg/kg biweekly (Q2W), with step-up doses, combined with DARZALEX FASPRO® and pomalidomide. In the QW arm (n=18), the overall response rate (ORR) was 100 percent, with 56 percent having a complete response (CR) or better. The Q2W arm (n=59) achieved 76 percent ORR, with 56 percent achieving CR or better. The median duration of response (DOR) in the Q2W arm was 26.4 months, and the median progression-free survival (PFS) was 20.3 months. Results showed 52 percent of patients who are anti-CD38 refractory (n=64) achieved CR or better and 70.8 percent of patients who received prior chimeric antigen receptor T cell (CAR-T) therapy (n=24) achieved CR or better. Patients who had received prior bispecific antibodies (n=29) achieved an 82.8 percent ORR.1 "The deep and durable responses shown in these latest results from TRIMM-2 further support the potential of TALVEY in combination with DARZALEX FASPRO, which has become a standard of care in multiple myeloma, and pomalidomide," said Nizar Bahlis, M.D., Associate Professor, Arnie Charbonneau Cancer Institute, University of Calgary and presenting author.* "With high overall response rates seen across cohorts, this combination shows potential for significant disease control and survival in patients who have received multiple lines of prior therapy, including exposure to prior bispecific antibodies." The safety profile of this combination reflected the known profiles of TALVEY®, DARZALEX FASPRO® and pomalidomide. Despite the incidence of neutropenia (83.3 percent in the QW arm and 79.7 percent in the Q2W arm) being high, the Grade 3/4 infection rate was generally low (16.7 percent and 37.3 percent, respectively). The majority of on-target, off-tumor treatment-related adverse events (TRAEs), including oral (100 percent in the QW arm, 84.7 percent in Q2W arm), skin (88.9 percent, 67.8 percent), nail (83.3 percent, 55.9 percent) and weight decrease (66.7 percent, 49.2 percent) were low-grade (Grade 1/2) and did not lead to discontinuation of therapy. These results support further investigation of TALVEY® in combination with DARZALEX FASPRO®, with or without pomalidomide, in patients who have received earlier lines of therapy, including a proteasome inhibitor and lenalidomide, which is currently being investigated in the registrational, Phase 3 MonumenTAL-3 study.1 "We continue to be encouraged by the potential versatility of TALVEY as a combination partner with other therapies to address unmet needs for patients with relapsed or refractory multiple myeloma who have limited treatment options at this advanced stage," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Innovative Medicine at Johnson & Johnson. "By simultaneously targeting GPRC5D and CD38 on myeloma cells with the combination of TALVEY and DARZALEX FASPRO, we are aiming to attack multiple myeloma in different ways to help improve outcomes for patients with this serious illness and limited treatment options." Additional data underscoring the combinability of TALVEY® from the RedirecTT-1 study will also be presented at IMS. Results from the TRIMM-2 study were previously presented at the 2023 ASCO Annual Meeting. About TRIMM-2 Study The TRIMM-2 (NCT04108195) study is an ongoing Phase 2 study of DARZALEX FASPRO® regimens in combination with TALVEY® for the treatment of patients with multiple myeloma. The primary objectives of the TRIMM-2 study were to identify the Phase 2 dose (RP2D) for each component of the treatment combination (Part One); characterize the safety of the treatment combination at the RP2D (Part 2); and assess antitumor activity, pharmacokinetics and pharmacodynamics for the combination treatment (Part 3). Patients in the study (N=65) all had multiple myeloma and had received a minimum three prior lines of therapy or were double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent; patients who had been exposed or refractory to an anti-CD38 therapy more than ninety days prior to the start of the trial were also included, as well as those refractory to anti-CD38 therapy. About MonumenTAL-3 The MonumenTAL-3 (NCT05455320) study is an ongoing Phase 3 study of TALVEY® in combination with DARZALEX FASPRO® with or without pomalidomide compared to DARZALEX FASPRO® combined with pomalidomide and dexamethasone in patients with relapsed of refractory multiple myeloma who have received at least one prior line of therapy. About Multiple Myeloma Multiple myeloma is a blood cancer affecting a type of white blood cell called plasma cells found in the bone marrow.2 In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow.3 Multiple myeloma is the second most common blood cancer worldwide and remains an incurable disease.4 In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 will die from the disease.5 People with multiple myeloma have a 5-year survival rate of 59.8 percent.6 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.7, 8 A bout TALVEY® TALVEY ® (talquetamab-tgvs) received approval from the U.S. FDA in August 2023 as a first-in-class GPRC5D-targeting bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.9 Since FDA approval, 1,500 patients were treated with TALVEY®. The European Commission (EC) granted conditional marketing authorization (CMA) of TALVEY ® in August 2023 as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.10 TALVEY ® is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel multiple myeloma target which is highly expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as some healthy tissues such as epithelial cells of the skin and tongue. For more information, visit . About DARZALEX FASPRO® DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.11 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology. In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. For more information, visit . TALVEY ® IMPORTANT SAFETY INFORMATION INDICATION AND USAGE TALVEY ® (talquetamab-tgvs) is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY ® . Initiate TALVEY® treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY ® until CRS resolves or permanently discontinue based on severity. Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur with TALVEY®. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment. Withhold or discontinue TALVEY ® based on severity. Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY ® is available only through a restricted program called the TECVAYLI® and TALVEY ® Risk Evaluation and Mitigation Strategy (REMS). CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Cytokine Release Syndrome (CRS): TALVEY® can cause cytokine release syndrome, including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 76% of patients who received TALVEY® at the recommended dosages, with Grade 1 CRS occurring in 57% of patients, Grade 2 in 17%, and Grade 3 in 1.5%. Recurrent CRS occurred in 30% of patients. CRS occurred in 33% of patients with step-up dose 3 in the biweekly dosing schedule (N=153). CRS occurred in 30% of patients with the first 0.4 mg/kg treatment dose and in 12% of patients treated with the first 0.8 mg/kg treatment dose. The CRS rate for both dosing schedules combined was less than 3% for each of the remaining doses in Cycle 1 and less than 3% cumulatively from Cycle 2 onward. The median time to onset of CRS was 27 (range: 0.1 to 167) hours from the last dose, and the median duration was 17 (range: 0 to 622) hours. Clinical signs and symptoms of CRS include but are not limited to pyrexia, hypotension, chills, hypoxia, headache, and tachycardia. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC). Initiate therapy with step-up dosing and administer pre-treatment medications (corticosteroids, antihistamine, and antipyretics) prior to each dose of TALVEY® in the step-up dosing schedule to reduce the risk of CRS. Monitor patients following administration accordingly. In patients who experience CRS, pre-treatment medications should be administered prior to the next TALVEY® dose. Counsel patients to seek medical attention should signs or symptoms of CRS occur. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care based on severity, and consider further management per current practice guidelines. Withhold TALVEY® until CRS resolves or permanently discontinue based on severity. Neurologic Toxicity including ICANS: TALVEY® can cause serious or life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including fatal reactions. In the clinical trial, neurologic toxicity occurred in 55% of patients who received the recommended dosages, with Grade 3 or 4 neurologic toxicity occurring in 6% of patients. The most frequent neurologic toxicities were headache (20%), encephalopathy (15%), sensory neuropathy (14%), and motor dysfunction (10%). ICANS was reported in 9% of 265 patients where ICANS was collected and who received the recommended dosages. Recurrent ICANS occurred in 3% of patients. Most patients experienced ICANS following step-up dose 1 (3%), step-up dose 2 (3%), step-up dose 3 of the biweekly dosing schedule (1.8%), or the initial treatment dose of the weekly dosing schedule (2.6%) (N=156) or the biweekly dosing schedule (3.7%) (N=109). The median time to onset of ICANS was 2.5 (range: 1 to 16) days after the most recent dose with a median duration of 2 (range: 1 to 22) days. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia. Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient and provide supportive care based on severity; withhold or permanently discontinue TALVEY® based on severity and consider further management per current practice guidelines. [see Dosage and Administration (2.5)]. Due to the potential for neurologic toxicity, patients receiving TALVEY® are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during the step-up dosing schedule and for 48 hours after completion of the step-up dosing schedule, and in the event of new onset of any neurological symptoms, until symptoms resolve. TECVAYLI® and TALVEY® REMS: TALVEY® is available only through a restricted program under a REMS, called the TECVAYLI® and TALVEY® REMS because of the risks of CRS and neurologic toxicity, including ICANS. Further information about the TECVAYLI® and TALVEY® REMS program is available at or by telephone at 1-855-810-8064. Oral Toxicity and Weight Loss: TALVEY® can cause oral toxicities, including dysgeusia, dry mouth, dysphagia, and stomatitis. In the clinical trial, 80% of patients had oral toxicity, with Grade 3 occurring in 2.1% of patients who received the recommended dosages. The most frequent oral toxicities were dysgeusia (49%), dry mouth (34%), dysphagia (23%), and ageusia (18%). The median time to onset of oral toxicity was 15 (range: 1 to 634) days, and the median time to resolution to baseline was 43 (1 to 530) days. Oral toxicity did not resolve to baseline in 65% of patients. TALVEY® can cause weight loss. In the clinical trial, 62% of patients experienced weight loss of 5% or greater, regardless of having an oral toxicity, including 28% of patients with Grade 2 (10% or greater) weight loss and 2.7% of patients with Grade 3 (20% or greater) weight loss. The median time to onset of Grade 2 or higher weight loss was 67 (range: 6 to 407) days, and the median time to resolution was 50 (range: 1 to 403) days. Weight loss did not resolve in 57% of patients who reported weight loss. Monitor patients for signs and symptoms of oral toxicity. Counsel patients to seek medical attention should signs or symptoms of oral toxicity occur and provide supportive care as per current clinical practice, including consultation with a nutritionist. Monitor weight regularly during therapy. Evaluate clinically significant weight loss further. Withhold TALVEY® or permanently discontinue based on severity. Infections: TALVEY® can cause infections, including life-threatening or fatal infections. Serious infections occurred in 16% of patients, with fatal infections in 1.5% of patients. Grade 3 or 4 infections occurred in 17% of patients. The most common serious infections reported were bacterial infection (8%), which included sepsis and COVID-19 (2.7%). Monitor patients for signs and symptoms of infection prior to and during treatment with TALVEY® and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Withhold or consider permanently discontinuing TALVEY® as recommended, based on severity. Cytopenias: TALVEY® can cause cytopenias, including neutropenia and thrombocytopenia. In the clinical trial, Grade 3 or 4 decreased neutrophils occurred in 35% of patients, and Grade 3 or 4 decreased platelets occurred in 22% of patients who received TALVEY®. The median time to onset for Grade 3 or 4 neutropenia was 22 (range: 1 to 312) days, and the median time to resolution to Grade 2 or lower was 8 (range: 1 to 79) days. The median time to onset for Grade 3 or 4 thrombocytopenia was 12 (range: 2 to 183) days, and the median time to resolution to Grade 2 or lower was 10 (range: 1 to 64) days. Monitor complete blood counts during treatment and withhold TALVEY® as recommended, based on severity. Skin Toxicity: TALVEY® can cause serious skin reactions, including rash, maculo-papular rash, erythema, and erythematous rash. In the clinical trial, skin reactions occurred in 62% of patients, with grade 3 skin reactions in 0.3%. The median time to onset was 25 (range: 1 to 630) days. The median time to improvement to grade 1 or less was 33 days. Monitor for skin toxicity, including rash progression. Consider early intervention and treatment to manage skin toxicity. Withhold TALVEY® as recommended based on severity. Hepatotoxicity: TALVEY® can cause hepatotoxicity. Elevated ALT occurred in 33% of patients, with grade 3 or 4 ALT elevation occurring in 2.7%; elevated AST occurred in 31% of patients, with grade 3 or 4 AST elevation occurring in 3.3%. Grade 3 or 4 elevations of total bilirubin occurred in 0.3% of patients. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TALVEY® or consider permanent discontinuation of TALVEY®, based on severity [see Dosage and Administration (2.5)]. Embryo-Fetal Toxicity: Based on its mechanism of action, TALVEY® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TALVEY® and for 3 months after the last dose. Adverse Reactions: The most common adverse reactions (≥20%) are pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, weight decreased, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension, and headache. The most common Grade 3 or 4 laboratory abnormalities (≥30%) are lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, and hemoglobin decreased. Please read full Prescribing Information, including Boxed Warning, for TALVEY®. DARZALEX FASPRO® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma: In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI) In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS  DARZALEX FASPRO® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation.  WARNINGS AND PRECAUTIONS  Hypersensitivity and Other Administration Reactions  Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®.  Systemic Reactions  In a pooled safety population of 1249 patients with multiple myeloma (N=1056) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO® as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 0.7%, Grade 4: 0.1%). Systemic administration-related reactions occurred in 7% of patients with the first injection, 0.2% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 2.9 hours (range: 5 minutes to 3.5 days). Of the 165 systemic administration-related reactions that occurred in 93 patients, 144 (87%) occurred on the day of DARZALEX FASPRO® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients. Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision. Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO®. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions. Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO®. Local Reactions  In this pooled safety population, injection-site reactions occurred in 7% of patients, including Grade 2 reactions in 0.8%. The most frequent (>1%) injection-site reaction was injection-site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO®. Monitor for local reactions and consider symptomatic management. Neutropenia Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO®, higher rates of Grade 3-4 neutropenia were observed. Thrombocytopenia  Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO® until recovery of platelets.  Embryo-Fetal Toxicity  Based on the mechanism of action, DARZALEX FASPRO® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO® and for 3 months after the last dose.  The combination of DARZALEX FASPRO® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy.  Interference With Serological Testing  Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted.  Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO®. Type and screen patients prior to starting DARZALEX FASPRO®.  Interference With Determination of Complete Response  Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO®-treated patients with IgG kappa myeloma protein.  ADVERSE REACTIONS  In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral neuropathy, peripheral sensory neuropathy, constipation, pneumonia, edema, peripheral edema, musculoskeletal pain, and rash. The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.  Please click here to read full Prescribing Information for DARZALEX FASPRO®. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen Global Services, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TALVEY® or DARZALEX FASPRO®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. * Nizar Bahlis, M.D., Associate Professor, Arnie Charbonneau Cancer Institute, University of Calgary, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Bahlis, N., et al. Talquetamab + daratumumab + pomalidomide in patients with relapsed/refractory multiple myeloma: Results from the phase 1b TRIMM-2 study. IMS 2024. September 27, 2024. 2 Rajkumar SV. Multiple Myeloma: 2020 Update on Diagnosis, Risk-Stratification and Management. Am J Hematol. 2020;95(5):548-5672020;95(5):548-567. 3 National Cancer Institute. Plasma Cell Neoplasms. Accessed January 17, 2024. Available at: 4 Multiple Myeloma. City of Hope, 2022. Multiple Myeloma: Causes, Symptoms & Treatments. Accessed May 2024. 5 American Cancer Society. Myeloma Cancer Statistics. Accessed May 2024. Available at: 6 SEER*Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute. Accessed: September 2024. 7 American Cancer Society. What is Multiple Myeloma? Accessed May 2024. Available at: 8 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. Accessed May 2024. Available at: 9 TALVEY® U.S. Prescribing Information, August 2023. 10 European Medicines Agency. TALVEY Summary of Product Characteristics. August 2023. 11 DARZALEX FASPRO® U.S. Prescribing Information. July 2024. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED