Latest news with #Talvey
Yahoo
16-06-2025
- Business
- Yahoo
J&J reports results from antibody combo trial for MM patients
Johnson & Johnson (J&J) has reported new outcomes from the Phase II RedirecTT-1 trial of bispecific antibodies, Talvey (talquetamab-tgvs) and Tecvayli (teclistamab-cqyv) for relapsed/refractory multiple myeloma (r/r MM). The data showed a high overall response rate (ORR) with durability in those who have triple-class-exposed (TCE) RRMM with true extramedullary disease (EMD). In the trial, which enrolled 90 subjects, the investigational combo resulted in an ORR of 78.9%, with over half of the subjects achieving a complete response or better, representing a significant improvement over the average ORR of less than 40% for this patient group. Notably, responses were also found to be high among those previously treated with B-cell maturation antigen (BCMA) CAR-T or anti-FcRH5 bispecific antibodies. According to the company, subjects in the trial showed deep and durable responses, with 66.2% remaining in response at the data cutoff and a median follow-up of 13.4 months. At one year, 61% of subjects were progression-free and alive, and 74.5% were alive, with median overall survival not yet reached. The combo was found to be consistent with prior reports of them as single agents. Subjects had the option to switch to once-a-month dosing, which might have contributed to better tolerability. The reports of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were found to be mostly low grade. The study's findings were featured at the 2025 European Hematology Association Congress. EMD represents a severe form of MM, where myeloma cells form tumours in soft tissues and organs. Johnson & Johnson innovative medicine multiple myeloma disease area leader and vice-president Jordan Schecter said: 'Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options. 'Our first-in-class bispecific antibodies, Talvey and Tecvayli, have transformed treatment for relapsed or refractory multiple myeloma.' Recently, J&J reported that Tremfya decreased the symptoms and signs of active psoriatic arthritis (PsA) at 24 weeks in individuals against a placebo in the Phase IIIb APEX trial. "J&J reports results from antibody combo trial for MM patients" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
16-06-2025
- Health
- Yahoo
EHA 2025: J&J's dual-targeting bispecifics could redefine SOC for r/r MM
At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 to 15 June, the preliminary results from the global, multi-centre open-label non-randomised Phase II RedirecTT-1 clinical trial (NCT04586426) were presented on 15 June. This trial evaluated the safety and efficacy of the combination of Johnson & Johnson's (J&J's) Tecvayli (teclistamab), an anti–G protein–coupled receptor family C group 5 member D (GPRC5D)-directed CD3 bispecific T-cell engager (BiTE) and Talvey (talquetamab), an anti–B-cell maturation antigen (BCMA)-CD3 BiTE, in treating patients with relapsed/refractory (r/r) multiple myeloma (MM) and extramedullary disease (EMD) who are already triple-class exposed (TCE) including proteasome inhibitor (PI), immunomodulatory drugs (IMiD), and an anti-CD38 monoclonal antibody. EMD is defined as soft tissue/organ-associated plasmacytomas that have no contact with bony structures. It represents an aggressive form of MM and occurs when myeloma cells spread and form tumours (plasmacytomas) in areas such as soft tissues and organs. EMD is commonly observed in haematologic malignancies such as MM, with a prevalence of roughly 6%–20% in r/r MM. The current standard of care (SOC) for patients with r/r MM with EMD includes combination regimens with PI, IMiD, or anti-CD38 monoclonal antibodies and may also involve chimeric antigen receptor (CAR)-T cell therapy or radiotherapy. Despite the promising efficacy of these advanced therapies, patients with MM and EMD consistently show lower response rates and shorter durations of remission across clinical trials compared to those with r/r MM without EMD. This highlights a significant unmet need for more effective therapeutic options in this high-risk population. According to GlobalData's Multiple Myeloma: Epidemiology Forecast to 2032 report, the number of diagnosed prevalent cases of MM in the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and China) is projected to increase from 328,151 in 2025 to 352,348 by 2032 at an annual growth rate of 1.12%. The RedirecTT-1 trial is the largest EMD study to date, with 90 patients enrolled who were TCE. The investigational combination of Tecvayli and Talvey demonstrated a robust overall response rate (ORR) of 78.9% (95% CI: 69.0–86.8), with 54.4% achieving a complete response or better. Notably, high response rates were maintained even among patients previously treated with BCMA CAR-T (ORR: 83.3%, 95% CI: 58.6–96.4) and anti-FcRH5 bispecifics (ORR: 75.0%, 95% CI: 34.9–96.8). At a median follow-up of 13.4 months, 66.2% of responders remained in remission, indicating the potential for deep and sustained responses. Progression-free survival at one year was 61.0%, while 64.1% of patients maintained their responses, with a median duration of response of 13.8 months. Overall survival data had not yet matured, but the one-year survival rate was reported at 74.5%. Discontinuations due to adverse events (AEs) were infrequent; only four patients discontinued Talvey. Most cases of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome were Grade 1 and 2. 10 patients (11.1%) experienced Grade 5 AEs, five of which were infection-related, consistent with infection rates observed in monotherapy studies involving BCMA-targeting bispecifics. The impressive results from the first oncology study to combine two bispecific antibodies are likely to reshape the SOC for patients with r/r MM and EMD. This dual-antigen targeting strategy enhances tumour cell recognition in a biologically and genetically heterogeneous patient population, helps overcome treatment resistance, and reduces the risk of relapse caused by antigen escape, particularly in those with EMD. Despite the strong efficacy and durability of response, the high incidence of Grade 3 and 4 infections and infection-related deaths highlights the need for careful consideration of dosing strategies and prophylactic interventions, including intravenous immunoglobulin, antibacterial, and antiviral therapies. In parallel, J&J is also advancing its BiTE portfolio through the Phase III MonumenTAL-6 clinical trial, which combines Tecvayli and Talvey, with results expected in 2026. J&J already dominates the MM market with Tecvayli, Talvey and its CAR-T cell therapy Carvykti (ciltacabtagene autoleucel), and is continuing to expand its pipeline. One of these assets, a trispecific T-cell engager, JNJ-79635322, is currently being evaluated in a Phase I clinical trial. It targets CD3, BCMA, and GPRC5D, and, if it progresses to later-stage trials and success, could become the first-in-class trispecific antibody in R/R MM. Its single-agent design offers a potential advantage in the overcrowded BiTE market, although it remains in early development. According to GlobalData's analyst consensus forecast, Tecvayli and Talvey are projected to generate global sales of $4.4bn and $1.8bn. respectively by 2031. "EHA 2025: J&J's dual-targeting bispecifics could redefine SOC for r/r MM" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
16-06-2025
- Business
- Yahoo
J&J reports results from antibody combo trial for MM patients
Johnson & Johnson (J&J) has reported new outcomes from the Phase II RedirecTT-1 trial of bispecific antibodies, Talvey (talquetamab-tgvs) and Tecvayli (teclistamab-cqyv) for relapsed/refractory multiple myeloma (r/r MM). The data showed a high overall response rate (ORR) with durability in those who have triple-class-exposed (TCE) RRMM with true extramedullary disease (EMD). In the trial, which enrolled 90 subjects, the investigational combo resulted in an ORR of 78.9%, with over half of the subjects achieving a complete response or better, representing a significant improvement over the average ORR of less than 40% for this patient group. Notably, responses were also found to be high among those previously treated with B-cell maturation antigen (BCMA) CAR-T or anti-FcRH5 bispecific antibodies. According to the company, subjects in the trial showed deep and durable responses, with 66.2% remaining in response at the data cutoff and a median follow-up of 13.4 months. At one year, 61% of subjects were progression-free and alive, and 74.5% were alive, with median overall survival not yet reached. The combo was found to be consistent with prior reports of them as single agents. Subjects had the option to switch to once-a-month dosing, which might have contributed to better tolerability. The reports of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were found to be mostly low grade. The study's findings were featured at the 2025 European Hematology Association Congress. EMD represents a severe form of MM, where myeloma cells form tumours in soft tissues and organs. Johnson & Johnson innovative medicine multiple myeloma disease area leader and vice-president Jordan Schecter said: 'Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options. 'Our first-in-class bispecific antibodies, Talvey and Tecvayli, have transformed treatment for relapsed or refractory multiple myeloma.' Recently, J&J reported that Tremfya decreased the symptoms and signs of active psoriatic arthritis (PsA) at 24 weeks in individuals against a placebo in the Phase IIIb APEX trial. "J&J reports results from antibody combo trial for MM patients" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-02-2025
- Business
- Yahoo
J&J Stock Up More Than 6% in a Month: Time to Buy, Sell or Hold?
J&J JNJ stock has risen more than 6% in the past month. The reason behind the increase was a strong-than-expected fourth-quarter earnings report and an optimistic outlook for the Innovative Medicine segment despite several headwinds, Let's understand the company's strengths and weaknesses to better analyze how to play J&J's stock amid the recent price increase. Johnson & Johnson's biggest strength is its diversified business model. It operates through pharmaceuticals and medical devices divisions. It has more than 275 subsidiaries, which clearly means that the business is extremely well-diversified. Its diversification helps it to withstand economic cycles more effectively. J&J has 26 platforms with more than $1 billion in annual sales. Meanwhile, J&J has one of the largest R&D budgets among pharma companies. J&J separated its Consumer Health business into a newly listed company called Kenvue (KVUE) in 2023, which allowed it to focus on its core pharmaceutical and medical device business. J&J's Innovative Medicine unit is showing a growing trend. The segment's sales rose 5.8% in 2024 on an organic basis. In 2025, J&J expects growth in the Innovative Medicine segment despite the loss of exclusivity ('LOE') for its multi-billion-dollar product Stelara, the approximately $2 billion negative impact of the Part D redesign and the greater impact of currency fluctuations. Growth is expected to be driven by its key products, such as Darzalex, Tremfya, Spravato and Erleada, as well as new drugs like Carvykti, Tecvayli and Talvey and new indications for Tremfya and Rybrevant. J&J expects to generate more than $57 billion in sales in the Innovative Medicines segment in 2025. It expects the Innovative Medicine business to grow 5% to 7% from 2025 to 2030. Moreover, J&J believes 10 of its new Innovative Medicine products, including new cancer drugs like Talvey and Tecvayli, and pipeline candidates like nipocalimab and icotrokinra (JNJ-2113), have the potential to deliver peak non-risk-adjusted operational sales of $5 billion. J&J lost U.S. patent exclusivity of its blockbuster drug, Stelara, in 2025. Stelara generated sales of $10.36 billion in 2024. The launch of generics is expected to significantly erode the drug's sales and hurt J&J's sales and profits in 2025. A biosimilar version of Stelara was launched in certain European markets for certain indications in July 2024. Several biosimilar versions of Stelara are expected to be launched in the United States in 2025. Amgen AMGN launched the first Stelara biosimilar, Wezlana, in January 2025. Stelara biosimilar competition is expected to accelerate throughout 2025 as the number of biosimilar entrants increases. Stelara's loss of exclusivity negatively impacted sales growth by 290 basis points worldwide and 720 basis points in Europe in the fourth quarter. The impact is expected to be higher in 2025. In addition, sales in 2025 will be hurt by greater Fx impact and approximately $2 billion impact from the Medicare Part D redesign. Sales in J&J's MedTech business are facing continued headwinds in the Asia Pacific, specifically in China. Sales in China are being hurt by the impact of the volume-based procurement (VBP) program and the anticorruption campaign. VBP is a government-driven cost-containment effort in China. J&J does not expect any improvement in its business in the Asia Pacific region, specifically in China, in 2025. Competitive pressure is also hurting sales growth in some MedTech businesses, such as PFA ablation catheters in U.S. electrophysiology. It expects continued impacts from VBP issues in China in 2025 as VBP continues to expand across provinces and products. Nonetheless, though issues in China are hurting sales, J&J is successfully shifting its portfolio to high-innovation, high-growth markets, particularly in Cardiovascular. With the recent acquisitions of Shockwave in 2024 and Abiomed in 2022, J&J has become a category leader in four of the largest and highest-growth cardiovascular intervention MedTech markets. J&J expects the overall MedTech market to grow in the range of 5-7% between 2022 and 2027. J&J faces more than 62,000 lawsuits for its talc-based products, primarily baby powders. The lawsuits allege that its talc products contain asbestos, which caused many women to develop ovarian cancer. J&J insists that its talc-based products are safe and do not cause cancer. The company permanently discontinued the sales of its talc-based Johnson's Baby Powder. J&J failed twice in its attempts to seek bankruptcy to fully resolve these thousands of lawsuits related to its talc products. However, in 2024, J&J made strong progress toward resolving the talc litigation. In May 2024, the company proposed a new plan committing to pay claimants approximately $6.5 billion nominally over 25 years, which could resolve 99.75% of all pending talc lawsuits against it. In September, J&J, via another subsidiary called Red River Talc, filed for voluntary bankruptcy (in Texas) for the third time after it received the support of around 83% of current claimants for the proposed bankruptcy plan. Red River also increased its settlement commitment by $1.75 billion to approximately $8 billion. The talc bankruptcy confirmation hearing is expected to take place in 2025. J&J's stock has outperformed the industry in the past six months. The stock has lost 2.2% in the past six months compared with 11.3% decline of the industry. The stock is also trading above its 200-day and 50-day moving averages. Image Source: Zacks Investment Research From a valuation standpoint, J&J appears attractive relative to the industry and is trading below its 5-year mean. Going by the price/earnings ratio, the company's shares currently trade at 14.67 forward earnings, lower than 16.39 for the industry and the stock's 5-year mean of 15.96. JNJ Stock Valuation Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2025 earnings has risen from $10.55 per share to $10.58 per share over the past 30 days, while that for 2026 has declined from $11.16 per share to $11.06 per share over the same timeframe. Image Source: Zacks Investment Research J&J's Innovative Medicines segment is showing a growth trend. The company has an interesting R&D pipeline that can generate innovative products and drive its growth further. J&J has been on an acquisition spree lately. It completed the acquisitions of Shockwave and V-Wave in MedTech and Ambrx, Proteologix and NM26 bispecific antibody in Innovative Medicine in 2024, which strengthened its pipeline. Continuing the M&A momentum, last month, J&J announced a definitive agreement to acquire Intra-Cellular Therapies ITCI for approximately $14.6 billion, which will strengthen its presence in the neurological and psychiatric drug market. However, the softness in the MedTech unit, Stelara patent cliff and the potential impact of Part D redesign will be big headwinds in 2025. It remains to be seen how the company navigates them in 2025. Those who already own this Zacks Rank #3 (Hold) company's shares may stay invested for some time as the visibility for a potential resolution of the talc lawsuits has improved, and J&J looks optimistic about a better performance in 2025. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Johnson & Johnson (JNJ) : Free Stock Analysis Report Amgen Inc. (AMGN) : Free Stock Analysis Report Intra-Cellular Therapies Inc. (ITCI) : Free Stock Analysis Report Kenvue Inc. (KVUE) : Free Stock Analysis Report To read this article on click here. Zacks Investment Research
