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ASCO25: J&J's trispecific antibody shows 100% response in Phase I multiple myeloma study
ASCO25: J&J's trispecific antibody shows 100% response in Phase I multiple myeloma study

Yahoo

time2 days ago

  • Business
  • Yahoo

ASCO25: J&J's trispecific antibody shows 100% response in Phase I multiple myeloma study

Johnson & Johnson (J&J) has unveiled first-in-human data on its trispecific antibody that demonstrates a 100% response rate in a small group of patients with relapsed or refractory multiple myeloma (r/r MM). The initial data from the Phase I trial (NCT05652335) of JNJ-5322 shows that the trispecific antibody led to a 100% overall response rate (ORR) in 27 patients who were naïve to anti-BCMA/-GPRC5D therapies at a median follow-up of 8.2 months. The patients were treated with the proposed Phase II dose of 100mg four times weekly (Q4W). JNJ-5322 simultaneously targets BCMA (B-cell maturation antigen), GPRC5D (G protein coupled receptor family C group 5 member D), and CD3 (cluster of differentiation 3). The drug engages both malignant B cells and T cells, inducing anti-cancer cytotoxicity and T-cell activation, while overcoming tumour heterogeneity. All responders remain in response as of a median 8.5 month follow-up, with a median time to first response of 1.2 months. The Phase I trial, initiated in November 2022, has enrolled 126 patients as of 15 January 2025 with r/r MM previously exposed to proteosome inhibitors, immunomodulatory drugs, and anti-CD3 monoclonal antibodies (mAb). After dose escalation, 36 patients were administered 100mg JNJ-5322 subcutaneously Q4W as the putative recommended Phase II dose. The data was presented at the 2025 American Society of Clinical Oncology (ASCO) conference held in Chicago, Illinois, on 3 June. However, 99% of the collective cohort experienced at least one adverse event (AE), most commonly cytokine release syndrome (59%), while 75% reported infection. In the case of five patients, toxicities proved dose-limiting, and four patients died as a result of AEs. J&J's candidate was granted an orphan drug status to treat r/r MM by the US Food and Drug Administration (FDA) on 27 November 2024. The data presented at ASCO 2025 represent the first clinical insight into the drug's potential. Abstract authors stated, 'first data with JN-5322 suggest a paradigm shift, offering ORRs similar to CAR-Ts (chimeric antigen receptor-Ts) but as an off-the-shelf therapy.' JN-5322 is developed using J&J's antibody discovery platform OmniAb technology. J&J licenced the technology to develop antibodies for multiple myeloma through a partnership with OmniAb's parent company Ligand Pharmaceuticals, which was spun out from Ligand in 2022. "ASCO25: J&J's trispecific antibody shows 100% response in Phase I multiple myeloma study" was originally created and published by Pharmaceutical Technology, 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

J&J may take a softer tariff hit after US-China pause, CFO says
J&J may take a softer tariff hit after US-China pause, CFO says

Yahoo

time2 days ago

  • Business
  • Yahoo

J&J may take a softer tariff hit after US-China pause, CFO says

This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Johnson & Johnson CFO Joseph Wolk, at the Bernstein investor conference last week, tempered the company's expectation that it would suffer a $400 million tariff impact this year. Wolk gave the update after the U.S. and China reached a temporary agreement to pause escalating tariff rates between the two countries for 90 days. Weeks before the pause, J&J had predicted on an April's earnings call that it would incur tariff-related costs of about $400 million this year, primarily affecting its medtech business. But Wolk, at the Bernstein conference, suggested the forecasted tariff hit could change in the future. 'Just based on the retaliatory China tariffs that we had in our $400 million assessment, that probably cuts the $400 million down to $200 million,' Wolk said, responding to a question about the shifting tariffs landscape. That does not include any impact that could result from the Trump administration's Section 232 investigations, he said. The Trump administration has launched special investigations into the pharmaceutical and semiconductor industries that could lead to tariffs. In addition, Wolk noted, tariffs between the U.S. and Europe remain in flux. J&J will provide its 'best and latest estimate in a transparent way' when it reports second-quarter earnings on July 16, the CFO said. 'It's a moving target,' he added. 'Johnson & Johnson has not changed its 2025 guidance that it provided during the Company's Q1 2025 earnings call on [April 15, 2025,] which included the $400 million allocated for the potential impact of tariffs,' a J&J spokesperson told MedTech Dive in an email. The U.S. on May 12 paused the 34% tariff on imports from China that President Donald Trump announced on April 2 and removed further duties that raised the combined tariff burden on goods from China to at least 145%. China also paused its matching 34% tariff on U.S. goods and rescinded all other levies enacted since April 2. Both countries are instead charging 10% baseline duties. On Monday, China accused the U.S. of undermining the May 12 agreement, after Trump on Friday said Beijing was violating the plan. J&J CEO Joaquin Duato, speaking at the Bernstein conference, said the company was "particularly confident' about its ability to meet its earnings-per-share guidance of about 5% to 7% growth from 2025 to 2030. In its medtech business, J&J already has a dual-source manufacturing footprint that allows the company to work with two separate supply chains, Duato noted. Boston Scientific, which also presented at the Bernstein conference, plans to update its $200 million tariff impact forecast to reflect changes since it provided the outlook, CEO Mike Mahoney told investors last week. Recommended Reading Boston Scientific plans changes to expected $200M tariff hit as situation shifts 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

Is Merck Stock About To Crash?
Is Merck Stock About To Crash?

Forbes

time3 days ago

  • Business
  • Forbes

Is Merck Stock About To Crash?

CHONGQING, CHINA - APRIL 20: In this photo illustration, the Merck logo is displayed on a smartphone ... More screen, with the company's green-themed branding visible in the background, on April 20, 2025, in Chongqing, China. (Photo by) Why would you consider buying Johnson & Johnson stock (NYSE:JNJ) at 17 times its trailing earnings when Merck stock (NYSE: MRK) trades at around 13 times? After all, Merck has nearly 10% average revenue growth compared to J&J's modest 4%, and Merck's operating cash flow margins are a healthier 33% versus J&J's 28%. This means more of Merck's robust top-line growth translates directly into free cash flow, which can be reinvested or returned to shareholders. So, why choose J&J over Merck? One could argue that J&J offers greater stability, with over a century of established operations. Merck's impressive recent growth, however, is largely attributed to the success of Keytruda, its blockbuster oncology drug. The concern is that this growth might not be sustainable, especially with increasing competition in the oncology space. See – Merck Stock's Ticking Keytruda Time Bomb. Here's the thing. Merck faces a significant challenge as Keytruda, accounting for nearly half of its revenue, loses U.S. market exclusivity in 2028. The drug's sales have soared, reaching $29 billion last year, but this reliance sets Merck up for a steep decline. History shows the dramatic impact of biosimilars: AbbVie's Humira sales plummeted by nearly 60% in just two years post-patent expiration, and Roche's Herceptin saw a similar sharp drop. Keytruda's sales are projected to peak around $36 billion by 2028, but a rapid decline to under $20 billion (or even $15 billion) is highly probable once biosimilar competition begins. This will inevitably slow Merck's growth and is expected to significantly impact its valuation. This scenario underscores the importance of building a resilient investment portfolio that balances risk and reward. Our Trefis High Quality (HQ) portfolio exemplifies this approach, having significantly outperformed the S&P 500, Nasdaq, and Russell 2000, clocking in over 91% returns since inception. Balancing risk and reward is precisely why diversifying across multiple stocks is crucial. Comparing Merck with J&J highlights the critical risk-reward trade-offs in investment decisions. In practice, investment choices are about understanding relative attractiveness. Should you buy J&J stock, keep your money in an interest-earning cash account, or invest in an S&P 500 ETF? You need to assess if the expected return on J&J stock sufficiently outweighs the return on cash, and what downside risk you're accepting for that potential extra return. Using a specific "anchor" asset, like Merck in this case, serves as a powerful tool to evaluate these risk-reward dynamics.

ASCO25: J&J's Carvykti shows strong efficacy across multiple myeloma risk groups
ASCO25: J&J's Carvykti shows strong efficacy across multiple myeloma risk groups

Yahoo

time4 days ago

  • Business
  • Yahoo

ASCO25: J&J's Carvykti shows strong efficacy across multiple myeloma risk groups

Updated analysis showed Carvykti (ciltacabtagene autoleucel) improved survival for multiple myeloma patients regardless of their cytogenetic risk or prior lines of therapy. Subgroup analysis of the Phase III CARTITUDE-4 trial (NCT04181827) showed Johnson & Johnson's (J&J) Carvykti improved overall (OS) and progression-free survival (PFS) for relapsed or refractory multiple myeloma patients (r/r MM) compared to standard-of-care (SOC). The drugmaker presented their abstract on 1 June at the 2025 American Society of Clinical Oncology (ASCO) conference in Chicago, taking place from 30 May to 3 June. CARTITUDE-4 enrolled 419 patients internationally who had refractory MM following treatment with lenalidomide. Patients were randomised to receive Carvykti infusion with either PVd (pomalidomide, bortezomib, and demathesone) or DPv (daratumumab, pomalidomide, and dexamethasone) SOC treatment, or PVd/DPv SOC alone. At a median follow-up of 33.6 months, median PFS among those with extramedullary disease, a risk factor associated with poor prognosis, was found to be 13 months for Carvytki-treated patients versus 4 months for those given SOC. Median OS was not reached for the Carykti subgroup, being 16 months for the SOC group. This benefit was consistent regardless of prior treatment. For patients with one, two, or three lines of prior therapy (pLOT), median PFS was not reached for all groups with Carvykti while SOC patients achieved median PFS of 17, 12, and eight months, respectively. Median OS was also not reached for all groups treated with Carvykti or those SOC patients with one or two pLOT but was 34 months for SOC patients with 3 prior lines. Carvykti first gained approval from the US Food and Drug Administration (FDA) to treat r/r MM in March 2022 based on results from the Phase Ib/II CARTITUDE-1 trial. It has since further proven its efficacy in this indication, including as part of presentations from prior years' ASCO conferences. The drug has since been approved by the FDA as a second-line MM therapy in April 2024. As per a June 2023 publication, primary data from CARTITUDE-4 showed that at 12 months, PFS was 75.9% with Carvykti and 48.6% without; minimal residual disease (MRD) was absent among 60.6% of patients on Carvykti, just 15.6% for those given SOC. GlobalData projects the drug will generate total global sales of $1.7bn in 2025, a figure estimated to rise to $7.2bn by 2031. GlobalData is the parent company of Clinical Trials Arena. "ASCO25: J&J's Carvykti shows strong efficacy across multiple myeloma risk groups" 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

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