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Adding Lurbinectedin Shows Benefit in SCLC

Adding Lurbinectedin Shows Benefit in SCLC

Medscape26-05-2025

The addition of lurbinectedin — a novel alkylating agent and transcription inhibitor — to first-line maintenance immunotherapy for extensive-stage small cell lung cancer (ES-SCLC) improved survival compared with standard maintenance therapy, according to new study results.
IMforte is the first phase 3 trial to show meaningful improvement in both progression-free survival (PFS) and overall survival (OS) with first-line maintenance treatment in ES-SCLC, 'highlighting the potential of lurbinectedin plus atezolizumab to become a new standard of care in this patient population…particularly considering this aggressive and difficult to treat disease,' said lead investigator Luis G. Paz Ares, MD, PhD, during a press conference for the American Society of Clinical Oncology (ASCO) 2025 annual meeting.
Paz Ares, chair of the Department of Medical Oncology at 12 de Octubre University Hospital in Madrid, Spain, described the current standard of care for first-line treatment of ES-SCLC. That involves induction therapy with a combination of etoposide, platinum chemotherapy plus either atezolizumab or durvalumab, followed by maintenance therapy with the same immune checkpoint (IC) inhibitor, he said, during the press conference.
'Most of those patients respond to treatment, but response is typically not long-lasting,' he explained, adding that relapse is common after a few months 'and second- and third-line treatments are not very effective.'
Previous research has shown lurbinectedin synergizes with IC inhibitors to achieve high rates of tumor regression and induce long-term T-cell memory, he added.
IMforte included 660 treatment naive ES-SCLC patients with no central nervous system metastases into a standard induction treatment of four cycles of atezolizumab plus carboplatin and etoposide.
Those whose disease did not progress after this (n = 483) were eligible for the maintenance phase of the study in which they were randomized to either a control group of standard therapy with atezolizumab (1200 mg intravenous [IV] every 3 weeks), or the experimental group with both atezolizumab plus lurbinectedin (3.2 mg/m2 IV every 3 weeks).
Follow-up was until disease progression or unacceptable toxicity, with primary endpoints being independent review facility–assessed PFS and OS.
The study showed a 'clear and significant improvement' in PFS for patients treated with the experimental therapy, with a median PFS of 5.4 months compared with only 2.1 months in the control group (hazard ratio [HR], 0.54; P <.0001). This corresponded to 6-month and 12-month PFS rates of 41.2% and 20.5% in the experimental group compared with 18.7% and 12% in the control group.
Similar improvements were seen for OS, with a median of 13.2 in the experimental group vs 10.6 months in the control group (HR, 0.73; P =.0174), and 12-month OS rates were 56.3% and 44.1%, respectively.
There was 'a predictable' safety profile for patients in the experimental group, with an expected increase in side-effects, but no new safety signals, Paz Ares said.
Treatment-related grade 3/4 adverse events (AEs) occurred in 25.6% of those in the experimental treatment group compared with 5.8% of those in the control group, and treatment-related grade 5 AEs were seen in 0.8% vs 0.4%. The percentage of patients requiring discontinuation because of AEs was 6.2% vs 3.3%.
Commenting on the results, Charu Aggarwal, MD, professor for lung cancer excellence at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, who was not involved in the study, said while immunotherapy has improved survival outcomes for this patient population 'long-term outcomes remain suboptimal, underscoring the need for better strategies.'
The integration of lurbinectedin alongside atezolizumab following initial chemo-immunotherapy 'represents an important next step,' she added. 'This approach offers a way to extend disease control and may signal a shift toward more durable benefit for patients.'
ASCO Chief Medical Officer and Spokesperson Judy Gralow, MD, noted that while lurbinectedin is currently US Food and Drug Administration approved in the second-line maintenance setting, 'with the results of this study, we would anticipate that it would be moved into the first-line maintenance setting.'
However, she emphasized that even with this change, PFS was 'still quite low' in both groups of the study. 'We need to work on additional ways of advancing this even further. So it is a small next step. It is extending the time that the tumor doesn't progress and the amount of time that the patients are living. But we need to do more research in extensive stage small cell lung cancer as well.'
Paz Ares disclosed leadership and stock and other ownership with Altum Sequencing and Stab Therapeutics; honoraria from Abbvie, Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Gilead Sciences, GlaxoSmithKline, Janssen, Lilly, Medscape, Merck Serono, MSD, Novartis, Pfizer, PharmaMar, Regeneron, Roche/Genentech, Sanofi, and Takeda; consulting or advisory roles with Abbvie, Amgen, Astellas Pharma, AstraZeneca, Bayer, BMS, GlaxoSmithKline, Janssen, Lilly, Merck, Mirati Therapeutics, MSD, Novartis, Pfizer, Pharmamar, Regeneron, Roche, Sanofi; and Takeda; speakers' bureauwithAmgen, AstraZeneca, BeiGene, BMS, Daiichi Sankyo Europe GmbH, Lilly, Merck Serono, MSD Oncology, Pfizer, and Roche/Genentech; research funding withAstraZeneca, BMS, MSD, Pfizer, and PharmaMar; and other relationships with Amgen, Astellas Pharma, Crinetics Pharmaceuticals, Esteve, HUTCHMED, Ipsen, ITM Isotope Technologies Munich, Merck, Novartis, Pfizer, Roche, Sanofi, and Servier.
Aggarwal made several kinds of disclosures involving various companies. Gralow disclosed no conflicts. The IMforte study was funded by Genentech.

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Scientists mapped what happens if a crucial system of ocean currents collapses. The weather impact would be extreme
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CNN

time44 minutes ago

  • CNN

Scientists mapped what happens if a crucial system of ocean currents collapses. The weather impact would be extreme

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New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis
New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis

Associated Press

timean hour ago

  • Associated Press

New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis

TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo in the Phase 3b APEX study More than 40% of TREMFYA®-treated patients across both dose groups achieved ACR50 at Week 24 Improvement in both joint and skin symptoms reinforce TREMFYA® as a first-line treatment option with a proven safety profile for adults with active psoriatic arthritis BARCELONA, June 11, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced findings from the Phase 3b APEX study showing that TREMFYA® (guselkumab) significantly reduced both signs and symptoms of active psoriatic arthritis (PsA) and inhibited progression of joint structural damage at 24 weeks compared to placebo.1 These data from a late-breaking abstract are among the 30 oral and poster presentations Johnson & Johnson is highlighting at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress. In the Phase 3b APEX study, TREMFYA® significantly inhibited progression of joint structural damage, including joint erosions and space narrowing, in patients with active PsA at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score. The mean change from baseline to Week 24 in the modified van der Heijde-Sharp (vdH-S) score was 0.55 and 0.54 for patients receiving TREMFYA® every four weeks (Q4W) and every eight weeks (Q8W) respectively, compared with 1.35 in the placebo group (p=0.002 for Q4W and p<0.001 for Q8W dosing versus placebo, respectively). In the two TREMFYA® dose groups, 67% (Q4W) and 63% (Q8W) of patients experienced no radiographic progression, versus 53% in the placebo group.a,1 'In psoriatic arthritis, joint damage can begin early and progress quickly if left untreated, significantly impacting a patient's ability to move, work and maintain independence,' said Philip J. Mease, MD, Director of Rheumatology Research at the Swedish Medical Center and study investigator.b 'The results of the APEX study are promising as the data show guselkumab to be the only IL-23 inhibitor in its class that has inhibited the progression of structural damage in patients, providing new clinical insights for the psoriatic community and underscoring the need for safe, effective options that address the full burden of disease.' TREMFYA® also improved both joint and skin symptoms in patients with active PsA. The data from the APEX study were consistent with the well-established safety profile of TREMFYA®, with no new safety signals identified.1 'With these results from the APEX study, TREMFYA has set a new bar for joint preservation as the only IL-23 inhibitor proven to significantly inhibit structural damage in active psoriatic arthritis, an inflammatory arthritis that can develop in up to 30% of people living with psoriasis,' said Terence Rooney, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. 'The efficacy and safety profile of TREMFYA offers psoriatic healthcare providers and patients an innovative option for disease control.' TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active psoriatic arthritis.2,3,4,5,6 Editor's notes: a. TREMFYA is not approved for Q4W dosing in the U.S. b. Dr. Philip J. Mease is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. c. ACR20/50 response is defined as both at least 20/50 percent improvement from baseline in the number of tender and number of swollen joints, and a 20/50 percent improvement from baseline in three of the following five criteria: patient GA, physician GA, functional ability measure (HAQ-DI), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or C-reactive protein.7 d. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate and 4 indicates severe disease.8 ABOUT THE APEX STUDY ( NCT04882098 ) APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment period is scheduled prior to the final safety follow-up.9 ABOUT PSORIATIC ARTHRITIS Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).10,11,12 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.13 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.14 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.15 Studies show up to 30% of people with plaque PsO also develop PsA.11 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA® is a prescription medicine approved in the U.S. to treat: TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA®? TREMFYA® is a prescription medicine that may cause serious side effects, including: Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See 'What is the most important information I should know about TREMFYA®?' The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. 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 @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. 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 nipocalimab. 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 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 most recent Annual Report on Form 10-K, 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. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. REFERENCES 1 Mease PJ, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: Results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Presented at EULAR 2025, June 11-14. LB0010. 2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504. 3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217. 4 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 7 Felson, D. T., & LaValley, M. P. The ACR20 and defining a threshold for response in rheumatic diseases: too much of a good thing. Arthritis Research & Therapy, 2014:16(1), 101. 8 Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis [published online April 25, 2020]. J Am Acad Dermatol. doi: 10.1016/ Accessed April 2025. 9 A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Identifier: NCT04882098. Available at: Accessed March 2025. 10 Donvito T., CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: Accessed March 2025. 11 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: Accessed March 2025. 12 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: Accessed March 2025. 13 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: Accessed March 2025. 14 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: Accessed March 2025. 15 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: Accessed March 2025. 16 TREMFYA® Prescribing Information. Available at: Accessed March 2025. View original content to download multimedia: SOURCE Johnson & Johnson

Biologic Therapeutic Drugs Technology Analysis and Global Market Forecast Report 2024-2025 & 2029 Featuring Key Players - Merck, F. Hoffmann-La Roche, Johnson & Johnson, Pfizer, & Bristol-Myers Squibb
Biologic Therapeutic Drugs Technology Analysis and Global Market Forecast Report 2024-2025 & 2029 Featuring Key Players - Merck, F. Hoffmann-La Roche, Johnson & Johnson, Pfizer, & Bristol-Myers Squibb

Associated Press

timean hour ago

  • Associated Press

Biologic Therapeutic Drugs Technology Analysis and Global Market Forecast Report 2024-2025 & 2029 Featuring Key Players - Merck, F. Hoffmann-La Roche, Johnson & Johnson, Pfizer, & Bristol-Myers Squibb

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