Latest news with #ES-SCLC
Business Standard
06-08-2025
- Business
- Business Standard
Intas Pharmaceuticals Launches HETRONIFLY™ (Serplulimab), India's First Novel Immunotherapy for Advanced Small Cell Lung Cancer
Intas Accord Logo PRNewswire Ahmedabad (Gujarat) [India], August 6: Intas Pharmaceuticals has launched HETRONIFLY™ (Serplulimab), the first PD-1 inhibitor globally approved for the treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC), in the Indian market. This marks another major milestone, following the successful Launch in Europe. This launch follows a strategic licensing agreement between Intas Pharmaceuticals Limited and Shanghai Henlius Biotech, Inc., further strengthening Intas' oncology portfolio and reinforcing its commitment to delivering cutting-edge therapies to patients in India. Serplulimab is the first PD-1 inhibitor worldwide to receive approval for ES-SCLC, and is currently present in over 40 countries, including key European markets. Its efficacy is supported by the landmark ASTRUM-005 trial, which demonstrated a 40% reduction in the risk of death and remarkably higher overall survival rate versus the current standard-of-care Chemotherapy regimen. Notably, Serplulimab achieved an ESMO-MCBS score of 4/5--the highest among current immunotherapies, signifying highest clinical benefit in this indication. The novel humanized mAb has a unique dual-blockade mechanism of PD-L1 and PD-L2, along with the highest PD-1 internalization, which sets a new benchmark in deep immune engagement for solid tumors. Globally, Serplulimab has been administered to over a lakh patients across a range of malignancies including SCLC, NSCLC, ESCC, and MSI-high cancers. Despite the promise of immuno-oncology, cost remains a significant barrier in India. HETRONIFLY™, introduced at approximately 75% lower cost than the currently available immunotherapies for this indication, underscores Intas' commitment to providing high-quality innovative therapies at affordable prices to cancer patients in India. Commenting on the launch, Binish Chudgar, Chairman & Managing Director of Intas Pharmaceuticals said, "The launch of HETRONIFLY™ reinforces our strategic position in oncology and reflects Intas' commitment to accelerating access to globally validated therapies. It aligns with our operating model of delivering high-impact innovations to the Indian market with speed and cost-efficiency."
Korea Herald
16-07-2025
- Business
- Korea Herald
SNB-101 Earns Government Backing as Promising Therapy for Small Cell Lung Cancer
SEONGNAM, South Korea, July 16, 2025 /PRNewswire/ -- In a strong endorsement of its cutting-edge drug delivery technology, SN BioScience announced that its anticancer candidate SNB-101 has been selected as a clinical-stage project under the 2025 Korea Drug Development Project, a government-initiated program led by the Korea Drug Development Fund (KDDF). The program includes two years of research support, aiding the company's advancement of SNB-101 into global Phase 1b/2 trials. The Korea Drug Development Fund (KDDF) is a government agency funded by three ministries. It aims to actively fund and provide necessary support for drug development in academia and the pharmaceutical industry. As Korea's most authoritative national drug development platform, the KDDF is dedicated to advancing innovative drug development projects, spanning the entire process from early discovery to clinical stages. SNB-101 is a polymeric nanoparticle-based nanoformulation of SN-38, the potent active metabolite of irinotecan, a topoisomerase I inhibitor in the Camptothecin class. Utilizing its proprietary dual nanomicelle platform, the drug is designed to maximize tumor-specific targeting by leveraging the Enhanced Permeability and Retention (EPR) effect, thereby enhancing therapeutic efficacy while minimizing toxicity to healthy tissues. SNB-101 has already garnered international recognition through multiple regulatory designations as a next-generation anticancer therapy. The U.S. FDA has granted SNB-101 Orphan Drug Designation for both small cell lung cancer (SCLC) and pancreatic cancer, and has also granted Fast Track Designation for SCLC — a regulatory green light to accelerate its development timeline. SN BioScience is set to launch a multinational Phase 1b/2 clinical trial for patients with extensive-stage small cell lung cancer (ES-SCLC), spanning key sites across South Korea, the United States, and Europe. The study will focus on dose optimization, safety, and efficacy, with particular emphasis on enrolling a racially and ethnically diverse patient population to support early commercialization efforts. Given the aggressive nature and poor prognosis of this rare cancer, SNB-101 is gaining attention as a potential second- or third-line treatment for patients who have failed existing therapies. Furthermore, the company is exploring combination strategies with immunotherapies to position SNB-101 as a potential first- or second-line standard of care in the future. "SNB-101 represents our commitment to overcoming the limitations of conventional cancer therapies," said Young-Hwan Park, CEO of SN BioScience. "This national grant will accelerate our global clinical development and solidify SNB-101's position as a next-generation anticancer therapy."
Business Wire
08-07-2025
- Health
- Business Wire
BostonGene Announces Collaboration with SWOG Cancer Research Network to Drive Personalized Approaches
WALTHAM, Mass.--(BUSINESS WIRE)-- BostonGene, a leader in AI-powered solutions for drug discovery and development, today announced a collaboration with the SWOG Cancer Research Network, a global cancer research community that designs and conducts publicly funded clinical trials, on a new multicohort study titled " S2409, PRISM: PRecIsion in SCLC via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab with or without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)." This study, which is supported by the National Cancer Institute (NCI), part of the National Institutes of Health, aims to redefine the standard of care for patients with ES-SCLC by employing biomarker-driven personalized treatment strategies. 'By combining advanced molecular profiling with AI, we're not only able to classify patients more precisely but also to advance therapy selection and accelerate the development of next-generation treatments." Currently, the standard treatment for ES-SCLC involves combination chemotherapy and anti-PD-L1 immunotherapy, followed by maintenance immunotherapy. While this broad approach extends overall survival by 2-3 months, it still results in disease progression in most patients. The PRISM study is designed to utilize novel biomarkers to identify and treat patients who may benefit from the addition of targeted agents, such as PARP inhibitors, to standard therapy. The study will be led by SWOG, conducted within the NCI's National Clinical Trials Network, and chaired by Drs. Anne Chiang, of the Yale Cancer Center, and Alberto Chiappori, of the Moffitt Cancer Center, in conjunction with Translational Medicine chairs Drs. Lauren Byers and Carl Gay, of The University of Texas MD Anderson Cancer Center. The trial will enroll up to 900 patients and use BostonGene's AI-powered multiomic platform to identify molecular subtypes, assigning patients to therapy based on their subtype. The platform enables deep characterization of each patient's tumor and immune profile, supporting the selection of more effective therapies and helping to accelerate translational insights that inform future drug development. The trial builds on the ongoing collaborative work between MD Anderson's lung cancer group, including Drs. Byers and Gay, and BostonGene to identify and validate four molecular subtypes of SCLC that exhibit distinct biological and therapeutic profiles. Initial findings from the SWOG S1929 trial demonstrated promising improvements in progression-free survival using this targeted approach. The goal of the upcoming study is to optimize outcomes for each subtype, offering patients more effective and individualized treatments. 'S2409 PRISM will test the hypothesis that we can be more effective in treating extensive-stage small-cell lung cancer by targeting the vulnerabilities of specific molecular subtypes,' said study chair Dr. Chiang, who also serves as SWOG's executive officer overseeing lung cancer and breast cancer research. 'We hope to demonstrate that it's feasible to identify the SCLC subtype in the clinical setting and to use that information to select the best therapy for each patient.' 'Collaborating with SWOG on this landmark study aligns with our mission to deliver innovative, data-driven insights that are transforming cancer care,' said Nathan Fowler, MD, Chief Medical Officer at BostonGene. 'By combining advanced molecular profiling with AI, we're not only able to classify patients more precisely but also to advance therapy selection and accelerate the development of next-generation treatments. This study is poised to reshape the treatment landscape in lung cancer and provide a roadmap of how to build and validate biomarker-driven treatment approaches across cancers.' About BostonGene Corporation BostonGene helps drug developers de-risk and accelerate research and development using a clinically validated AI platform purpose-built for oncology and supported by a CLIA-certified and CAP-accredited clinical laboratory. By integrating advanced molecular and immune profiling with clinical data, we uncover actionable insights that inform trial design, optimize patient selection and improve clinical outcomes. Our diagnostic and treatment recommendation solutions are used in clinical settings to personalize care and guide therapy decisions for patients. For more information, visit
Malaysian Reserve
20-06-2025
- Business
- Malaysian Reserve
Delta-like Ligand 3 Targeted Therapies Market is Predicted to Heat Up During the Forecast Period (2025-2034) Across 7MM Owing to a Robust Pipeline
The delta-like ligand 3 targeted therapies market is witnessing significant growth, driven by the rising incidence of small cell lung cancer (SCLC) and neuroendocrine tumors. Advancements in antibody-drug conjugate (ADC) technology and increasing clinical trial activity are propelling the development of DLL3-targeted candidates. Growing interest from biopharma companies and strategic collaborations are also accelerating the DLL3-targeted therapies market expansion. LAS VEGAS, June 19, 2025 /PRNewswire/ — DelveInsight's Delta-like Ligand 3 Targeted Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, emerging delta-like ligand 3 targeted therapies, market share of individual therapies, and current and forecasted delta-like ligand 3 targeted therapies market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Delta-like Ligand 3 Targeted Therapies Market Report As per DelveInsight's analysis, the total market size of delta-like ligand 3 targeted therapies in the 7MM is expected to surge significantly by 2034. The approval of the first DLL3-targeted Bispecific T-cell Engager therapy, IMDELLTRA, by the US Food and Drug Administration (FDA) in May 2024 marked a pivotal moment for patients battling Extensive-stage small-cell lung Cancer (ES-SCLC). Leading delta-like ligand 3 targeted therapies companies, such as Phanes Therapeutics, Merck, Daiichi Sankyo, Legend Biotech, Novartis, Abdera Therapeutics, Boehringer Ingelheim, Chugai Pharmaceutical, Roche, Molecular Partners, Orano Med, Zai Lab, Allogene Therapeutics, and others, are developing novel delta-like ligand 3 targeted therapies that can be available in the delta-like ligand 3 targeted therapies market in the coming years. Some of the key delta-like ligand 3 targeted therapies in the pipeline include Peluntamig (PT217), MK-6070/DS3280, LB2102/ DLL3-targeted CAR Ts, 225Ac-ABD147, Obrixtamig (BI 764532), ALPS12/RG6524, MP0712, ZL-1310, ALL-213, and others. In February 2025, Phanes Therapeutics announced that the first patient was dosed in the clinical study of peluntamig (PT217) in combination with chemotherapy. In September 2024, Abdera Therapeutics announced that the US FDA granted ODD to ABD-147 for the treatment of NEC. In August 2024, Daiichi Sankyo and Merck expanded their existing global co-development and co-commercialization agreement for Merck's MK-6070 for the treatment of SCLC. Discover which indication is expected to grab the major delta-like ligand 3 targeted therapies market share @ Delta-like Ligand 3 Targeted Therapies Market Report Delta-like Ligand 3 Targeted Therapies Market Dynamics The delta-like ligand 3 targeted therapies market is emerging as a dynamic and promising area in oncology, particularly for hard-to-treat cancers like SCLC and other neuroendocrine tumors. With a growing understanding of its role in tumorigenesis, drug developers have shifted focus toward exploiting this target through various modalities, including ADCs, BiTEs, and CAR-T cell therapies. The FDA approval of tarlatamab (IMDELLTRA), a DLL3-targeted BiTE, has catalyzed commercial and clinical interest in this space. The competitive landscape is rapidly evolving, driven by both established pharmaceutical players and biotech innovators. Several companies are advancing DLL3-targeted assets through clinical pipelines, highlighting the growing investment and belief in the target's therapeutic value. Tarlatamab, in particular, has set a precedent by demonstrating durable responses in patients with extensive-stage SCLC who have limited treatment options after frontline chemotherapy. Its clinical success has validated DLL3 as a viable target and opened the door for additional programs in earlier lines of therapy and combination regimens. However, the DLL3-targeted therapy market faces challenges that could shape its trajectory. The heterogeneity of DLL3 expression among patient populations, potential for resistance mechanisms, and safety concerns, especially cytokine release syndrome (CRS) in immune-engaging therapies, are critical issues under active investigation. Additionally, biomarker-based patient selection strategies are essential to optimize efficacy, which may limit the addressable population unless companion diagnostics evolve in parallel. Market dynamics are also influenced by the broader shift toward personalized and immune-based treatments. The rise of bispecific and cell-based platforms enhances the flexibility in targeting DLL3, but also introduces manufacturing and logistical hurdles. As such, scalability, cost-effectiveness, and global accessibility will be important considerations in the commercial rollout. Reimbursement strategies and payer acceptance will further impact uptake, especially given the premium pricing associated with novel biologics. Looking ahead, the DLL3-targeted therapies market is poised for expansion beyond SCLC. Preliminary studies are exploring DLL3 expression in other neuroendocrine carcinomas, prostate cancer, and some pediatric tumors. This potential for label expansion, coupled with advancing drug formats and supportive regulatory pathways, indicates a robust growth trajectory. As the clinical pipeline matures and real-world data accumulate, DLL3-targeted approaches are expected to play an increasingly integral role in the precision oncology landscape. Delta-like Ligand 3 Targeted Therapies Treatment Market DLL3-targeted therapies are emerging as a promising new approach in the treatment of small-cell lung cancer and neuroendocrine carcinomas, bringing renewed optimism for patients with these aggressive cancers. A major breakthrough came in May 2024, when the US FDA approved IMDELLTRA, the first bispecific T-cell engager therapy targeting DLL3. Developed by Amgen, this first-in-class immunotherapy is designed to bind DLL3 on tumor cells and CD3 on T cells, triggering a T-cell–mediated attack on DLL3-expressing cancer cells through the formation of a cytolytic synapse. The approval and subsequent launch of IMDELLTRA have been widely recognized as a significant advancement in DLL3-focused treatments, generating approximately USD 115 million in US sales in 2024. This therapy offers a game-changing option for patients with previously treated Extensive-stage SCLC, showing durable responses. As the second FDA-approved BiTE molecule from Amgen, IMDELLTRA underscores the company's commitment to tackling hard-to-treat cancers. For patients urgently needing new therapeutic solutions, this approval delivers a much-needed and long-awaited source of hope. Learn more about the FDA-approved delta-like ligand 3 targeted therapies @ Approved Delta-like Ligand 3 Targeted Therapies Key Emerging Delta-like Ligand 3 Targeted Therapies and Companies The current pipeline is dominated with early-stage DLL-3 targeted therapies like peluntamig (Phanes Therapeutics), MK-6070/ HPN328-4001/ DS3280 (Merck / Daiichi Sankyo), LB2102/ DLL3-targeted CAR-Ts (Legend Biotech and Novartis), 225Ac-ABD147 (Abdera Therapeutics), BI 764532 (Boehringer Ingelheim), ALPS12/ RG6524 (Chugai Pharmaceutical and Roche), ZL-1310 (Zai Lab), and others. Peluntamig (PT217) is a first-in-class, native IgG-like bispecific antibody designed to target both DLL3 and CD47. It is being developed for the treatment of SCLC and neuroendocrine carcinomas, including neuroendocrine prostate cancer (NEPC). The FDA has awarded peluntamig two Orphan Drug Designations (ODDs) for SCLC and NEC, along with two Fast Track Designations (FTDs): one for extensive-stage SCLC that has progressed following platinum-based chemotherapy (with or without checkpoint inhibitors), and another for metastatic de novo or treatment-emergent NEPC. The therapy is currently undergoing evaluation in the Phase I/II SKYBRIDGE trial (NCT05652686) for SCLC and NEC. MK-6070 is an experimental tri-specific T-cell engager targeting DLL3, under Phase I/II clinical investigation. It is being tested as a standalone therapy in patients with advanced DLL3-expressing tumors and in combination with atezolizumab for certain cases of SCLC. The FDA granted MK-6070 Orphan Drug Designation for SCLC in March 2022. In March 2024, Merck finalized its acquisition of Harpoon Therapeutics, the original developer. In August 2024, Daiichi Sankyo and Merck expanded their global partnership to include MK-6070 under their co-development and co-commercialization agreement for DXd antibody-drug conjugates. Merck retains exclusive rights in Japan and will handle all manufacturing and supply responsibilities for MK-6070. The two companies also plan to explore the use of MK-6070 in combination with ifinatamab deruxtecan (I-DXd) for SCLC, along with other potential combination strategies. The anticipated launch of these emerging therapies is poised to transform the delta-like ligand 3 targeted therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the delta-like ligand 3 targeted therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about delta-like ligand 3 targeted therapies clinical trials, visit @ Delta-like Ligand 3 Targeted Therapies Treatment Delta-like Ligand 3 Targeted Therapies Overview Delta-like ligand 3 (DLL3) targeted therapies is an unconventional ligand within the Notch signaling pathway that, when overexpressed, supports the growth, migration, and invasiveness of small cell lung cancer (SCLC) cells. It also contributes to the development of metastatic and therapy-resistant traits in neuroendocrine carcinomas (NECs), enhancing both tumor cell proliferation and resistance to platinum-based chemotherapy. In normal cells, DLL3 expression is minimal and confined to the Golgi apparatus and cytoplasmic vesicles. This specific intracellular localization is regulated by its transmembrane domain and nearby protein sequences, which serve as retention signals. In contrast, SCLC cells exhibit high levels of DLL3 that are abnormally localized to the cell surface, a characteristic observed in up to 85% of human SCLC cases. While the mechanisms behind this overexpression and altered trafficking are not fully understood, DLL3's distinct expression pattern positions it as a promising biomarker and therapeutic target in SCLC. Beyond SCLC, DLL3 is also widely expressed in various NECs, including certain molecular subtypes of pulmonary large cell NEC (LCNEC) and NECs originating from the gastroenteropancreatic tract, bladder, prostate, and cervix. In these tumors, elevated DLL3 expression correlates with more advanced disease and poorer overall survival, suggesting a strong association between high DLL3 levels and unfavorable clinical outcomes. Delta-like Ligand 3 Targeted Therapies Epidemiology Segmentation The delta-like ligand 3 targeted therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases in Selected Indications for DLL3-targeted Therapies Total Eligible Patient Pool in Selected Indications for DLL3-targeted Therapies Total Treated Cases in Selected Indications for DLL3-targeted Therapies Delta-like Ligand 3 Targeted Therapies Report Metrics Details Study Period 2020–2034 Delta-like Ligand 3 Targeted Therapies Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Delta-like Ligand 3 Targeted Therapies Companies Phanes Therapeutics, Merck, Daiichi Sankyo, Legend Biotech, Novartis, Abdera Therapeutics, Boehringer Ingelheim, Chugai Pharmaceutical, Roche, Molecular Partners, Orano Med, Zai Lab, Allogene Therapeutics, Amgen, and others Key Delta-like Ligand 3 Targeted Therapies Peluntamig (PT217), MK-6070/DS3280, LB2102/ DLL3-targeted CAR Ts, 225Ac-ABD147, Obrixtamig (BI 764532), ALPS12/RG6524, MP0712, ZL-1310, ALL-213, IMDELLTRA, and others Scope of the Delta-like Ligand 3 Targeted Therapies Market Report Delta-like Ligand 3 Targeted Therapies Therapeutic Assessment: Delta-like Ligand 3 Targeted Therapies current marketed and emerging therapies Delta-like Ligand 3 Targeted Therapies Market Dynamics: Conjoint Analysis of Emerging Delta-like Ligand 3 Targeted Therapies Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Delta-like Ligand 3 Targeted Therapies Market Access and Reimbursement Discover more about delta-like ligand 3 targeted therapies in development @ Delta-like Ligand 3 Targeted Therapies Clinical Trials Table of Contents 1. Key Insights 2. Report Introduction 3. Executive Summary 4. Key Events 5. Market Forecast Methodology 6. Delta-like Ligand 3 Targeted Therapies Market Overview at a Glance in the 7MM 6.1. Market Share (%) Distribution by Therapies in 2025 6.2. Market Share (%) Distribution by Therapies in 2034 6.3. Market Share (%) Distribution by Indications in 2025 6.4. Market Share (%) Distribution by Indications in 2034 7. Delta-like Ligand 3 (DLL3)-targeted Therapies: Background and Overview 7.1. Introduction 7.2. The Potential of Delta-like Ligand 3 (DLL3)-targeted Therapies in Different Indications 7.3. Clinical Applications of Delta-like Ligand 3 (DLL3)-targeted Therapies 8. Target Patient Pool of Delta-like Ligand 3 (DLL3)-targeted Therapies 8.1. Assumptions and Rationale 8.2. Key Findings 8.3. Total Cases of Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 8.4. Total Eligible Patient Pool of Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 8.5. Total Treatable Cases in Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 9. Marketed Therapies 9.1. Key Competitors 9.2. IMDELLTRA (tarlatamab-dlle): Amgen 9.2.1. Product Description 9.2.2. Regulatory milestones 9.2.3. Other developmental activities 9.2.4. Clinical development 9.2.5. Safety and efficacy List to be continued in the report 10. Emerging Therapies 10.1. Key Competitors 10.2. Peluntamig (PT217): Phanes Therapeutics 10.2.1. Product Description 10.2.2. Other developmental activities 10.2.3. Clinical development 10.2.4. Safety and efficacy 10.3. MK-6070/ HPN328-4001/ DS3280: Merck/ Daiichi Sankyo 10.3.1. Product Description 10.3.2. Other developmental activities 10.3.3. Clinical development 10.3.4. Safety and efficacy List to be continued in the report 11. Delta-like Ligand 3 Targeted Therapies: Seven Major Market Analysis 11.1. Key Findings 11.2. Market Outlook 11.3. Conjoint Analysis 11.4. Key Market Forecast Assumptions 11.4.1. Cost Assumptions and Rebates 11.4.2. Pricing Trends 11.4.3. Analogue Assessment 11.4.4. Launch Year and Therapy Uptakes 11.5. Total Market Sizes of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in the 7MM 11.6. The United States Market Size 11.6.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies in the United States 11.6.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indication in the United States 11.6.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in the United States 11.7. EU4 and the UK 11.7.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies in EU4 and the UK 11.7.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in EU4 and the UK 11.7.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in EU4 and the UK 11.8. Japan 11.8.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies Inhibitors in Japan 11.8.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in Japan 11.8.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in Japan 12. SWOT Analysis 13. KOL Views 14. Unmet Needs 15. Market Access and Reimbursement 16. Appendix 16.1. Bibliography 16.2. Report Methodology 17. DelveInsight Capabilities 18. Disclaimer 19. About DelveInsight Related Reports Small Cell Lung Cancer Market Small Cell Lung Cancer Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SCLC companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, GlaxoSmithKline, Advanced Accelerator Applications, Trillium Therapeutics, Vernalis, Oncoceutics, NewBio Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, Xencor, Jiangsu HengRui Medicine, Aileron Therapeutics, Roche, Ipsen, Celgene, Lee's Pharmaceutical Limited, AbbVie, G1 Therapeutics, Chipscreen Biosciences, Luye Pharma Group, Shanghai Henlius Biotech, CSPC ZhongQi Pharmaceutical Technology, Impact Therapeutics, among others. Extensive-Stage Small Cell Lung Cancer Market Extensive-Stage Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ES-SCLC companies, including Shanghai Henlius Biotech, MacroGenics, Inc., RayzeBio, Inc., Genentech, Eli Lilly and Company, Amgen, Hutchison Medipharma Limited, Biocity Biopharmaceutics Co., Ltd., Biotheus Inc., GSK, InxMed (Shanghai) Co., Ltd., Daiichi Sankyo, Merck Sharp & Dohme LLC, among others. Neuroendocrine Carcinoma Market Neuroendocrine Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NEC companies, including Novartis AG, Boehringer Ingelheim International GmbH, Pfizer, Inc., Ipsen Pharma, AVEO Oncology, Hutchison MediPharma Limited, Progenics Pharmaceuticals, among others. Neuroendocrine Prostate Cancer Market Neuroendocrine Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key neuroendocrine prostate cancer companies, including Pfizer, Novartis, Bristol-Myers Squibb, Exelixis, Ipsen, Takeda, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content:
Yahoo
06-06-2025
- Health
- Yahoo
ASCO 2025: DeLLphi-304 helps Amgen to pave the way for BiTEs in solid cancers
Small cell lung cancer (SCLC) accounts for 10-15% of all lung cancer cases annually, with 250,000 incident cases diagnosed every year and 200,000 deaths occurring. With such a high healthcare burden, rapid advancements have been made with the advent of programmed cell death protein-1 checkpoint inhibition and immunotherapy, although they have only been proven successful in the first-line paradigm. Unlike non-small cell lung cancer (NSCLC), the treatment options for SCLC are more limited, as it is more aggressive and develops resistance to available treatments rapidly. One of the current standards of care (SOC) is the use of platinum-based chemotherapy such as cisplatin in combination with Roche's Tecentriq or AstraZeneca's Imfinzi in the first-line treatment for extensive-stage SCLC (ES-SCLC). Following treatment, many patients with NSCLC will develop platinum resistance through strengthened DNA-repair capabilities and reduced chemotherapy uptake in the cancerous cells. Amgen's Imdelltra, a bispecific T-cell engager (BiTE) that targets Delta-like canonical Notch ligand 3 (DLL3) and cluster of differentiation 3 (CD3) receptors, received US Food and Drug Administration approval for the treatment of patients with ES-SCLC following disease progression or following platinum-based chemotherapy, based on results from the DeLLphi-301 trial. While the approval is a historic event for the BiTE drug class in solid tumours, the market share opportunity is restricted as DeLLphi-301 was a Phase II trial with only one arm and no comparator. Results from the American Society of Clinical Oncology 2025 have shown the latest in Imdelltra's clinical results from the DeLLphi-304 trial. DeLLphi-304 enrolled 254 patients receiving Imdelltra and 255 receiving one of the following: topotecan, amrubicin, or Jazz Pharmaceutical's Zepzelca. Zepzelca and topotecan are preferred systemic treatment options for SCLC. Imdelltra was found to increase overall survival by 5.3 months (hazard ratio: 0.60, P<0.001) and increase median progression-free survival. There was also a large difference in grade 3 treatment-related adverse events, with Imdelltra reducing the rate by 35% compared to the control arm. Absent any competing immunotherapies with a preferred National Comprehensive Cancer Network opinion, Imdelltra is expected to be an attractive option for many patients looking to enhance their care. The annual cost of Imdelltra therapy totals $167,600 per patient. As a result, Imdelltra will likely struggle to receive reimbursement outside of the US. Despite the high cost, the clinical benefits are clear and Imdelltra's US market share uptake will be enhanced with these positive results, particularly owing to its more manageable safety profile when compared to existing options for this segment. Leading data and analytics company GlobalData's indication-based forecast shows Imdelltra will reach $1.76bn globally by 2031. "ASCO 2025: DeLLphi-304 helps Amgen to pave the way for BiTEs in solid cancers" 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
