This open label, randomized study will evaluate safety and tolerability of sargramostim when combined with an ipilimumab-containing regimen received as part of standard of care therapy. The study will evaluate 2 sargramostim administration schedules. Patients will be randomized 1:1 to the sargramostim administration schedules and stratified based on planned dose of ipilimumab (1 mg/kg, 3 mg/kg).
Sargramostim will be administered for the first 12 weeks following the assigned treatment schedule or until disease progression, intolerable toxicity, consent withdrawal, pregnancy, or death, whichever comes first. Checkpoint inhibitor therapy will be administered in accordance with institutional standard of care guidelines, at the Investigator's discretion.
Patients will be followed up for to 24 weeks following end of sargramostim treatment for safety, efficacy, and survival.

开始日期2024-01-01

申办/合作机构

Partner Therapeutics, Inc.初创企业

NCT05677633 / Active, not recruiting临床1期IIT

A Phase 1, Open-label Study to Validate Treatment-induced Biomarkers Following Sargramostim Treatment in Parkinson's Disease

Investigators will evaluate the safety of a 48 week regimen of Leukine administered as a weight-based dose at 3 ug/kg/ day for 5 days followed by a 2-day holiday. This 48 week long study will extend the prior biomarker evaluations observed in a previous study. Clinical signs and symptoms will be measured by personal well-being, physical, and neurological examinations (UPDRS Parts I, II, III, and IV assessments) and blood tests (CBC with differential, total T cell count, and a comprehensive metabolic sera panel). Leukapheresis will be performed to collect large numbers of immune cells for biomarker testing and immune phenotyping. Additionally, the investigators will determine whether immune deficits of PD are consistent during baseline data collection, and the potential Leukine-induced motor control and mobility improvements will be determined by UPDRS part I, II, III, and IV scores off treatment and on treatment.

开始日期2023-01-19

申办/合作机构

University of Nebraska

[+1]

NCT04902703 / Recruiting临床2期IIT

Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD)

A medicine that is FDA-approved for bone marrow stimulation (called sargramostim) will be tested for its safety and efficacy in individuals with mild-to-moderate Alzheimer's disease over a six month treatment period.

开始日期2022-06-01

申办/合作机构

University of Colorado Denver

[+3]

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项与 Partner Therapeutics, Inc. 相关的文献（医药）

2024-04-15·International Journal of Cancer

GM‐CSF, G‐CSF or no cytokine therapy with anti‐GD2 immunotherapy for high‐risk neuroblastoma

Review

作者: Mora, Jaume ; Ragsdale, Carolyn E ; Lazarus, Hillard M ; Modak, Shakeel ; Kinsey, Joyce

AbstractColony‐stimulating factors have been shown to improve anti‐disialoganglioside 2 (anti‐GD2) monoclonal antibody response in high‐risk neuroblastoma by enhancing antibody‐dependent cell‐mediated cytotoxicity (ADCC). A substantial amount of research has focused on recombinant human granulocyte‐macrophage colony‐stimulating factor (GM‐CSF) as an adjuvant to anti‐GD2 monoclonal antibodies. There may be a disparity in care among patients as access to GM‐CSF therapy and anti‐GD2 monoclonal antibodies is not uniform. Only select countries have approved these agents for use, and even with regulatory approvals, access to these agents can be complex and cost prohibitive. This comprehensive review summarizes clinical data regarding efficacy and safety of GM‐CSF, recombinant human granulocyte colony‐stimulating factor (G‐CSF) or no cytokine in combination with anti‐GD2 monoclonal antibodies (ie, dinutuximab, dinutuximab beta or naxitamab) for immunotherapy of patients with high‐risk neuroblastoma. A substantial body of clinical data support the immunotherapy combination of anti‐GD2 monoclonal antibodies and GM‐CSF. In contrast, clinical data supporting the use of G‐CSF are limited. No formal comparison between GM‐CSF, G‐CSF and no cytokine has been identified. The treatment of high‐risk neuroblastoma with anti‐GD2 therapy plus GM‐CSF is well established. Suboptimal efficacy outcomes with G‐CSF raise concerns about its suitability as an alternative to GM‐CSF as an adjuvant in immunotherapy for patients with high‐risk neuroblastoma. While programs exist to facilitate obtaining GM‐CSF and anti‐GD2 monoclonal antibodies in regions where they are not commercially available, continued work is needed to ensure equitable therapeutic options are available globally.

2024-04-01·Journal of Pharmacy Practice

Adverse Drug Reaction vs Care Complication: Response to “Use of Colony-Stimulating Factors in Patients With Systemic Lupus Erythematous”

Letter

作者: Ragsdale, Carolyn E. ; Rock, Edwin P.

2023-11-27·Open Forum Infectious Diseases

279. Inhaled Sargramostim (rhu GM-CSF) Leads to Enhanced SARS-CoV-2 Virus-Specific Immune Response and Viral Clearance: Results of the Biomarker Cohort of a Randomized, Double-Blind, Placebo-Controlled Phase 2b Trial in Non-Hospitalized Patients with COVID-19

作者: Garner, Fiona ; Paine, Robert ; Bacchelli, Sandro ; Ahuja, Sanjeev ; Roychowdhury, Debasish F ; Simms, Lorinda ; Joshi, Ila ; McManus, John L ; Rock, Edwin P ; Perez, Rodolfo

AbstractBackgroundProgression from mild to severe SARS-CoV-2 infection correlates with humoral and cellular immune signatures that adjust to a multiplying viral load. Enhancing immunity with host-directed therapy, such as sargramostim (yeast-derived, recombinant human granulocyte-macrophage colony-stimulating factor [GM-CSF]), may prevent disease progression and reduce severity.MethodsThis prospective, randomized, double-blind, placebo-controlled study enrolled symptomatic vaccinated and unvaccinated non-hospitalized patients with mild/moderate COVID-19 at high risk for progression. Patients received daily sargramostim 250 mcg or placebo, inhaled via nebulizer, for 5 days. Figure 1 lists study endpoints.ResultsFrom April 28, 2021 to January 31, 2022, 101 patients consented and provided samples for the biomarker cohort (Fig 2).No difference was seen in the overall study primary endpoint (n=21/301 sargramostim, n=16/299 placebo, p=0.4). Treatment-emergent adverse events were similar in both arms. In the biomarker cohort, SARS-CoV-2 viral clearance by day 14 was enhanced on the sargramostim arm (p=0.0064, Fig 3). Virus was undetectable in a larger proportion on the sargramostim arm. Sargramostim reduced viral load more in vaccinated than unvaccinated patients. Inflammatory cytokine levels did not increase with treatment.Kinetics and magnitude of antibody response against SARS-CoV-2 antigens differed by group. After an initial IgM-titer peak at day 14, IgM titers at day 28 were lower in the vaccinated-sargramostim arm than the vaccinated-placebo arm (Fig 4A). The unvaccinated-sargramostim arm maintained higher IgM titers than the unvaccinated-placebo arm. Overall IgG titers were higher for vaccinated patients across both treatment arms. However, the vaccinated-sargramostim arm had higher IgG4 titers associated with IgG4-isotype-class switching than the vaccinated-placebo arm (Fig 4B).ConclusionThe primary clinical endpoint was not met. Biomarker analyses suggest inhaled sargramostim reduces SARS-CoV-2 viral load and alters humoral kinetics and expression, more so in those vaccinated. Results suggest the potential of sargramostim as a virus agnostic, host-directed immunomodulator.DisclosuresIla Joshi, PhD, Partner Therapeutics, Inc.: Patents|Partner Therapeutics, Inc.: Salary|Partner Therapeutics, Inc.: Stocks/Bonds Fiona Garner, PhD, Partner Therapeutics, Inc.: Employment|Partner Therapeutics, Inc.: Stocks/Bonds Debasish F. Roychowdhury, MD, Partner Therapeutics, Inc.: Employment|Partner Therapeutics, Inc.: Ownership Interest|Partner Therapeutics, Inc.: Stocks/Bonds Lorinda Simms, MSc, Partner Therapeutics, Inc.: Advisor/Consultant|Partner Therapeutics, Inc.: Stocks/Bonds Sanjeev Ahuja, MD, Partner Therapeutics, Inc.: Employment|Partner Therapeutics, Inc.: Stocks/Bonds|Scioto Biosciences: Past Employee John L. McManus, n/a, JPEO-CBRND's Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical: Project agreement MCDC2006-012. Included references to commercial products do not constitute an endorsement by the US DoD or the JPEO-CBRND.|Partner Therapeutics, Inc.: Employment|Partner Therapeutics, Inc.: Stocks/Bonds Edwin P. Rock, MD, PhD, Partner Therapeutics: Employment Robert Paine III, MD, Partner Therapeutics, Inc.: Advisor/Consultant

项与 Partner Therapeutics, Inc. 相关的新闻（医药）

2024-10-07

·PRNewswire

BioNJ's Prestigious Speaker Roster for Its 12th Annual C-Suite Summit

TRENTON, N.J., Oct. 7, 2024 /PRNewswire/ -- BioNJ is hosting its C-Suite Summit this Thursday, October 10, 2024, at the Bridgewater Marriott. In its twelfth year, the C-Suite Summit convenes executives from across the life sciences sector, representing a diverse array of companies — from early stage start-ups to established industry leaders, spanning both public and private sectors, as well as revenue-generating and pre-revenue enterprises. Together, they engage in insightful discussions on the critical issues shaping C-Suite decision-making as the industry strives to bring groundbreaking treatments to market. In the face of unprecedented change, the biopharmaceutical industry stands at a pivotal juncture. With the next wave of innovation on the horizon, this Summit offers a unique opportunity to reflect on the current landscape of life sciences and explore how companies can successfully navigate this dynamic era of transformation. "As shifts in policy and fluctuations in biopharma investment continue, the future of innovation in our industry continues to be closely scrutinized," said BioNJ President and CEO Debbie Hart. "The C-Suite Summit offers a vital platform for industry leaders to engage in open dialogue, exploring where the most promising opportunities exist and how to collectively navigate and shape the next frontier in life sciences and medical breakthroughs." The speaker roster, featuring world-class leaders, includes: Britt Byers, Sr. Vice President, Human Resources NA, Kyowa Kirin Jan Campbell, Managing Partner, Pharmaceuticals & Biotechnology, Korn Ferry Donna Conroy, Founder & CEO, SciMar ONE Vikki Conway, Sr. Vice President & Head, Human Resources US, Teva Pharmaceuticals Kiran Dattani, Customer Success, Transformation, Strategy & Architecture, Google Cloud Healthcare & Life Sciences, Google Tom Evegan, Principal, Strategy & Management Consulting; National Consulting Leader Life Sciences, RSM Hon. Jim Greenwood, Former Congressman & Former President & CEO, BIO Hisham Hamadeh , Ph.D., Sr. Vice President & Global Head, Data Science & AI, Genmab John Harlow, Chief Commercial Officer, Melinta Therapeutics Debbie Hart, President & CEO, BioNJ Paul Hunter, Vice President, Market Access & Commercial Operations, Halozyme Garrett Ingram, President & CEO, Cipla Therapeutics Christopher Jackson, Managing Member, The Law Office of Christopher S. Jackson Haripriya Jain, MS, MBA, Executive Director, Global Value & Access Consulting, Evidera, part of Thermo Fisher Scientific Rohan Jain, General Manager, Commercial, Nusano Harriet Keane, Partner, McKinsey & Company Sydney Klein, Chief Information Security Officer & Head, IT Core Services, Bristol Myers Squibb Keith Koharski, Executive Director, Global Development IT, Regeneron Emer Leahy, Ph.D., MBA, President & CEO, PsychoGenics & Chair, BioNJ Lisa LeCointe-Cephas, J.D., Partner, Compliance & Investigations & Global Chair, Life Sciences Sector, DLA Piper Will Lewis, J.D., MBA, Chair & CEO, Insmed Husseini Manji, M.D., F.R.C.P.C., Professor, Oxford University; Co-Chair, UK Govt MH Mission; Former Global Head, Neuroscience, Janssen/Johnson & Johnson Jake McDowell, Vice President & Head, Market Access, Pricing & Value, Partner Therapeutics Clive Meanwell, M.D., Chairman & Partner, Population Health Partners Aamir Mecklai, Managing Director, Healthcare Investment Banking, Bank of America Heather Meade, J.D., Principal, EY Christopher Mortko, Ph.D., MBA, Vice President, Business Development & Licensing, Merck Gina Murdoch, MBA, President & CEO, Multiple Sclerosis Association of America Brandon Parry, Sr. Partner, McKinsey & Company Tarek Rabah, President & CEO, Otsuka Pharmaceuticals Deiva Ramachandran, Ph.D., Partner, Generative AI-Automation Practice Leader, Healthcare, Life Sciences, State & Local Govt., IBM Arda Ural, Ph.D., Partner & Americas Industry Market Leader for Life Sciences and Healthcare, EY Monika Vnuk, M.D., Sr. Vice President, Global Partnering & Business Development, Sanofi Scott White, MBA, Chief Operations Officer, NA Innovative Medicine, Johnson & Johnson The action-packed agenda includes these topics: The Next Wave of Innovation in Life Sciences Harnessing Change to Deliver Impactful Innovation Policy Uncertainties in an Election Year Market Access & Reimbursement Topics in Talent: Attraction, Retention & Diversity Research & Development in Mental Health Continued Evolutions in Go-to-Market Models Including Patient Services Evolving Capital Markets & Implications for Innovation The Digital & AI Era in the Biopharma Industry: How Can Companies Across Functions Transition from Hype Into Reality? Click here for the full agenda. "From access, regulation and policy to talent and AI, our experts will dive into what the industry should be doing ― and how we can work together ― to foster medical innovation and ensure Patient access," added Hart. "We hope all stakeholders will join us for this very important discussion." Click here to register. Registration is $695 for BioNJ Members and $895 for future BioNJ Members. The C-Suite Summit is closed to media. Contact Randi Bromberg Sr. Vice President, Communications and Marketing O) 609-890-3185 C) 609-955-1067 [email protected] SOURCE BioNJ WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-06-11

·PRNewswire

Global Anti-Radiation Drugs Market to Register Incremental Growth at a CAGR of ~9% by 2030 | DelveInsight

The rise in demand for anti-radiation drugs is mainly driven by several factors. These include the growing occurrence of side effects linked to cancer screening methods, heightened risks of exposure to radiological or nuclear emergencies, and the increasing focus of nuclear-capable nations on safeguarding against radiation. These trends are expected to fuel the expansion of the anti-radiation drugs market from 2024 to 2030. LAS VEGAS, June 11, 2024 /PRNewswire/ -- DelveInsight's Anti-Radiation Drugs Market Insights report provides the current and forecast market analysis, individual leading anti-radiation drugs companies' market shares, challenges, anti-radiation drugs market drivers, barriers, trends, and key market anti-radiation drugs companies in the market. Key Takeaways from the Anti-Radiation Drugs Market Report As per DelveInsight estimates, North America is anticipated to dominate the global anti-radiation drugs market during the forecast period. In the compound type segment of the anti-radiation drugs market, the Potassium iodide sub-category had a significant revenue share in the year 2023. This can be ascribed to the various characteristics and advantages associated with potassium iodide. Notable anti-radiation drugs companies such as Novartis AG, Anbex Inc., Amgen Inc., Myelo Therapeutics, Arco Pharmaceuticals LLC, BTG International Inc., Cellphire Inc., Darnitsa, Enzychem Lifesciences Corporation, Humanetics Corporation, Mission Pharmacal Company, Chrysalis BioTherapeutics Inc., Pluri Inc., Partner Therapeutics, HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG., RxBio Inc., Coherus Biosciences, Onconova Therapeutics, Jubilant Life Sciences, Soligenix Inc., and several others, are currently operating in the anti-radiation drugs market. In September 2023, the U.S. Department of Defense awarded Edina-based Humanetics a USD 20 million contract to develop a pill that prevents radiation damage in military members and first responders affected by events such as nuclear accidents, warfare, and dirty bombs. In May 2023, the first-in-human clinical trial of an experimental oral drug for removing radioactive contaminants from inside the body, testing the safety, tolerability, and processing in the body of escalating doses of the investigational drug product HOPO 14-1 was initiated in healthy adults. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, was funding the Phase 1 trial, which was sponsored and conducted by SRI International of Menlo Park, California. In March 2022, Novartis announced that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that has spread to other parts of the body. These patients have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy). To read more about the latest highlights related to the anti-radiation drugs market, get a snapshot of the key highlights entailed in the Global Anti-Radiation Drugs Market Report Anti-Radiation Drugs Overview Anti-radiation drugs are pharmaceutical compounds designed to mitigate the damaging effects of radiation exposure on the human body. These drugs work by either scavenging free radicals generated by radiation or by enhancing the repair mechanisms of cells damaged by radiation. One class of anti-radiation drugs includes radioprotectors, which are administered before radiation exposure to prevent or reduce its harmful effects. Another class, known as radiomitigators, is given after exposure to alleviate the severity of radiation-induced damage. These drugs hold significant promise in scenarios such as nuclear accidents, medical radiation therapy, and space travel, where the risk of radiation exposure is a concern. Research into anti-radiation drugs is ongoing, with scientists continually striving to improve their efficacy and minimize side effects. Some compounds under investigation show potential not only in protecting against acute radiation sickness but also in mitigating long-term effects such as cancer development. As our understanding of radiation biology advances, coupled with advancements in drug development technologies, the prospects for more effective and accessible anti-radiation drugs continue to brighten, offering hope for safer environments in radiation-prone situations. Anti-Radiation Drugs Market Insights In 2023, North America dominated the anti-radiation drugs market, primarily due to several factors contributing to growth. These include a substantial patient population afflicted with various illnesses like cancer, increasing numbers of diagnostic procedures, and governmental initiatives aimed at public health in the region. This trend is expected to continue from 2024 to 2030. The prevalence of cancer in the United States, for example, drives a significant demand for anti-radiation drugs. Statistics from the American Cancer Society projected around 2 million new cancer cases in the United States in 2024, leading to heightened demand for these drugs to support cancer diagnostic procedures. Additionally, the US benefits from a strong focus on clinical research and the presence of leading pharmaceutical companies, further bolstering the market for anti-radiation drugs. Moreover, in 2022, the US Department of Health and Human Services (HHS) allocated USD 290 million for the purchase of Nplate, a drug produced by Amgen USA Inc., intended to treat radiation sickness in the event of a nuclear emergency. This investment reflects ongoing efforts to enhance preparedness for radiological and nuclear emergencies and underscores the commitment to saving lives in such scenarios. To know more about why North America is leading the market growth in the anti-radiation drugs market, get a snapshot of the Anti-Radiation Drugs Market Outlook Anti-Radiation Drugs Market Dynamics The market dynamics of anti-radiation drugs are driven by a complex interplay of factors ranging from technological advancements to geopolitical events and regulatory frameworks. One of the primary drivers is the increasing threat of radiation exposure from various sources such as nuclear accidents, medical procedures, and potential radiological terrorism. This heightened awareness has propelled research and development efforts to create effective anti-radiation drugs that can mitigate the harmful effects of radiation exposure. Moreover, the growing prevalence of cancer and the widespread use of radiation therapy as a treatment modality has further fueled the demand for anti-radiation drugs. As more individuals undergo radiation-based treatments, there is a parallel need for medications that can protect healthy tissues and organs from the damaging effects of ionizing radiation. The competitive landscape of the anti-radiation drugs market is characterized by both established pharmaceutical companies and innovative startups vying for market share. Established players often leverage their resources and expertise to develop and commercialize new anti-radiation drugs, while startups focus on disruptive technologies and novel approaches to address unmet needs in radiation protection. Government initiatives and regulatory frameworks also play a crucial role in shaping the market dynamics of anti-radiation drugs. Regulatory agencies set standards for safety, efficacy, and quality assurance, which impact the development, approval, and commercialization of these medications. Additionally, government investments in research and development, as well as funding for procurement and stockpiling of anti-radiation drugs for emergency preparedness, influence market dynamics. Overall, the anti-radiation drugs market is characterized by a dynamic landscape driven by technological innovation, healthcare trends, regulatory factors, and geopolitical considerations. As the threat of radiation exposure continues to evolve, so too will the demand for effective anti-radiation drugs, driving further growth and innovation in this important sector of the pharmaceutical industry. Get a sneak peek at the anti-radiation drugs market dynamics @ Anti-Radiation Drugs Market Dynamics Analysis Anti-Radiation Drugs Market Assessment Anti-Radiation Drugs Market Segmentation Anti-Radiation Drugs Market Segmentation By Compound: Potassium Iodide, Prussian Blue, Diethylenetriamine Pentaacetic Acid, Colony Stimulating Factors, and Others Anti-Radiation Drugs Market Segmentation By Indication: Acute Radiation Syndrome, Cancer Treatment, and Others Anti-Radiation Drugs Market Segmentation By Radiation Type: Ionizing Radiations and Non-Ionizing Radiations Anti-Radiation Drugs Market Segmentation By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, and Others Anti-Radiation Drugs Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the anti-radiation drugs market are set to emerge as the trendsetter explore @ Anti-Radiation Drugs Companies Table of Contents Interested in knowing the anti-radiation drugs market by 2030? Click to get a snapshot of the Anti-Radiation Drugs Market Trends Related Reports Cancer Biomarkers Market Cancer Biomarkers Market Insight, Competitive Landscape, and Market Forecast – 2030 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key cancer biomarkers companies, including F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific, Inc., QIAGEN N.V., Illumina, Inc., Bio-Rad Laboratories, Inc., Abbott Laboratories, bioMérieux SA, BD, Merck Millipore, Agilent Technologies, Myriad Genetics, Sysmex Corporation, Hologic, Inc., Quest Diagnostics, Centogene N.V., PerkinElmer, Inc., Siemens Healthineers, Exact Sciences, R&D Systems, Inc., BioVision, Inc., among others. 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Hoffmann-La Roche Ltd, AbbVie Inc., Amgen Inc., Sanofi, Merck & Co., Inc, Novartis AG, Pfizer Inc, AstraZeneca, Bristol Myers Squibb., Gilead Sciences, Inc., Janssen Global Services, LLC, BAYER AG., Celldex Therapeutics Inc., Alaunos Therapeutics, Inc., Astellas Pharma Inc., Genentech, Inc., Sandoz International GmbH, BeiGene, among others. Liquid Biopsy in Cancer Diagnostics Market Liquid Biopsy in Cancer Diagnostics Market Insight, Competitive Landscape, and Market Forecast – 2030 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key liquid biopsy in cancer diagnostics companies, including Myriad Genetics Inc., Exact Sciences Corporation, Biocartis, Sysmex Corporation, Thermo Fisher Scientific Inc, Biocept Inc, Agilent Technologies Inc, MDx Health, Neogenomics Laboratories, F. Hoffman La Roche Ltd, Guardant Health, Bio-Techne, Illumina Inc, QIAGEN, Lucence Health Inc, Personal Gemone Diagnostics Inc, SAGA Diagnostics, Agena Bioscience Inc, The Menarini Group, MiRXES Pte Ltd., 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. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

放射疗法

2024-04-18

·PRNewswire

Comprehensive Review Highlights Potential Benefits of Leukine® in Management of Gastrointestinal (GI) Adverse Events Associated with Immune Checkpoint Inhibitors (ICIs) in the Treatment of Cancer

NCI sponsored, ECOG-ACRIN Phase 3 Study of Leukine in Combination with Ipilimumab and Nivolumab in Front Line Treatment of Melanoma Heads to Last Stages of Enrollment LEXINGTON, Mass., April 18, 2024 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced publication of a comprehensive review by Dougan et al.1 in Cancers summarizing the mechanistic rationale and pre-clinical and clinical data regarding the use of Leukine (sargramostim; glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor [rhu GM-CSF]) to manage gastrointestinal (GI) immune-related adverse events (irAEs) for patients taking immune checkpoint inhibitors (ICIs) for the treatment of cancer. Leukine is not FDA approved for treatment of irAEs or melanoma. Continue Reading Addition of sargramostim (recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF)) to ipilimumab significantly lowered grade 3-5 adverse events compared to the ipilimumab-alone arm in a multi-center, randomized clinical trial for advanced melanoma. (Figure and caption from Dougan 20241 illustrating results from Hodi 20142) The authors describe the mechanisms underlying GI irAEs and their similarities to inflammatory bowel disease and review the available clinical data supporting a potential role for Leukine in both settings. In the prospective, randomized study E1608, Hodi and colleagues2 observed that advanced melanoma patients who received Leukine plus ipilimumab had a reduction in GI irAEs (p=0.05) (see figure below) as well as a significant improvement in overall survival (p=0.01) compared to those who received ipilimumab alone. "Immune checkpoint inhibitors have meaningfully improved prognoses for cancer patients in a number of cancers," said Michael Dougan MD, PhD, Associate Professor of Medicine at Massachusetts General Hospital. "Unfortunately, these drugs also can cause the immune system to attack healthy cells creating unwanted GI side effects including some that lead to discontinuation of treatment and more severe outcomes. The potential Leukine has shown in mitigating GI irAEs and improving patient outcomes, including survival, are encouraging." Ongoing Phase 3 Study of Leukine with Ipilimumab and Nivolumab in Front Line Metastatic Melanoma Leukine continues to be studied in combination with ICIs to assess differences in the rate of serious adverse events as well as its impact on overall survival. EA6141 (NCT02339571) is a randomized, controlled phase 2/3 study of Leukine in combination with ipilimumab and nivolumab for the front line treatment of patients with unresectable stage III or stage IV melanoma that is sponsored by the National Cancer Institute (NCI) and being conducted by ECOG-ACRIN Cancer Research Group.3 It is led by Study Chair F. Stephen Hodi Jr., MD, Director of the Center for Immuno-Oncology at Dana-Farber Cancer Institute, and Study Co-Chair Ahmad A. Tarhini, MD, PhD, Professor of Oncologic Sciences and Director of Cutaneous and Clinical Translational Research at H. Lee Moffitt Cancer Center and Research Institute. Both are members of the ECOG-ACRIN Melanoma Committee. "The phase 2 portion of study EA6141 was completed previously, and after a successful planned interim analysis, advanced to the phase 3 portion, which is now in the last stages of enrollment," said Dr. Hodi in a recent statement. "The primary objective is to compare the overall survival rates of patients who receive nivolumab/ipilimumab/rhu GM-CSF versus those who receive only nivolumab/ipilimumab." REFERENCES Dougan M, Nguyen LH, Buchbinder EI, Lazarus HM. Sargramostim for Prophylactic Management of Gastrointestinal Immune-Related Adverse Events of Immune Checkpoint Inhibitor Therapy for Cancer. Cancers. 2024; 16(3):501. doi.org/10.3390/cancers16030501 Hodi FS, Lee S, McDermott DF, et al. Ipilimumab Plus Sargramostim vs Ipilimumab Alone for Treatment of Metastatic Melanoma: A Randomized Clinical Trial. JAMA. 2014; 312(17):1744-1753. doi:10.1001/jama.2014.13943 National Cancer Institute. A Phase II/III Trial of Nivolumab, ipilimumab, and GM-CSF in patients with advanced melanoma. Available at: . NLM identifier: NCT02339571. Accessed April 16, 2024. ABOUT MELANOMA Melanoma is the most aggressive form of skin cancer and rates of melanoma have been rising for the past 30 years. The American Cancer Society estimates 96,480 new melanoma cases will be diagnosed in the US and 7,230 people will die from the disease in 2019. The FDA grants orphan drug designation to promote the development of promising treatments for conditions that affect 200,000 or fewer U.S. patients annually. ABOUT LEUKINE LEUKINE (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast. The product is commercially available in the United States and accessible through a named patient program operated by Tanner Pharma Group outside of the United States. LEUKINE is indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). Important Safety Information for Leukine (sargramostim) Contraindications Do not administer LEUKINE to patients with a history of serious allergic reaction, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factor, sargramostim, yeast-derived products, or any other component of LEUKINE. Warnings and Precautions Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. If a serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy, and institute medical management. Discontinue LEUKINE permanently for patients with serious allergic reactions. LEUKINE can cause infusion-related reactions that may be characterized by respiratory distress, hypoxia, flushing, hypotension, syncope, and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease; dose adjustment or discontinuation may be needed. LEUKINE should not be administered simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy. Edema, capillary leak syndrome, and pleural or pericardial effusions have been reported in patients after LEUKINE administration. LEUKINE should be used with caution in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure. Such patients should be monitored. Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE administration, particularly in patients with a history of cardiac arrhythmia. Use LEUKINE with caution in patients with preexisting cardiac disease. If absolute neutrophil count (ANC) > 20,000 cells/mm3 or if white blood cell (WBC) counts > 50,000/mm3, LEUKINE administration should be interrupted, or the dose reduced by half. Monitor complete blood counts (CBC) with differential twice per week. Discontinue LEUKINE therapy if tumor progression, particularly in myeloid malignancies, is detected during LEUKINE treatment. Treatment with LEUKINE may induce neutralizing anti-drug antibodies. Use LEUKINE for the shortest duration needed. Avoid administration of solutions containing benzyl alcohol (including LEUKINE for injection reconstituted with Bacteriostatic Water for Injection, USP [0.9 % benzyl alcohol]) to neonates and low birth weight infants. Drug Interactions Avoid the concomitant use of LEUKINE and products that induce myeloproliferation. Monitor for clinical and laboratory signs of excess myeloproliferative effects. Adverse Reactions Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported at a higher frequency than in placebo patients are: In recipients of autologous bone marrow transplantation (BMT)–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder In recipients of allogeneic BMT–abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high glucose, low albumin In patients with AML–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema ABOUT PARTNER THERAPEUTICS Partner Therapeutics, Inc. (PTx), an integrated biotechnology company, focuses on development and commercialization of late-stage therapeutics to improve health outcomes in treatment of cancer and other serious diseases. The company believes in delivering products and supporting medical teams with the purpose of achieving superior outcomes for patients and their families. Visit . SOURCE Partner Therapeutics, Inc.