An exploratory randomized controlled trial of the clinical efficacy of anamorelin hydrochloride in patients after radical surgery for upper gastric cancer and esophagogastric junction cancer - a phase II trial

Start Date20 Feb 2024

Sponsor / Collaborator-

JPRN-jRCTs041230138 / RecruitingPhase 2

A randomized controlled trial of Anamorelin to prevent weight loss in post-pancreaticoduodenectomy patients

Start Date01 Feb 2024

Sponsor / Collaborator-

JPRN-jRCTs031230446 / RecruitingPhase 2

Prospective, open-label, interventional study to explore the efficacy of the ghrelin agonist anamorelin in patients with cachexia associated with chronic obstructive pulmonary disease

Start Date13 Nov 2023

Sponsor / Collaborator-

100 Clinical Results associated with Anamorelin Hydrochloride

100 Translational Medicine associated with Anamorelin Hydrochloride

100 Patents (Medical) associated with Anamorelin Hydrochloride

Literatures (Medical) associated with Anamorelin Hydrochloride

01 Feb 2024·Clinical nutrition (Edinburgh, Scotland)

Addressing cancer anorexia-cachexia in older patients: Potential therapeutic strategies and molecular pathways

Review

Author: Prokopidis, Konstantinos ; Kanatas, Anastasios ; Ispoglou, Theocharis ; McCullough, Deaglan ; Windle, Angela ; Burke, Dermot ; Cox, Natalie ; White, Helen ; Nair, Sherena

Cancer cachexia (CC) syndrome, a feature of cancer-associated muscle wasting, is particularly pronounced in older patients, and is characterised by decreased energy intake and upregulated skeletal muscle catabolic pathways. To address CC, appetite stimulants, anabolic drugs, cytokine mediators, essential amino acid supplementation, nutritional counselling, cognitive behavioural therapy, and enteral nutrition have been utilised. However, pharmacological treatments that have also shown promising results, such as megestrol acetate, anamorelin, thalidomide, and delta-9-tetrahydrocannabinol, have been associated with gastrointestinal and cardiovascular complications. Emerging evidence on the efficacy of probiotics in modulating gut microbiota also presents a promising adjunct to traditional therapies, potentially enhancing nutritional absorption and systemic inflammation control. Additionally, low-dose olanzapine has demonstrated improved appetite and weight management in older patients undergoing chemotherapy, offering a potential refinement to current therapeutic approaches. This review aims to elucidate the molecular mechanisms underpinning CC, with a particular focus on the role of anorexia in exacerbating muscle wasting, and to propose pharmacological and non-pharmacological strategies to mitigate this syndrome, particularly emphasising the needs of an older demographic. Future research targeting CC should focus on refining appetite-stimulating drugs with fewer side-effects, specifically catering to the needs of older patients, and investigating nutritional factors that can either enhance appetite or minimise suppression of appetite in individuals with CC, especially within this vulnerable group.

01 Dec 2023·Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

Systemic inflammation adversely affects response to anamorelin in patients with pancreatic cancer

Article

Author: Onda, Shinji ; Okui, Norimitsu ; Furukawa, Kenei ; Ikegami, Toru ; Tsunematsu, Masashi ; Ishizaki, Shunta ; Matsumoto, Michinori ; Shirai, Yoshihiro ; Uwagawa, Tadashi ; Haruki, Koichiro

PURPOSE:

Anamorelin, a selective ghrelin receptor agonist, has been approved for pancreatic cancer treatment in Japan. We aimed to investigate whether systemic inflammation, represented by the neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), lymphocyte-monocyte ratio (LMR), and C-reactive protein (CRP)-albumin ratio (CAR), could predict the effect of anamorelin in patients with advanced pancreatic cancer.

METHODS:

This study included 31 patients who had received anamorelin for advanced pancreatic cancer between 2021 and 2023. Patients' NLR, PLR, LMR, and CAR were evaluated before anamorelin administration. The patients were classified as responders and non-responders based on whether they gained body weight after 3 months of anamorelin administration. We investigated the association between systemic inflammation and anamorelin efficacy using a univariate analysis.

RESULTS:

Twelve (39%) patients were non-responders. A high serum CRP level (p = 0.007) and high CAR (p = 0.013) was associated with non-response to anamorelin. According to the receiver operating characteristics analysis, the CAR cutoff value was 0.06, and CAR ≥ 0.06 was a risk factor (odds ratio, 5.6 [95% confidence interval 1.2-27.1], p = 0.032) for non-response to anamorelin.

CONCLUSION:

CAR can be a predictor of non-response to anamorelin in patients with advanced pancreatic cancer, suggesting the importance of a comprehensive assessment of the inflammatory status.

01 Nov 2023·Asia-Pacific journal of oncology nursing

The role of pharmacists in multimodal cancer cachexia care

Review

Author: Yamada, Yunami ; Suzuki, Akio ; Fujii, Hironori ; Iihara, Hirotoshi

Cancer cachexia is a complex syndrome, and multidisciplinary management has the potential to improve patient outcomes and efficiency of care. Multidisciplinary management consists primarily of exercise, nutrition, and pharmacotherapy. The pharmacist's role in cancer cachexia is to contribute to appropriate pharmacotherapy practices. For example, anamorelin is an oral drug with ghrelin-like effects that may improve the pathogenesis of cancer cachexia by stimulating appetite and increasing food intake and body weight. Many patients with cancer cachexia are under treatment with anticancer agents, and pharmacists need to determine whether symptoms such as anorexia and nausea are due to cancer cachexia or anticancer agents. Based on that determination, they are then expected to suggest supportive care to the physician. Provision of multidisciplinary care for cancer cachexia requires communication with not only physicians but also with nurses, dietitians, and other professionals so that nutritional therapy can be provided at the time cachexia is detected. However, the role of pharmacists in the management of cancer cachexia is not well established, and there is no evidence that pharmacist interventions are of benefit to patients. In this article, to contribute to the treatment of cancer cachexia by multidisciplinary care, we describe the role of pharmacists in cancer cachexia as currently practiced at our hospital. We also consider future challenges to this type of multidisciplinary care. Evidence concerning multidisciplinary treatment of cancer cachexia is scarce, including therapeutic agents, and there is a current lack of collaboration among medical professionals and education in cancer cachexia. Solving these problems will require efforts in the practice and evaluation of treatment for cancer cachexia.

News (Medical) associated with Anamorelin Hydrochloride

13 Feb 2024

·www.biospace.com

Yinuoke publication demonstrates a new orally delivered molecule that reverses cancer cachexia and increases survival using in vivo models

Yinuoke, a biopharmaceutical company pioneering breakthrough therapeutics for late-stage cancer patients announced today the publication of a manuscript in the peer-reviewed Journal of Cachexia, Sarcopenia and Muscle demonstrating the effectiveness of a new compound in alleviating cachexia and increasing the survival of tumor-bearing mice in a T-cell dependent manner. Cancer cachexia, a devastating tumor-induced immune disorder leading to body wasting and reduced tolerability to therapeutics, occurs in 80% of all cancer patients and causes 25% of deaths. Previous attempts to treat cachexia have failed due to lack of efficacy in stabilizing patient weight and strength. Yinuoke treats cachexia as a tumor-driven autoimmune disorder rather than a metabolic condition. YNK105 reduces systemic inflammation without the toxic side effects caused by NSAIDS that limit its use. The data shows a significant improvement in cachexigenic tumor-bearing mice in overall survival, increases in body, fat, and muscle weight, and reductions in plasma IL-6 and tissue- derived Stat3. Most impressively, cachectic mice achieved a 100% survival rate with a combination treatment of YNK105 and chemotherapy. “This research is the first demonstration that severe cachexia can be halted and reversed”, said Dr. Lingbing Zhang, founder and CEO of Yinuoke. “The ability to reverse cachexia expands the options for late-stage cancer patients to extend survival and live a higher quality of life. Reversing cachexia requires modulating the immune system’s inflammatory response for longer than an NSAID will allow. We identified R-ketorolac as a potential treatment for cachexia and now have significant evidence to support a superior efficacy and safety pro to current approaches using GDF-15 inhibitors or Anamorelin.” “YNK105 has the potential to be a breakthrough treatment for cancer cachexia that I am excited to bring into the clinic,” said Dr. Andrew Hendifar of Cedars-Sinai. “Pancreatic cancer patients are highly susceptible to cachexia and treatment outcomes are severely impacted. Getting control of cachexia is critical for overall survival of patients with pancreatic cancer and especially for stage 4 and late diagnosed patients. These early studies support moving this program into clinical trials.” The research appearing in the February 1st issue of the Journal of Cachexia, Sarcopenia and Muscle is led by Dr. Martina Schweiger and a team of scientists at the Institute of Molecular Biosciences, University of Graz, Austria. About Yinuoke Yinuoke is on a mission to save lives and conquer late-stage cancer through groundbreaking science and the development of first-in-class therapies where no options currently exist. Our vision is to revolutionize late-stage cancer by pushing boundaries and transforming it from a terminal disease to a manageable lifelong condition. Through innovative approaches and tailored treatments, we aim to empower patients with new possibilities for long-term remission and improved quality of life. For inquiries on partnering and investing please contact Suzanne Kennedy at skennedy@yinuokeus.com.

Clinical Result

03 Aug 2023

·www.pharmaceutical-technology.com

Taiho Oncology and Taiho Pharmaceutical gain FDA approval for Lonsurf

Lonsurf has been approved to treat adult patients with metastatic colorectal cancer. Credit: crystal light / Shutterstock.com. Taiho Oncology and Taiho Pharmaceutical have received approval from the US Food and Drug Administration (FDA) for Lonsurf to treat adult patients with metastatic colorectal cancer (mCRC). The approval is intended for using Lonsurf either as a single agent or with bevacizumab in patients previously treated with oxaliplatin, fluoropyrimidine and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type [without mutations], with an anti-EGFR therapy. Recommended Reports Reports LOA and PTSR Model - Anamorelin Hydrochloride in Chemotherapy Effects GlobalData Reports Innovation in Pharmaceuticals: Pancreatic extract-based compositions GlobalData View all Companies Intelligence Taiho Pharmaceutical Co Ltd Taiho Oncology Inc SUN LIGHT CORPORATION View all Taiho Pharmaceutical discovered and developed Lonsurf, an oral nucleoside antitumour agent. It contains trifluridine, a nucleoside analogue based on thymidine, along with tipiracil, an inhibitor of thymidine phosphorylase (TP). This combination enhances exposure to trifluridine by inhibiting its metabolism by TP. Based on data from the Phase III SUNLIGHT study, the FDA granted approval for the combination of Lonsurf and bevacizumab. This combination showed improvements in progression-free survival and overall survival in patients with mCRC after disease progression or who could not tolerate two previous chemotherapy regimens. These results were compared to the outcomes using LONSURF alone. Taiho Oncology president and CEO Timothy Whitten stated: “The treatment of advanced colorectal cancer has been a core focus of our work at Taiho Oncology since our inception and with good reason: approximately 22% of patients with colorectal cancer in the US are diagnosed after the cancer has metastasised. “The FDA approval of Lonsurf in combination with bevacizumab is another example of how we are continuing to advance care in this disease and provide new hope to patients and their families.”

Drug ApprovalClinical ResultPhase 3

08 May 2023

·www.prnewswire.com

Global Pancreatic Cancer Competitive Landscape Report 2023: Comprehensive Insights about 250+ Companies and 300+ Drugs

DUBLIN, May 8, 2023 /PRNewswire/ -- The "Pancreatic Cancer - Competitive landscape, 2023" report has been added to ResearchAndMarkets.com's offering. This "Pancreatic Cancer- Competitive landscape, 2023" report provides comprehensive insights about 250+ companies and 300+ drugs in Pancreatic Cancer Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. In March 2023, Adaptimmune Therapeutics plc. and TCR Therapeutics Inc. (NASDAQ: TCRR), announced entry into a definitive agreement under which Adaptimmune will combine with TCR in an all-stock transaction to create a preeminent cell therapy company focused on treating solid tumors. The combination provides extensive benefits for clinical development and product delivery supported by complementary technology platforms. As a result, and following the closing of the transaction, it is anticipated that the combined company's cash runway will extend into 2026. In February 2023, Akamis Bio, announced an expansion of its ongoing partnership with the Parker Institute for Cancer Immunotherapy (PICI) to include a clinical collaboration with the Cancer Research Institute (CRI) that will focus on advancing novel treatments for pancreatic cancer. As part of the Akamis Bio, PICI, and CRI partnership, NG-350A, an immuno-stimulatory tumor gene therapy driving intratumoral expression of a CD40 agonist monoclonal antibody, will be evaluated in combination with standard-of-care chemotherapy and the CTLA-4 inhibitor ipilimumab (YERVOY). In February 2023, Gritstone bio, Inc. announced that it has entered into a clinical trial agreement with the National Cancer Institute (NCI), an institute of the National Institutes of Health, to evaluate an autologous T cell therapy expressing a T cell receptor targeting mutated KRAS in combination with Gritstone's KRAS-directed vaccine candidate, SLATE-KRAS, in a Phase 1 study. Under the terms of the agreement, NCI will identify patients with metastatic cancer that are eligible for adoptive cell transfer based on the presence of a G12V or G12D KRAS mutation (KRASmut). In February 2023, Keymed Biosciences Inc., jointly announced a global exclusive license agreement with AstraZeneca for CMG901, a potential first-in-class Claudin 18.2 antibody drug conjugate (ADC). Under the license agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialization of CMG901 globally. CMG901 is currently in a Phase I clinical trial for the treatment of Claudin 18.2-positive solid tumors. In January 2023, AIM ImmunoTech Inc. announced it has entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca. Under the agreement, Erasmus MC is planning to perform an investigator-initiated clinical study, entitled "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect. DURIPANC Study," in which it will use both Study Drugs provided by AstraZeneca and AIM ImmunoTech. Pancreatic Cancer Analytical Perspective In-depth Commercial Assessment: Pancreatic Cancer Collaboration Analysis by Companies The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form. Key Questions Answered Current Treatment Scenario and Emerging Therapies: How many companies are developing Pancreatic Cancer drugs? How many Pancreatic Cancer drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Pancreatic Cancer? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Pancreatic Cancer therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Pancreatic Cancer and their status? What are the key designations that have been granted to the emerging and approved drugs? Key Players Panbela Therapeutics ERYtech Pharma Jiangsu HengRui Medicine Co., Ltd. FibroGen Novartis AG AB Science TME Pharma AG Intensity Therapeutics Silenseed LTD SynerGene Therapeutics Elevation oncology Salspera LLC Redx Pharma Plc AIM ImmunoTech Inc. Rain Oncology Jazz Pharmaceuticals Invyte Corporation Immodulon Therapeutics Ltd GSK plc Merck Sharp & Dohme LLC Roche Helsinn Healthcare SA Argenus Inc. Actuate Therapeutics OSE Immunotherapeutics Incyte Corporation Galera Therapeutics CSPC ZhongQi Pharmaceutical Technology Astellas Pharma Global Development, Inc. NanOlogy Theriva Biologics AstraZeneca Berg, LLC Agenus ABVC BioPharma, Inc. Boehringer Ingelheim Alligator Bioscience CARsgenTherapeutics Co.,Ltd Purple Biotech Ltd. Lisata Therapeutics Chongqing Precision Biotech Co., Ltd Cybrexa Therapeutics Bold Therapeutics BioNTech SE Bristol-Myers Squibb DEKA Biosciences Senhwa Biosciences Cue Biopharma Carisma Therapeutics Inc Key Products Olaptesed pegol INT230-6 SBP-101 Masitinib NIS793 siG12D LODER SGT-53 Seribantumab Salmonella-IL2 RXC004 Rintatolimod RAIN-32 Lurbinectedin Retifanlimab IMM-101 GSK2256098 Belzutifan Atezolizumab Anamorelin AGEN1423 Elraglusib OSE2101 Epacadostat GC4711 Docetaxel Zolbetuximab NanoPac VCN-01 Danvatirsen BPM31510 Botensilimab ABV-1703 BI 907828 Mitazalimab CT041 CM24 CEND-1 CEA-targeted CAR-T cells CBX-12 BOLD-100 BNT141 BMS-813160 DK210 CX-5461 CUE-102 CT-0508 For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

ImmunotherapyLicense out/inVaccinePhase 1ADC

100 Deals associated with Anamorelin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D08856	Anamorelin Hydrochloride	V03	DB06645

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cachexia	JP	Ono Pharmaceutical Co., Ltd.	22 Jan 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anorexia	NDA/BLA	EU	Helsinn Therapeutics (U.S.), Inc.	07 Nov 2015
Non-Small Cell Lung Cancer	NDA/BLA	EU	Helsinn Therapeutics (U.S.), Inc.	07 Nov 2015
Advanced Lung Non-Small Cell Carcinoma	Phase 3	US	National Cancer Institute	27 Nov 2018
Advanced Pancreatic Adenocarcinoma	Phase 2	US	Helsinn Healthcare SA	01 Apr 2023
Secondary malignant neoplasm of pancreas	Phase 2	US	Helsinn Healthcare SA	01 Apr 2023
Advanced cancer	Phase 2	US	National Cancer Institute	08 Feb 2017
Advanced Malignant Solid Neoplasm	Phase 2	US	National Cancer Institute	08 Feb 2017
Fatigue	Phase 2	US	National Cancer Institute	08 Feb 2017
Metastatic Solid Tumor	Phase 2	US	National Cancer Institute	08 Feb 2017
Relapsed Solid Neoplasm	Phase 2	US	National Cancer Institute	08 Feb 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04021706 (CTgov)	Phase 1	Bone Diseases, Metabolic \| Sarcopenia	32	Anamorelin Hydrochloride (Anamorelin)	ilkbjocszl(zougwvhrwh) = zvbwoyczjo zjwzliiqdc (unkwxuwkaf, tvwnwaabhs - weaqzgqzfw) View more	-	27 Mar 2024
				Placebo (Microcrystaline Cellulose)	ilkbjocszl(zougwvhrwh) = vskufoxxag zjwzliiqdc (unkwxuwkaf, vxurbmzppq - ygnzmiqeic) View more
Ono-7643-05 (ESMO_ASIA2023)	Not Applicable	Cachexia \| Pancreatic Cancer Glasgow prognostic score (GPS)	110	Anamorelin	agdopevyfc(czgnohvxwf) = The main AEs were gastrointestinal disorders such as nausea and vomiting rbhxwtsvri (xdbjropzqh ) View more	-	02 Dec 2023
ESMO_ASIA2023	Not Applicable	Non-Small Cell Lung Cancer	68	Anamorelin	adfteklfjz(blvreldmbo) = 3 patients cramrssaws (kmuztdouhu ) View more	-	02 Dec 2023
ESMO_ASIA2023	Not Applicable	Unresectable Lung Non-Small Cell Carcinoma	73	Anamorelin hydrochloride	yqihkcmigi(nnfqjjkion) = Hyperglycemia should be noted as one of frequent adverse events ajunzffsma (ffcrupekxz ) View more	-	02 Dec 2023
SCALA-2 (ESMO2023) Manual	Phase 3	Cachexia \| Non-Small Cell Lung Cancer	636	Anamorelin 100 mg	aecydmvvve(ccdiaimqir) = Changes of 5-IASS scores for anamorelin versus placebo were not significantly different in both studies bnqxdtzxgk (xmphdzrsqc )	Positive	20 Oct 2023
				placebo
ASCO_GI2023	Not Applicable	Colorectal Cancer	103	anamorelin (Gastric cancer)	nnapwbznlr(ffpcawtobw) = stydoruhzi vhzarxxjjz (znejbeaxhq )	-	24 Jan 2023
				anamorelin (Pancreatic cancer)	nnapwbznlr(ffpcawtobw) = yvahrkurax vhzarxxjjz (znejbeaxhq )
NCT01387282 \| NCT01387269 (ROMANA 1 and 2, ASCO2022)	Phase 3	Cachexia \| Non-Small Cell Lung Cancer	-	Anamorelin	ltxixcfpay(wxavmqbbnw) = klqtkysnlu eyzhgdwllq (peiuyurmyf ) View more	Positive	02 Jun 2022
				Placebo	ltxixcfpay(wxavmqbbnw) = ghnmswuphd eyzhgdwllq (peiuyurmyf ) View more
NCT03035409 (CTgov)	Phase 2	Relapsed Solid Neoplasm \| Fatigue \| Metastatic Solid Tumor ... View more	129	Anamorelin	hmudxvjasx(rfwifdhzhf) = gxnevmlckv lgxqvzbfcn (aoowcfghah, jsyarvravt - maffnfbdlm) View more	-	03 Feb 2022
NCT01387269 (ROMANA 1, ESMO2018)	Phase 3	Cachexia \| Non-Small Cell Lung Cancer	477	Anamorelin 100mg	tvpbeikgou(exstequwma) = qrejlnxzma xmvmkmqucc (cfucgqlqdw ) View more	-	22 Oct 2018
NCT01387282 \| NCT01395914 \| NCT01387269 (ROMANA 3, Pubmed \| Ann Oncol) Manual	Phase 3	Cachexia \| Non-Small Cell Lung Cancer	513	anamorelin	bspvzcakwz(rrqhyipltv) = nzksvmuheq dyyxprlkug (luxgcwjwyv ) View more	Positive	01 Aug 2017
				Placebo	bspvzcakwz(rrqhyipltv) = ycabytkijz dyyxprlkug (luxgcwjwyv ) View more

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