Gastric Cancer – Pipeline Review, 2024

Gastric cancer, also referred to as stomach cancer, refers to the cancer that originates through the growth of cells in the stomach. The stomach is located, just below the ribs and allows for the breakdown and the digestion of food. While gastric cancer can occur in any part of the stomach, it generally occurs in the stomach body. Some of the types of gastric cancer includes:

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  • Adenocarcinomas
  
  
  • Gastrointestinal stromal tumors (GISTs)
  
  
  • Others
  
  
  
  

Epidemiology:

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While the causes of gastric cancer are fully not ascertained, some of the probable causes that leads to the development of this disease includes Helicobacter pylori infection, age and sex (this cancer is more common among the females, and is more prevalent over the age of 60), being overweight or obese, tobacco and alcohol consumption, and other factors. According to the data published by the Global Cancer Observatory (GLOBOCAN) in 2022, stomach/gastric cancer was the fifth most common form of cancer, with an estimated 968,784 cases globally.

Incidence (Number of New Cases) of Gastric Cancer, By Continent, 2022

According to the data published by Global Cancer Observatory (GLOBOCAN) in 2022, Asia recorded the highest number of cases of gastric cancer in 2022, with China accounting for 358,672 cases, which is more than half of the total cases in the Asia region.

Therapeutic Assessment:

Diagnosis:

According to the European Society for Medical Oncology (ESMO), the standard diagnosis algorithm for gastric cancer involves the utilization of endoscopic examinations (upper endoscopy (also called esophagogastroduodenoscopy or EGD)) and forceps biopsies, which are considered to be the gold standard diagnostics. The biopsy samples are particularly tested to check the presence of cancer, and if cancer is present, these samples are tested to ascertain the form of cancer. Some of the other tests used for gastric cancers includes imaging tests such as the upper gastrointestinal (GI) series, computed tomography (CT) scan, or positron emission tomography (PET) scan.

Treatment:

In terms of the current treatment guidelines, the treatment algorithm is determined on the basis of factors such as the stage of the disease, the surgical fitness of the patient and the patient’s comorbidities and preferences. However, some of the most common treatment measures utilized includes surgeries, and chemotherapy with drugs such as oxaliplatin, cisplatin and paclitaxel. In recent times, after the development of targeted therapies and immunotherapies, these therapies are given in combination with chemotherapy.

Key Products:

Some of the drugs approved by the U.S. FDA for the treatment of gastric cancer includes OPDIVO (nivolumab), CYRAMZA (ramucirumab), and KEYTRUDA (pembrolizumab).

Major Players in Gastric Cancer:

The major players in the gastric cancer market include Bristol-Myers Squibb Company, Merck & Co., Inc., Eli Lilly and Company, Pfizer Inc., Accord Healthcare, and other prominent players.

Market Outlook:

As gastric cancer is one of the most prevalent forms of cancers globally, the market is witnessing a very strong growth potentially, as a number of players are getting involved in this market. For instance, OPDIVO (nivolumab), which is approved for gastric cancer, registered a global overall sales of USD 9.01 billion in 2023.

Pipeline Analysis:

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In terms of the current clinical trials scenario, an estimated 60% of all the pipeline candidates for gastric cancers belong to the Phase 2 of clinical trials. Approximately 44% of these clinical trials are being funded by the industry players.

Pipeline, By Mechanism of Action:

One of the first targeted therapies approved for gastric cancer was trastuzumab, a monoclonal antibody that targeted the human epidermal receptor 2 (HER2). In terms of the mechanism of action of recent pipeline drug candidates, these pipeline candidates have focused on anti-HER2 therapy, and also various biomarker directed mechanism of action. Some of the mechanism of actions of the upcoming drugs are as follows:

• HER2 Signaling Pathway: A number of approved therapies belong to this category of mechanism of action. Furthermore, several pipeline candidates are based on this mechanism of action. This mechanism of action, focuses on the direction of efforts towards the inhibition of the association of HER2 with the other types of EGFR receptor, especially HER3 protein


• FGF/FGFR Signaling Pathway: The FGFR is being increasingly considered as a therapeutic target for the inhibition of the development of the gastric tumors.


• Claudin 18.2 Signaling Pathway: The aberrant expression of the CLDN18.2, a marker protein, is being increasingly studied as a common factor in the initiation and progression of several malignant gastric tumors. As this protein has a high expression in the gastric cancer tumors, this is also being targeted through adoptive T-cell strategies.

Pipeline, By Route of Administration:

In terms of the route of administration of the pipeline drugs, these candidates are present in the form of oral, and parenteral routes. For instance, the pipeline drug of PCS6422 by Processa Pharmaceuticals, Inc. is in the form of tablets.

Pipeline By Molecule Type:

In terms of the molecule type under the various stages of clinical trials for gastric cancer, there has been increase in the influx of candidates belonging to the biologics category. For instance, the pipeline candidate of CT041 by the company CARsgen Therapeutics Holdings Limited, belongs to the biologics molecule type and is currently in Phase 2/3 of clinical trials in various companies.

Pipeline, By Company:

Some of the major players in terms of the pipeline candidates includes Ambrx, RemeGen Co., Ltd., Aston Sci., and others. These players are majorly based in the U.S., Europe, and the Asian countries such as China, South Korea, and Japan.

Clinical Trial Insights:

Ongoing Clinical Trials: Some of the key pipeline candidates under clinical trials are as follows:

Phase 1:

• EO-3021: Elevation Oncology

• This study is being conducted for patients with solid tumors and are likely to express anti-claudin 18.2 (CLDN18.2) biomarker.

• ARX788: Ambrx

• This study is a multicenter, open-label, multiple dose-escalation and expansion study of ARX788, which is to be administered as a monotherapy for advanced solid tumors with HER2 Expression.

Phase 2:

• RC48-ADC: RemeGen Co., Ltd.
  
  
  
  • This clinical trial is evaluating the efficacy and safety of RC48-ADC for the patients with local advanced or metastatic gastric cancer, with the tumor having an overexpression of HER2. The primary purpose of the study is treatment, and the interventional model is single group assignment, with the masking being none (open label). The study type of this clinical trial is interventional.
  
  
  
  


• AZD0901: AstraZeneca
  
  
  
  • The purpose of this clinical trial is to study the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 to be utilized as a monotherapy or in combination with other anticancer drugs for patients suffering from locally advanced unresectable or metastatic solid tumours that are gastric cancers expressing CLDN18.2. The study type of this clinical trial is interventional and the trial’s primary purpose is treatment. Also, the allocation of this clinical trial is randomized, and the interventional model is parallel assignment. The masking in this clinical trial is none (open label).
  
  
  
  

Phase 3:

• JS001: Shanghai Junshi Bioscience Co., Ltd.
  
  
  
  • This study is an international, multicenter, randomized, double bind study that aims to recruit patients that have undergone radical gastrectomy and are suffering from postoperative pathological stage II or III gastric or esophagogastric junction (EGJ) adenocarcinoma to evaluate the efficacy and safety of JS001 in combination with other anti-cancer agents. The primary purpose of this clinical trial is treatment, with the allocation being randomized. The interventional model is sequential assignment with the masking being quadruple. The study type of this model is interventional.
  
  
  
  

• ASKB589: AskGene Pharma, Inc.
  
  
  
  • This study which is being conducted in China is a multicenter, randomized, double-blind, standard-of-care controlled phase 3 clinical study that evaluates the efficacy of ASKB589 to be used in combination with CAPOX (capecitabine and oxaliplatin) and PD-1 inhibitor in patients with advanced or metastatic gastric cancer/ GEJ Adenocarcinoma. This clinical trial’s study type is interventional, with the primary purpose being treatment. The allocation of this study is randomized, and the interventional model is parallel assignment. The masking of this clinical trial is quadruple.
  
  
  
  

Future Trial Prospects:

• June 2024: A team of researchers for the Vanderbilt University Medical Center announced the receipt of a funding of USD 2.5 million Department of Defense Translational Team Science Award for the development of therapies for gastric cancer. This funding will enable the launch of clinical trials in the U.S. for gastric cancer.


• May 2024: The National Medical Products Administration (NMPA) of China granted the breakthrough designation to the pipeline drug of IBI343 for advanced gastric cancer. This designation was granted on the basis of Phase 1 results, and will lead to the launches of new clinical trials for this pipeline candidate.

Regulatory Landscape:

• FDA and EMA Approvals: In the U.S., the regulatory agency of the U.S. FDA approves the drugs related to gastric cancer, while in Europe, it is approved by the European Medicines Agency. In November 2023, the U.S. FDA announced the approval of pembrolizumab (Keytruda) along with fluoropyrimidine- and platinum-containing chemotherapy as a first line of treatment for adults with “locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma”.


• Orphan Drug Designations: In recent times, a number of pipeline candidates for gastric cancer has received the regulatory designation from the U.S. FDA of an Orphan Drug Designation (ODD). In October 2023, the pipeline candidate of BDC-1001 of the U.S. based company Bolt Biotherapeutics, received this designation for the treatment of gastric cancers.


• Market Authorization Challenges: Some of the market authorization challenges that the drugs for gastric cancer face are lengthy regulatory processes, which significantly delays the companies’ ability to launch these drugs onto the market. This reduces these companies’ profitability prospects.

Report Scope:

• A thorough assessment of the pipeline products by areas such as development stage; route of administration; drug class; indication; sponsor; molecule type and drug target


• Comprehensive profiles of the pipeline products with details such as company overview; product description; R&D status; development activities; mechanism of action; molecule type; development stage; indications; funding and route of administration


• Overview of dormant and discontinued pipeline products


• Key insights about the epidemiology of conditions being treated by the pipeline products and overview of the addressable or current market for the pipeline products


• Overview of the latest developments; news articles, press releases, and relevant conferences

Report Methodology:

• All pipeline reports are built through the analysis of data primarily collected through credible desk research sources. Secondary research is supplemented by interviews conducted with key opinion leaders.


• Desk research sources include global and regional clinical trials databases; annual reports, websites, press releases & investor presentations of companies; white papers; news articles; reports published by industry associations; articles/reports published on databases such as NCBI, ResearchGate; internal databases

Reasons to Buy this Report:

• Develop effective growth strategies based on a comprehensive overview of the R&D activity and pipeline products for gastric cancer


• Identify emerging players or competition in the market based on pipeline products and develop strategies to counter the emergence of these players


• Identify the focus of leading players about R&D for Gastric Cancer


• Identify potential companies from a partnership or acquisition point of view based on current synergy in R&D activities or strategies to diversify R&D focus to drive growth in business


• Analyze the reasons behind dormant and discontinued products to make changes in the R&D focus if necessary