Gastric Cancer Awareness Month 2024: Looking Back at Progress for Cell Therapy
In observance of Gastric Cancer Awareness Month, held annually in November, we took a look back at the past few months' news in cell therapy for gastric cancer indications.
According to the American Association for Cancer Research, gastric cancer is diagnosed in approximately 26,890 people in the United States each year.1 In 2024 alone, 10,880 people in the US are expected to die from gastric cancer. The disease more commonly affects men than women and nonhispanic white people than people of other ethnicities. Smoking, age, diet, and long-term stomach inflammation are all considered risk factors for gastric cancer.
An important areas of interest for new therapeutic development in gastric cancer is cell therapy. A number of companies and academic institutions are now pursuing the development of chimeric antigen receptor T-cell (CAR-T) therapy and other such advanced treatments for gastric cancers. In honor of Gastric Cancer Awareness Month, observed annually in November by the patient and clinician communities, CGTLive® is taking a look back at the progress that has been made for cell therapy candidates in gastric cancer over the past year. Click the "READ MORE" buttons for more details and information about each item.
CARsgen Finishes Enrolling Patients in Pivotal Trial in China for Gastric/Gastroesophageal CAR-T Satri-Cel
August 23, 2024 — CARsgen has completed the enrollment of patients in its pivotal phase 2 clinical trial (NCT04581473) evaluating satricabtagene autoleucel (satri-cel; CT041), an investigational CAR-T therapy that targets CLDN18.2, for the treatment of CLDN18.2-positive advanced gastric/gastroesophageal (GC/GEJ) cancer.
The open-label, multicenter, and randomized trial, which is taking place in China, is assessing satri-cel against a control group, in which patients will be treated with either paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab, according to the judgement of the treating physician. The study was open to patients with advanced GC/GEJ whose disease was not successfully treated with 2 or more previous lines of therapy.
“We are very pleased to announce the successful completion of patient enrollment in the pivotal phase 2 clinical trial of satri-cel in China,” Zonghai Li, MD, PhD, the founder, chairman of the board, CEO, and chief scientific officer of CARsgen Therapeutics, said in a statement. “This significant milestone marks another solid step forward in our development of CAR T-cell therapies for solid tumors. We extend our gratitude to all the investigators, the patients and their families for their trust and support. We look forward to the submission of a New Drug Application and the approval in China, to benefit patients with gastric cancer. As one of the leading companies in the field of CAR T-cell therapies, we remain committed to addressing the major challenges faced by existing CAR T-cell therapies and will develop more innovative CAR-T products for cancer patients.”
First Patient With Gastric Cancer Dosed in iNKT/CTLA-4 Inhibitor/Anti-PD-L1 Trial
April 24, 2024 — The first participant with refractory gastroesophageal cancer has been dosed in a phase 2 trial evaluating the novel combination of the company’s allogeneic invariant natural killer T (iNKT) cell therapy agenT-797 and Agenus’ botensilimab and balstilimab (BOT/BAL).
“This study is an important step in new treatment combinations to improve outcomes for patients with refractory gastric cancers, an incurable disease with limited response to available therapies,” Yelena Janjigian, MD, Chief Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, said in a statement. Janjigian is leading the investigator-sponsored trial at Memorial Sloan Kettering.
"AgenT-797, an off-the-shelf iNKT cell-based therapy, has shown the capacity to target cancerous cells in diseased tissues and is compatible with immune checkpoint inhibitors. This study builds upon the promising outcomes observed with iNKTs in gastric cancer and with botensilimab/balstilimab in GI cancers. By harnessing the immune-enhancing potential of agenT-797, we aspire to improve outcomes for a greater number of patients facing challenging GI cancers,” Janjigian continued.
Triumvira Immunologics’ TAC T-cell Therapy TAC01-CLDN18.2 to be Evaluated in Phase 1/2 Clinical Trail for Solid Tumors
January 19, 2024 — Triumvira Immunologics’ TAC01-CLDN18.2, an investigational autologous T-cell antigen coupler (TAC) CLDN18.2-targeted T-cell product, is set to be evaluated in the first-in-human phase 1/2 TACTIC-3 (NCT05862324) clinical trial for patients with various types of solid tumors. Triumvira recently presented a poster detailing the design of the dose escalation and dose expansion clinical trial at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers (GI) Symposium, held January 18-20, in San Francisco, California.
TAC01-CLDN18.2 integrates TAC, Triumvira’s proprietary chimeric receptor that is intended to activate and direct T-cells against tumor cells. TAC01-CLDN18.2 specifically expresses the CLDN18.2 TAC with the intention of targeting tumor cells that are CLDN18.2-positive. The TACTIC-3 trial is currently recruiting patients with gastric cancer, GEJ, esophageal adenocarcinoma (AC), non–small cell lung cancer (NSCLC), cholangiocarcinoma, pancreatic ductal AC (PDAC), ovarian mucinous cancer, and colorectal cancer.
The phase 1 dose escalation portion of the study will follow a standard 3+3 design and aims to treat 9 to 24 patients in total. Four different dose levels will be evaluated: 1-3x105 cells/kg, 6-8x105 cells/kg, 1-3x106 cells/kg, and 6-8x106 cells/kg. Patients with gastric cancer, GEJ, esophageal AC, NSCLC, PDAC, cholangiocarcinoma, ovarian mucinous cancer, and colorectal cancer are eligible for this portion of the trial. These participants must have cancer that is negative for expression of HER2 and must have had at least 2 lines of prior therapy.
TCR-T Therapy Cleared for Lung, Gastric Cancer Trial
October 16, 2023 — The FDA has granted investigational new drug application clearance to Biosyngen’s phase 1/2 clinical trial of the company’s T-cell receptor T-cell (TCR-T) therapy BRL03 for patients with lung cancer, gastric cancer and other advanced solid tumors.
BRL03 will be the company’s first TCR-T therapy to enter clinical trials, although Biosyngen stated that the preliminary safety and efficacy of BRL03 have been demonstrated in data from exploratory clinical trials.
Taking together small cell and non-small cell lung cancer, lung cancer is the leading cause of cancer deaths worldwide. In 2020, there were 2.21 million new cases and 1.8 million deaths due to the disease. Gastric cancer is the third most deadly of all malignant tumors, with 1.27 million new cases and almost 1 million deaths per year due to the disease.
