CARsgen Therapeutics’ CAR-T improved progression-free survival (PFS) compared to approved therapies for patients with advanced stomach cancer in a phase 2 trial.
The open-label study assessed CT041-ST-01, also known as satricabtagene autoleucel or satri-cel, a cell therapy that has nabbed the attention of both big biotech Moderna and was previously subject to an FDA hold due to manufacturing issues.
Now, China-based CARsgen has shared pivotal results from the latter portion of a phase 1/2 study evaluating the therapy for patients with gastric or gastroesophageal junction cancers that haven’t responded to at least two prior lines of treatment.
The study hit its primary goal of statistically significant improvement in PFS for patients receiving satri-cel compared to those receiving their physician's choice of an approved treatment, according to a Dec. 30 release. The company didn’t share specific data figures for either PFS or the statistical significance p-value.
Trial participants, which all had Claudin18.2 expression-positive cancer, were randomized to receive either satri-cel infusion or their physician's choice of paclitaxel, docetaxel, irinotecan, apatinib or nivolumab. Satri-cel is designed to target the protein Claudin18.2 with the potential of becoming the first-in-class autologous CAR T-cell product to do so, according to CARsgen.
Earlier data demonstrated a manageable safety profile for satri-cel, the biotech said in the release.
“This represents a groundbreaking milestone for the field of CAR-T therapies against solid tumors,” CARsgen CEO, Chief Scientific Officer and founder Zonghai Li, M.D., Ph.D., said in the release.
The biotech plans to submit a new drug application to China regulators in the first half of this year, Li said. The asset has also snagged both orphan drug and regenerative medicine advance therapy tags from the FDA in the indication.
CARsgen is already studying satri-cel in a phase 1 pancreatic cancer trial and a phase 1b/2 trial for advanced gastric or pancreatic adenocarcinoma.
Over the last five days, the company’s stock has risen 10%, hitting 9.38 Hong Kong dollars per share on the Hong Kong stock exchange as of 10:30 a.m. ET on Jan. 2.
Back in August 2023, the biotech teamed up with Moderna to “contemplate conducting preclinical studies and a phase 1 clinical trial” for satri-cel in combination with Moderna’s investigational Claudin18.2 mRNA cancer vaccine, according to a release at the time. An update on the partnership hasn’t been publicly shared yet.
Then, at the end of 2023, three clinical trials for CARsgen’s cell therapies—including satri-cel—were hit by an FDA hold after the regulatory agency visited the company’s manufacturing facility. The biotech didn’t share what the FDA found at its North Carolina site at the time. The hold was lifted nearly a year later in November 2024.