CAR-T improves PFS for certain patients with gastric, gastroesophageal junction cancers
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Satricabtagene autoleucel improved PFS compared with physician’s choice of therapy for patients with Claudin18.2 expression-positive advanced gastric or gastroesophageal junction cancers, according to the agent’s manufacturer.
Satricabtagene autoleucel (CARsgen Therapeutics) — often called satri-cel — is an autologous chimeric antigen receptor T-cell product candidate that targets the protein Claudin18.2.
Researchers conducted an open-label phase 2 study to evaluate the efficacy and safety of satri-cel for patients with Claudin18.2 expression-positive, advanced gastric/gastroesophageal junction cancers who had failed at least two prior lines of therapy.
Investigators randomly assigned patients 2:1 to satri-cel or physician’s choice of treatment. Physician’s choice options included paclitaxel, docetaxel, irinotecan, apatinib or nivolumab (Opdivo, Bristol Myers Squibb).
The study met its primary endpoint, demonstrating a statistically significant improvement in PFS with satri-cel per independent review committee assessment.
“We are thrilled to see that satri-cel has achieved positive results in the pivotal phase 2 clinical trial in China,” Zonghai Li, MD, PhD, founder, chairman of the board, CEO and chief scientific officer of CARsgen Therapeutics, said in a press release. “We look forward to satri-cel becoming the world’s first CAR-T product for solid tumors, bringing hope to more patients as soon as possible. Additionally, we will continue to explore the potential of satri-cel in adjuvant therapy for gastric and pancreatic cancers, aiming to deliver even greater benefits to patients.”