#China #Shanghai #CARsgen #Satri-cel #G/GEJC

CARsgen's Innovative CAR T-Cell Therapy for Gastric Cancer

CARsgen Therapeutics Holdings Limited, known for its focus on CAR T-cell therapies, has announced a groundbreaking step in cancer treatment with the release of its research findings on satricabtagene autoleucel, commonly referred to as Satri-cel. The results come from a confirmatory Phase II clinical trial targeting advanced gastric and gastroesophageal junction cancer (G/GEJC), and are now available on the American Society of Clinical Oncology (ASCO) website.

Overview of the Clinical Trial

Conducted in China, the randomized, open-label study aimed to compare the safety and efficacy of Satri-cel against standard treatment options for patients diagnosed with CLDN18.2 positive G/GEJC who had previously undergone at least two lines of therapy. The trial's primary goal was to evaluate progression-free survival (PFS), which was assessed by an independent review committee. Secondary endpoints included overall survival (OS).

From March 2022 to August 2024, a total of 156 patients were randomized into two groups: one receiving Satri-cel (104 patients) and the other undergoing treatment of physician's choice (TPC) involving drugs like apatinib and nivolumab (52 patients). Patients treated with Satri-cel received a dose of 250 million cells up to three times, while patients in the TPC arm had the option for subsequent Satri-cel infusion upon disease progression or treatment intolerance.

Key Findings

The results highlighted a significant enhancement in PFS for patients receiving Satri-cel. The median PFS was 3.25 months compared to 1.77 months in the TPC group, demonstrating a remarkable 63% reduction in the risk of disease progression or death. Furthermore, despite some patients not receiving the full therapy, Satri-cel also illustrated a favorable trend toward improving overall survival, with a median OS of 7.92 months versus 5.49 months for TPC.

In the subset of patients who actually received the treatment, PFS jumped to 4.37 months and OS extended to 8.61 months. Notably, those who transitioned from TPC to Satri-cel exhibited an even better median OS of 9.20 months. This evidence underscores the substantial survival benefits of Satri-cel infusion.

Safety Profile

CARsgen’s satri-cel also recorded a favorable safety profile. The study noted only four instances of Grade 3 cytokine release syndrome (CRS), with no severe CRS cases or neurotoxicity events reported. These findings are promising considering the seriousness of advanced G/GEJC.

Implications for Future Cancer Treatment

Not only does this trial represent the first confirmatory randomized controlled trial of CAR-T therapy in solid tumors, but it also positions Satri-cel as a potential new standard of care for advanced G/GEJC, which currently has limited effective treatment options. The trial's outcomes provide strong evidence that Satri-cel can significantly improve the prognosis for patients who have exhausted conventional treatment avenues.

About Satri-cel

Satri-cel is a pioneering CAR T-cell therapy focused on targeting the Claudin18.2 protein, particularly in solid tumors. The research initiative for Satri-cel includes various trials demonstrating its efficacy in treating G/GEJC and pancreatic cancer. The therapy has been granted Breakthrough Therapy Designation and Orphan Drug Designation by the U.S. and Chinese regulatory bodies, emphasizing its potential in treating difficult-to-manage cancers.

As CARsgen Therapeutics continues to refine its offerings and expand its research, the hope remains high for innovative treatments that can conquer the challenges posed by advanced forms of cancer. Their mission is clear: to lead the biopharmaceutical arena with novel and impactful cell therapies that could change the landscape of cancer treatment globally.