Satricabtagene autoleucel improves survival in advanced gastric and GEJ cancers

In the phase 2 CT041-ST-01 trial, the Claudin18.2-specific autologous CAR T-cell therapy, satricabtagene autoleucel (satri-cel), significantly improved both progression-free survival (PFS) and overall survival (OS) compared with treatment of physician’s choice (TPC) in participants with advanced gastric or gastroesophageal junction (GEJ) cancer.

Dr Muhammad Shaalan Beg (University of Texas Southwestern Medical Center, TX, USA) presented the results of the randomised, open-label, multi-centre phase 2 CT041-ST-01 trial (NCT04581473), which randomised participants with previously treated (≥2 lines of therapy) advanced gastric or GEJ cancer 2:1 to satri-cel or TPC. Participants in the satri-cel arm received up to 3 doses of 250 x 10⁶ cells; the standard-of-care included standard drugs per TPC. Cross-over was allowed from TPC to satri-cell in case of disease progression or drug intolerance. The primary endpoint was PFS, and the key secondary outcome was OS [1].

In the intent-to-treat population (n=156), median PFS was 3.25 months with satri-cel versus 1.77 months with TPC (HR 0.366; 95% CI 0.241–0.557; P<0.0001), and median OS was 7.92 months versus 5.49 months, respectively (HR 0.693; 95% CI 0.457–1.051; P=0.0416). In the treated population (n=136), median PFS by independent review was 4.37 compared to 1.84 months, and OS was 8.61 over 5.49 months, both favouring satri-cel. The data were published a few days later in the Lancet [2].

The median follow-up was 8.90 months for PFS and 12.29 months for OS, and the baseline characteristics were balanced, including the number of prior lines of therapy (≥3 in 26.9% vs 19.2%) and prevalence of peritoneal metastases (69.2% vs 59.6%).

None of the participants in the satri-cel arm discontinued due to treatment-emergent adverse events, compared with 3 in the TPC arm. A single treatment-emergent adverse event-related death occurred in each arm. Cytokine release syndrome occurred in 95.5% of participants receiving satri-cel, with grade ≥3 in 4.5%.

Dr Beg noted this is the first positive randomised CAR T-cell trial in solid tumours.

1. Qi C, et al. Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01). Abstract #4003, ASCO Annual Meeting 2025, 30 May–3 June, Chicago, IL, USA.
2. Qi C, et al. Lancet. 2025;405(10494):2049–2060.

Posted on 30 July 2025