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Led the CT041 trials that produced the first CAR-T therapy approved for a solid tumour, in gastric cancer.
Lin Shen is Professor and Director of the Department of Gastrointestinal Oncology at Peking University Cancer Hospital in Beijing. Her group ran the phase 1 and randomised phase 2 trials of satricabtagene autoleucel, the Claudin 18.2 CAR-T cell therapy from CARsgen Therapeutics also known as CT041, which produced the first CAR-T therapy approved for a solid tumour, in gastric cancer. Her publications include the interim phase 1 results of Claudin 18.2-specific CAR T cells in gastrointestinal cancers, which also included pancreatic cancer patients. She leads Chinese gastric cancer immunotherapy and HER2 studies, with interests in CAR-T for solid tumours and immunotherapy.
Patients with newly diagnosed metastatic colorectal cancer whose tumour carries a BRAF V600E mutation, which is about 8-12% of cases, should now be offered encorafenib and cetuximab together with FOLFOX from the start rather than after chemotherapy fails; median survival has roughly doubled to about two and a half years. BRAF testing at diagnosis is therefore essential, alongside RAS and mismatch repair testing. The regimen is more toxic than chemotherapy alone.
This is the trial behind the first approval of a CAR-T therapy for a solid tumour, in China. The gain in progression-free survival is real but measured in weeks, 15 percent of patients randomised to satri-cel never received it, and nearly every treated patient had cytokine release syndrome, so the trade-off is very different from CAR-T in blood cancers. Overall survival is not reported in the abstract.
Patients with newly diagnosed advanced stomach or oesophageal adenocarcinoma whose tumour is HER2-negative and PD-L1 positive (CPS 5 or more, or at least 1 in some regions) should receive chemotherapy with nivolumab (or pembrolizumab, from KEYNOTE-859), which adds about three months of median survival and doubles the chance of being alive at three years. The benefit in PD-L1-negative tumours is doubtful, and these patients may be better served by chemotherapy alone or by trials.
Shares CT041-ST-01, Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial, Satricabtagene autoleucel, Peking University Cancer Hospital.
Shares CARsgen Therapeutics, Satricabtagene autoleucel, Claudin 18.2, CAR-T cell therapy.
Shares CARsgen Therapeutics, Satricabtagene autoleucel, CAR-T cell therapy, Gastric & gastro-oesophageal junction cancer.
Shares CARsgen Therapeutics, Gastric & gastro-oesophageal junction cancer, Pancreatic ductal adenocarcinoma.
Shares Satricabtagene autoleucel, Claudin 18.2, Gastric & gastro-oesophageal junction cancer.
Shares Peking University Cancer Hospital, Gastric & gastro-oesophageal junction cancer.
Shares Claudin 18.2, Gastric & gastro-oesophageal junction cancer, Pancreatic ductal adenocarcinoma.
Shares CARsgen Therapeutics, CAR-T cell therapy.