Onco-Summaries: Daily Oncology Updates at a Glance

24/06/2025

CARsgen Therapeutics submitted a NDA for Satri-cel to China’s NMPA (Ref)

• CARsgen Therapeutics submitted the New Drug Application (NDA) for satricabtagene autoleucel (satri-cel; an autologous anti-Claudin18.2 CAR-T) to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy

• The submission is based on the results from the randomized Phase 2 CT041-ST-01 trial in which satri-cel demonstrated significant PFS improvement and a clinically meaningful OS benefit with a manageable safety profile vs SOC in Claudin18.2 positive gastric/gastroesophageal junction cancer patients with failure to at least 2 prior lines of treatment

The US FDA granted the RMAT Designation for enGene’s detalimogene in High-Risk, Non-Muscle Invasive Bladder Cancer (Ref)

• enGene Holdings announced that the US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (detalimogene; non-viral gene-based immunotherapy) for the treatment of high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS)

• The designation was based on preliminary results from the ongoing pivotal LEGEND study, which demonstrated promising clinical activity and a generally favorable tolerability profile in BCG-unresponsive NMIBC with CIS

• Ron Cooper, CEO, enGene: “Receiving the RMAT designation highlights the promising profile of detalimogene and its potential to address the high unmet need in NMIBC. Bladder cancer patients with limited options cannot wait, and we are enthusiastic about potentially expediting the regulatory process to bring a first-in-class treatment to patients.”