Encouraging preliminary data for glecirasib in pancreatic ductal adenocarcinoma

Glecirasib displayed promising anti-tumour activity in patients with KRAS G12C-mutated pancreatic ductal adenocarcinoma (PDAC) or other solid tumours previously treated with other therapies. Based on these preliminary data, a pivotal clinical study has been initiated to further assess glecirasib in patients with PDAC in China.

Dr Jian Li (Peking University Cancer Hospital and Institute, China) evaluated the efficacy and safety of the highly selective covalent KRAS inhibitor glecirasib in patients with PDAC and other solid tumours who were enrolled in either JAB-21822-1001 (NCT05002270) or JAB-21822-1002 (NCT05009329). These phase 1/2 trials enrolled Chinese, American, European, and Israeli participants with locally advanced or metastatic solid tumours who had progressed on a first-line therapy. The current analysis looked at 52 participants with PDAC (n=31) or other solid tumours (n=21) which were not colorectal cancer or non-small cell lung cancer [1].

The overall response rate was 56.0%, with all of these responses being partial responses. An additional 34.0% of the participants had stable disease. The response rate was consistent across tumour types, albeit the 3 included participants with small bowel cancer had a response rate of 100%. Furthermore, in participants with PDAC, the median progression-free survival (PFS) was 5.6 months and the median overall survival (OS) was 10.7 months. In participants with other solid tumours, the corresponding median PFS and median OS were 7.0 months and ‘not reached’, respectively.

Grade ≥3 adverse events were reported in 25.0% of the participants, most commonly being anaemia (5.8%) or hypertriglyceridaemia (3.8%). Other common any-grade side effects were increased blood bilirubin (50.0%), increased conjugated bilirubin (36.5%), and asthenia (23.1%). No treatment-emergent adverse events led to drug discontinuation or death.

“The impressive clinical activity of glecirasib in patients with PDAC and other solid tumours, together with a favourable safety profile, warrant further development of this agent,” concluded Dr Li.

1. Li J, et al. Preliminary activity and safety results of KRAS G12C inhibitor glecirasib (JAB-21822) in patients with pancreatic cancer and other solid tumors. Abstract 604, ASCO Gastrointestinal Cancers Symposium 2024, 18–20 January, San Francisco, CA, USA.

 

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Posted on 13 February, 202427 March, 2024