Mirati Therapeutics has reported positive data from the Phase II KRYSTAL-1 clinical trial assessing adagrasib at 600mg twice daily dose in already treated pancreatic ductal adenocarcinoma and other gastrointestinal (GI) tumour patients with a KRAS-G12C mutation.

Adagrasib is an investigational oral small-molecule KRAS-G12C inhibitor.

The trial included patients with cancers of the appendix, biliary tract, small bowel, oesophagus and gastro-oesophageal junction. 

As of 10 September last year, the subset of 30 GI cancer patients harbouring a KRAS-G12C mutation in the adagrasib monotherapy arm received a minimum of two lines of systemic anticancer treatments previously.

They were followed up for a median of 6.3 months

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According to the findings, adagrasib had a substantial clinical activity and wide-ranging disease control.

The objective response rate (ORR) and the disease control rate (DCR) were 41% and 100%, respectively in the 27 evaluable subjects.

In evaluable individuals with pancreatic cancer and other GI tumours, the response rate (RR) was reported to be 50% and 35%, respectively.

The median progression-free survival (mPFS) was 6.6 months and 7.9 months in pancreatic cancer patients and those with the other GI tumours, respectively.

Adagrasib demonstrated to be well-tolerated with a manageable safety profile in the overall subset of subjects with KRAS-G12C GI cancers analysed in this cohort. 

Furthermore, the grade 3/4 treatment-related adverse events were observed in 27% of subjects who received adagrasib without any Grade 5 TRAEs noted.

Mirati Therapeutics research and development head and founder, president Charles Baum said: “The results demonstrated positive clinical activity in patients with KRAS-G12C GI cancers treated with single agent adagrasib, particularly in those with pancreatic cancer where options are limited.

“We continue to aggressively evaluate adagrasib as a single agent and in combination with other cancer medicines in a broad development plan to help more people living with cancer.”

In November last year, Mirati and Verastem Oncology signed a non-exclusive clinical collaboration agreement to assess adagrasib plus VS-6766 in a Phase I/II trial for non-small cell lung cancer treatment.