Amgen reported the first data from a Phase I study on use of its experimental oral KRAS inhibitor AMG 510 in colorectal cancer patients with previously treated KRAS G12C-mutated solid tumours at the European Society for Medical Oncology (ESMO) congress. Results showed that in 12 patients who received the target dose of 960 mg once daily, one experienced a partial response (PR) and 10 had stable disease for a disease control rate of 92%.
The trial enrolled 76 patients with KRAS G12C-mutant solid tumours, including 29 with colorectal cancer. Amgen added that AMG 510 also showed tumour responses in two evaluable patients with appendiceal cancer with one PR and one experiencing stable disease. The company announced earlier this month that in 13 evaluable patients with non-small-cell lung cancer, 54% experienced a PR at the target dose of 960 mg, while 46% had stable disease.
David Reese, executive vice president of R&D at Amgen, said "the data suggest there are relevant molecular differences between tumour types," with Greg Friberg, the company's head of oncology development, adding that "additional work in understanding mutational drivers is ongoing." Friberg remarked "the fact that we saw one response is encouraging," although the drugmaker indicated that it has not decided whether to move AMG510 into a Phase II study in colorectal cancer as a monotherapy. Reese said "we are initiating combination studies to further explore the potential of AMG 510 in lung and colorectal tumours," including with MEK inhibitors.
For related analysis, read ViewPoints: Some bloom comes off Amgen's KRAS rose.
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