Amgen has reported additional results from the Phase I clinical trial of its investigational cancer drug AMG 510, which irreversibly targets the KRASG12C protein.
The open-label, multi-centre study involved patients with KRAS G12C-mutated solid tumours who previously received a minimum of two or more lines of therapy.
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It assessed a once-daily, oral 180mg, 360mg, 720mg and 960mg dose of AMG 510.
The primary endpoint of the trial is safety, while key secondary endpoints include pharmacokinetics, progression-free survival, duration of response and objective response rate.
Initial data revealed anti-tumour activity in non-small cell lung cancer (NSCLC) patients, without any dose-limiting toxicities.
The new results are from a subset of 34 NSCLC patients. Of the 23 participants evaluable for efficacy, 13 were treated with a once-daily dose of 960mg.
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By GlobalDataOf the patients administered with the dose, 54% experienced a partial response at one or more timepoints and 46% had stable disease, indicating a 100% disease control rate.
Amgen Research and Development executive vice-president David Reese said: “These new data reinforce the earlier positive response rate we shared at ASCO in more non-small cell lung cancer patients receiving AMG 510.
“We remain enthusiastic about the promise of AMG 510 and continue to rapidly advance its development programme both as monotherapy and in combination.”
In the 34 participants, no dose-limiting toxicities were found and no adverse events led to discontinuation. Of these patients, 27 are currently on treatment.
Out of the 34 subjects, 26.5% had grade one or two treatment-related adverse events (TRAEs). None of the patients experienced grade four or higher TRAEs.
Amgen intends to present the new Phase I data of AMG 510 at the European Society for Medical Oncology (ESMO) 2019 Congress, which is taking place in Barcelona, Spain from 27 September to 1 October.
