Amgen has reported long-term efficacy and safety results from the first-in-human Phase I/II CodeBreaK 100 clinical trial of Lumakras (sotorasib) in KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) patients.
An inhibitor of KRASG12C, Lumakras had demonstrated lasting clinical benefit and overall survival in NSCLC patients with KRAS G12C mutation.
The open-label, multicentre trial enrolled KRASG12C-mutant solid tumour patients who were previously treated with a prior line of systemic anticancer therapy, in line with the type of tumour and disease stage.
According to data from the long-term, two-year assessment of 174 heavily pre-treated subjects, Lumakras was found to offer a 40.7% and 83.7% centrally confirmed objective response rate (ORR) and disease control rate (DCR), respectively.
The treatment also demonstrated a median duration of response (DOR) of 12.3 months.
Furthermore, five subjects attained complete responses while 65 subjects had partial responses.
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The findings also showed median progression-free survival (PFS) of 6.3 months and overall survival (OS) of 12.5 months, with 32.5% of the participants still alive at two years.
In the trial, no new safety signals for Lumakras were reported during the long-term follow-up.
Lumakras obtained approval in the US under an accelerated process, in May last year.
Amgen Research and Development executive vice-president David Reese said: “With regulatory approvals in nearly 40 countries and thousands of patients treated, Lumakras, the only approved KRASG12C inhibitor, is a transformative targeted therapy for the treatment of patients living with KRAS G12C-mutated NSCLC.
“We are pleased with these latest results from the CodeBreaK 100 study, which represent the longest follow-up of patients treated with a KRASG12C inhibitor and confirm rapid, deep and durable responses in patients receiving Lumakras.”
In September last year, the company reported favourable data from two analyses of the Phase II CodeBreaK 100 trial of Lumakras to treat advanced or metastatic KRAS G12C-mutated NSCLC patients.