Amgen (AMGN) announced new combination study results from the Phase 1b CodeBreaK 101 study, a comprehensive global master protocol trial evaluating the safety and efficacy of Lumakras (sotorasib) in more than 10 different investigational combination regimens for the treatment of patients with KRAS G12C-mutated cancers.
The company will present results from two arms of the study — Lumakras with afatinib, a pan-ErbB tyrosine kinase inhibitor, and LUMAKRAS with trametinib, a mitogen-activated protein kinase inhibitor (MEKi) — at the plenary session titled 'Drugging Difficult Targets' during the AACR-NCI-EORTC 2021 Virtual International Conference on Molecular Targets and Cancer Therapeutics on October 9, 2021.
The Lumakras and afatinib combination arm enrolled 33 heavily pre-treated patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC), including five patients previously treated with LUMAKRAS monotherapy.
Ten patients received 20 mg of afatinib/960 mg of sotorasib and 23 patients received 30 mg of afatinib/960 mg of sotorasib. The objective response rate (ORR) was 20% in cohort 1 and 35% in cohort 2, and the disease control rate was 70% and 74% in the two cohorts, respectively.
In CodeBreaK 101, the combination of Lumakras and trametinib showed antitumor activity in heavily pre-treated patients with KRAS G12C-mutated solid tumors, including those with prior KRASG12C inhibitor treatment.
Lumakras is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
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