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Large, randomized Phase 3 trials in colorectal cancer have found that panitumumab, when combined with chemotherapy, results in prolonged progression-free survival compared to chemotherapy alone in patients with wild-type KRAS, but not in patients with mutant KRAS (Douillard et al., 2010; 20921465, Peeters et al., 2010; 20921462, Douillard et al., 2014; 24718886, Peeters et al., 2014; 24356622).
A Phase 2 trial of selumetinib in patients with KRAS-mutant colorectal carcinoma who were progressing on first-line therapy reported partial response and stable disease lasting at least four weeks in 9.7% (3/31) and 51.6% (16/31) of patients, respectively; notably, three patients were reported to have stable disease lasting more than one year (Hochster et al., 2014; 25322874).
In a Phase 1 trial of the MEK inhibitor selumetinib (AZD6244) combined with cetuximab, preliminary anti-tumor activity was reported in KRAS-mutant CRC patients, with two partial responses and two cases of stable disease reported out of 14 CRC patients in the expansion cohort (Deming et al., 2012; ASCO 2012, Abstract 3103).
ERBB2-V842I is an activating mutation. ERBB2 (also known as HER2/neu) encodes the receptor tyrosine kinase Her2, in the same family as Egfr (Higgins and Baselga, 2011; 21965336).
Activating ERBB2 alterations may predict sensitivity to Her-targeted drug therapies. The anti-Her2 monoclonal antibody trastuzumab has been FDA-approved for use in Her2-amplified or Her2-overexpressing breast and metastatic gastric and gastroesophageal junction cancer (