The Phase Ib/II trial will assess dosage and antitumor activity of MEN1611 plus Erbitux for patients with PIK3CA-mutated, RAS and RAF wildtype advanced colorectal cancer.
The company recently presented results from its Aurora assay for multi-cancer screening and plans to launch a $100 test for the US and Chinese markets.
The approval is supported by a randomized trial showing that pembrolizumab nearly doubled progression-free survival compared to the standard chemotherapy regimen.
The Phase II DESTINY-CRC01 and DESTINY-Gastric01 underscore the importance of HER2 testing in patients with colorectal cancers and gastric cancers, respectively.
Based on an eight-month progression-free survival advantage in Keynote-177, oncologists said that Keytruda may be the new frontline option for this subset of patients.
Researchers used microarray data from colorectal cancer patients to develop a model 15-mRNA prognostic signature, which they hope will ultimately guide treatment decisions.
The tool, which has been validated in two independent patient cohorts, uses artificial intelligence to predict patients likely to benefit from upfront FOLFOX.
