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Cancer Biomarkers

News on molecular markers used to guide cancer treatment, assess prognosis, or detect relapse.

A Phase I study used a less toxic dosing schedule that yielded encouraging response rates in patients with difficult-to-treat KRAS-mutated cancers.

Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.

The FDA also granted priority review for Enhertu for the treatment of patients with HER2-positive metastatic gastric cancer.

The company presented on the preliminary activity of RMC-4630 combined with Cotellic and said it is studying the SHP2 inhibitor alongside an AstraZeneca drug.

Researchers showed that ctDNA levels predicted who would respond to first-line immune checkpoint inhibition but were not useful in second-line therapy.

The agency made the recommendation based on data showing that Keytruda improved outcomes and was cost-effective compared to the standard treatment.

The study will assess the safety and anti-tumor activity of the IL-7 agent and the checkpoint inhibitor combination for patients with PD-L1-expressing NSCLC. 

The drug firm expects to begin a Phase I/II tumor-agnostic trial of the drug in genetically defined cancers in the second half of 2021.

The company submitted data from the ADAURA study, and the agency is slated to issue a decision on the application by the first quarter in 2021.

The NCCN's research program will put out a request for proposals early next year for studies to investigate neratinib in various molecularly defined cancers.