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Some oncologists said 10 mutations/Mb is an acceptable TMB cutoff in patients who are out of options, while others worry it will drive immunotherapy use in those unlikely to have a lasting benefit.
The companies plan to enroll 1,000 patients with lung cancer to assess whether technology-enabled trial enrollment can expand access to precision oncology to more patients.
The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
The prospective study will combine real-world, clinical, and genomic data to streamline lung cancer clinical trials and find treatment-response biomarkers.
The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.
The FDA approved the drug based on data on response rate but continued approval is contingent on the results of a randomized study showing a PFS and OS advantage.
A new analysis suggests hypermutation can occur in some chemotherapy-treated gliomas, producing heterogeneous, mutation-rich tumors with poor response to anti-PD-1 treatment.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
Foundation Medicine's liquid biopsy test will be used in the third stage of SCRUM-Japan, which focuses on advanced cancer patientsin Japan and other Asian countries.
Paired tumor/germline analysis is not routinely done in cancer care, but some labs are starting to report incidental germline findings alongside patient's tumor profiles.