In the Phase I/IB study, only patients with NTRK or ROS1 fusions, or an ALK fusion or mutation responded to entrectinib, while patients without these tumor markers didn’t respond.
In the JAMA study, researchers confirmed the previously known clinical and genomic features of NSCLC patients in their large clinico-genomics database.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
The new guidelines said ROS1, KRAS, BRAF, MET, RET, and HER2 should be included in targeted and expanded panels.
Next year, the company will submit regulatory filings for the drug in two molecularly defined indications and a next-generation sequencing companion diagnostic.
Patients are organizing themselves in groups based on the molecular features driving their tumors to better advocate for themselves, raise money, and influence research.
The changes include recommendations for first line immunotherapy in patients with high PD-L1 expression, and clarification on use of targeted therapies.
The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments.
Data from the meeting suggest that lung cancer patients with ALK-positive tumors may soon have two first-line options and more choices when their disease progresses.
Genentech's Alecensa and AstraZeneca's Tegrisso are the latest precision lung cancer drugs, and Xalkori might soon be an option for a new molecular subpopulation.