In KEYNOTE-522, early-stage TNBC patients on the immunotherapy and chemotherapy combination benefitted regardless of their PD-L1 expression status.
The assay was developed in partnership with Merck and is intended as a companion diagnostic for that firm's anti-PD-L1 immunotherapy.
Findings from three Phase III clinical trials suggest that PARP inhibitors may prolong disease-free survival in some advanced ovarian cancer patients without BRCA1/2 mutations.
Although the FDA has already approved the regimen in this indication after seeing its impact on progression-free survival, the latest data speaks to its impact on survival.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.
The diagnostic can now be used to identify patients with esophageal squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.
The successful development of new targeted tissue-agnostic cancer drugs will be tied to the use of real-world data and new clinical trial formats.
The drug is for first-line maintenance therapy after BRCA-mutated advanced ovarian cancer patients respond to platinum chemo and the test will identify those with BRCA mutations.
The PARP inhibitor is approved as a maintenance treatment for advanced ovarian cancer patients who responded to first-line platinum chemotherapy and have BRCA mutations.