PD-L1 Biomarkers

Opdivo plus chemotherapy extended survival for gastric cancer patients whose tumors expressed PD-L1 and in all comers in the Phase III CheckMate-649 trial.

The agency approved Agilent/Dako's PD-L1 IHC test for identifying TNBC patients who are most likely to respond to Keytruda and chemo.

The company decided this after the Keytruda-Yervoy combination did not improve overall survival or progression-free survival compared to Keytruda monotherapy.

The combination treatment was approved for metastatic NSCLC patients without EGFR or ALK gene mutations and regardless of their PD-L1 status.

The Phase I/II trials will study Reqorsa in combination with Merck's Keytruda and AstraZeneca's Tagrisso in certain molecularly defined lung cancer subgroups.

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 firm said that adjuvant nivolumab had benefitted patients regardless of PD-L1 expression, and that the company will submit the data to regulatory agencies.