Bristol Myers Squibb Co. said Thursday that a Phase 3 trial testing the use of its Opdivo and Yervoy medications to treat unresectable advanced or metastatic esophageal squamous cell carcinoma showed positive results.
The trial tested the efficacy of two treatments: Opdivo plus chemotherapy, and Opdivo plus Yervoy.
Opdivo plus chemotherapy met its primary and secondary endpoints of providing a benefit both to patients whose tumors express PD-L1, and in the all-randomized population. The combination also met its primary endpoint of progression-free survival by blinded independent central review in patients whose tumors express PD-L1.
Opdivo plus Yervoy also demonstrated improvement in overall survival in patients whose tumors express PD-L1 and in the all-randomized population. It didn't meet the other primary endpoint of progression-free survival by BICR in patients whose tumors express PD-L1.
The drugs' safety profiles were consistent with prior research, the company said.
Dr. Ian Waxman, Bristol Myers Squibb's development lead for gastrointestinal cancers, said the results could lead to new treatment options for patients with esophageal cancer.
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