Merck Sharp & Dohme Ireland Ltd.

In male and female subjects 18 years of age or older with treatment-naïve metastatic non-small cell lung cancer expressing programmed cell death protein ligand 1 (tumor proportion score ≥50%): Comparison of progression-free survival and overall survival assessed by blinded independent central review according to RECIST 1.1 with pembrolizumab plus gosartumomab versus pembrolizumab alone.

BICR evaluated the PFS of MK-4280A and chemotherapy of physician's choice based on the Lugano efficacy criteria; and the OS of MK-4280A and chemotherapy of physician's choice was compared.

This study involved two cohorts, namely, adult subjects (≥18 years old) with HR NMIBC who had persistent or recurrent disease after BCG induction therapy (cohort A) or b) had not received BCG treatment before (cohort B). China joined cohort B to explore the efficacy and safety of pembrolizumab combined with BCG in patients with HR NMIBC who had not received BCG treatment before.