What are the specifics of the India Phase IV data that supported the trial waiver granted by the subject expert committee and marketing approval for Keytruda for the two new indications?

Rehan Khan: Indian patients were not enrolled for new indications. However, MSD is committed to the safety of Keytruda in Indian patients. For this, we undertook a Phase-IV study enrolling 150 patients from India.

The interim analysis of this study demonstrated that:

Pembrolizumab has a tolerable and manageable safety profile for patients in India.
The safety profile of pembrolizumab in this study was generally consistent with the established safety profile of Pembrolizumab monotherapy & no new safety concerns were identified

The approval in esophageal cancer is supported by a global study (KN 590) which delivers outcomes (overall survival, progression-free survival, overall response rate, duration of response, tolerability, and quality of life) as compared to standard chemotherapy, in a set of patients who expressed PD-L1 positivity (a type of biomarker) at a particular level.

For cervical cancer, the approval is backed by a global study (KN 826) that delivers outcomes with pembrolizumab + chemo +/- bevacizumab (OS, PFS, ORR, DoR) as compared to chemotherapy in a set of patients who expressed PD-L1 positivity at a particular level.

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