Merck has secured approval from the China National Drug Administration (CNDA) for the use of its Keytruda medicine to treat adults suffering from unresectable or metastatic melanoma.
Keytruda is an anti-PD-1, humanised monoclonal antibody designed to help the body’s immune system in detecting and fighting tumour cells.
The drug works by inhibiting interaction between PD-1 and its ligands and in turn activates T lymphocytes.
Indicated for patients who failed one previous line of therapy, Keytruda is said to be the only anti-PD-1 therapy approved in China for advanced melanoma.
Merck Research Laboratories chief medical officer and global clinical development senior vice-president and head Roy Baynes said: “The approval of Keytruda in China, for this first indication, was made possible through extensive collaborative effort with the Chinese patients and investigators who participated in Keynote-151, as well as the regulatory and government authorities who prioritised this filing.
“We appreciate their commitment to bringing forward the first anti-PD-1 therapy for advanced melanoma in China.”
Keynote-151 is an open-label, single-arm, multi-centre Phase Ib clinical trial performed to assess 2mg/kg of Keytruda every three weeks as a monotherapy in 103 Chinese patients.
The CNDA decision was based on overall response rate (ORR) data obtained during this Phase Ib trial.
ORR was the primary efficacy outcome measure in Keynote-151, while secondary efficacy outcomes included duration of response (DOR), progression-free survival (PFS) and overall survival (OS).
Keytruda is currently being studied in more than 750 trials across various cancers and therapy settings.
The drug obtained the CNDA granted priority review status earlier this year. The designation expedited its approval process through simultaneous clinical validation.