The U.S. FDA granted breakthrough therapy designation for pembrolizumab – a humanized monoclonal anti-PD-1 therapy – for the treatment of patients with relapsed/refractory classic Hodgkin lymphoma.
The designation was granted based on results of the ongoing phase Ib KEYNOTE-013 and phase II KEYNOTE-087 studies evaluating pembrolizumab as a single-agent therapy for classic Hodgkin lymphoma. In data from KEYNOTE-013, which were presented at the 2015 ASH Annual Meeting, treatment with pembrolizumab led to an objective response rate (ORR) of 64.5 percent in patients with previously treated classic Hodgkin lymphoma. Findings from KEYNOTE-087 are yet to be presented.
This is the fourth breakthrough therapy designation for pembrolizumab. It is also indicated for the treatment of patients with:
- Unresectable or metastatic melanoma
- Metastatic non-small cell lung cancer whose tumors express PD-L1
Source: Merck press release, April 18, 2016.