FDAnews Drug Daily Bulletin

Merck, Amgen to Collaborate on Melanoma Immunotherapies

Feb. 6, 2014

Global drug giants Merck and Amgen have agreed to evaluate the safety and efficacy of Amgen’s talimogene laherparepvec alongside Merck’s MK-3475 in a multi-center, open-label Phase Ib/II study of patients with mid- to late-stage melanoma, the drugmakers said Wednesday.

The trial will be conducted in two parts starting this fall: Phase Ib will focus on the combination’s safety and tolerability in 110 patients with previously untreated, unresected stage IIIb to IVM1a melanoma, with the 1:1 randomized Phase II comparing those to MK-3475 monotherapy in stage IIIb to IVM1c melanoma patients. The trial will also evaluate efficacy of the two in the face of disease progression following Merck monotherapy.

The collaborative effort “highlights Merck’s aggressive pursuit of a leadership position with its PD1 antibody” by “gaining access to unpartnered immune-oncology assets via shared research collaborations,” Leerink Research’s Seamus Fernandez said in a research note Wednesday.

Both Merck’s and Amgen’s immunotherapy compounds are investigational. Talimogene laherparepvec is designed to replicate in tumor tissue and initiate an anti-tumor response in the immune system. The drug has shown encouraging results in Phase III, with an interim overall survival rate of 23.3 months, compared to 19 months with granulocyte-macrophage colony-stimulating factor, the drugmakers say.

MK-3475 is designed to restore the immune system’s ability to recognize and target cancer cells by achieving dual ligand blockage of the PD-1 protein. Merck faces competition from Bristol-Myers Squibb, however, whose PD-1 antibody program consists of 25 studies of nivolumab as a monotherapy or in combination with other drugs, targeting multiple tumor types, including melanoma, non-small-cell lung cancer and triple-negative breast cancer. — Lena Freund

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.