Amgen and Merck Collaborate To Assess Investigational Combination Treatment For Melanoma
Amgen and Merck have entered into an agreement through a subsidiary to assess an investigational and combinational therapy for advanced melanoma. The collaboration will focus on determining safety and efficacy of the companies’ cancer immunotherapies.
Investigational oncolytic immunotherapy talimogene laherparepvec will be studied in combination with investigational anti-PD-1 immunotherapy MK-3475 in a Phase 1b/2 study of patients with mid- to late-stage melanoma.
The clinical trial will be multi-center and open label. It will be conducted in two parts: Phase 1b will determine the combination’s tolerability and safety in 110 patients with previously untreated and unresected stage IIIb to IVM1a melanoma. Phase II will be 1:1 randomized and will focus on comparing the previous phase to MK-3475 monotherapy in stage IIIb to IVM1c melanoma patients. In addition, the two treatments’ efficacy will be evaluated with disease progression after Merck monotherapy.
Amgen’s talimogene laherparepvec is intended to replicate in tumor tissue and activate the body’s own immune system to launch an anti-tumor response. Amgen Global Development Vice President David D. Chang said, “Talimogene laherparepvec has shown encouraging Phase 3 clinical results as a monotherapy in patients with metastatic melanoma. We look forward to working with Merck on this collaboration to evaluate the potential of these two novel immunotherapies to improve clinical outcomes for patients.”
Merck’s MK-3475 works to restore the recognition ability of the immune system and enable it to target cancer cells. The treatment accomplishes this by achieving dual ligand blockage of the PD-1 protein. Merck Research Laboratories Clinical Development for Oncology Vice President Dr. Eric Rubin said, “We are pleased to be collaborating with Amgen to study MK-3475 as part of this novel combination regimen. Early evaluation of immunotherapeutic combinations is important in accelerating the development of new options for patients with cancer.”
The clinical trial for talimogene laherparepvec in combination with MK-3475 is expected to begin this fall.
Source:
http://wwwext.amgen.com/media/media_pr_detail.jsp?year=2014&releaseID=1896999
http://www.fdanews.com/articles/162228-merck-amgen-to-collaborate-on-melanoma-immunotherapies