AVEO Oncology and Merck KGaA, Darmstadt, Germany have signed a clinical trial partnership and supply agreement to analyse ficlatuzumab plus ERBITUX (cetuximab) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients.
An investigational potent humanised immunoglobulin G1 monoclonal antibody of AVEO, ficlatuzumab acts on the hepatocyte growth factor while ERBITUX is an EGFR-targeted antibody.
According to the deal, Merck KGaA will supply cetuximab needed for AVEO’s proposed registrational clinical trial, which will analyse the combination treatment for HPV negative R/M HNSCC.
Cetuximab will be supplied in all nations outside of Canada and the US.
AVEO will act as trial sponsor and handle the expenses to conduct the trial.
AVEO Oncology president and CEO Michael Bailey said: “This collaboration with Merck KGaA, Darmstadt, Germany will play an important role in the advancement of both the ficlatuzumab and cetuximab programmes.
“The ficlatuzumab and cetuximab combination has demonstrated the potential to play a meaningful part in the treatment of patients with human papillomavirus (HPV) negative R/M HNSCC, which is associated with particularly poor outcomes.”
The company plans to start production of ficlatuzumab required for the clinical supply in the second quarter of this year, based on the key raw material and manufacturing supply availability.
These supplies are also utilised to manufacture Covid-19 vaccines.
AVEO anticipates continuing talks with the US FDA to decide on the design of the pivotal trial, anticipated to begin in the first half of next year.
Last July, Bristol Myers Squibb (BMS) reported that Opdivo (nivolumab), along with Yervoy (ipilimumab), failed to meet the primary endpoints of the Phase III CheckMate -651 trial that enrolled patients with platinum-eligible R/M HNSCC.