Celldex concludes Phase IIb enrolment for breast cancer drug
US-based Celldex Therapeutics has concluded patient enrolment in Phase IIb METRIC clinical trial of glembatumumab vedotin to treat metastatic triple negative breast cancer characterised by over-expression of gpNMB.
Glembatumumab vedotin is an antibody-drug conjugate being developed to target and bind to gpNMB protein that is expressed by various types of tumours such as breast cancer, melanoma, lung cancer, uveal melanoma and osteosarcoma.
The randomised Phase IIb trial will evaluate glembatumumab vedotin in patients with an over-expression greater than or equal to 25% of tumour cells testing positive for gpNMB.
The effect of the investigational candidate will be compared to that of capecitabine (Xeloda) in a total of 327 subjects recruited into the trial.
Celldex Therapeutics co-founder, president and CEO Anthony Marucci said: "Patients with triple negative breast cancer have very limited treatment options.
“We believe glemba holds significant promise as a potential new targeted treatment for patients with this devastating disease and look forward to top-line data, likely in the second quarter of 2018."
The trial’s primary endpoint is progression-free survival (PFS) defined as time from randomisation to the earlier of disease progression or death, with an assessment of 203 progression events.
Secondary endpoints such as response rate, overall survival, duration of response and safety will also be monitored during the METRIC trial.
Designed to be stable in the bloodstream, as well as release toxic monomethyl auristatin E (MMAE) into gpNMB-expressing tumour cells, glembatumumab vedotin is being further studied for treating stage III and IV melanoma, squamous cell lung cancer and uveal melanoma.