MacroGenics announced this week that it would be voluntarily closing its phase 2 study evaluating drug combination regimens for the treatment of head and neck cancer, following the death of seven patients.
The study, CP-MGA271-06, enrolled a total of 62 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) and evaluated a combination of MacroGenics' investigational enoblituzumab (Fc-optimized B7-H3-directed monoclonal antibody) with either retifanlimab (anti-PD-1 monoclonal antibody) or tebotelimab, an investigational bispecific DART® molecule.
Following the review of internal safety data, the Maryland-based company found that the seven fatalities were associated with hemorrhagic events in both study groups and that this incidence observed is higher than what has been reported for this patient population in the medical literature. These findings prompted the company to confirm with the FDA that the study is now closed and no additional patients will be enrolled or receive treatments as of July 7, 2022.
“We were surprised by the emergence of these events in first line SCCHN patients, as we had not observed any such events in an earlier, smaller study in patients with later-line SCCHN disease who were treated with enoblituzumab in combination with an anti-PD-1 antibody,” said Scott Koenig, president and CEO of MacroGenics. “Similar safety events have not been reported in patients treated with MGC018, our B7-H3-targeted ADC molecule, and the decision to close the CP-MGA271-06 study does not impact our ongoing MGC018 study activities. We’d like to thank all patients, their families and caregivers who participated in the CP-MGA271-06 study,” he concluded.
