Brooklyn ImmunoTherapeutics says the phase 2 INSPIRE trial “achieved its primary objective” of finding patients that might respond to the immunotherapy IRX-2. Unfortunately, that wasn’t the primary endpoint, rendering the mid-phase study in patients with cancer of the oral cavity a failure.
The New York biotech was hoping to show an improvement in event-free survival, a measure of the time it takes between treatment and having a specific symptom. In this case, Brooklyn hoped to see that IRX-2 extended the time that patients could go after having surgery without an event related to their cancer. Secondary goals were overall survival, which is how long a patient lives after treatment, and safety.
But the therapy did not meet the main goal at the two year mark. Patients in the treatment arm had an event-free survival rate of 48 months, while the control arm never reached this mark, the company said Tuesday.
Taking a page from the usual biotech playbook, Brooklyn pointed to subgroup analyses to claim a win on the trial anyway. The company said that when broken out by stage of cancer and type of adjuvant treatment, “outcomes favored IRX-2.” These patients were less likely to experience an event-free survival event, particularly in the patients who had later-stage disease. Brooklyn said in the stage 4 and 5 subgroup, patients taking the treatment had an event-free survival rate of 57 months compared to 49 for the control group.
In patients who received radiation but not chemotherapy, event-free survival was 76 months in the IRX-2 arm compared to 60 for the control.
“The Inspire study achieved its primary objective of identifying patient populations that may benefit from IRX-2 in the neoadjuvant setting,” Brooklyn CEO Matt Angel, Ph.D., said. However, the primary endpoint, which is the measure of whether a trial was successful or not, was not achieved.
Angel said that the “encouraging results” from the subgroup analyses “provide a clear path forward” for testing IRX-2 in combination with checkpoint inhibitors.
“The potential to offer an effective, well tolerated treatment to patients with advanced head and neck cancer who are ineligible for chemotherapy is particularly exciting,” Angel said.
Further results from the INSPIRE trial will be presented at an upcoming medical meeting.
IRX-2 is a biologic immunotherapy that Brooklyn is developing in a number of solid tumors including cervical cancer, head and neck cancer and breast cancer.