An interim analysis demonstrated positive efficacy and safety in patients with metastatic solid tumors who were treated with etigilimab plus nivolumab.
Etigilimab, an anti–T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains, showed promising efficacy and safety in combination with nivolumab (Opdivo) for patients with metastatic solid tumors, according to a press release on interim results from the phase 1b/2 ACTIVATE study (NCT04761198) from developer Mereo BioPharma Group.
At data cutoff, 1 patient with cervical cancer had a complete response, 1 patient with ovarian cancer had a partial response, and 4 patients with ovarian cancer, cervical cancer, and uveal melanoma achieved stable disease. The cohort of patients with ovarian cancer has now crossed futility for expansion into the second phase of research, which will help to support further development of the dual checkpoint combination.
“These early results from the ACTIVATE study are highly encouraging and support the further study of etigilimab in combination with an anti-PD-1 antibody in solid tumor types, especially in gynecologic malignancies,” Denise Scots-Knight, PhD, chief executive officer at Mereo, said in the press release.
Investigators plan to enroll roughly 125 patients across a total of 7 parallel cohorts. At the time of data cutoff, 22 patients were included in the safety analysis. Additionally, 20 patients were evaluable and 15 were included in the efficacy analysis population. In all 7 cohorts, patients received an intravenous infusion of etigilimab and nivolumab every 2 weeks.
The primary endpoint of the study was object response rate, defined as those whose best response rate is a confirmed complete response or partial response confirmed radiographically according to RECISTv1.1; best response rate will be investigator-assessed.
Eligibility criteria included histological or cytological diagnosis of relevant tumor type, available tumor tissues, and adequate hematologic and end organ function measured by a laboratory screening panel. Additionally, patients were required to have a life expectancy greater than 12 weeks and an ECOG status of 0 to 1.
No new safety signals were observed during in this trial, with investigators reporting that the regimen was safe and well tolerated. Seven patients had skin reactions as a treatment-related adverse effect, but none required systemic steroids. Additionally, 1 patient developed immune diabetes mellitus.
Mereo reports interim data from ACTIVATE phase 1b/2 study of etigilimab. News Release. Mereo BioPharma Group. November 30, 2021. Accessed December 14, 2021. https://bit.ly/3DVAhjk