The etiglimab / nivolumab combination shows promise in solid tumors

The combination elicited a complete response in a patient with cervical cancer and a partial response in a patient with ovarian cancer.

Combination of Etigilimab, an Anti-TIGIT Antibody, in Combination with Nivolumab (Opdivio) Has Demonstrated Antitumor Efficacy and Acceptable Safety Data in Patients With Solid Tumors, Interim Results Release Says of the Phase 1b / 2 ACTIVATE trial of Mereo BioPharma Group plc.

The phase 1b / 2 study (NCT04761198) has a target recruitment of 125 participants and an estimated study completion date of June 2023. The primary endpoint is the objective response rate.

During the study, patients will receive an etigilimab infusion every 2 weeks and a nivolumab infusion every 2 weeks. Cohorts include squamous cell carcinoma of the head and neck, cervical cancer under or after chemotherapy, adenocarcinoma of the gastric or gastroesophageal junction, endometrial carcinoma, high tumor burden, and solid tumors stable on microsatellites, rare disease with elevated TIGIT expression, ovarian cancer and endometrial carcinoma after standard treatment.

At the time of data closing, 22 patients had been included in the safety analysis. Twenty patients were evaluable with a minimum of at least one CT scan and 15 were included in the efficacy analysis.

Analysis revealed that one patient in the cervical cancer cohort had a complete response. In the ovarian cancer cohort, 1 patient had a partial response. Four patients with stable disease were observed with ovarian cancer, cervical cancer and uveal melanoma. Plus, the ovarian cancer cohort went through futility for expansion in the second stage of the study.

The combination was found to be well tolerated and no new safety signals were observed. Common side effects included skin reactions, which were seen in 7 patients. No patient required systemic steroids. One case of immune diabetes mellitus has been reported.

“These first results from the ACTIVATE study are very encouraging and support the continuation of the study of etigilimab in combination with an anti-PD-1 antibody in solid tumor types, in particular in gynecological malignancies”, Denise Scots-Knight, PhD, CEO of Mereo said in a press release. “We are particularly excited about the complete response in the cervical cancer cohort and the partial response in one of the ovarian cancer patients treated to date. Overall efficacy analysis, biomarker analysis showed a positive trend between baseline PVR expression and clinical benefit, including in the absence of PD-L1 expression in the population. efficiency analysis. Clinical benefit also occurred in tumor types with historically low response rates to anti-PD-1 / PDL-1 antibodies. We look forward to providing further updates on the study in 2022. “

To participate in the study, patients must have a confirmed diagnosis of a relevant tumor type and are not candidates for curative surgery or radiotherapy, have available tumor tissue, adequate hematologic function and target organs, a life expectancy of over 12 weeks, and an ECOG performance status of 0 to 1.

Patients with concomitant active malignancy, major surgery within 4 weeks of treatment, active or suspected autoimmune disease, previous treatment with anti-TIGIT antibodies, history of adverse events related to the immune system , active HIV infection or who are pregnant are not eligible to participate.

The study is currently recruiting from Arizona, California, Florida, Massachusetts, Michigan, Minnesota, New York, North Carolina, Oklahoma, Tennessee, Texas, Utah and Virginia.

Mereo reports interim data from the phase 1b / 2 ACTIVATE study with etigilimab. Press release. Mereo. November 30, 2021. Accessed December 1, 2021.
A study of etigilimab and nivolumab in subjects with locally advanced or metastatic tumors. Accessed December 1, 2021.

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