On November 30, 2021 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical stage biopharmaceutical company focused on oncology and rare diseases, reported promising interim efficacy, safety, and biomarker data on patients from ACTIVATE, a Phase 1b/2 study of its anti-TIGIT antibody, etigilimab, in combination with nivolumab in select recurrent advanced / metastatic solid tumors (Press release, Mereo BioPharma, NOV 30, 2021, View Source [SID1234596277]).
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"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," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "We are particularly excited by the complete response in the cervical cancer cohort and the partial response in one of the ovarian cancer patients treated to-date. In the efficacy analysis set, biomarker analysis showed a positive trend between baseline PVR expression and clinical benefit including in the absence of PD-L1 expression in the efficacy analysis population. Clinical benefit also occurred in tumor types with historically low response rates to anti-PD-1/PDL-1 antibodies. We look forward to providing additional updates on the study in 2022."
The ACTIVATE study aims to enroll approximately 125 patients across seven parallel cohorts. At the time of the data cut-off, 22 patients were included in the safety analysis set, 20 patients were evaluable with a minimum of at least one scan (as of November 8, 2021) and 15 patients were included in the efficacy analysis population.
As of the cut-off date, there are one complete response in cervical cancer, one partial response in ovarian cancer and four instances of stable disease in ovarian cancer, cervical cancer, and uveal melanoma. The ovarian cohort in ACTIVATE has now crossed futility for expansion into the second stage of the study (IDMC review pending). These results add to the earlier Phase 1b data of etigilimab in combination with nivolumab, with a partial response in the single ovarian cancer patient of the 8 patients evaluable and support the continued development of this dual checkpoint combination regimen.
The combination of etigilimab and nivolumab has been safe and well tolerated, with no new safety signals. The most common treatment-related adverse events were skin reactions, observed in seven patients. None of these reactions required treatment with systemic steroids. There was one case of immune diabetes mellitus.
Conference Call and Webcast
Mereo BioPharma will hold a conference call today, November 30, 2021, at 8:30am ET. To participate by telephone, please dial (866) 688-2942 (Domestic) or (561) 569-9224 (International). The conference ID number is 6585106. To view the slideshow please use the live webcast which can be accessed through the Investors section of the Company’s website at www.Mereobiopharma.com/investors. An archived replay of the webcast will be available on the Company’s website for two weeks following the live presentation.