On October 25, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported the initiation of a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1) (Press release, Corvus Pharmaceuticals, OCT 25, 2022, View Source [SID1234622343]). The Phase 1b/2 study is being conducted by the Kidney Cancer Research Consortium (KCRC) and is led by The University of Texas MD Anderson Cancer Center, one of seven partner institutions that make up the KCRC. The study is expected to enroll up to 60 patients at KCRC partner institutions.
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"Ciforadenant is one of the most studied adenosine receptor antagonists and we have presented encouraging clinical data in very advanced refractory patients with renal cell cancer, demonstrating its anti-tumor activity as a monotherapy and in combination with anti-PD-L1 therapy," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "In addition, we published preclinical data in Cancer Immunology Research in 2018 that showed that ciforadenant combined with anti-CTLA-4 and anti-PD-1 therapy is highly active, which resulted in complete elimination of tumors, even in the setting of treatment of established tumors. Further laboratory studies have uncovered a novel mechanism of action that we believe may synergize with anti-CTLA-4 therapy. Together we believe this provides strong rationale for this Phase 1b/2 clinical trial in first line renal cell cancer and we are excited to partner with the Kidney Cancer Research Consortium, who is leading the clinical trial. And given this is an open-label study, we hope to have preliminary results relatively early in the trial."
About the Ciforadenant Phase 1b/2 Trial
The open-label Phase 1b/2 clinical trial is expected to enroll up to 60 patients with newly diagnosed or recurrent stage IV clear cell RCC that have not received any prior systemic therapy. Patients will receive ciforadenant 100 mg oral, twice-daily in combination with ipilimumab (anti-CTLA-4) 1mg/kg given once every three weeks for twelve weeks (4 doses) and nivolumab (anti-PD-1) 3mg/kg given once every three weeks. In the Phase 1b portion of the clinical trial (N=8), the primary endpoints are safety, tolerability and anti-tumor activity. In the Phase 2 portion of the clinical trial, the primary endpoint is the percent of patients that achieve a deep response, defined as complete response or depth of partial response of >50% tumor reduction. Historical data has shown that deep responses correlate with prolonged progression free survival and is seen in approximately 35% of patients receiving ipilimumab and nivolumab. The trial design is based on Corvus’ preclinical research published in 2018 in Cancer Immunology Research, which demonstrated antitumor control and complete elimination of tumors in several animal models using ciforadenant in combination with anti-CTLA4 and anti-PD1.