On October 17, 2025 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that interim data from the Phase 1b/2 clinical trial of ciforadenant for patients with metastatic renal cell cancer (RCC) will be presented today in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, which is taking place October 17-21, 2025 in Berlin, Germany. The data will be presented by Katy Beckermann, M.D., Ph.D., Director of Genitourinary Cancer Research at Tennessee Oncology and member of the Kidney Cancer Research Consortium (KCRC), the group that is conducting the trial in collaboration with Corvus.
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"We are encouraged by these results exploring ciforadenant in combination with ipilimumab and nivolumab as a potential front-line treatment for renal cell carcinoma," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Despite enrolling patients with more unfavorable disease compared to historical trials, the triplet combination demonstrated activity that compares favorably to historical results with the doublet alone. These data support our view that blocking adenosine signaling with ciforadenant may provide meaningful benefit for RCC patients. We appreciate the partnership with the Kidney Cancer Research Consortium and we look forward to continuing to follow the 19 patients who remain on therapy to better understand the potential of this approach."
The open-label Phase 1b/2 clinical trial is evaluating ciforadenant, the Company’s adenosine A2a receptor inhibitor, as a potential first line therapy for metastatic RCC in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The trial enrolled 50 patients (8 in Phase 1b portion, 42 in Phase 2 portion) with newly diagnosed or recurrent stage IV clear cell RCC that had not received any prior systemic therapy. Patients received 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.
The primary endpoint for the Phase 1b portion is safety, tolerability and anti-tumor response. The primary endpoint for the Phase 2 portion is the percent of patients that achieve a deep response, defined as complete response or depth of partial response of >50% tumor volume reduction. Historical data from the Kidney Cancer Research Consortium has shown that deep responses correlate with prolonged progression free survival and that they occur in approximately 32% of patients receiving ipilimumab and nivolumab. Secondary endpoints for the Phase 2 portion include objective response rate (ORR), progression-free survival (PFS) and treatment-related adverse events.
The interim data being presented at ESMO (Free ESMO Whitepaper) demonstrates that triplet therapy with ciforadenant, ipilimumab and nivolumab is feasible and well tolerated. Key highlights from the presentation (data as of May 2025) include:
Patients in the trial had a median age of 61.5 years (53-70 years range) and had unfavorable disease characteristics, with only 54% having a prior nephrectomy (~75-85% is typical for studies involving similar patients). Nephrectomy is associated with improved outcomes in advanced RCC and is often not performed in patients with poor prognosis. In addition, 82% of patients in the trial had a poor or intermediate prognosis by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria.
The treatment was well-tolerated, in-line with the safety profile of combination treatment with ipilimumab and nivolumab.
The deep response rate was 34%, demonstrating an improvement compared to historical data for the combination of ipilimumab and nivolumab alone, though not statistically significant at this point in time. 19 patients with stable or responding disease remain on therapy with the potential to achieve deep responses.
The ORR by was 46%, including two complete responses and 21 partial responses. The median PFS is 11.04 months.
Dr. Beckermann commented, "Early results from this trial are encouraging, demonstrating consistent efficacy and favorable safety in a challenging RCC population, and we look forward to data from the 19 patients still on treatment."
(Press release, Corvus Pharmaceuticals, OCT 17, 2025, View Source [SID1234656730])