Corvus Pharmaceuticals Announces Presentation of Interim Data from the Phase 1b/2 Clinical Trial of Ciforadenant for Patients with Metastatic Renal Cell Cancer at the European Society for Medical Oncology (ESMO) Congress 2025

Rhea-AI Summary

Corvus Pharmaceuticals (Nasdaq: CRVS) announced interim Phase 1b/2 data (data cutoff May 2025) for ciforadenant combined with ipilimumab and nivolumab in first-line metastatic renal cell carcinoma presented at ESMO 2025 on October 17, 2025.

Key points: the open-label trial enrolled 50 patients, showed the triplet was feasible and well tolerated, deep response rate 34% versus ~32% historical doublet rate, objective response rate 46% (2 CR, 21 PR), median PFS 11.04 months, and 19 patients remain on therapy for longer follow-up.

Positive

• Deep response rate 34% (versus ~32% historical)
• Objective response rate 46% including 2 complete responses
• Median progression-free survival 11.04 months
• 19 patients remain on therapy for additional follow-up

Negative

• Interim result is not statistically significant versus historical control
• Small trial size: 50 patients limits definitive conclusions
• Population had unfavorable baseline features: only 54% prior nephrectomy and 82% IMDC poor/intermediate

Insights

Clinical/Oncology Translational Expert

Interim triplet data show tolerable safety and efficacy signals versus historical doublet, but significance and durable benefit remain unproven.

The regimen combined ciforadenant with ipilimumab and nivolumab in 50 first‑line metastatic clear cell RCC patients. Key reported figures: deep response rate 34% versus historical 32%, objective response rate 46% (including 2 complete responses and 21 partial responses), median progression‑free survival 11.04 months, and 19 patients remain on therapy. Safety is described as feasible and consistent with the known ipilimumab/nivolumab profile.

The business mechanism is straightforward: blocking adenosine A2a receptor with ciforadenant aims to augment checkpoint blockade activity; the disclosed data show a small absolute increase in deep responses but no statistical proof of superiority yet. The analysis depends on longer follow‑up, maturation of events, and appropriate comparative statistics; current statements note non‑significance and remaining patients who may affect endpoints.

Watch for final, fully‑analyzed Phase 2 results with statistical testing, updated PFS events and duration of response as the 19 patients complete follow‑up, and any safety signals with larger exposure; expect meaningful clarity only after event maturation and prespecified analyses over the next several months to a year (months implied by continued follow‑up).

Trial is 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)

Interim data shows triplet therapy with ciforadenant, ipilimumab and nivolumab is feasible and well tolerated; longer follow-up with patients still on therapy needed to determine potential benefit of blocking adenosine signaling

SOUTH SAN FRANCISCO, Calif.,, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced 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) 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.

“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 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.”

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com or follow the Company on LinkedIn.

About Ciforadenant
Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine to immune cells present in the tumor microenvironment. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2a receptor present on immune cells and block their activity. Ciforadenant has been shown to block the immunosuppressive effects of myeloid cells present in tumors and preclinical studies published in 2018 demonstrated synergy with combinations of anti PD1 and anti-CTLA4 antibodies.

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates; the interim results from the Phase 1b/2 clinical trial in patients with metastatic RCC, including feasibility, tolerability and potential to achieve deep responses; ongoing conduct of the trial; and potential benefits for RCC patients; . All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the second quarter ended June 30, 2025, filed with the Securities and Exchange Commission on August 7, 2025, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the cash on hand providing funding into the fourth quarter of 2026 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com

MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com

FAQ

What interim results did Corvus (CRVS) present for ciforadenant at ESMO 2025 on October 17, 2025?

Interim data (May 2025 cutoff) showed the triplet was feasible and well tolerated with deep response rate 34%, ORR 46%, 2 CRs, and median PFS 11.04 months.

How many patients were enrolled in the Phase 1b/2 ciforadenant trial reported by Corvus (CRVS)?

The open-label trial enrolled a total of 50 patients (8 in Phase 1b, 42 in Phase 2).

What is the primary endpoint for the Phase 2 portion of the Corvus (CRVS) ciforadenant trial?

The Phase 2 primary endpoint is the percent of patients achieving a deep response (complete response or >50% tumor volume reduction).

Does the interim ciforadenant data from Corvus (CRVS) show a statistically significant benefit over ipilimumab plus nivolumab?

No; the press release notes the improvement versus historical doublet was observed but is not statistically significant at this time.

What adverse baseline characteristics were present in the Corvus (CRVS) ciforadenant trial population?

Patients had unfavorable features: only 54% had prior nephrectomy and 82% were IMDC poor or intermediate risk.