New Data from Ciforadenant Phase 1b/2 Clinical Study Presented at ESMO Virtual Congress 2020

Rhea-AI Summary

Corvus Pharmaceuticals (CRVS) announced new data from its collaboration with Genentech during the ESMO Virtual Congress 2020. The data focuses on ciforadenant combined with atezolizumab for treating non-small cell lung cancer (NSCLC). In a small study, patients showed longer disease control and overall survival compared to chemotherapy. The median overall survival was 11.5 months for the combination group versus 9.4 months for chemotherapy. Safety data indicated fewer adverse events. Corvus aims to advance ciforadenant into pivotal studies for advanced refractory renal cell cancer.

Positive

• The combination therapy of ciforadenant and atezolizumab showed promising results with a median overall survival of 11.5 months compared to 9.4 months in chemotherapy.
• Eleven patients were assessed, with one achieving a long-term partial response and others maintaining stable disease.
• No Grade 5 adverse events were reported in the ciforadenant group, indicating a favorable safety profile.

Negative

• The small sample size may limit the statistical significance of the findings.
• The Adenosine Gene Signature biomarker was not utilized in this study, which may affect patient selection for future trials.

Data is part of Genentech’s MORPHEUS umbrella program and covers patients with resistant/refractory NSCLC treated with ciforadenant in combination with atezolizumab

Results consistent with prior studies, showing prolonged survival compared to chemotherapy and favorable safety data

BURLINGAME, Calif., Sept. 17, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that new data from its clinical collaboration with Genentech, which is being conducted under Genentech’s MORPHEUS umbrella program, will be presented in a poster presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which is taking place September 19-21, 2020. The poster was made available online today 9:00 am CEST (3:00 am ET) as part of the pre-release of e-Posters.

“In this small study in non-small cell lung cancer (NSCLC), more patients treated with ciforadenant and atezolizumab had longer disease control and overall survival as compared to chemotherapy,” said Richard A. Miller, M.D., president and chief executive officer of Corvus. “The trend seen in longer disease control and overall survival, although not statistically significant given small sample size, is consistent with prior studies demonstrating that immunotherapies can prolong survival compared to chemotherapy, which often produces tumor responses of short duration. Also as expected, the safety data for the ciforadenant and atezolizumab combination compared favorably to chemotherapy. Looking forward, we remain focused on advancing ciforadenant into a pivotal study in patients with advanced refractory renal cell cancer that utilizes our Adenosine Gene Signature biomarker to select patients who may be most likely to benefit from the treatment.”

The ESMO poster (#1315P) covers results from the MORPHEUS Phase 1b/2 study of ciforadenant in combination with Genentech’s Tecentriq® (atezolizumab), compared to a docetaxel chemotherapy control arm, as a second- or third-line therapy in patients with NSCLC who had previously failed on treatment with a platinum-containing chemotherapy regimen and a PD-L1/PD-1 checkpoint inhibitor. The data includes results from 15 patients treated in the combination arm and 14 patients treated in the control arm. The recently described adenosine gene signature biomarker was not utilized in this study.  The key data related to ciforadenant from the poster include:

• In the ciforadenant and atezolizumab combination arm (N=15), 11 patients had response assessment. Of these, one patient achieved a long-term, ongoing partial response (PR) of 13+ months and six patients had long-term, stable disease (SD) including one ongoing SD of 15+ months. In total, four patients (one with a PR and three patients with SD) had disease control of 6+ months, including two patients that are still on therapy.
• In the docetaxel chemotherapy control arm (N=14), three patients achieved short-term PR (4, 7 and 9 months), two patients achieved disease control beyond six months and all patients have discontinued treatment.
• The median overall survival (OS) was 11.5 months in the ciforadenant and atezolizumab combination arm, compared to 9.4 months in the control arm.
• The safety profile in both arms was as expected: no patients receiving ciforadenant and atezolizumab combination had Grade 5 adverse events or adverse event that led to treatment withdrawal. Of the patients receiving docetaxel chemotherapy, 1 experienced a Grade 5 adverse event and 3 had adverse events that led to treatment withdrawal. The overall treatment related adverse event rate was 67% in the combination arm, compared to 93% in the control arm.

To-date, more than 300 patients have been treated with ciforadenant across multiple clinical studies and the Company’s most advanced development program with ciforadenant is for treatment of patients with advanced refractory renal cell carcinoma (RCC). Corvus presented the latest data on RCC patients treated with ciforadenant, along with data supporting the Adenosine Gene Signature’s ability to identify patients likely to respond to treatment with ciforadenant, at the ASCO20 Virtual Scientific Program in May 2020. The data covered 51 patients and showed an objective response rate (ORR) of 17% by RECIST criteria in Adenosine Gene Signature positive patients (n=31) and 0% ORR in the Adenosine Gene Signature negative group (n=20).  The Company plans to meet with the U.S. Food & Drug Administration (FDA) to discuss the study design and plans for a ciforadenant pivotal study in advanced refractory RCC using the Adenosine Gene Signature as a biomarker.

About Genentech’s MORPHEUS Platform
The MORPHEUS platform consists of multiple, global, open-label, randomized, umbrella Phase 1b/2 trials designed to accelerate the development of combinations for several indications by identifying early signals and establishing proof-of-concept clinical data.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells. These product candidates are being studied in ongoing Phase 1b/2 and Phase 1/1b clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort Phase 1b/2 trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company’s third cancer clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. The Company is also evaluating CPI-006 as a treatment for COVID-19 patients.  For more information, visit www.corvuspharma.com.

Tecentriq® (atezolizumab) is a registered trademark of Genentech.

About Ciforadenant
Ciforadenant (CPI-444) is a 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 in the tumor microenvironment to the A2A receptor. 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. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine.

Adenosine Gene Signature
The adenosine gene signature is a biomarker that reflects adenosine induced immunosuppression in the tumor.  These genes express chemokines that recruit myeloid cells including immunosuppressive tumor associated myeloid cells, which are thought to mediate resistance to anti-PD-(L)1 treatment. To date, in our clinical trial of renal cell cancer, this biomarker has been associated with a higher rate of response to ciforadenant.  It is anticipated that the adenosine gene signature may also be useful in identifying patients most likely to respond in NSCLC.

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of ciforadenant, CPI-006, and CPI-818, the Company’s ability to develop and advance product candidates into and successfully complete clinical trials, the utility of the Adenosine Gene Signature and the timing of certain product development milestones.  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 quarter ended June 30, 2020, filed with the Securities and Exchange Commission on July 30, 2020, 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 ciforadenant, CPI-006 and CPI-818; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials; the results of preclinical studies and clinical trials may not be predictive of future results; 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 raise additional capital; and the effects of COVID-19 on the Company’s clinical programs and business operations. 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
W2O pure
+1-213-262-9390
sseapy@purecommunications.com

FAQ

What are the results of the Corvus Pharmaceuticals study presented at ESMO 2020?

The study showed that patients treated with ciforadenant and atezolizumab had longer disease control and overall survival compared to chemotherapy.

What is the median overall survival for the ciforadenant and atezolizumab combination?

The median overall survival was 11.5 months for the combination therapy, compared to 9.4 months for the chemotherapy control.

What safety data was reported for ciforadenant in the latest study?

The safety profile was favorable with no Grade 5 adverse events reported in the ciforadenant group, and a 67% adverse event rate compared to 93% in the control group.

How many patients were involved in the ciforadenant and atezolizumab trial?

The trial involved 15 patients in the ciforadenant and atezolizumab arm and 14 patients in the chemotherapy control arm.

What are the next steps for Corvus Pharmaceuticals regarding ciforadenant?

Corvus plans to advance ciforadenant into pivotal studies for advanced refractory renal cell cancer using the Adenosine Gene Signature as a biomarker.