Corvus Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, today announced interim data demonstrating the potential of CPI-818, the Company’s ITK inhibitor, for the treatment of T cell lymphoma (TCL) at the 10th Whistler Global Summit on Hematologic Malignancies, which took place March 29 to April 2, 2023 in Whistler British Columbia, Canada. The CPI-818 data was presented by John Reneau, MD, PhD, from The Ohio State University Comprehensive Cancer Center. Dr. Reneau is a hematologist who specializes in treating patients with lymphoma and an investigator for the Phase 1/1b clinical trial of CPI-818 for TCL.

“T cell lymphoma is a challenging disease to treat and there is significant need for new approaches given the limited efficacy of current therapeutic options,” said Dr. Reneau. “CPI-818 has a novel mechanism of action that includes the stimulation of normal T cells to infiltrate and destroy tumors. Our recent work indicates that the peripheral blood absolute lymphocyte count is a biomarker that may predict patients most likely to benefit from CPI-818. This positions our trial to build on the results CPI-818 has already demonstrated - monotherapy activity in advanced, relapsed patients, with potential for higher response rates driven by this new biomarker.”

CPI-818 Phase 1/1b T Cell Lymphoma Data
CPI-818 is currently being studied in a Phase 1/1b clinical trial as a single agent therapy in patients with relapsed TCL. As of February 23, 2023, 20 patients were enrolled in the 200 mg cohort (optimal dose), including 13 evaluable for tumor response. There have been 1 complete response (CR) of 24 months duration, 1 equivocal CR awaiting confirmatory PET scan of 13+ months duration (a previous partial response (PR)), 1 nodal CR of 21 months duration and 1 PR of 7 months duration. Ten patients continue on therapy, including seven who have not yet been evaluated for tumor response.

Corvus has identified minimum absolute lymphocyte count (ALC) above 900 per cubic milliliter of blood as a biomarker associated with response to CPI-818. Interim data from the 200 mg cohort in the Phase 1/1b clinical trial indicate that this minimum ALC level is required for tumor response and disease control. As of February 23, 2023, four of eight patients with ALC above 900 had objective responses (those four patients are described above), all eight had disease control (stable disease, PR, CR) and the median progression free survival (PFS) was 28.1 months. No objective responses were seen in five patients (0 of 5) with ALC below 900 and the PFS was 2.1 months.

New interim data, as of February 23, 2023, presented by Dr. Reneau evaluated the effect of ALC on PFS of patients based on their last prior chemotherapy treatment before receiving CPI-818. There was no significant difference in the PFS achieved in patients with ALC less than 900 per cubic milliliter (PFS = 3.2 months) compared to patients with ALC greater than or equal to 900 per cubic milliliter (PFS = 3.4 months), which suggests the ALC biomarker is not predictive for standard therapies. This result is consistent with CPI-818’s proposed mechanism of action, which involves the enhancement of normal lymphocyte function, and indicates that the improved results seen with CPI-818 in patients with ALC above 900 is not due to more favorable patient characteristics.

The swimmer and waterfall tumor plots for these patients, along with the data summarizing the ALC biomarker data, are included in Dr. Reneau’s presentation slides, which are available on the Publications and Presentations page of the Corvus website.

“The data from our Phase 1/1b trial of CPI-818 for T cell lymphoma continues to be strong, with durable and deep tumor responses observed to date,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “We are encouraged that enrollment has accelerated and that we have implemented a biomarker that we believe will enable us to enroll patients most likely to benefit from CPI-818, which is of particular importance as we plan for a registration Phase 3 randomized clinical trial. I want to thank Dr. Reneau and all our investigators for their participation in the trial and for the work they do in support of patients.”

 

Source: globenewswire.com

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