On February 1, 2020 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies with biomarker patient enrichment selection, reported that updated results from its Phase 1/1b clinical trial of CPI-818, the Company’s ITK-inhibitor, which were presented in an oral presentation at the 12th Annual T-Cell Lymphoma Forum in La Jolla, California, taking place January 30 to February 1, 2020 (Press release, Corvus Pharmaceuticals, FEB 1, 2020, View Source [SID1234553771]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Our Phase 1/1b clinical trial of CPI-818, our selective covalent ITK inhibitor designed to address T-cell lymphomas, is enrolling well and continues to provide promising clinical data for patients with advanced, refractory forms of this cancer," said Mehrdad Mobasher, M.D., chief medical officer of Corvus. "To-date, the data demonstrates that the biology and pharmacology of ITK inhibition with CPI-818 has been as expected and the trial is proceeding according to plan. We are pleased to provide this update at the T-Cell Lymphoma Forum, a meeting dedicated to this difficult to treat family of cancers. We are now ready to advance the trial to higher drug doses where we will evaluate its activity in specific disease cohorts."
The CPI-818 Phase 1/1b study is currently enrolling patients with several types of advanced, refractory T-cell lymphomas, including peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), cutaneous T-cell lymphoma (CTCL) and other T-cell lymphomas. The study employs an adaptive, expansion cohort design to select the dose and evaluate the safety, pharmacokinetics (PK), target occupancy, biomarkers and efficacy of CPI-818. The initial phase of the trial is evaluating escalating doses in successive cohorts of patients in order to determine the optimum dose. A second phase will evaluate safety and tumor response to this optimum dose of CPI-818 in disease-specific patient cohorts that may be expanded based on early signs of efficacy. The study is enrolling patients at major medical centers in the United States, Australia and South Korea.
CPI-818 Phase 1/1b Clinical Trial Results at 12th Annual T-Cell Lymphoma Forum
The preclinical and early clinical data from the Phase 1/1b clinical trial of CPI-818 were presented by Dr. Mobasher in an oral presentation session at the T-Cell Lymphoma Forum. The data builds on preclinical and early clinical data from the first seven patients in the study presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 61st Annual Meeting, which took place in December 2019. The key updates from Dr. Mobasher’s presentation, which is titled "CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor. Pre-clinical Characterization and Interim Results of a Phase I/Ib Dose-Escalation Trial in Patients with Relapsed/Refractory T-Cell Lymphoma," included:
16 patients have been enrolled in the first four dose cohorts in the initial phase of the trial, receiving a 100 mg, 200 mg, 400 mg or 600 mg oral dose of CPI-818 two times per day, with no dose limiting toxicities and no grade 3 or 4 treatment related adverse events observed.
The median patient follow-up period is now three months, with 11 patients remaining on therapy. One patient with CTCL treated with the 200 mg dose of CPI-818 achieved a reduction in lymphadenopathy and improvement of PET scan imaging; another patient with CTCL receiving the 400 mg dose has exhibited improvement in cutaneous disease. These patients continue on therapy.
The results from the pharmacokinetic and occupancy studies for the first 12 patients have been in-line with expectations, with increasing target occupancy with higher doses based on available data from the 100 mg, 200 mg, and 400 mg doses. The maximum target occupancy has not yet been achieved in the first three dose cohorts, but the Company continues to anticipate that maximum target occupancy will be achieved in the 600 mg cohort, which was recently initiated.