Calithera Biosciences has announced the enrolment of the first participant in a Phase II clinical trial of mivavotinib (CB-659) to treat relapsed/refractory non-GCB (ABC) diffuse large B-cell lymphoma (DLBCL) patients.
Mivavotinib is a spleen tyrosine kinase (SYK) inhibitor, which has been developed to target the constitutively active BCR pathway in many non-Hodgkin’s lymphoma (NHL) cases and the constitutively active inflammatory signalling pathway in MyD88-mutated NHL.
It will be used in identifying patients in genetically defined subgroup associated with poorer outcomes.
The multicentre, open-label, Phase II study is designed to assess mivavotinib’s single-agent activity in relapsed/refractory non-GCB/ABC DLBCL patients.
It will evaluate the activity as per the MYD88/CD79b mutational status and refine dose/schedule in the patient population.
In the study, nearly 50 non-GCB DLBCL patients, with or without MYD88/CD79b mutations, will be recruited and randomised 1:1 to one of two oral dose/schedule cohorts.
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The cohorts will include a continuous dosing schedule, where the participants will be given 100mg dose once daily (QD) and an induction dosing schedule, where 120mg dose will be administered QD for 14 days, then 80mg dose QD starting from Day 15.
The overall response rate as assessed by an independent radiology review committee and safety will be the study’s primary endpoints.
Duration of response, progression-free survival, and complete response will be some of the key secondary endpoints of the study.
The company stated that the non-GCB DLBCL patients treated with mivavotinib had 53% response rate compared to 22% in GCB DLBCL patients in a retrospective analysis of prior Phase I/II studies conducted in DLBCL patients.
Calithera Biosciences president and CEO Susan Molineaux said: “Mivavotinib has demonstrated potential to be a first-to-market approach for non-GCB DLBCL, including the genetic subset of patients harbouring MYD88 and/or CD79 mutations.
“This study will advance understanding of how our novel biomarker-driven approach could help address this high unmet therapeutic need, and we look forward to sharing data by the first quarter of 2023.”