A phase 2a study is evaluating cerdulatinib, an oral SYK/JAK inhibitor, in pre-treated patients with relapsed/refractory follicular lymphoma.
Cerdulatinib, an oral spleen tyrosine kinase/Janus kinase inhibitor, demonstrated efficacy and safety in previously-treated patients with relapsed/refractory follicular lymphoma (FL), according to data from an ongoing clinical trial.
The FDA granted cerdulatinib Orphan Drug Designation for the treatment of peripheral T-cell lymphoma in September 2018.
“Despite recent advances, relapsed or refractory follicular lymphoma remains a challenging and heterogenous disease,” Paul Hamlin, MD, medical director for the David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, said in a press release. “Oral therapies that can address multiple signaling pathways and overcome chemoresistance without cumulative side effects are urgently needed.”
The phase 2a study was designed to assess the safety and efficacy of cerdulatinib in patients with relapsed/refractory FL, small lymphocytic leukemia, and specific subtypes of T-cell non-Hodgkin lymphoma. Single-agent cerdulatinib treatment was evaluated in comparison with cerdulatinib plus rituximab.
According to the interim data, 40 patients with relapsed/refractory FL received single agent cerdulatinib at 30 mg twice daily and 17 patients received cerdulatinib at 30 mg twice daily in combination with a standard dosing regimen of rituximab. Two of the patients treated with cerdulatinib monotherapy received 35 mg doses.
Prior treatment regimens included anti-CD20 antibody bendamustine and anthracyclines and ranged from 1 to 9, with a median of 3.
Of the 40 cerdulatinib-only patients, the objective response rate (ORR) was 45%, according to the study. Five patients achieved a complete response (CR), 13 patients achieved a partial response (PR), and 10 patients achieved stable disease (SD). Sixty-three percent of the patients with a PR or SD at first evaluation had a further reduction in tumor volume at a subsequent efficacy evaluation, according to the data.
Thirty-eight of the 40 patients in the cerdulatinib-only cohort have been on the study drug for at least 10 months.
Among the 13 patients in the cerdulatinib plus rituximab cohort, ORR was 62%. One patient achieved CR, 7 patients achieved PR, and 5 patients achieved SD. Ten of the 13 patients have been on the study drug from 3 to 10 months, according to the study.
Overall, cerdulatinib was generally well-tolerated with a similar safety profile between both cohorts. The most common adverse effects (AEs) included lipase increase, neutropenia, amylase increase, and diarrhea.
“Cerdulatinib continues to show promise across a range of B- and T-cell malignancies, and I am encouraged by these interim results, indicating sustained clinical activity and good tolerability of cerdulatinib in these follicular lymphoma patients,” Hamlin added.
The data were presented in a poster session at the 24th Congress of the European Hematology Association in Amsterdam and during an oral session at the 15th International Conference on Malignant Lymphoma in Lugano, Switzerland.
Portola Presents New Interim Data on its Oral SYK/JAK Inhibitor Cerdulatinib in Heavily Pre-Treated Patients with Relapsed/Refractory Follicular Lymphoma [news release]. Portola. http://investors.portola.com/news-releases/news-release-details/portola-presents-new-interim-data-its-oral-sykjak-inhibitor. Accessed June 20, 2019.