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Portola interim results for lymphoma med mixed

June 15, 2017

Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced the presentation of interim data from a Phase 2a study evaluating cerdulatinib in patients with relapsed/refractory B-cell malignancies. Cerdulatinib is an investigational oral, dual SYK/JAK kinase inhibitor for the treatment of relapsed/refractory B-cell and other hematological malignancies, specifically in patients who have not responded to prior therapies. The data were presented by Paul Hamlin, M.D., chief of the Medical Oncology Service at Memorial Sloan Kettering Basking Ridge during an oral presentation given earlier today at the International Congress on Malignant Lymphoma (ICML) in Lugano, Switzerland.

The interim results presented at ICML demonstrated evidence of clinical activity in patients with relapsed/refractory (r/r) B-cell malignancies. To date, overall response rates are as follows:

  • 12 out of 18 (67%) partial responses (PRs) in patients with r/r CLL/SLL
  • 5 out of 9 (56%) PRs in patients with r/r FL
  • 1 out of 7 (14%) PRs in patients with other r/r iNHL (marginal zone lymphoma and Waldenstrom macroglobulinemia)
  • A complete response (CR) was seen in the first r/r peripheral T cell lymphoma (PTCL) patient evaluated in the study

Results also showed that cerdulatinib was generally well-tolerated in these heavily pre-treated patients (at target drug levels). However, three patients at 35 mg BID achieved higher than expected drug concentrations and had severe adverse events (SAEs) including two grade 5 infections and one case of grade three pancreatitis. The dose was subsequently reduced to 30 mg BID and a PK monitoring strategy was implemented. This has resulted in an improved PK and safety profile without compromising clinical activity.

“While we continue to focus our efforts on gaining regulatory approval of our two lead programs, betrixaban and AndexXa® (andexanet alfa), we are pleased that our third molecule, cerdulatinib, continues to show promising results in hematologic cancers — an area of great unmet need,” said John Curnutte, M.D., Ph.D., executive vice president, research and development of Portola. “We believe these results of our Phase 2a trial further validate cerdulatinib’s potential to control relapsed/refractory B-cell malignancies by a differentiated mechanism of action, inhibiting two key cell signaling pathways that promote cancer. We anticipate an update on the ongoing study and a decision regarding future development by the end of 2017.”

“Patients with relapsed/refractory CLL and NHL are difficult to treat and have limited options after failing standard therapy,” said Dr. Hamlin. “Presently, there are few effective treatments for patients who have failed prior therapies. The interim results of this clinical trial are very encouraging, and cerdulatinib could represent an important treatment option for these patients if confirmed in further trials.”

Additional detail on the interim Phase 2a data will be provided at the upcoming European Hematology Association (EHA) 22nd Annual Congress from June 22-25, 2017.

About the Phase 1/2a Study

The open-label, multicenter, Phase 1/2a proof-of-concept study assessed the safety, pharmacokinetics, pharmacodynamics and clinical activity of oral cerdulatinib in patients with CLL and NHL. In the multi-dose, dose-escalation Phase 1 part of the study, cerdulatinib was administered orally once or twice daily in sequential dose cohorts at increasing dose levels until the maximum tolerated dose was identified. The clinical expansion cohorts in the Phase 2a part of the study are evaluating the safety and efficacy of cerdulatinib in cancer types identified based on results from the dose-escalation phase of the study. Up to 40 patients each will be enrolled in the clinical expansion cohorts including patients with relapsed/refractory chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL), and indolent lymphomas such as follicular lymphoma (FL) and peripheral T cell lymphoma (PTCL).

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