Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced the publication of results posted in the online journal of Cancer of a Phase I-II study that evaluated the safety and efficacy of pixantrone when used in combination with fludarabine, dexamethasone and rituximab ("FPD-R") replacing mitoxantrone in the standard FND-R regimen with FPD-R among 28 patients with relapsed or refractory indolent non-Hodgkin's lymphoma ("INHL").
The Phase I-II study results showed that the FPD-R regimen was highly active in patients with relapsed or refractory INHL and produced complete responses ("CR") in 63% of patients with an overall response rate ("ORR") of 89%. Responses were long lasting for a median of 23 months with the longest responding patient in remission longer than 40 months, with an estimated 92% survival rate at three years. The primary side effects were hematologic with 89% of patients developing grade 3-4 neutropenia, which was managed with growth factor administration. No patient developed congestive heart failure with no grade 3-4 cardiac side effects observed. The authors concluded the FPD-R regimen was well-tolerated and highly active in patients with relapsed or refractory INHL.
"This study further adds to the evidence of substantial anti-tumor activity for pixantrone in late stage lymphoid malignancies," said Jack W. Singer, M.D., Chief Medical Officer at CTI. "Of interest, of the 14 patients who were treated at M.D. Anderson Cancer Center, six who obtained a complete remission and did not have a stem-cell transplant remain in complete remission 55 to 83 months after completing therapy. Seven went on to receive a stem-cell transplant and six remain in remission. The high and durable complete response rate in this study indicates that additional clinical trials in relapsed or refractory INHL are warranted."
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