New data from Allos Therapeutics' FOLOTYN trial for PTCL

Dec 7 2009

Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported a new analysis of data from the Company’s pivotal PROPEL trial of FOLOTYN™ (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. The analysis evaluated the outcomes of patients who received a stem cell transplant (SCT) before or after treatment with FOLOTYN. The results demonstrate that FOLOTYN may be a potential treatment option for patients who have progressed after receiving a prior autologous SCT and may also be a potential bridge to an autologous or allogeneic SCT following response to FOLOTYN therapy. These data were presented during a poster session at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.

Among the 109 patients in the PROPEL trial evaluable for response, 18 (17%) had received autologous SCT previously, including 8 (7%) who underwent autologous SCT as the most recent therapy prior to study enrollment. Sixty-three percent (5/8) of patients who received autologous SCT as their most recent therapy responded to treatment with FOLOTYN, including two complete responses (CRs). In patients who underwent autologous SCT at any time prior to treatment with FOLOTYN, an overall response rate (ORR) of 33% (6/18) was observed, suggesting single agent FOLOTYN can be an effective therapeutic option for patients who have progressed after being exposed to an intense transplant regimen. Importantly, the ORR to FOLOTYN for patients who had progressed after prior SCT was comparable to that of the ORR of 29% (32/109) observed in the overall PROPEL population.

Additionally, the data demonstrated that promising results were observed in patients who responded to treatment with FOLOTYN and proceeded to receive SCT as initial subsequent therapy. Of the 109 patients evaluable for response, 6 proceeded to SCT after responding to FOLOTYN. Four of the 6 patients had responded according to independent central review and 2 of the 6 patients had responded according to investigator assessment. Thus, responses to FOLOTYN permitted patients to proceed to a potential curative transplant option.

“Stem cell transplant may be offered with curative intent in patients with PTCL,” said Barbara Pro, M.D., associate professor, T-cell Lymphoma team leader at The University of Texas M D Anderson Cancer Center in Houston. “Patients with PTCL are recognized as having a poor prognosis; therefore, it is important to identify new tolerable agents with the ability to induce a response for relapsed or refractory patients. This analysis underscores the important role FOLOTYN may play for PTCL patients who have failed to respond to prior therapies, progressed after prior autologous stem cell transplant and as a bridge to stem cell transplant for patients who respond to FOLOTYN therapy.”