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.”
SOURCE Allos Therapeutics