Threshold Pharmaceuticals, Inc.
) recently announced an amendment in the protocol for its pivotal
phase III study of TH-302. The company said that the amendments
have been accepted by the US Food and Drug Administration (FDA)
under the existing Special Protocol Agreement (SPA). The phase
III study will compare TH-302 in combination with Doxil to Doxil
alone for treating patients with advanced soft tissue sarcoma
As per The American Cancer Society, around 11,410 new patients
will be affected by soft tissue sarcoma in 2013.
The two changes made to the protocol include trial expansion
to 620 patients (from 450) and the elimination of an interim
futility analysis of progression-free survival (PFS).
The enlarged sample size will strengthen the study's ability
to find a clinically meaningful effect of TH-302 with
statistically significant data. An interim futility analysis will
no longer serve its original purpose as the study would have been
through its enrollment phase by the time the analysis would be
An Independent Data Monitoring Committee (IDMC) will monitor
the safety of patients in this study. The IDMC will conduct an
interim analysis for survival most likely in the first half of
2014, after 235 events are reached. The study will be terminated
early if the IDMC finds pre-specified statistical results in its
interim analysis. Otherwise, the study will continue until the
final analysis, when 434 events would be completed. In that case,
Threshold Pharma will come out with top-line results in the first
half of 2015.
Threshold Pharma has a partnership with
) for TH-302. TH-302 is in another phase III study that is
evaluating the efficacy and safety of TH-302 plus
Eli Lilly and Company
Gemzar in patients with advanced pancreatic cancer.
The successful development of TH-302 will be a major milestone
for Threshold Pharma, which currently does not have any marketed
product in its portfolio. Threshold Pharma carries a Zacks Rank
#4 (Sell). Right now,
Biogen Idec Inc. (
looks more attractive with a ZacksRank #1 (Strong Buy).
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