Threshold Pharmaceuticals: QuickView

Threshold’s partner Merck KGaA is poised to launch a Phase III trial with TH-302 in pancreatic cancer, running alongside its Phase III study in soft tissue sarcoma. This is a bold move and not one without commercial risks, given potential near-term read-outs from competitor studies. Results are expected in the next few weeks from Phase III studies of Celgene’s Abraxane and separately Clavis/Clovis’s CP-4126 in pancreatic cancer as well as Ziopharm’s palifosfamide in STS. A positive result for any of these drugs could shift the standard of care, although there is no reason to assume TH-302 could not ultimately be included in a new combination.

Laying A Course For Pancreatic Cancer
Merck KGaA is initiating a 600-patient Phase III trial of TH-302 in previously untreated metastatic or locally advanced unresectable pancreatic cancer, testing gemcitabine ± TH-302. The study, subject to an SPA, has overall survival as the primary endpoint and should render results in 2015. Pancreatic cancer is a notoriously challenging indication and is one where the commercial landscape could change fast if either of the competitors has positive Phase III result.

Death Grip In Pancreatic Cancer
This study was designed on the basis of a 214-patient Phase IIb trial that demonstrated a 63%, two-month increase (p=0.005) in PFS for the TH-302/ gemcitabine arm. There was a non-significant trend in OS, the secondary endpoint, where TH-302/gemcitabine showed a median OS of 9.2 at the higher dose (340mg/m2), compared to 6.9 months for gemcitabine alone. The trial was not designed to detect a statistically significant improvement in OS.

Exploring The Soft Tissue Sarcoma Universe
Threshold is conducting a 450-patient Phase III trial of doxorubicin ± TH-302 in metastatic or locally advanced unresectable STS. However, this again could be affected by a positive result in Ziopharm’s PICASSO III Phase III trial of doxorubicin ± palifosfamide, expected in Q412.

Valuation: EV Of $181m
Threshold’s EV is $181m, which has halved since mid-September after the presentation of updated Phase IIb pancreatic data at ESMO. Although this may present an attractive opportunity, investors might be wise to await the outcome of these competing studies before coming to a decision.

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