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Merck KGaA/Threshold: TH-302

An interim futility analysis of Merck KGaA and Threshold’s TH-302 in soft tissue sarcoma (STS) is expected in mid-2013. Phase III progression-free survival (PFS) data on the hypoxia-targeted agent are up first and interim overall survival data are expected early next year.

The first-line sarcoma trial is testing TH-302 plus doxorubicin versus doxorubicin alone and is being run under a special protocol assessment. In a phase I/II trial in advanced STS patients, this combination yielded median overall survival of 21.5 months. According to analysts at Cowen, the historic median survival in this patient population is closer to 12 months. Median PFS with the combination was 6.7 months and overall response rate was 36%.

A physician survey conducted by Piper Jaffray analysts noted that, while the study’s primary endpoint is overall survival, TH-302 could gain approval based on PFS if it generated at least a three-month benefit over doxorubicin.

Ziopharm Oncology’s Zymafos (palifosfamide), which was once considered a competitor, failed to meet its PFS primary endpoint in a first-line setting in metastatic STS patients. Ziopharm subsequently terminated development in STS (Sarcoma miss an unpleasant surprise for Ziopharm, March 26, 2013).

Ziopharm had not secured a partner for its project, perhaps signifying big pharma's lack of confidence in the product. Meanwhile Threshold bagged Merck in February last year, gaining $25m up front and up to $525m in potential milestone payments (Threshold brings on Merck KGaA as validation approaches, February 3, 2012).

While TH-302 has a 2018 sales forecast of $53m in STS, according to EvaluatePharma, the bigger opportunity is pancreatic cancer, with $276m in expected revenue in the same year. Earlier this year, Merck began a phase III trial in first-line pancreatic cancer, in which TH-302 is being added to the standard of care, gemcitabine. The start of the study triggered a $30m milestone payment to Threshold.

While the Merck partnership shows that there is confidence in TH-302, other projects using the same mechanism of action – targeting oxygen-deprived regions of a tumour – have been fraught with clinical failures (Threshold's hypoxia success is notable for field that has disappointed, February 22, 2012). If it is not to join this club Threshold must prove that TH-302 can deliver the goods.

Study Trial ID 
Soft tissue sarcoma NCT01440088
Maestro, pancreatic cancer NCT01746979

To contact the writer of this story email Joanne Fagg in London at joannef@epvantage.com or follow @JoEPVantage on Twitter

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