After six months, 69% and 73% of patients treated with TH-302/gemcitabine were still alive compared to 51% for the gemcitabine patients.
After one year, 37% and 38% of the TH-302/gemcitabine patients were still alive compared to 21% of the gemcitabine patients.
While encouraging, the new survival analysis is not without caveats. Removing crossover patients creates selection bias, meaning the improved survival benefit may not be attributable to TH-302 but instead to patients remaining in the control arm who were sicker and therefore didn't live as long. The analysis was also retrospective, meaning it wasn't conducted as part of the original design of the study -- lessening its significance.
Almost half the pancreatic patients enrolled in the Threshold study were also treated with additional drugs after TH-302 or gemcitabine stopped working. These "subsequent" therapies could have also helped patients live longer, making it even harder to tease out the survival benefit attributable to TH-302 alone.On the safety side, TH-302 was associated with higher rates of thrombocytopenia (low platelets), neutropenia (low white blood cells) and anemia. TH-302's blood-related toxicities coupled with anticipation for upcoming results from a phase III study of Celgene's (CELG - Get Report) Abraxane in pancreatic cancer dampened enthusiasm for TH-302 at ESMO, wrote Pieter Droppert, a cancer consultant who writes the Biotech Strategy Blog/ Droppert writes: "If
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