Pamrevlumab arm of the Precision Promise study in metastatic pancreatic cancer, and LAPIS study in locally advanced, unresectable pancreatic cancer, did not meet the primary endpoints
FibroGen, Inc. announces topline results from two late-stage trials evaluating the efficacy and safety of pamrevlumab in patients with pancreatic cancer
The pamrevlumab experimental arm in PanCAN’s Precision Promise Phase II/III adaptive platform trial compared treatment with pamrevlumab combined with gemcitabine + nab-paclitaxel to gemcitabine + nab-paclitaxel alone for treatment in first line (1L) and second line (2L) patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The pamrevlumab arm of the study did not meet the primary endpoint of overall survival as determined by the protocol pre-specified Bayesian statistical analysis.
The Phase III LAPIS trial compared treatment with pamrevlumab combined with gemcitabine + nab-paclitaxel or Folfirinox to placebo combined with gemcitabine + nab-paclitaxel or Folfirinox for the treatment of locally advanced, unresectable pancreatic cancer (LAPC). The study did not meet the primary endpoint of overall survival.
Based upon the results of the late-stage pamrevlumab trials in pancreatic cancer, the Company plans to implement an immediate and significant cost reduction plan in the U.S. The pamrevlumab development program will be terminated and the Company plans to expeditiously wind down any remaining pamrevlumab obligations. As a result of the cost reduction plan, headcount in the U.S. will be reduced by approximately 75%.
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