FibroGen: LAPIS study did not meet the primary endpoint of OS

FibroGen announced topline results from two late-stage trials evaluating the efficacy and safety of pamrevlumab in patients with pancreatic cancer and a corporate update. The pamrevlumab experimental arm in PanCAN’s Precision Promise Phase 2/3 adaptive platform trial compared treatment with pamrevlumab combined with gemcitabine + nab-paclitaxel to gemcitabine + nab-paclitaxel alone for treatment in first line and second line 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 3 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 or LAPC. The study did not meet the primary endpoint of overall survival. “We are deeply disappointed that the pamrevlumab arm in the Precision Promise trial and the LAPIS trial did not meet the primary endpoint of overall survival,” said Thane Wettig, Chief Executive Officer, FibroGen. “We were hopeful that pamrevlumab could bring meaningful innovation to pancreatic cancer patients in desperate need of new therapies. FibroGen would like to thank the patients, their families and the clinical trial investigators and teams for their dedication to participating in these studies. I would also like to express my deepest gratitude to our FibroGen colleagues who have dedicated so much of their time and energy for the prospect of bringing much needed therapies to some of the most challenging and deadly diseases affecting humanity.” 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%. FibroGen’s collaboration agreement with AstraZeneca for roxadustat in China, where roxadustat is the market leader by brand value share in the chronic kidney disease CKD anemia category, as well as FibroGen’s collaboration agreement with Astellas for roxadustat in the E.U., Japan, and other territories, remain in place.