FibroGen to Slash 75% of US Staff After Pamrevlumab Pancreatic Cancer Setback

FibroGen, a biopharmaceutical company, has announced plans to reduce its US workforce by approximately 75% after deciding to halt the development of its leading drug candidate, pamrevlumab, following unsuccessful results from two clinical trials in pancreatic cancer. This announcement led to a significant drop in the company's shares, falling over 44% in premarket trading.

CEO Thane Wettig expressed profound disappointment in the outcomes of the Precision Promise trial and the LAPIS study. He stated that the company will implement an "immediate and significant cost reduction plan in the US" as a result.

The Phase II/III Precision Promise study, sponsored by the Pancreatic Cancer Action Network (PanCAN), involved a pamrevlumab treatment group with 102 patients who had metastatic pancreatic ductal adenocarcinoma in the first line and 111 participants in the second line. These patients were treated with pamrevlumab, an anti-CTGF fully human monoclonal antibody, in conjunction with gemcitabine and nab-paclitaxel. Simultaneously, the Phase III LAPIS trial enrolled 284 patients with locally advanced, unresectable pancreatic cancer. Participants were treated with either pamrevlumab or a placebo combined with gemcitabine and nab-paclitaxel or FOLFIRINOX.

The top-line results revealed that neither study achieved its primary goal of improving overall survival (OS). For the Precision Promise study, the mean hazard ratio for the primary efficacy analysis was 1.184. In the LAPIS trial, the median OS was 17.3 months in the pamrevlumab group, compared to 17.9 months in the control group.

Following the discontinuation of the pamrevlumab program, FibroGen plans to concentrate its efforts on the renal anaemia treatment roxadustat, along with its cancer drug pipeline, which includes the CD46-targeting antibody-drug conjugate FG-3246. Earlier this year, FibroGen regained certain rights to roxadustat from AstraZeneca after facing challenges with the oral HIF-PH inhibitor in the US. The drug is approved in China for renal anaemia patients on dialysis and is marketed in Europe under the name Evrenzo through a partnership with Astellas. However, in April, Astellas reported an impairment charge of around $100 million, citing disappointing sales of Evrenzo after evaluating the "sales situation in each country."

This strategic shift highlights FibroGen’s focus on optimizing its resources and enhancing its drug portfolio, especially given the setbacks encountered with pamrevlumab.

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