One Year, Five Trial Failures: FibroGen Terminates Pancreatic Cancer Treatment Program

FibroGen Inc. FGEN saw its share price plummet after the release of topline results from two late-stage trials evaluating the efficacy and safety of pamrevlumab in pancreatic cancer patients.

What Happened: The pamrevlumab arm of 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.

Also Read: FibroGen Unveils Early Data From Prostate Cancer Candidate, Analyst Advocates Further Exploration In The Landscape.

And the pamrevlumab development program will be terminated.

As a result of the cost reduction plan, headcount in the U.S. will be reduced by approximately 75%.

Median overall survival of 17.3 months was observed in the pamrevlumab combined with gemcitabine + nab-paclitaxel or FOLFIRINOX arm compared to the median overall survival of 17.9 months in the control arm of placebo combined with gemcitabine + nab-paclitaxel or FOLFIRINOX (HR: 1.08)

The preliminary safety analyses across both studies indicate that the safety profile of pamrevlumab combined with gemcitabine + nab-paclitaxel or FOLFIRINOX was generally well tolerated, with an acceptable safety profile.

No clinically meaningful differences in treatment-emergent adverse events were seen between the treatment arms.

William Blair writes, “We believe investors had exceedingly low expectations for pamrevlumab in pancreatic cancer following several clinical setbacks in both idiopathic pulmonary fibrosis and Duchenne muscular dystrophy.”

The analyst notes that investor interest in FibroGen has surged following recent mergers and acquisitions in the antibody-drug conjugates (ADC) sector and the release of competitive topline data.

The primary focus is on FG-3246, an ADC targeting CD46. The company plans to start a Phase 2/3 monotherapy trial later this year, with the Phase 3 portion potentially beginning in the first half of 2027. Notably, FG-3246 is the only clinical pipeline candidate with a possible registrational-enabling study in the near future.

William Blair reiterates the Market Perform rating.

Price Action: FGEN stock is down 47.9% at 54 cents at last check Wednesday.

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