FibroGen, Inc. (NASDAQ:FGEN) recently held its Q1 2024 earnings call, providing updates on its key strategic pillars: pamrevlumab, roxadustat, its early-stage oncology pipeline, and its strong cash position. The company is focusing on advancing pamrevlumab for pancreatic cancer, expanding roxadustat's market presence, and developing its oncology assets, while maintaining financial stability.
Pamrevlumab for Pancreatic Cancer
Pancreatic cancer remains a significant unmet medical need, with a five-year survival rate of only 12.5% and approximately 3% for metastatic cases. FibroGen is developing pamrevlumab, a novel anti-CTGF human monoclonal antibody, for both metastatic and locally-advanced unresectable pancreatic cancer (LAPC). Preclinical data suggests that CTGF plays a crucial role in pancreatic tumor growth and progression, and pamrevlumab has shown potential in early clinical studies.
In an open-label Phase 1/2 trial, enhanced clinical benefit was observed at higher pamrevlumab exposure levels. Patients with plasma levels exceeding 150 micrograms per ml demonstrated a one-year survival rate of 37%, compared to 11% for those with lower levels. These higher exposure patients also showed improved median overall survival and progression-free survival.
FibroGen expects top-line data from two pivotal Phase 3 studies in the near term:
- Precision Promise: A Phase 2/3 adaptive platform trial for metastatic pancreatic cancer, evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel. The pamrevlumab arm completed enrollment with 213 patients and is expected to report top-line data in mid-2024.
- LAPIS: A double-blind, placebo-controlled trial in 284 patients with LAPC, comparing pamrevlumab to placebo in combination with standard-of-care chemotherapy. Top-line data is expected in the third quarter of 2024.
Roxadustat Expansion and U.S. Rights
Roxadustat, approved in over 40 countries for anemia associated with chronic kidney disease (CKD), continues to perform strongly in China. In Q1 2024, total roxadustat net sales in China reached $79.4 million, a 24% increase compared to $64.1 million in Q1 2023, driven by a 39% volume increase. FibroGen's portion of the net product revenue was $30.5 million, a 26% increase.
The company anticipates an approval decision from Chinese authorities in the second half of 2024 for chemotherapy-induced anemia, which could further boost revenue. Despite the expiration of composition of matter patents in June 2024, FibroGen does not expect a significant deterioration of the roxadustat business in the near term, as originator products in China have historically maintained revenue streams even after generic entry.
FibroGen has regained the rights to roxadustat from AstraZeneca in the U.S. and ROW territories (excluding China and South Korea), allowing the company to explore potential partnerships for indications like anemia in patients with lower-risk myelodysplastic syndromes (MDS). Data from the Phase 3 MATTERHORN study showed a statistically significant and clinically meaningful advantage in transfusion independence in patients with higher transfusion burden at baseline treated with roxadustat versus placebo.
Early-Stage Oncology Pipeline: FG-3246
FibroGen is also advancing its early-stage oncology pipeline, with FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting CD46, showing promising results in metastatic castration-resistant prostate cancer (mCRPC). In a Phase 1 monotherapy trial, FG-3246 demonstrated a median radiographic progression-free survival of 8.7 months in heavily pre-treated patients. PSA reductions of at least 50% were observed in 36% of patients, and 20% of RECIST evaluable patients achieved a partial response.
A combination trial of FG-3246 with enzalutamide is ongoing at UCSF, with interim data selected for presentation at the 2024 ASCO Annual Meeting. FibroGen plans to meet with the FDA in Q3 2024 to discuss the FG-3246 development program and anticipates initiating a Phase 2/3 dose optimization and registration-enabling study in mCRPC in Q4 2024.
Financial Position
FibroGen reported $214.7 million in cash, cash equivalents, investments, and accounts receivable as of March 31, 2024. The company expects this strong balance sheet to fund operating plans into 2026.
