FibroGen Reveals Initial Findings from Phase 1 Solo Treatment Study of FG-3246 in mCRPC Patients

FG-3246, an innovative antibody drug conjugate (ADC), has shown promising results in treating adenocarcinoma within a heavily pre-treated patient group. The drug, characterized by a median radiographic progression-free survival of 8.7 months, achieved a PSA50 response rate in 36% of the patients studied. Additionally, it demonstrated a confirmed radiographic objective response rate of 20%, with the responses lasting a median of 7.5 months. The safety profile of FG-3246 was deemed acceptable, with adverse events in line with those typical of ADC therapies containing a monomethyl auristatin E (MMAE) payload.
FibroGen, Inc., the company behind the development of FG-3246, intends to consult with the FDA to map out the drug's development path, with a Phase 2 trial expected to commence in the latter half of 2024. The positive data from the Phase 1 study of FG-3246, also known as FOR46, were announced by FibroGen, highlighting its potential as a novel treatment for metastatic castration-resistant prostate cancer (mCRPC) that has progressed after treatment with at least one androgen receptor-signaling inhibitor (ARSI).
Dr. Deyaa Adib, FibroGen's Chief Medical Officer, expressed enthusiasm about the clinical data from the FOR46-001 Phase 1 ADC trial, noting the drug's favorable safety and significant clinical activity. The Phase 1 study involved 56 patients, with efficacy observed in those receiving a starting dose of 1.2 mg/kg or more. The most common adverse events were consistent with other MMAE-based ADCs and included reactions such as infusion-related reactions, fatigue, weight loss, neutropenia, and peripheral neuropathy.
Dr. Rahul Aggarwal, the lead investigator of the study and a Professor of Medicine at the University of California San Francisco, praised the study's outcomes, emphasizing the drug's manageable safety profile and robust clinical activity signals. He also mentioned the potential for combination therapies with FG-3246, with upcoming data presentations at the ASCO 2024 annual meeting expected to showcase its combination with enzalutamide.
The Phase 1 FOR46-001 study, which evaluated the safety, tolerability, pharmacokinetics, biological activity, and preliminary anti-tumor effects of FG-3246, included both a dose-escalation phase and a dose-expansion phase. The study's complete findings are slated for submission to a medical journal in 2024.
Metastatic castration-resistant prostate cancer is an advanced form of prostate cancer that continues to grow despite low testosterone levels and can be life-threatening if it spreads. FG-3246, a fully human ADC targeting CD46, is being developed to address this condition and is currently in a Phase 1/2 study in combination with enzalutamide, with initial data expected in mid-2024.
FibroGen, Inc. is a biopharmaceutical company dedicated to the advancement of novel cancer therapies, with a focus on Pamrevlumab for pancreatic cancer treatment and Roxadustat for anemia in chronic kidney disease. The company is also expanding its R&D efforts to include immuno-oncology product candidates for solid tumors.

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