Kyntra Bio, previously known as Fibrogen, has released encouraging preliminary findings from its Phase 1b/2 clinical study. The research examined the efficacy of FG-3246, in conjunction with enzalutamide, for individuals battling metastatic castration-resistant prostate cancer. These results, unveiled during Tuesday's premarket session, indicate a noteworthy median radiographic progression-free survival of 10.1 months among patients who had previously undergone treatment with a single androgen receptor pathway inhibitor. The overall cohort demonstrated a composite response rate of 21%, providing a hopeful outlook for future therapeutic developments.
The comprehensive study encompassed 44 participants, with a more focused subgroup showing a 40% response rate after experiencing progression on only one prior ARPI. Furthermore, the investigation revealed a correlation between increased tumor uptake of FG-3180 and a higher likelihood of achieving a PSA50 response, a significant indicator in prostate cancer treatment. This pivotal information was shared at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium, underscoring the potential impact of this novel combination therapy.
Remarkably, the median radiographic progression-free survival for the entire study population stood at 7.0 months. The safety profile of the FG-3246 and enzalutamide combination therapy mirrored that observed in earlier Phase 1 monotherapy trials of FG-3246. The risk of neutropenia, a common side effect, was effectively managed through the prophylactic administration of G-CSF. Currently, FG-3246 is undergoing a Phase 2 monotherapy trial, with interim data anticipated in the latter half of 2026, which could further solidify its therapeutic promise.
Leading analyst firm William Blair offered its perspective on these developments, acknowledging the inherent limitations of cross-trial comparisons but nonetheless describing the FG-3246 combination results as "provocative" and a strong validation for the forthcoming interim analysis of the Phase 2 monotherapy trial. An analyst from William Blair specifically highlighted that the strategic use of prophylactic growth factors appears to diminish dose-limiting neutropenia, a positive sign for the monotherapy study's prospects. Despite the early stage of FG-3246's development and the highly competitive landscape of the prostate cancer market, William Blair maintains a 'Market Perform' rating on Kyntra shares, advocating for further data before a definitive stance.
The recent findings from Kyntra Bio's clinical trial for FG-3246 in advanced prostate cancer signify a potential advancement in treatment options. With promising response rates and a manageable safety profile, the ongoing research and anticipated interim data from the monotherapy trial will be crucial in determining the full therapeutic value and market position of this innovative drug candidate.
