Iqirvo ‘effective, well-tolerated treatment option’ for advanced-stage PBC

Key takeaways:

• Elafibranor demonstrated significant biochemical response in advanced-stage disease patients with primary biliary cholangitis.
• There was “little to no response” in patients with PBC who received placebo.

PHILADELPHIA — Iqirvo demonstrated significant biochemical response and alkaline phosphatase normalization in patients with both early- and advanced-stage primary biliary cholangitis, according to late-breaking data presented here.

“Elafibranor — a peroxisome proliferator-activated receptor agonist — has demonstrated significant biochemical response in 51% vs. 4% of placebo-treated patients in the phase 3 ELATIVE trial,” Marlyn J. Mayo, MD, FACG, professor of internal medicine at UT Southwestern Medical Center, told attendees at the ACG Annual Scientific Meeting.

“Patients with advanced stage PBC are at greater risk for adverse clinical outcomes and they experience lower transplant-free survival,” she said. “Due to limited efficacy and safety of treatments in this population, there is a need to evaluate the response to treatment with elafibranor according to baseline stage in the ELATIVE trial.”

The researchers classified PBC disease stage as either early or advanced based on liver stiffness measurement (≤ 10 kPa or > 10 kPa) or histology (Nakanuma fibrosis score < 2 or > 2) in patients in the ELATIVE trial who underwent liver biopsy.

Among patients with advanced-stage PBC (n = 54), 35 were treated with Iqirvo (elafibranor, Ipsen/Genfit) and 19 received placebo; among patients with early-stage disease (n = 107), 73 were treated with elafibranor and 34 were given placebo. The researchers reported that the mean baseline values of alkaline phosphatase, total bilirubin, albumin, alanine aminotransferase, aspartate transaminase, gamma-glutamyl transferase and liver stiffness were higher for patients with advanced-stage vs. early-stage PBC across treatment groups.

The study endpoint was biochemical response at 52 weeks, defined as alkaline phosphatase less than 1.67 times the normal upper limit with at least a 15% reduction from baseline, and normal total bilirubin. Mayo and colleagues also examined changes in alkaline phosphatase, total bilirubin, albumin, ALT, AST, gamma-glutamyl transferase and liver stiffness from baseline to 52 weeks.

“Regardless of disease stage, the biochemical responses were similar in those who received elafibranor,” Mayo said. “Among patients with advanced-stage disease who received elafibranor, biochemical response occurred in 45.7%, similar to the 53.4% of patients with early-stage disease who responded. There was little to no response in the patients who received placebo.”

The researchers reported that reductions in alkaline phosphatase, ALT, AST and gamma-glutamyl transferase were found in patients with advanced-stage PBC who received elafibranor, noting that total bilirubin, liver stiffness and albumin were relatively unchanged.

“Alkaline phosphatase normalization was seen only in patients treated with elafibranor, occurring in 8.6% of patients who had advanced disease and 17.8% of patients with early-stage disease,” Mayo said.

Among patients with advanced-stage PBC who received placebo, alkaline phosphatase, ALT and AST levels remained stable, but total bilirubin and liver stiffness levels increased as albumin levels decreased.

“Biochemical response and alkaline phosphatase normalization were achieved in a greater proportion of patients receiving elafibranor vs. placebo in both early- and advanced-stage PBC,” Mayo told attendees. “These results suggest that elafibranor is an effective and well-tolerated treatment option for patients who have advanced stage PBC.”

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Sources/Disclosures

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Source:

Mayo MJ, et al. Impact of elafibranor on markers of disease activity and progression in patients with advanced primary biliary cholangitis (late-breaking abstract). Presented at: ACG Annual Scientific Meeting; Oct. 25-30, 2024; Philadelphia (hybrid meeting).

Disclosures:
Mayo reports receiving consulting fees, grants or travel support from CymaBay, Genfit, Gilead, GSK, Ironwood, Intercept, Intra-Sana, Ipsen, Mallinckrodt and Mirum. Please see the study for all other authors’ relevant financial disclosures. The study was sponsored by Ispen and Genfit.

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