Oncopeptides has reported new phase 2 data supporting the use of Pepaxti in relapsed refractory multiple myeloma patients with moderate to severe renal impairment, a group that accounts for around half of all myeloma diagnoses and typically faces poorer long‑term outcomes.
The prospective open‑label BRIDGE study, published in Clinical Lymphoma, Myeloma and Leukemia, assessed the pharmacokinetics, safety and efficacy of Pepaxti plus dexamethasone in patients with reduced kidney function. According to the company, the findings reinforce the role of renal function‑based dose adjustments in maintaining disease control without compromising safety.
Dr Ludek Pour, Clinic of Internal Medicine – Hematology and Oncology, University Hospital Brno, and lead author, said: “The findings are highly significant for everyday clinical practice because they demonstrate that with proper renal function-based dose adjustments, we can maintain strong disease control and survival outcomes without compromising safety or worsening kidney function in a very fragile patient segment.”
Final analyses showed that although exposure to the active metabolite melphalan varies with baseline renal function, a reduced starting dose of 30 mg in patients with moderate impairment produced a consistent safety profile and treatment responses aligned with earlier trials in broader populations.
Exploratory data also indicated that renal function remained stable or slightly improved during therapy, suggesting Pepaxti does not adversely affect the kidneys at the studied doses.
Key results included an overall response rate of 47.6 percent in patients receiving a 40 mg starting dose and 70.0 percent in those receiving 30 mg, with median progression‑free survival of 8.6 and 7.7 months respectively. No new safety signals were identified, and the most common adverse events were haematological, consistent with previous studies.
Stefan Norin, Chief Medical Officer at Oncopeptides, said: “This publication adds critical scientific peer-reviewed validation to the treatment algorithm of Pepaxti, specifically strengthening our data footprint in patient subgroups with renal impairment.”
He added: “By demonstrating that Pepaxti can be safely administered at an optimized 30 mg dose, BRIDGE gives healthcare professionals the clinical confidence they need to confidently utilize this therapy in a broader patient population.”
