Dr Rutkowski on JPB898 With Ipilimumab in Stage III or Metastatic Stage IV Melanoma

"This trial will be open and activated in 23 countries, including [the] US and [countries within the] EU, and more than 700 patients will be included. From my perspective, [this study is[ very attractive."

Piotr Rutkowski, MD, a professor of surgical oncology, head of the Department of Soft Tissue/Bone Sarcoma and Melanoma, and the plenipotentiary director of the Institute for Clinical Trials at the Maria Sklodowska-Curie National Research Institute of Oncology, discussed the design and objectives of the NivoReach study (NCT06587451), a phase 3 trial evaluating the proposed nivolumab (Opdivo) biosimilar JPB898 in combination with ipilimumab (Yervoy) vs reference nivolumab plus ipilimumab in patients with untreated, unresectable stage III or metastatic stage IV melanoma.

To conduct the study, investigators are enrolling approximately 720 patients across approximately 23 countries, including the United States (US) and nations within the European Union (EU). Patients must have an ECOG performance status of 0 or 1; those with active brain metastases, uveal melanoma, or other untreated or progressive malignancies will be excluded. Eligible patients will be randomly assigned 2:1 to receive either JPB898 or EU/US-authorized nivolumab, each combined with ipilimumab. Randomization is stratified by BRAF V600 mutation status, PD-L1 expression, and metastasis stage.

In the 12-week induction phase, all patients will receive nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg every 3 weeks. Rutkowski highlighted the rationale for this dosing approach, referencing prior data from the phase 3b/4 CheckMate 511 trial (NCT02714218) that demonstrated a favorable toxicity profile and comparable efficacy with lower-dose ipilimumab. He emphasized the potential clinical appeal of such a regimen in routine practice, particularly if a biosimilar option like JPB898 is shown to perform comparably to the reference product.

During the maintenance phase, patients will receive fixed-dose JPB898 or reference nivolumab monotherapy at 480 mg every 4 weeks from week 16 to week 48. The coprimary pharmacokinetic end points include area under the serum concentration–time curve after the first and fourth induction doses. The primary efficacy end point is best overall response (complete or partial) assessed at 28 weeks, with additional secondary end points of safety, immunogenicity, and further efficacy outcomes up to 52 weeks.