JPB-898 (nivolumab biosimilar) / Sandoz - LARVOL DELTA

CJPB898A12101: A PK study to compare JPB898 (proposed nivolumab biosimilar) and US-licensed Opdivo in participants with resected stage IIB, IIC, or III melanoma in the adjuvant setting (clinicaltrialsregister.eu) - P1 | N=77 | Recruiting | Sponsor: H e x a l AG | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

NivoReach: Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy® (clinicaltrials.gov) - P3 | N=52 | Terminated | Sponsor: Sandoz | N=720 ➔ 52 | Suspended ➔ Terminated; In light of the evolving regulatory landscape and growing indications that major Health Authorities will move towards a streamlined clinical development, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.

Enrollment change • Trial termination • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

CJPB898A12101: A PK study to compare JPB898 (proposed nivolumab biosimilar) and US-licensed Opdivo in participants with resected stage IIB, IIC, or III melanoma in the adjuvant setting (clinicaltrialsregister.eu) - P1 | N=77 | Not yet recruiting | Sponsor: H e x a l AG

New P1 trial • Melanoma • Oncology • Solid Tumor

NivoReach: Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy® (clinicaltrials.gov) - P3 | N=720 | Suspended | Sponsor: Sandoz | Trial completion date: Jul 2027 ➔ Feb 2026 | Recruiting ➔ Suspended | Trial primary completion date: Jul 2027 ➔ Feb 2026

Trial completion date • Trial primary completion date • Trial suspension • Melanoma • Oncology • Solid Tumor

NivoReach: Integrated study to demonstrate similarity of JPB898 to reference nivolumab in combination with ipilimumab in patients with advanced melanoma. (ASCO 2025) - P3 | "Other PK, efficacy, safety, and immunogenicity endpoints will also be assessed up to 52 weeks. The planned randomized sample size is 720 participants."

Clinical • Combination therapy • IO biomarker • Metastases • Eye Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy® (clinicaltrials.gov) - P3 | N=720 | Recruiting | Sponsor: Sandoz | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor