Tumors, subcutaneous nivolumab approved in Europe for multiple indications

Green light for the first PD-1 inhibitor in this formulation for solid forms in monotherapy, maintenance or in combination

The European Commission (EC) has approved a new formulation of nivolumab associated with a new administration method (Sc, subcutaneous), a new pharmaceutical formulation (solution for injection) and a new dosage (600 mg/vial). Nivolumab Sc, or nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20) - Bristol Myers Squibb (Bms) informs in a note - has been approved for use in multiple adult solid tumors as monotherapy, maintenance monotherapy following completion of combination therapy with intravenous nivolumab plus ipilimumab, or in combination with chemotherapy or cabozantinib. Nivolumab is the first PD-1 inhibitor approved for subcutaneous use in the European Union.

“The European Commission’s decision to approve nivolumab Sc ushers in a new era of cancer care, where we can deliver a 3-5 minute injection of a treatment that has demonstrated comparable efficacy and safety to intravenous (IV) nivolumab, which changed the landscape of cancer care more than a decade ago,” said Dana Walker, M.D., Ph.D., Global Program Lead for nivolumab, BMS. “BMS is committed to developing medicines that help improve the patient experience, and with the approval of nivolumab Sc in the European Union, we are achieving that goal.”

The EC’s positive decision is based on results from the CheckMate -67T clinical study and additional data that demonstrated comparable pharmacokinetic (Pk) and safety profiles between nivolumab Sc and nivolumab Iv, a statement said. The clinical study showed non-inferiority in the primary endpoints of Pk, Cavgd28 (mean nivolumab serum concentration over the first 28 days) and Cminss (minimum steady-state serum concentration) with nivolumab Sc compared to Iv in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRcc) who had received no more than 2 prior lines of systemic therapy but had not received prior immuno-oncology therapy. The geometric mean ratio (GMR) for Cavgd28 was 2.10 and for Cminss was 1.77. Additionally, as a key secondary endpoint, the objective response rate (ORR) in the nivolumab Sc arm (n=248) was 24% versus 18% in the Iv arm (n=247), demonstrating that Sc has similar efficacy compared to Iv. The safety profile of nivolumab Sc remained consistent with the intravenous formulation.

Pharmacokinetic, efficacy, and safety results from the CheckMate-67T study were presented at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium 2024. Further analyses were disclosed at the ASCO Annual Meeting 2024, the European Society for Medical Oncology (ESMO) Congress 2024, and were published in the Annals of Oncology.

"As the first subcutaneous PD-1 inhibitor approved in the European Union," said Laurence Albiges, Professor of Medical Oncology at the Université Paris-Saclay and Director of the Department of Oncology at Gustave Roussy, Villejuif, France, "subcutaneous nivolumab is helping to reshape the treatment landscape for eligible patients by offering them a new way to potentially achieve the same benefits as the intravenous formulation of nivolumab, in a more convenient way. This approval offers eligible patients and physicians a new way to personalize treatment plans based on the needs of each individual and to improve the effectiveness with which nivolumab can be administered from the perspective of the patient and the organization of our healthcare resources."

The EC approval is valid in all 27 EU Member States, as well as Iceland, Liechtenstein and Norway. On 27 December 2024, subcutaneous nivolumab and hyaluronidase-nvhy was approved by the US Food and Drug Administration (FDA).