Opdivo SC approved EU

Bristol Myers Squibb announced that the European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). Opdivo SC, or nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20), has been approved for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

“The EC’s decision to approve Opdivo SC ushers in a new era of cancer care in which we are able to deliver a 3- to 5-minute injection of a treatment that has shown consistent efficacy and comparable safety to intravenous Opdivo, which changed the cancer treatment landscape over a decade ago,” said Dana Walker, M.D., M.S.C.E., Opdivo global program lead, Bristol Myers Squibb. “BMS is committed to advancing medicines that help improve the patient experience, and with the approval of Opdivo SC in the European Union, we are delivering on this goal.”

The positive EC decision is based on results from the CheckMate -67T clinical trial and additional data that demonstrated comparable pharmacokinetics (PK) and safety profiles between Opdivo SC and IV Opdivo. The CheckMate –67T clinical trial showed noninferiority of PK primary endpoints, Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state), with Opdivo SC vs. IV Opdivo in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who had received no more than two prior lines of systemic therapy but had not received prior immuno-oncology therapy. The geometric mean ratio (GMR) for Cavgd28 was 2.10 (90% CI: 2.00-2.20) and the GMR for Cminss was 1.77 (90% CI: 1.63-1.93). Additionally, as a key powered secondary endpoint, the objective response rate (ORR) in the Opdivo SC arm (n=248) was 24% (95% CI: 19-30), compared with 18% (95% CI: 14-24) in the IV Opdivo arm (n=247), showing that Opdivo SC has similar efficacy compared to IV Opdivo. The safety profile of Opdivo SC remained consistent with the IV formulation.

“As the first and only subcutaneously administered PD-1 inhibitor approved in the European Union, subcutaneous nivolumab is helping to transform the treatment landscape for eligible patients by giving them a new way to potentially receive the same benefits of the IV formulation of nivolumab, in a more convenient manner,” said Laurence Albiges, M.D., Ph.D., a professor of medical oncology at Université Paris-Saclay, and head of the Department of Oncology at Gustave Roussy, Villejuif, France. “This approval provides eligible patients and their doctors a new way to tailor treatment plans for each individual’s needs and to improve the efficiency with which nivolumab can be administered from a patient perspective as well as in the organization of our healthcare resources.”

The approval by the EC is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. On December 27, 2024, subcutaneous nivolumab and hyaluronidase-nvhy, marketed under the brand name Opdivo Qvantig was approved by the FDA.

CheckMate -67T was a Phase III, randomized, open-label, noninferiority trial evaluating Opdivo Qvantig compared to intravenous (IV) Opdivo, in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received prior systemic therapy. A total of 495 patients were randomized to receive either Opdivo Qvantig (1,200 mg of nivolumab and 20,000 units of hyaluronidase) every 4 weeks subcutaneously (n = 248), or Opdivo 3 mg/kg every 2 weeks intravenously (n = 247). The coprimary endpoints were time-averaged concentration over 28 days (Cavgd28) and minimum concentration at steady state (Cminss). The key powered secondary endpoint was overall response rate, as assessed by blinded independent central review.

Select Safety Profile from CheckMate -67T - Serious adverse reactions occurred in 28% of patients receiving Opdivo Qvantig (n=247). The most frequent serious adverse reactions reported in >1% of patients who received Opdivo Qvantig were pleural effusion (1.6%), pneumonitis (1.6%), hyperglycemia (1.2%), hyperkalemia (1.2%), hemorrhage (1.2%) and diarrhea (1.2%). The most common adverse reactions (≥10%) in patients treated with Opdivo Qvantig (n=247) were musculoskeletal pain (31%), fatigue (20%), pruritus (16%), rash (15%), hypothyroidism (12%), diarrhea (11%), cough (11%), and abdominal pain (10%). Fatal adverse reactions occurred in 3 (1.2%) patients who received Opdivo Qvantig; these included myocarditis, myositis, and colitis complications. Study therapy was discontinued in 10% of patients due to adverse reactions. The safety profile of Opdivo Qvantig was comparable with the safety profile of IV Opdivo.

About Subcutaneous Administration - Subcutaneous administration is delivery of treatment beneath the skin and is an alternative to IV infusion. There are several potential benefits of subcutaneous administration: it may offer the flexibility to provide and receive treatment where it is best for the healthcare provider and patient, may impact infusion chair capacity, and may reduce time spent preparing and administering treatment. It may also simplify administering treatment for patients who have difficult-to-access veins or do not want a port. Subcutaneous treatment has the potential to be administered by a healthcare professional without site of care restrictions.