Bristol Myers Squibb: Opdivo-Qvantig is the first FDA approved subcutaneous version of cancer immunotherapy targeting PD-1

1. Opdivo-Qvantig had a non-inferior objective response rate compared to intravenous formulation in patients with locally advanced or metastatic clear cell renal cell carcinoma.

2. About 8.1% of patients treated with Opdivo-Qvantig experienced a transient, local injection-site reaction.

The Latest

In the randomized phase 3 Checkmate-67T trial, researchers evaluated the subcutaneous formulation of nivolumab (Opdivo-Qvantig) to compare its pharmacokinetics, efficacy, and safety to the intravenous formulation in patients with locally advanced or metastatic clear cell renal cell carcinoma. Opdivo-Qvantig demonstrated a non-inferior objective response rate compared to the intravenous formulation. The safety profile of the subcutaneous formulation was similar to the intravenous formulation. However, about 8.1% of patients experienced a transient, local injection-site reaction.

Physician’s Perspective

Nivolumab has proven effective in improving overall survival across a range of advanced cancers, including melanoma, non-small cell lung cancer, advanced renal cell carcinoma, relapsed or recurrent Hodgkin’s lymphoma, metastatic squamous cell carcinoma of the head and neck, metastatic urothelial carcinoma, and others. Currently, it is delivered via intravenous infusion, a process that takes 30–60 minutes and typically requires patients to visit specialized infusion centers. Developing formulations that can be more conveniently administered could eliminate the need for frequent travel to these centers, making nivolumab more accessible to patients who face socioeconomic or geographic barriers to care.

Molecular Target of Therapy

Nivolumab is a human monoclonal antibody that targets programmed death-1 (PD-1) receptors on T cells and blocks PD-1’s interaction with PD-1 ligands. Interaction between PD-1 and its ligand usually suppresses the immune response to tumors. Therefore, by inhibiting this interaction nivolumab enhances the immune system’s ability to recognize and attack tumor cells. Opdivo-Qvantig co-formulates nivolumab with recombinant human hyaluronidase, an enzyme that facilitates subcutaneous absorption of nivolumab.

Company History

Bristol Myers Squibb is an American pharmaceutical company with products in a wide range of therapeutic areas including cancer, HIV/AIDS, cardiovascular disease, rheumatoid arthritis, and psychiatric disorders. The initial FDA approval for intravenous formulation of Opdivo was granted to Bristol Myers Squibb in 2014.

Further reading: https://www.annalsofoncology.org/article/S0923-7534(24)03996-6/fulltext

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