Tumors, immunotherapy under the skin

In the near future, immunotherapy against tumors will be increasingly administered subcutaneously, with important advantages for patients and the healthcare system. The new formulation of nivolumab, an immunotherapy drug widely used for the treatment of numerous solid tumors, has in fact obtained the green light from the European Commission for marketing.

The advantages of the subcutaneous route

Subcutaneous administration, i.e. under the skin, is an alternative to intravenous infusion. This modality has been spreading in the oncology field for some years thanks to new formulations of drugs already approved and widely used. The advantages concern the impact on the availability of infusion chairs, the reduced time dedicated to the preparation and administration of the treatment, which becomes a few minutes, and the possibility, for patients, to avoid repeated venous access or central venous access.

How immunotherapy works

As is known, immunotherapy is based on the concept of strengthening our immune system. Drugs such as nivolumab have the task of removing the "brake" on the immune response against the tumor, acting on what are called immune checkpoints. Nivolumab, in particular, is an inhibitor of the PD-1 immune checkpoint used since 2014, and can now also be administered subcutaneously as monotherapy, maintenance monotherapy following the completion of combination therapy with intravenous nivolumab plus ipilimumab, or in combination with chemotherapy or another drug (cabozantinib).

The European Commission's approval

The European Commission's decision is based on the results of the CheckMate -67T clinical study and additional data which demonstrated that the subcutaneous formulation is non-inferior – in efficacy and safety – to the intravenous formulation in adult patients with advanced or metastatic kidney cancer (clear renal cell carcinoma, ccRCC) who had received no more than two prior lines of systemic therapy and who had not been treated with prior immunotherapy.

“This approval offers eligible patients and physicians a new way to personalize treatment plans to each individual’s needs,” says Laurence Albiges , professor of Medical Oncology at Université Paris-Saclay, and director of the Department of Oncology at Gustave Roussy in Villejuif, France.

The pharmacokinetic, efficacy and safety results were presented last year at the ASCO Genitourinary Cancers Symposium, the ASCO Annual Congress, the European Society for Medical Oncology Congress, and published in Annals of Oncology . “This decision ushers in a new era of cancer care, where we can deliver a 3-5 minute injection of a treatment that changed the landscape of cancer care over a decade ago,” said Dana Walker , M.D., Ph.D., Head of the Global Nivolumab Program at Bristol Myers Squibb. “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 this goal.”