The CheckMate -67T trial showed that the subcutaneous nivolumab demonstrated noninferior pharmacokinetics and objective response rate compared to intravenous Opdivo
SC Opdivo shows noninferiority against IV Opdivo in Phase 3 study. (Credit: Myriams-Fotos from Pixabay)
Bristol Myers Squibb (BMS) announced that the subcutaneous (SC) formulation of Opdivo (nivolumab) has shown noninferiority compared to intravenous (IV) Opdivo in Phase 3 CheckMate -67T trial of patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC).
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor. It is designed to use the body’s immune system to assist restore anti-tumour immune response.
The randomised, open-label CheckMate -67T study evaluated Opdivo co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20 against IV Opdivo in ccRCC patients who have received prior systemic therapy.
According to the results, subcutaneous nivolumab showed noninferiority for the co-primary endpoints of Cavgd28, which is the time-averaged Opdivo serum concentration over 28 days compared to IV Opdivo.
In addition, the SC formulation also met the co-primary endpoint of Cminss, which is a trough serum concentration at a steady state.
Furthermore, SC nivolumab exhibited noninferior objective response rate (ORR) compared to IV Opdivo, as evaluated by Blinded Independent Central Review (BICR).
Bristol Myers Squibb global program lead vice president Gina Fusaro said: “These results from the CheckMate -67T trial build on our deep scientific expertise in the use of immunotherapy in solid tumour oncology and our commitment to finding ways to help improve quality of life for patients.
“We are thrilled to present this research for the first time evaluating subcutaneous nivolumab, demonstrating noninferiority compared to intravenous Opdivo and supporting subcutaneous nivolumab as a potential new option to improve healthcare efficiency.”
In a separate development, BMS said that the Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation approval of Abecma (idecabtagene vicleucel) to treat adult patients with relapsed and refractory multiple myeloma (MM)
European Medicines Agency’s (EMA) committee has recommended Abecma for MM patients who have received at least two prior therapies.
The positive opinion was based on the final progression-free survival (PFS) analysis from the Phase 3 KarMMa-3 study.
The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medications for the European Union (EU).