The phase 3 CheckMate-67T trial has been evaluating subcutaneous Opdivo, co-formulated with Halozyme’s proprietary recombinant human hyaluronidase technology, compared to the drug’s intravenous form in patients with advanced or metastatic clear cell RCC who have received prior systemic therapy. According to the results presented at this year’s American Society of Clinical Oncology Genitourinary Cancers Symposium, subcutaneous Opdivo met the study’s co-primary endpoints by demonstrating non-inferior pharmacokinetics, and also demonstrated a non-inferior objective response rate compared to intravenous administration, a key secondary endpoint of the trial. More than 430,000 new cases of RCC are diagnosed globally each year, with clear cell RCC affecting about 70% of RCC patients. Gina Fusaro, vice president, global programme lead, BMS, said: “Convenience is an important benefit of subcutaneous immunotherapy and we are excited about the potential for this treatment to reduce patient burden and provide greater flexibility to patients and health care providers.
“We look forward to discussing next steps for subcutaneous [Opdivo] across multiple tumour types with health authorities.” “Having the option to administer immunotherapy subcutaneously could undoubtedly reduce the treatment burden that patients diagnosed with cancer currently face, as well as help maximise efficiencies within healthcare systems,” said Saby George, professor of oncology and medicine, director of Network Clinical Trials, Department of Medicine, Roswell Park Comprehensive Cancer CenterCancer Center.