OPDIVO QVANTIG(nivolumab and hyaluronidase-nvhy)

OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy) is a biologic drug submitted for a 351(a) Biologics License Application (BLA) on February 29, 2024. The applicant proposed its use, in combination with cabozantinib, for the first-line treatment of adult patients with advanced RCC. Recommended indications from regulatory review include adjuvant treatment of adult patients with UC at high risk of recurrence after radical resection, and adult patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. It is also recommended for adult patients with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as monotherapy or following combination treatment with intravenous nivolumab and ipilimumab, and for adult patients with HCC previously treated with sorafenib and following combination treatment with intravenous nivolumab and ipilimumab.

In efficacy studies, the Objective Response Rate (ORR) for OPDIVO QVANTIG was 24.2% (95% CI lower bound: 19.0%, upper bound: 30.0%). The ORR for the nivolumab IV arm was 18.2% (95% CI lower bound: 13.6%). Overall survival was reported at 6.3 months and 8.3 months in different analyses. PD-L1 expression was observed in 3 patients with >= 1% expression and 2 patients with >= 50% expression. MSI-H colorectal cancer patients numbered 7 and 4 in different cohorts.

Safety data indicates that 81.8% of subjects in the nivolumab SC arm received concomitant non-study medications. The incidence of treatment-emergent anti-nivolumab antibodies was 22.8% for the SC arm and 7.0% for the IV arm. Anti-rHuPH20 antibodies were observed in 8.8% of subjects. Treatment discontinuation due to disease progression occurred in 109 subjects in the nivolumab SC arm and 110 in the nivolumab IV arm. Treatment discontinuation due to study drug toxicity was observed in 14 subjects in the nivolumab SC arm.