BMS's Subcutaneous Opdivo (Nivolumab) Set for FDA Approval Two Months Ahead of Schedule

May 22, 2024 07:45 CST Updated 07:45

Bristol-Myers Squibb

Biopharmaceutical and Nutritional Product R&D and Sales

On May 21, Bristol-Myers Squibb (BMS) announced that the U.S. FDA had readjusted nivolumab.（Opdivo，nivolumab) Subcutaneous injection preparationsBiological ProductsBiologics License Application (BLA)PDUFA Date, the regulatory deadline has been moved up from the previously announced February 28, 2025, toDecember 29, 2024. This also means that the drug is expected to receive FDA approval two months in advance, and is expected to become the first...The first approved subcutaneous PD-1 inhibitor.

NivolumabUstekinumab subcutaneous injection formulation byNivolumabUstekinumab &Halozyme's proprietary recombinant human hyaluronidase PH20 (rHuPH20).

Its marketing application is primarily based on aRandomized, Open-labelIPhase II CheckMate-67T Study（N=495）Data, the studyAim to evaluate subcutaneous injection versus intravenous infusion of nivolumabLiyudanabIn patients previously treated with systemic therapyAdvanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)Efficacy in patients.

The results showed,AndCompared with intravenous infusion of nivolumab, subcutaneous injection of nivolumab demonstrated non-inferiority in both average serum concentration over 28 days (Cavgd28) and steady-state serum trough concentration (Cminss), achieving the co-primary endpoints.The geometric mean ratios were 2.098 (90% Cl: 2.001-2.200）、1.774 (90% CI: 1.633-1.927)。

The key secondary endpoint, objective response rate (ORR), also demonstrated non-inferiority.The ORR of patients in the subcutaneous injection nivolumab group was 24.2%, while the ORR of patients in the intravenous infusion group was 18.2% (RR=1.33; 95% CI: 0.94-1.87), demonstrating non-inferiority; the PFS of patients in the subcutaneous injection nivolumab group was 7.23 months, while the latter value was...For 5.65 months.

In terms of safety,Subcutaneous injection of Nivolumab is consistent with intravenous infusion. The incidence of local injection site reactions for subcutaneous Nivolumab is 8.1%, all of which are low-grade and transient. Additionally,For subcutaneous injection and intravenous injection formulations, the proportions of patients experiencing grade 3-4 adverse events (AE) were 35.2% and 40.8%, respectively.The incidence rates of treatment-related AE were 9.7% and 14.7%, the incidence rates of serious AE were 21.1% and 22.9%, and the incidence rates of treatment-related serious AE were both 6.5%.

Currently, multiple companies are developing PD-(L)1 subcutaneous injection therapies,RocheAtezolizumabSubcutaneous InjectionTecentriq SCHas been approved for marketing in the UK,Compared with intravenous infusion which takes 30-60 minutes,Tecentriq SCIt takes approximately only 7 minutes;Merck & Co.The pivotal Phase III clinical trial for the subcutaneous injection of K drug was initiated in February 2023 and is expected to be completed in the third quarter of 2024.

In China, Junshi Biosciences launchedToripalimab (JS001) Subcutaneous injectionJS001scThePhase III Study; BeiGene is also developing a subcutaneous injection formulation of tislelizumab, which is currently in Phase I research.

Overall, the launch of subcutaneous injectable formulations not only helps companies extend the patent life of branded drugs but also significantly reduces treatment time for patients, saving time costs. It is believed that as cancer treatment progresses toward chronic disease management, subcutaneous injectable formulations, with better compliance, will have broad market potential in the future.

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