NuLeusin, 3SBio’s second-generation IL-2, is a genetically modified form of IL-2 possessing improved biochemical properties over naturally occurring IL-2. Clinical trials examined the safety and efficacy of two treatment cycles of subcutaneous injections of NuLeusin. During each six-week treatment cycle, patients were given daily doses of 7MIU/square meter in the induction phase and daily doses of 3.5MIU/square meter in the maintenance phase.
The results showed an overall efficacy (complete response + partial response) of 12.73% and a disease control rate (complete response + partial response + stable disease) of 60%. Compared to Chiron’s Proleukin, a treatment available in the US, which is believed to be the only similar product on the market,
NuLeusin demonstrated similar levels of efficacy with a much lower dosage.
More importantly, NuLeusin showed an improved safety and tolerability profile in patients who participated in the Phase III study, the company said.
Jing Lou, CEO of 3SBio, said: “NuLeusin was developed to provide a new immunotherapy regimen for oncologists to treat patients with late stage metastatic renal cell carcinoma. Upon approval, we believe many patients who have exhausted their treatment options will benefit from this new alternative. In addition, NuLeusin is expected to further expand 3SBio’s existing presence in the oncology market in China.”