From March 13 to 16, 2026, the 41st Annual Congress of the European Association of Urology (EAU26) was held in London, UK. Data from a Phase I/II clinical study of SIM0237, a PD-L1/IL-15 bifunctional fusion protein independently developed by Simcere Zaiming, were presented in an oral presentation at the congress. The available data demonstrated excellent safety and antitumor efficacy of SIM0237 monotherapy in patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC), garnering significant attention from the international academic community.
NMIBC is a common type of bladder cancer, accounting for approximately 75% of newly diagnosed cases. Despite undergoing local surgical resection and postoperative intravesical chemotherapy or BCG therapy, patients still face a high risk of recurrence and progression. New treatment options are urgently needed for NMIBC patients who are unresponsive to BCG therapy.
SIM0237 is an anti-PD-L1 monoclonal antibody fused with a potency-reduced IL-15/IL-15Rα sushi domain. This molecule exerts synergistic antitumor effects through dual targeting mechanism. The attenuated IL-15 increases drug tolerability and exposure.
In this open-label, multicenter Phase I/II study （SIM0237-102）in high-risk NMIBC patients who are unresponsive to BCG，49 subjects had received SIM0237 monotherapy as of the data cut-off date. Among 10 subjects with carcinoma in situ (CIS), 8 (80%) achieved a complete response (CR). The median duration of complete response (DurCR) was not yet reached, and the probability of DurCR ≥ 12 months was 71.4%. Among 35 subjects with papillary carcinoma only, the median disease-free survival (DFS) was not yet reached, and the 12-month DFS rate was 65.8%.