Dr Cigliola on Potential Implications of the SURE-01 and SURE-02 Trials in MIBC

Antonio Cigliola, MD, medical oncologist, IRCCS San Raffaele Hospital, discusses potential clinical implications of data from the phase 2 SURE-01 study (NCT05226117), as well as anticipated data from the phase 2 SURE-02 trial (NCT05535218), for patients with cisplatin-ineligible muscle-invasive bladder cancer (MIBC).

The SURE-01 trial investigated the use of neoadjuvant sacituzumab govitecan-hziy (Trodelvy) in patients with MIBC, Cigliola begins. Patients in this population historically have limited treatment options, particularly those ineligible for cisplatin, he notes. Interim results from the SURE-01 trial, presented at the 2024 ASCO Annual Meeting, revealed a pathological complete response (pCR) rate of 36.4% (95% CI, 14.9%-64.8%) among the 11 patients who underwent radical cystectomy following neoadjuvant treatment. In the intention-to-treat population, the pCR rate was 47.6% (95% CI, 28.3%-67.6%).

These results indicate that sacituzumab govitecan, which has been effective in treating patients with other cancers such as breast cancer, also holds promise for patients with MIBC who face poor prognoses with current standard treatments, Cigliola states. Importantly, the trial monitored safety profiles closely, with dose adjustments implemented after the first 8 patients experienced high rates of adverse effects, he details. This careful management underscores the potential of sacituzumab govitecan as a viable neoadjuvant option in MIBC, Cigliola emphasizes.

Looking ahead, investigators are optimistic that the findings from SURE-01, along with forthcoming data from the SURE-02 trial, could significantly impact the treatment landscape for cisplatin-ineligible MIBC patients, Cigliola says. The SURE-02 trial is evaluating perioperative therapy with sacituzumab govitecan in combination with pembrolizumab (Keytruda), followed by adjuvant pembrolizumab after radical cystectomy. If successful, this combination approach may offer a new therapeutic strategy for a patient population that currently has few effective options, he concludes.