Dr Cigliola on the Efficacy of Sacituzumab Govitecan in MIBC

Antonio Cigliola, MD, medical oncologist, IRCCS San Raffaele Hospital, discusses interim efficacy findings from the phase 2 SURE-01 study (NCT05226117) investigating neoadjuvant sacituzumab govitecan-hziy (Trodelvy) in patients with muscle-invasive bladder cancer (MIBC).

Of the 38 patients who were enrolled onto SURE-01, 31 received neoadjuvant sacituzumab govitecan and 18 completed all 4 cycles of treatment. In total, 21 efficacy-evaluable patients comprised the intention-to-treat (ITT) population, and 11 patients underwent radical cystectomy. Seven patients refused to undergo radical cystectomy after displaying evidence of clinical complete response (CR; n = 6) or according to patient decision (n = 1); these patients received repeat transurethral resection of their bladder tumors. The median duration of treatment was 11.7 weeks (range, 0.4-16.4), and the median time from the end of sacituzumab govitecan therapy to surgery was 6.9 weeks (range, 4.3-9.9).

At a median follow-up of 7.1 months, patients who underwent radical cystectomy had a pathologic CR (pCR) rate of 36.4% (95% CI, 14.9%-64.8%). In the ITT population, the pCR rate was 47.6% (95% CI, 28.3%-67.6%), and 11 patients had pathological downstaging.

Furthermore, all patients with residual ypT3 to ypT4N0 or ypTanyN-positive disease following treatment with sacituzumab govitecan were circulating tumor DNA (ctDNA)–negative after radical cystectomy, Cigliola says. The remaining ctDNA analyses of pre- and post-therapy biomarker associations are ongoing and immature.

Regarding safety, the most common any-grade treatment-related adverse effects (TRAEs) were anemia (42.8%), neutropenia (33.3%), thrombocytopenia (4.8%), diarrhea (42.9%), nausea (14.3%), vomiting (4.8%), alopecia (38.1%), cutaneous AEs (4.8%), hematuria (4.8%), urinary tract infections (4.8%), creatinine increases (9.5%), sepsis (14.3%), and fatigue (28.6%). The most common grade 3/4 TRAEs were anemia (grade 3, 4.8%; grade 4, 0%), neutropenia (9.5%; 19.1%), diarrhea (23.9%; 0%), increased creatinine (9.5%; 0%), and sepsis (0%; 9.5%). One instance of grade 5 sepsis was observed.

Notably, the phase 2 SURE-02 trial (NCT05535218) is evaluating sacituzumab govitecan plus pembrolizumab (Keytruda) followed by adjuvant pembrolizumab in patients with MIBC.