Sacituzumab Govitecan + Pembrolizumab for MIBC: Efficacy & Maintenance Study
Summary of the SURE-02 Study Findings on Sacituzumab Govitecan and Pembrolizumab for Muscle-Invasive Bladder Cancer (MIBC)
This article details the initial findings from the SURE-02 study, investigating the combination of sacituzumab govitecan and pembrolizumab as a neoadjuvant therapy for patients with MIBC who are ineligible for or refuse cisplatin-based chemotherapy.
Key findings:
Clinical Complete Response (cCR) Rate: 44.4% (95% CI, 27.9%-61.9%) in the intention-to-treat (ITT) population (n=36).This is considered promising, especially as all patients achieving cCR were able to avoid bladder removal.
Pathological Response: ypT ≤ 1N0-x rate was 55.6%.
Subtype Response: Patients with luminal subtype tumors showed a greater likelihood of responding to treatment, despite luminal subtypes typically being associated with immunotherapy resistance.
Event-Free Survival (EFS): 12-month EFS rate was 71.3% (95% CI, 55.7%-91.2%).
Metastasis-Free Survival (MFS): 12-month MFS rate was 84.2% (95% CI, 72%-98.5%).
Bladder-Intact EFS: 100% for patients achieving cCR (n=16) and 74% (95% CI, 54.8%-99%) for those undergoing TURBT (n=23).
Safety: Any-grade treatment-related adverse effects (TRAEs) occurred in 90% of patients (n=49). (Further details on specific TRAEs are not provided in this excerpt).
study Design:
Type: Italian, open-label, single-arm study.
Participants: Adult patients with MIBC ineligible for/refusing cisplatin-based chemotherapy.
Treatment: Sacituzumab govitecan (7.5 mg/kg) + pembrolizumab (200 mg) every 3 weeks for 4 cycles, followed by radical cystectomy/TURBT and then adjuvant/maintenance pembrolizumab for 13 cycles.
Primary Endpoint: cCR rate at 36 months.
Secondary Endpoints: Pathological response, EFS, MFS, overall survival, and safety.
* Baseline Characteristics: Median age 64, predominantly male (77.8%), mostly refused chemotherapy (63.9% & 80.6%), had residual disease (72.2%), and stage cT2N0 disease (69.4%).
the initial results from SURE-02 suggest that the combination of sacituzumab govitecan and pembrolizumab might potentially be a promising treatment option for patients with MIBC who cannot receive or refuse cisplatin-based chemotherapy, especially those with luminal subtype tumors. Further follow-up is needed to assess long-term outcomes and confirm thes findings.