To report urinary bother, urinalysis changes, disease-free survival (DFS), and overall survival (OS) over 2 years for subjects enrolled in a phase I dose-escalation trial (NCT02324582) of intravesical Bacillus Calmette-Guérin (BCG) in combination with systemic pembrolizumab for recurrent or persistent high-grade non-muscle invasive bladder cancer (HGNMIBC). Eighteen patients consented to the study. Five were screen failures. Clinical activity was determined using cystoscopy and cytology with a biopsy of suspicious lesions. Urinalysis and International Prostate symptom score were assessed at pre-treatment, Week 10 (during combined BCG and pembrolizumab treatment), and 3 and 6 months from treatment completion. IPSS was analyzed using a mixed-model repeated measures analysis. A Chi-square test was used to compare urinalysis results at each interval. The pathologic disease stage after restaging transurethral resection and before treatment was pTa in 6 (46.2%), CIS in 6 (46.2%), and pT1 in 1 (7.7%). There was no increase in reported urinary bother throughout treatment. Quality of life measurements demonstrated no change in subjective burden. On urinalysis, we did not observe significant differences at 3 months compared to baseline evaluation. At 12 months, the DFS and OS were 69.23% and 92.31%, respectively. At 24 months, the DFS and OS were 38.46% and 92.31%, respectively. Treatment with BCG combined with intravenous pembrolizumab is not showing increased urinary bother or adverse urinalysis changes. Two-year response data is promising and await confirmation in the phase III study (Keynote 676)

中文翻译：

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膀胱灌注卡介苗联合静脉注射帕博利珠单抗治疗卡介苗治疗后复发或持续性高级别非肌层浸润性膀胱癌的 I 期试验的尿路不适、尿液分析和两年疗效随访结果

报告参加膀胱内卡介苗 (BCG) 联合用药 I 期剂量递增试验 (NCT02324582) 的受试者 2 年以上的尿路不适、尿液分析变化、无病生存 (DFS) 和总生存 (OS)联合派姆单抗全身治疗复发性或持续性高级别非肌层浸润性膀胱癌 (HGNMIBC)。十八名患者同意这项研究。五是屏幕故障。使用膀胱镜检查和细胞学检查以及可疑病变的活检来确定临床活性。在治疗前、第 10 周（BCG 和派姆单抗联合治疗期间）以及治疗完成后 3 个月和 6 个月评估尿液分析和国际前列腺症状评分。 IPSS 使用混合模型重复测量分析进行分析。卡方检验用于比较每个时间间隔的尿液分析结果。经尿道电切术后和治疗前的病理疾病分期为 pTa 6 例（46.2%），CIS 6 例（46.2%），pT1 1 例（7.7%）。在整个治疗过程中，报告的排尿问题没有增加。生活质量测量表明主观负担没有变化。在尿液分析中，与基线评估相比，我们在 3 个月时没有观察到显着差异。 12 个月时，DFS 和 OS 分别为 69.23% 和 92.31%。 24 个月时，DFS 和 OS 分别为 38.46% 和 92.31%。卡介苗联合静脉注射派姆单抗治疗未显示排尿问题增加或尿液分析不良变化。两年的反应数据很有希望，并等待 III 期研究的确认（主题演讲 676）