Rebecca Suk Heist and Aditya Bardia, Massachusetts General Hospital Cancer Center; Rebecca Suk Heist and Aditya Bardia, Harvard Medical School, Boston, MA; Michael J. Guarino and Gregory Masters, Helen F. Graham Cancer Center & Research Institute, Newark, DE; W. Thomas Purcell, Wells A. Messersmith, and D. Ross Camidge, University of Colorado Cancer Center, Aurora, CO; Alexander N. Starodub, Indiana University Health Center for Cancer Care, Goshen, IN; Leora Horn and Jordan Berlin, Vanderbilt-Ingram Cancer Center, Nashville, TN; Ronald J. Scheff and Allyson J. Ocean, Weill Cornell Medicine, New York, NY; and Serengulam V. Govindan, Pius Maliakal, Boyd Mudenda, William A. Wegener, Robert M. Sharkey, and David M. Goldenberg, Immunomedics, Morris Plains, NJ.
J Clin Oncol. 2017 Aug 20;35(24):2790-2797. doi: 10.1200/JCO.2016.72.1894. Epub 2017 May 26.
Purpose Trop-2, expressed in most solid cancers, may be a target for antibody-drug conjugates (ADCs) in non-small-cell lung cancer (NSCLC). We studied sacituzumab govitecan (IMMU-132), a Trop-2 ADC, for the targeting of SN-38. Patients and Methods We evaluated IMMU-132 in a single-arm multicenter trial in patients with pretreated metastatic NSCLC who received either 8 or 10 mg/kg on days 1 and 8 of 21-day cycles. The primary end points were safety and objective response rate (ORR). Progression-free survival and overall survival were secondary end points. Results Fifty-four patients were treated. In the response-assessable study population (n = 47), which had a median of three prior therapies (range, two to seven), the ORR was 19%; median response duration, 6.0 months (95% CI, 4.8 to 8.3 months); and clinical benefit rate (complete response + partial response + stable disease ≥ 4 months), 43%. ORR in the intention-to-treat (ITT) population was 17% (nine of 54). Responses occurred with a median onset of 3.8 months, including patients who had relapsed or progressed after immune checkpoint inhibitor therapy. Median ITT progression-free survival was 5.2 months (95% CI, 3.2 to 7.1 months) and median ITT overall survival, 9.5 months (95% CI, 5.9 to 16.7 months). Grade 3 or higher adverse events included neutropenia (28%), diarrhea (7%), nausea (7%), fatigue (6%), and febrile neutropenia (4%). One patient developed a transient immune response, despite patients receiving a median of 10 doses. More than 90% of 26 assessable archival tumor specimens were highly positive (2+, 3+) for Trop-2 by immunohistochemistry, which suggests that Trop-2 is not a predictive biomarker for response. Conclusion IMMU-132 was well-tolerated and induced durable responses in heavily pretreated patients with metastatic NSCLC. This ADC should be studied further in this disease and in other patients with Trop-2-expressing tumors.
目的 Trop-2 在大多数实体瘤中表达,可能成为非小细胞肺癌(NSCLC)中抗体药物偶联物(ADC)的靶点。我们研究了 Trop-2 ADC 药物 sacituzumab govitecan(IMMU-132)用于靶向 SN-38。
患者和方法 我们在一项多中心、单臂试验中评估了 IMMU-132,该试验纳入了接受过治疗的转移性 NSCLC 患者,这些患者接受了 8 或 10mg/kg 的剂量,每 21 天治疗一次,用药 2 天。主要终点是安全性和客观缓解率(ORR)。无进展生存期和总生存期为次要终点。
结果 54 例患者接受了治疗。在可评估反应的研究人群(n=47)中,中位既往治疗线数为 3 条(范围 2-7 条),ORR 为 19%;中位缓解持续时间为 6.0 个月(95%CI,4.8-8.3 个月);临床获益率(完全缓解+部分缓解+疾病稳定≥4 个月)为 43%。在意向治疗(ITT)人群中,ORR 为 17%(54 例中的 9 例)。反应的中位发生时间为 3.8 个月,包括免疫检查点抑制剂治疗后复发或进展的患者。中位 ITT 无进展生存期为 5.2 个月(95%CI,3.2-7.1 个月),中位 ITT 总生存期为 9.5 个月(95%CI,5.9-16.7 个月)。3 级或以上不良事件包括中性粒细胞减少症(28%)、腹泻(7%)、恶心(7%)、疲劳(6%)和发热性中性粒细胞减少症(4%)。尽管患者接受了中位数为 10 剂的治疗,但有 1 例患者发生了短暂的免疫反应。26 例可评估的存档肿瘤标本中,超过 90%的标本通过免疫组化检测呈高度阳性(2+、3+),这表明 Trop-2 不是反应的预测生物标志物。
结论 IMMU-132 耐受性良好,在接受过大量治疗的转移性 NSCLC 患者中诱导了持久的缓解。这种 ADC 药物应该在这种疾病和其他 Trop-2 表达肿瘤的患者中进一步研究。