Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Republic of Korea.
Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
J Immunother Cancer. 2023 Oct;11(10). doi: 10.1136/jitc-2023-007444.
This study assessed the antitumor activity and safety of durvalumab plus tremelimumab combined with neoadjuvant chemotherapy (NAC) in patients newly diagnosed with advanced ovarian cancer. Here, we report the primary endpoint of the original cohort of the KGOG 3046/TRU-D study.
In this investigator-initiated single-arm, phase II trial, patients with stage IIIC-IVB ovarian cancer were administered three cycles of durvalumab (1500 mg) and tremelimumab (75 mg) with NAC, followed by interval debulking surgery (IDS). After surgery, three cycles of durvalumab (1120 mg) and adjuvant chemotherapy followed by durvalumab maintenance (1120 mg [total 12 cycles]) were administered. The primary endpoint of the study was 12-month progression-free survival (PFS) rate.
Twenty-three patients were enrolled. The median patient age was 60 years (range 44-77 years), and most patients presented with high-grade serous carcinoma (87.0%) and stage IV disease (87.0%). At the time of data cut-off on January 17, 2023, the median follow-up duration was 29.2 months (range 12.0-42.2). The 12-month, 24-month, and 30 month PFS rates were 63.6%, 45.0%, and 40.0%, respectively. All patients underwent IDS, with an R0 resection rate of 73.9%, and 17.4% achieved pathological complete response. Skin rashes were the most common treatment-related adverse events (TRAEs, 69.6%). However, all TRAEs completely resolved after steroid use.
This study showed promising activity with a durable clinical response, supporting the potential of NAC with dual immune checkpoint blockade in advanced-stage ovarian cancer.
NCT03899610.
本研究评估了度伐利尤单抗联合替西木单抗联合新辅助化疗（NAC）在新诊断为晚期卵巢癌患者中的抗肿瘤活性和安全性。在此，我们报告了 KGOG 3046/TRU-D 研究原始队列的主要终点。
在这项由研究者发起的、单臂、Ⅱ期临床试验中，ⅡC 期-IVB 期卵巢癌患者接受了 NAC 联合度伐利尤单抗（1500 mg）和替西木单抗（75 mg）的三个周期治疗，随后进行间隔减瘤手术（IDS）。手术后，患者接受三个周期的度伐利尤单抗（1120 mg）和辅助化疗，然后进行度伐利尤单抗维持治疗（1120 mg[共 12 个周期]）。研究的主要终点是 12 个月无进展生存期（PFS）率。
共纳入 23 例患者。患者中位年龄为 60 岁（范围 44-77 岁），大多数患者为高级别浆液性癌（87.0%）和 IV 期疾病（87.0%）。截至 2023 年 1 月 17 日数据截止时，中位随访时间为 29.2 个月（范围 12.0-42.2）。12 个月、24 个月和 30 个月的 PFS 率分别为 63.6%、45.0%和 40.0%。所有患者均接受了 IDS，R0 切除率为 73.9%，17.4%达到病理完全缓解。皮肤皮疹是最常见的治疗相关不良事件（TRAEs，69.6%）。然而，所有 TRAEs 在使用类固醇后完全缓解。
本研究显示出有前景的活性和持久的临床缓解，支持 NAC 联合双重免疫检查点阻断在晚期卵巢癌中的应用潜力。
NCT03899610。
