Prognosis of metastatic triple negative breast cancer (mTNBC) remains poor despite recent advances in therapeutic options. Trastuzumab deruxtecan (T-DXd) has shown promising efficacy in patients with human epidermal growth factor receptor 2 (HER2)-low breast cancer, which is defined by immunohistochemistry (IHC) 1+ or 2+ and lack of HER2 amplification by fluorescence in situ hybridization (FISH) testing. The purpose of the study is to evaluate the safety and initial evidence of efficacy of intratumoral administration of CF33-hNIS-anti-PD-L1 (CHECKvacc) against mTNBC. Oncolytic virus CHECKvacc intratumoral injection is currently undergoing investigation in patients with mTNBC as a single agent (NCT05081492). The patient was enrolled on the clinical trial CHECKvacc for the Treatment of Metastatic Triple Negative Breast Cancer, received a single dose of CHECKvacc, and discontinued the study due to lack of immediate response. We report a case of a patient with mTNBC who was heavily pretreated and presented with extensive dermal metastasis. Two dermal metastasis biopsies in 2021 showed HER2 0 by IHC. The patient received a single dose of CHECKvacc and discontinued the study due to lack of immediate response. Twenty-five days later, the patient received treatment with T-DXd, and her tumor regressed significantly. The patient's disease-free survival was 10 months (December 2021-October 2022). The sequential treatment with intratumoral injection of CHECKvacc followed by T-DXd may have significant clinical activity in select patients with heavily pretreated mTNBC. ClinicalTrials.gov NCT05081492.

中文翻译：

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CF33-hNIS-抗 PD-L1 溶瘤病毒治疗转移性三阴性乳腺癌患者，随后使用曲妥珠单抗-deruxtecan：案例研究。

尽管治疗方案最近取得了进展，但转移性三阴性乳腺癌（mTNBC）的预后仍然很差。曲妥珠单抗 deruxtecan (T-DXd) 在人表皮生长因子受体 2 (HER2) 低乳腺癌患者中显示出良好的疗效，这种乳腺癌的定义是免疫组织化学 (IHC) 1+ 或 2+ 且缺乏原位荧光 HER2 扩增杂交（FISH）测试。本研究的目的是评估肿瘤内注射 CF33-hNIS-抗 PD-L1 (CHECKvacc) 对抗 mTNBC 的安全性和有效性的初步证据。溶瘤病毒 CHECKvacc 瘤内注射目前正在 mTNBC 患者中作为单一药物进行研究 (NCT05081492)。该患者参加了治疗转移性三阴性乳腺癌的临床试验 CHECKvacc，接受了单剂量的 CHECKvacc，但由于缺乏立即反应而终止了研究。我们报告了一例 mTNBC 患者，该患者经过大量预处理后出现广泛的皮肤转移。2021 年的两次皮肤转移活检显示 IHC 为 HER2 0。该患者接受了单剂量的 CHECKvacc，但由于缺乏立即反应而终止了研究。25天后，患者接受T-DXd治疗，肿瘤明显消退。患者无病生存期为10个月（2021年12月至2022年10月）。瘤内注射 CHECKvacc 随后进行 T-DXd 的序贯治疗可能对特定接受过大量治疗的 mTNBC 患者具有显着的临床活性。ClinicalTrials.gov NCT05081492。