医学
彭布罗利珠单抗
内科学
肿瘤科
临床终点
肺癌
临床研究阶段
溶瘤病毒
无进展生存期
进行性疾病
化疗
外科
胃肠病学
癌症
免疫疗法
临床试验
作者
Jian Guan,Kai Sun,Carlo Guerrero,Junjun Zheng,Yitian Xu,Sunil Mathur,Bin S. Teh,Andrew M. Farach,Jun Zhang,Edward C. V. Butler,Ping-Ying Pan,Eva M Zsigmond,Zhuyong Mei,Jaime Mejia,Shu‐Hsia Chen,Jenny C. Chang,Eric H. Bernicker
标识
DOI:10.1016/j.ijrobp.2023.08.044
摘要
A phase 2 study of stereotactic body radiation therapy (SBRT) and in situ oncolytic virus therapy in metastatic non-small cell lung cancer (mNSCLC) followed by pembrolizumab (STOMP) was designed to explore the dual approach in enhancing single pembrolizumab with ADV/HSV-tk plus valacyclovir gene therapy and SBRT in mNSCLC.STOMP is a single-arm, open-label phase 2 study. Patients with mNSCLC received intratumoral injections of ADV/HSV-tk (5 × 1011 vp) and SBRT (30 Gy in 5 fractions) followed by pembrolizumab 200 mg IV every 3 weeks until disease progression or intolerable toxicity. The primary endpoint was overall response rate (ORR) (complete response [CR] and partial response [PR]). Secondary endpoints included clinical benefit rate (CBR) (CR, PR and stable disease [SD]), progression-free survival (PFS), overall survival (OS), and safety.28 patients were enrolled, of whom 27 were evaluated for response. The ORR was 33.3%, including 2 CR (7.4%) and 7 PR (25.9%). CBR was 70.4%. Six of eight (75.0%) patients who were immune checkpoint inhibitor (ICI) refractory derived clinical benefits. Responders had durable responses with median PFS, and OS not reached. The entire cohort had a median PFS of 7.4 months (95% CI, 5.1-9.6 months), and median OS of 18.1 months (95% CI, 15.4-20.9 months). The combination was well tolerated, with grade 3 or higher toxicity in 6 (21.4%) patients.The dual approach of in situ ADV/HSV-tk plus valacyclovir gene therapy and SBRT as a chemotherapy-sparing strategy to enhance the antitumor effect of pembrolizumab is a well-tolerated encouraging treatment in patients with mNSCLC.
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