Runcie Karie, Bracero Yadriel, Samouha Avishai, Manji Gulam, Remotti Helen E, Gonda Tamas A, Saenger Yvonne
Department of Hematology, Oncology New York Presbyterian Hospital, New York, NY 10032, United States.
Department of Oncology Albert Einstein College of Medicine, Bronx, NY 10461, United States.
Oncologist. 2025 Jan 17;30(1). doi: 10.1093/oncolo/oyae200.
Pancreatic ductal adenocarcinoma (PDAC) presents a redoubtable challenge due to late-stage diagnosis and limited treatment options, necessitating innovative therapeutic strategies.
Here, we report our results investigating the safety and efficacy of talimogene laherparepvec (T-VEC), an FDA-approved oncolytic herpes simplex virus type 1, in patients with advanced PDAC. Nine patients with treatment-refractory advanced PDAC received escalating doses of T-VEC via endoscopic injection.
While no objective responses were observed, stable disease was achieved in 44% of patients, with a median overall survival of 7.8 months, including one patient who survived 28 months. Adverse events were manageable, with the maximum tolerated dose determined to be 108 PFU/mL.
Our findings underscore the feasibility of intratumoral T-VEC administration in advanced PDAC. Further investigation, particularly in combination with immunotherapies administered systemically is warranted to more optimally assess T-VEC in this challenging malignancy.ClinicalTrials.gov Identifier: NCT03086642.
胰腺导管腺癌（PDAC）由于诊断晚期和治疗选择有限，带来了严峻的挑战，因此需要创新的治疗策略。
在此，我们报告了对talimogene laherparepvec（T-VEC）（一种经美国食品药品监督管理局批准的1型溶瘤单纯疱疹病毒）在晚期PDAC患者中的安全性和疗效进行研究的结果。9例治疗难治性晚期PDAC患者通过内镜注射接受了递增剂量的T-VEC。
虽然未观察到客观缓解，但44%的患者病情稳定，中位总生存期为7.8个月，其中1例患者存活了28个月。不良事件可控，确定最大耐受剂量为108 PFU/mL。
我们的研究结果强调了在晚期PDAC中瘤内注射T-VEC的可行性。有必要进行进一步研究，特别是与全身免疫疗法联合使用，以便在这种具有挑战性的恶性肿瘤中更全面地评估T-VEC。临床试验注册号：NCT03086642。
