Phase I study of intratumoral injection of talimogene laherparepvec for the treatment of advanced pancreatic cancer.

IF 4.8 2区医学 Q1 ONCOLOGY Oncologist Pub Date : 2025-01-17 DOI:10.1093/oncolo/oyae200

Karie Runcie, Yadriel Bracero, Avishai Samouha, Gulam Manji, Helen E Remotti, Tamas A Gonda, Yvonne Saenger

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Abstract

Background: Pancreatic ductal adenocarcinoma (PDAC) presents a redoubtable challenge due to late-stage diagnosis and limited treatment options, necessitating innovative therapeutic strategies.

Methods: 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.

Results: 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.

Conclusion: 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.

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瘤内注射 talimogene laherparepvec 治疗晚期胰腺癌的 I 期研究。

背景：胰腺导管腺癌（Pancreatic ductal adencarcinoma， PDAC）由于诊断晚期和治疗方案有限而面临着巨大的挑战，需要创新的治疗策略。方法：本文报告了fda批准的1型溶瘤性单纯疱疹病毒talimogene laherparepvec （T-VEC）治疗晚期PDAC患者的安全性和有效性。9例难治性晚期PDAC患者通过内镜注射逐步增加T-VEC剂量。结果：虽然没有观察到客观反应，但44%的患者实现了疾病稳定，中位总生存期为7.8个月，其中1例患者存活了28个月。不良事件是可控的，最大耐受剂量为108 PFU/mL。结论：我们的研究结果强调了肿瘤内给药T-VEC治疗晚期PDAC的可行性。进一步的研究，特别是与免疫疗法的系统应用相结合，有必要更优化地评估T-VEC在这种具有挑战性的恶性肿瘤中的作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Oncologist 医学-肿瘤学

CiteScore

10.40

自引率

3.40%

发文量

309

审稿时长

3-8 weeks

期刊介绍： The Oncologist® is dedicated to translating the latest research developments into the best multidimensional care for cancer patients. Thus, The Oncologist is committed to helping physicians excel in this ever-expanding environment through the publication of timely reviews, original studies, and commentaries on important developments. We believe that the practice of oncology requires both an understanding of a range of disciplines encompassing basic science related to cancer, translational research, and clinical practice, but also the socioeconomic and psychosocial factors that determine access to care and quality of life and function following cancer treatment.