Survival, safety, and response patterns in a phase 1b multicenter trial of talimogene laherparepvec (T-VEC) and ipilimumab (ipi) in previously untreated, unresected stage IIIB-IV melanoma.
Survival, safety, and response patterns in a phase 1b multicenter trial of talimogene laherparepvec (T-VEC) and ipilimumab (ipi) in previously untreated, unresected stage IIIB-IV melanoma.
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talimogene laherparepvec (T-VEC) 和 ipilimumab (ipi) 在先前未经治疗、未切除的 IIIB-IV 期黑色素瘤中进行的 1b 期多中心试验的生存率、安全性和反应模式。
DOI：
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发表时间：
2015
期刊：
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通讯作者：
H. Kaufman
中科院分区：
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作者：
I. Puzanov;M. Milhem;R. Andtbacka;D. Minor;O. Hamid;Ai Li;J. Chou;H. Kaufman
9063背景：T-VEC是一种hsv衍生的溶瘤免疫疗法，旨在诱导全身抗肿瘤免疫。在一项3期黑色素瘤研究中，T-VEC单药治疗与GM-CSF相比显著提高了持久缓解率（DRR，≥6个月缓解）（16% vs 2%, P < 0.0001）。与GM-CSF相比，T-VEC的中位生存期延长4.4个月（23.3个月vs 18.9个月；HR = 0.79, 95% CI: 0.62-1.00； P= 0.051; Kaufman et al, ASCO 2014）。与单独使用任何一种药物相比，联合使用T-VEC促进肿瘤源性抗原释放和免疫检查点抑制剂可能会提高疗效。该1b/2期联合研究（NCT01740297）的1b期部分完成了入组并达到了其主要目标，无剂量限制性毒性（dlt），客观缓解率（ORR）为56% （Puzanov等）。ASCO 2014)。方法：主要纳入标准包括IIIB-IV期黑色素瘤；既往无系统治疗；可衡量的疾病;≥1个可注射性皮肤、皮下或淋巴结病变。T-VEC是内注射的…
9063 Background: T-VEC is an HSV-derived oncolytic immunotherapy designed to induce systemic antitumor immunity. In a phase 3 melanoma study, T-VEC monotherapy significantly improved durable response rate (DRR, ≥ 6 month response) vs GM-CSF (16% vs 2%, P < 0.0001; Andtbacka et al. ASCO 2013), and median OS was 4.4 months longer for T-VEC vs GM-CSF (23.3 vs 18.9 months; HR = 0.79, 95% CI: 0.62-1.00; P= 0.051; Kaufman et al, ASCO 2014). Combining T-VEC to promote tumor-derived antigen release with an immune checkpoint inhibitor may enhance efficacy compared to either agent alone. The phase 1b portion of this phase 1b/2 combination study (NCT01740297) completed enrollment and met its primary objective with no dose-limiting toxicities (DLTs) and an objective response rate (ORR) of 56% (Puzanov et al. ASCO 2014). Methods: Key inclusion criteria included stage IIIB-IV melanoma; no prior systemic treatment; measurable disease; and ≥ 1 injectable cutaneous, subcutaneous, or nodal lesion. T-VEC was given intralesi...