Phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma.
Phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma.
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DOI：
10.1002/hed.26885
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发表时间：
2021-12
影响因子：
2.9
通讯作者：
Gillenwater, Ann M.
中科院分区：
文献类型：
--
作者：
Cognetti, David M.;Johnson, Jennifer M.;Curry, Joseph M.;Kochuparambil, Samith T.;McDonald, Darren;Mott, Frank;Fidler, Mary J.;Stenson, Kerstin;Vasan, Nilesh R.;Razaq, Mohammad A.;Campana, John;Ha, Patrick;Mann, Grace;Ishida, Kosuke;Garcia-Guzman, Miguel;Biel, Merrill;Gillenwater, Ann M.
关键词：
复发性头颈部鳞状细胞癌（rHNSCC）是一个重大的全球健康负担，医疗需求未得到满足。在这项研究中，我们确定了RM-1929光免疫疗法在重度预治疗rHNSCC患者中的安全性和有效性。输注RM-1929（抗EGFR-IR 700染料偶联物），然后进行肿瘤照射。我们评估了安全性、肿瘤反应和药代动力学。9例患者入组第1部分（剂量探索），30例患者入组第2部分（安全性和疗效）。第1部分未出现剂量限制性毒性;第2部分推荐640 mg/m2和固定光剂量（50 J/cm 2或100 J/cm 2）。第2部分的不良事件（AE）大多为轻度至中度，但19例（63.3%）患者发生≥ 3级AE，包括3例（10.0%）导致死亡（与治疗无关）的严重AE。第2部分的疗效：未确认的客观缓解率（ORR）为43.3%（95% CI 25.46%-62.57%）;确认的ORR为26.7%（95% CI 12.28%-45.89%）;中位总生存期为9.30个月（95% CI 5.16-16.92个月）。治疗耐受性良好。RM-1929光免疫疗法在接受过大量预治疗的rHNSCC患者中的缓解和生存期具有临床意义，需要进一步研究。NCT02422979。
Recurrent head and neck squamous cell carcinoma (rHNSCC) represents a significant global health burden with an unmet medical need. In this study we determined the safety and efficacy of RM‐1929 photoimmunotherapy in patients with heavily pretreated rHNSCC. RM‐1929 (anti‐EGFR–IR700 dye conjugate) was infused, followed by tumor illumination. We evaluated safety, tumor response, and pharmacokinetics. Nine patients were enrolled in Part 1 (dose‐finding) and 30 patients in Part 2 (safety and efficacy). No dose‐limiting toxicities were experienced in Part 1; 640 mg/m2 with fixed light dose (50 J/cm2 or 100 J/cm) was recommended for Part 2. Adverse events (AEs) in Part 2 were mostly mild to moderate but 19 (63.3%) patients had AE ≥Grade 3, including 3 (10.0%) with serious AEs leading to death (not treatment related). Efficacy in Part 2: unconfirmed objective response rate (ORR) 43.3% (95% CI 25.46%–62.57%); confirmed ORR 26.7% (95% CI 12.28%–45.89%); median overall survival 9.30 months (95% CI 5.16–16.92 months). Treatment was well tolerated. Responses and survival following RM‐1929 photoimmunotherapy in heavily pretreated patients with rHNSCC were clinically meaningful and warrant further investigation. NCT02422979.
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影响因子：
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作者：
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