Guo Xiaoning, Wang Xiaohui, Shen Sui, Oronsky Bryan, Reid Tony R, Stirn Meaghan, Caroen Scott, Brinkhaus Franck, Abrouk Nacer A, Yang Liandai, Wu Lianzong, Yu Zhongwen
SciClone Pharmaceuticals Co., Ltd. 22 Floor, Shanghai Central Plaza No. 381 Middle Huaihai Road, Huangpu, Shanghai 200020, China.
EpicentRx Inc. 11099 North Torrey Pines Road, Suite 160, La Jolla, CA 92037, USA.
Am J Cancer Res. 2022 Sep 15;12(9):4448-4457. eCollection 2022.
RRx-001, a CD47 antagonist via its inhibition of MYC and the γ-subtype of the peroxisome proliferator-activated receptor (PPAR) has been associated to date with minimal toxicity. The aim of this analysis was to evaluate the toxicity and efficacy of RRx-001 in Asian patients since RRx-001, in the context of multiple Phase 3 studies, will be administered in China and Chinese territories as well as potentially throughout the rest of Asia. Patients received 4 mg of RRx-001 in three different antitumor clinical trials with chemotherapy and/or radiation and a retrospective subset efficacy and toxicity analysis was conducted for patients with Asian ancestry in comparison to patients with other ethnic backgrounds. The toxicity and efficacy data from these studies were similar between Asians and the rest of the treated patients. While the sample sizes are too small to draw definitive conclusions, at a dose of 4 mg, when RRx-001 is combined with chemotherapy, no apparent differences in terms of safety and efficacy are observed in cancer patients with Asian ancestry.
RRx-001是一种CD47拮抗剂，通过抑制MYC和过氧化物酶体增殖物激活受体（PPAR）的γ亚型发挥作用，迄今为止其毒性极小。本分析的目的是评估RRx-001在亚洲患者中的毒性和疗效，因为在多项3期研究的背景下，RRx-001将在中国及中国领土以及亚洲其他地区使用。患者在三项不同的抗肿瘤临床试验中接受4mg的RRx-001联合化疗和/或放疗，并对亚洲血统患者与其他种族背景患者进行回顾性亚组疗效和毒性分析。这些研究中亚洲人和其他接受治疗患者的毒性和疗效数据相似。虽然样本量太小无法得出明确结论，但在4mg剂量下，当RRx-001与化疗联合使用时，亚洲血统的癌症患者在安全性和疗效方面未观察到明显差异。
