Merck与Advaxis合作开发晚期前列腺癌联合用药

Merck与Advaxis合作开发晚期前列腺癌联合用药

                               
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发布日期：2014-08-28  来源：njbiz

这项合作主要是Merck公司的抗PD1抗体pembrolizumab与Advaxis公司独有的免疫治疗药物ADXS-PSA在晚期前列腺癌治疗上的结合。

Advaxi公司声称，这项合作将开展关于ADXS-PSA单独用药以及与pembrolizumab联合用药的临床I/II期试验，用于治疗不能手术的晚期转移性肿瘤。

Merck公司的pembrolizumab被看做肿瘤治疗学上的一个重要里程碑，并且是欧洲上市的第一个抗PD1药物。这项合作必将使得pembrolizumab的地位更上一层楼。该药属于目前正逐渐发展起来的抗PD1免疫治疗药，能够促进机体免疫系统抵抗疾病。

其他的抗PD1药物还有施贵宝和Ono公司的nivolumab，该药已于上个月在日本上市。施贵宝也正在研究nivolumab用于联合疗法，上周，施贵宝公司宣布与赛尔基因合作，研究该药与Abraxane联合用药，用于晚期乳腺癌患者。

默克副总裁，肿瘤学博士Eric Rubin说：“这类合作是开发pembrolizumab联合用药潜力过程中的重要组成部分。”

这项合作意味着Advaxis将投资这项研究，而默克公司将提供pembrolizumab。I期临床试验计划于2015年上半年开展，主要目的是确认ADXS-PSA单独用药或者与pembrolizumab联合用药的给药剂量。II期临床试验将评估联合用药的安全性和有效性。

Advaxis, Merck team up to study prostate cancer drugs

Princeton-based biotechnology company Advaxis, Inc., announced Monday that it has joined with Merck on a clinical trial collaboration agreement that will study a combination of an Advaxis cancer immunotherapy with a Merck investigational antibody.

The planned Phase 1/2 study will examine whether the combination of the drugs will help patients with previously treated, metastatic, castration-resistant prostate cancer, Advaxis said in a news release.

“We are excited to be working with Merck. Equally as exciting is the combination potential of our Lm-LLO immunotherapy with Merck’s anti-PD-1 immune checkpoint inhibitor,” Daniel J. O’Connor, CEO and president of Advaxis, said in a prepared statement. “We believe the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant promise for the treatment of prostate and other cancers.”

Phase 1 of the trial would establish a recommended dose regimen, and Phase 2 would assess safety and efficacy of the combined drugs. Advaxis will sponsor and fund the study, while Merck will provide its antibody; the companies will jointly oversee the study, which is scheduled to begin early in 2015.

“Collaborations such as this are an integral part of Merck’s strategy to evaluate the potential of pembrolizumab in multiple combinations for a broad range of cancers,” Dr. Eric Rubin, vice president oncology, Merck Research Laboratories, said in a statement. “We look forward to working with Advaxis to evaluate this novel investigational combination immunotherapy for the treatment of advanced prostate cancer.”

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