强生双抗组合一期结果：晚期前列腺癌患者73% PSA降幅过半，近半数降幅逾90%
强生公司（Johnson & Johnson，纽交所代码：JNJ）11月8日在新泽西州 New Brunswick 宣布，其在研药物 pasritamig 与 JNJ-9401 联合疗法用于晚期前列腺癌的首次人体一期研究结果：在推荐方案组的15名转移性去势抵抗性前列腺癌患者中，73%（11人）的前列腺特异性抗原（PSA）降幅达到50%或以上，47%（7人）降幅达到90%或以上，其中4人的 PSA 降至检测不到的水平。结果已在美国癌症免疫治疗学会（SITC）2026年年会的迟突破性口头报告环节公布（摘要编号1175）。
这一组合是首个在前列腺癌中开展临床评估的双肿瘤抗原靶向双特异性抗体方案：pasritamig 靶向前列腺癌蛋白 KLK2、为 T 细胞提供第一重激活信号，JNJ-9401 靶向 PSMA、提供第二重共刺激信号，两种信号互补，共同增强免疫细胞对癌细胞的攻击。推荐方案为每六周给药一次：pasritamig 300毫克静脉注射（先经两次每周一次的递增导入剂量），JNJ-9401 200毫克皮下注射，公司称这一节奏具备在门诊给药的潜力。
研究细节方面，这项开放标签、多中心一期研究（编号 NCT06095089）针对至少接受过一线系统治疗的转移性去势抵抗性前列腺癌患者，截至2026年6月15日共入组144人；推荐方案组的患者此前接受的系统治疗中位数为四线（范围二至六线）。安全性方面，推荐方案组未报告3级或以上治疗相关不良事件，也没有剂量限制性毒性、因不良事件停药或死亡的病例；3名患者（20%）出现细胞因子释放综合征，均为1级、一过性发热，无人需要用托珠单抗治疗，也未出现免疫效应细胞相关神经毒性综合征。PSA 降幅达到90%或以上的7名患者，全部已维持治疗超过六个月且疾病未进展。
负责报告这项研究的科罗拉多大学医学院医学助理教授 Laura Graham 博士说：「前列腺癌长期以来难以用免疫疗法治疗，这使我们看到的活性尤其值得关注。通过结合两种互补的 T 细胞激活方式，我们正在探索一种让免疫系统对抗这种疾病的新途径。本研究中观察到的 PSA 降幅深度，包括持续六个月或更久的应答，为 pasritamig 与 JNJ-9401 组合提供了令人鼓舞的早期证据，值得在更大规模的三期研究中进一步检验。」
强生全球肿瘤治疗领域负责人 Yusri Elsayed 博士说：「这一全新的双抗原靶向双特异性方案，把我们前列腺癌管线的基础组成部分 pasritamig 与 JNJ-9401 结合起来，显示出互补机制协同工作的潜力。随着这一组合进入三期开发，我们正在早期前景的基础上继续推进，努力为晚期患者带来新的治疗选择。」
该组合目前正在进行中的三期 KLK2-comPAS 研究（编号 NCT07164443）中接受评估，该研究检验在 pasritamig 基础上加入 JNJ-9401 能否改善转移性去势抵抗性前列腺癌患者的结局。强生同时提醒，这批结果来自推荐方案组的小样本初步分析，该组合的临床获益与安全性仍需在更大规模人群中进一步验证，两种药物均为在研药物、尚未获批。（来源：强生公司）
Johnson & Johnson Phase 1 results: pasritamig plus JNJ-9401 posts 73% PSA response rate in advanced prostate cancer
Johnson & Johnson (NYSE: JNJ) announced on November 8 in New Brunswick, New Jersey, promising first-in-human Phase 1 results for the investigational combination of pasritamig and JNJ-9401 in advanced prostate cancer. At the recommended regimen, 73 percent (11 of 15 patients) with metastatic castration-resistant prostate cancer (mCRPC) achieved reductions of at least 50 percent in prostate-specific antigen (PSA), a marker used to monitor prostate cancer activity, including 47 percent (7 of 15 patients) who achieved reductions of at least 90 percent, and four patients achieved undetectable PSA levels. The results were presented in a late-breaking oral session at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting (Abstract #1175).
The combination is the first dual-tumor-antigen-targeted bispecific antibody regimen clinically evaluated in prostate cancer. Pasritamig targets kallikrein-related peptidase 2 (KLK2) and provides a first signal directing T cells toward prostate cancer cells, while JNJ-9401 targets prostate-specific membrane antigen (PSMA) and provides a second, costimulatory signal designed to strengthen and sustain T-cell activity. The recommended regimen is given every six weeks: pasritamig 300 mg intravenously, following two initial weekly step-up doses, combined with JNJ-9401 200 mg subcutaneously, a schedule the company says has potential for outpatient administration.
The ongoing, open-label, multicenter Phase 1 study (NCT06095089) is evaluating the combination in patients with mCRPC who have received at least one prior systemic therapy; as of June 15, 2026, 144 patients had enrolled. Patients at the recommended regimen were heavily pretreated, with a median of four prior lines of systemic therapy (range, two to six). On safety, no Grade 3 or higher treatment-related adverse events were reported at the recommended regimen, and there were no dose-limiting toxicities or treatment-related events leading to discontinuation or death. Cytokine release syndrome was observed in three patients (20 percent); all cases were Grade 1, presenting as temporary fever, none required tocilizumab, and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported. All seven patients who achieved PSA reductions of at least 90 percent remained on treatment for more than six months without disease progression.
"Prostate cancer has long been difficult to treat with immunotherapy, which makes the activity we're seeing particularly interesting," said Laura Graham, M.D., Assistant Professor of Medicine-Medical Oncology at the University of Colorado School of Medicine, who presented the study. "By combining two complementary approaches to T-cell activation, we are exploring a new way to engage the immune system against this disease. The depth of PSA reductions observed in this study, including responses sustained for six months or longer, provides encouraging early evidence for the pasritamig-JNJ-9401 combination that warrants further investigation in a larger Phase 3 study."
"This novel dual-antigen-targeted bispecific regimen combines pasritamig, a foundational component of our prostate cancer pipeline, with JNJ-9401, highlighting the potential of complementary mechanisms working together," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, at Johnson & Johnson. "With this combination now in Phase 3 development, we are building on the early promise of this approach as we work to bring new treatment options to patients with advanced disease."
The combination is being evaluated in the ongoing Phase 3 KLK2-comPAS study (NCT07164443), which is investigating whether adding JNJ-9401 to pasritamig can improve outcomes for patients with mCRPC. Johnson & Johnson noted that the findings are preliminary and based on a small number of patients at the recommended regimen, and that further evaluation is needed to determine the clinical benefit and safety of the combination in a larger population; both medicines are investigational and have not been approved. (Source: Johnson & Johnson)
来源：强生公司
发布：GSM·美国（发布链接）
图片来源：图：强生公司旗下杨森（Janssen）位于荷兰 Leiden 的办公楼，楼体带 Janssen 与 Johnson & Johnson 标识。Michielverbeek 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / Photo: The Janssen building in Leiden, the Netherlands, a pharmaceutical company of Johnson & Johnson. Photo by Michielverbeek, CC BY-SA 4.0, via Wikimedia Commons.
GSM Global · 本篇英文版 English edition of this story
