Celcuity 公布 VIKTORIA-1 三期新数据：gedatolisib 三联方案在无肝转移乳腺癌患者中无进展生存期达21.5个月
Minneapolis 消息：美国生物技术公司 Celcuity Inc.（纳斯达克代码：CELC）10月24日在欧洲肿瘤内科学会（ESMO）2026年大会上公布三期临床试验 VIKTORIA-1 研究2的最新亚组分析。在激素受体阳性、HER2阴性（HR+/HER2-）且携带 PIK3CA 突变的晚期乳腺癌患者中，无肝转移者接受 gedatolisib 三联方案（gedatolisib＋fulvestrant＋palbociclib）治疗的中位无进展生存期为21.5个月，对照组 alpelisib＋fulvestrant 为9.1个月，风险比0.46（p=0.0016）。
这组数据由法国 Gustave Roussy 乳腺癌中心负责人 Barbara Pistilli 博士在大会的最新突破性快速口头报告（摘要号 LBA16）中发布。在有肝转移的患者中，三联方案中位无进展生存期为9.1个月，对照组为4.6个月（风险比0.47，p<0.0001）；在有内脏转移的患者中，三联方案为9.8个月，对照组为5.6个月（风险比0.52）。在可评估病灶的 PIK3CA 突变队列患者中，三联方案的客观缓解率为59%，中位缓解持续时间为19.4个月，对照组分别为33%和7.5个月。
安全性方面，PIK3CA 突变队列中因治疗相关不良事件停用 gedatolisib 的比例，三联方案为5%、双联方案为4%，对照组 alpelisib 为19%。公司称，三联与双联方案因口腔炎停药的比例分别为1%和0%，3级口腔炎多为一过性，到第二个治疗周期时发生率降至3%以下。
Celcuity 首席医学官 Igor Gorbachevsky 说：「VIKTORIA-1 研究2的补充数据显示，gedatolisib 方案对重要的乳腺癌患者亚组有一致且显著的临床获益。无肝转移患者约占这一治疗场景全部患者的60%至70%，三联方案在这组患者中的中位无进展生存期约为21个月，对照方案约为9个月。」他还表示，三联方案在两个队列中19个月以上的中位缓解持续时间，是据其所知二线 HR+/HER2- 晚期乳腺癌三期试验主要分析中报告过的最长纪录。
背景方面，gedatolisib 的商品名为 REVTORPYK，是一种泛 PI3K 与 mTORC1/2 抑制剂，已获美国食品药品监管局（FDA）批准，用于在转移阶段接受过至少一线内分泌治疗后进展、且未检出 PIK3CA 突变的患者；本次公布的是 PIK3CA 突变队列的研究数据。HR+/HER2- 是最常见的乳腺癌亚型，约占全部乳腺癌的70%。Celcuity 总部位于 Minneapolis，正在进行的 VIKTORIA-2 三期试验则在评估 gedatolisib 方案用于晚期一线治疗的效果。
Celcuity Reports VIKTORIA-1 Update: Gedatolisib Triplet Median PFS of 21.5 Months in Breast Cancer Patients Without Liver Metastases
MINNEAPOLIS — Celcuity Inc. (Nasdaq: CELC) on October 24 presented new subgroup analyses from Study 2 of the Phase 3 VIKTORIA-1 trial at the European Society for Medical Oncology (ESMO) Congress 2026. In patients with HR-positive, HER2-negative advanced breast cancer carrying a PIK3CA mutation who had no liver metastases, the gedatolisib triplet (gedatolisib plus fulvestrant and palbociclib) produced a median progression-free survival of 21.5 months, versus 9.1 months for alpelisib plus fulvestrant, a hazard ratio of 0.46 (p=0.0016).
The data were presented by Dr. Barbara Pistilli, head of the Breast Cancer Unit at Gustave Roussy, in a late-breaking rapid oral presentation (LBA 16). Among patients with liver metastases, median progression-free survival was 9.1 months on the triplet versus 4.6 months on the control regimen (hazard ratio 0.47, p<0.0001); among patients with visceral metastases it was 9.8 versus 5.6 months (hazard ratio 0.52). In evaluable patients in the PIK3CA-mutant cohort, the triplet's objective response rate was 59 percent with a median duration of response of 19.4 months, versus 33 percent and 7.5 months for the control.
On safety, discontinuation of gedatolisib due to treatment-emergent adverse events in the mutant cohort was 5 percent for the triplet and 4 percent for the doublet, compared with 19 percent for alpelisib. The company said grade 3 stomatitis with gedatolisib was transient, falling below 3 percent by the second treatment cycle, and discontinuations due to stomatitis were 1 percent and 0 percent for the triplet and doublet.
"The additional data from Study 2 of VIKTORIA-1 show consistent and significant clinical benefit for important sub-groups of breast cancer patients treated with gedatolisib regimens," said Igor Gorbachevsky, Celcuity's chief medical officer, noting that patients without liver metastases represent approximately 60 to 70 percent of all patients treated in this setting. He said the triplet's median duration of response of over 19 months in both VIKTORIA-1 cohorts was, to the company's knowledge, the longest ever reported in the primary analysis of a Phase 3 trial in second-line HR+/HER2- advanced breast cancer.
Gedatolisib, marketed as REVTORPYK, is a pan-PI3K and mTORC1/2 inhibitor approved by the U.S. Food and Drug Administration (FDA) for patients in whom no PIK3CA mutation was detected, following progression on or after endocrine therapy in the metastatic setting; the new results concern the separate PIK3CA-mutant cohort. HR+/HER2- is the most common breast cancer subtype, accounting for about 70 percent of cases. Celcuity, headquartered in Minneapolis, is also running the Phase 3 VIKTORIA-2 trial of gedatolisib regimens as first-line treatment for advanced disease.
来源：GSM·美国（原文链接）
图片来源：图：实验室研究人员进行样本处理（资料图）。照片：美国疾控中心（CDC），公共领域，经 Wikimedia Commons。 / Photo: A researcher at work in a laboratory (file photo). Photo by the U.S. Centers for Disease Control and Prevention, public domain, via Wikimedia Commons.
