在2026年妇科肿瘤学会（SGO）年会上，美国匹兹堡大学医学院Magee-Womens医院的Alexander B.Olawaiye教授代表GOG-3073/ENGOT-ov72等国际协作组，口头报告了III期ROSELLA试验的最终总生存分析结果。本报在2026 SGO会场现场特别采访了Olawaiye教授，深入解读该研究对临床实践的重大影响。

 

铂耐药性卵巢癌患者的总生存期约为一年，亟需新的治疗方案。卵巢癌表达糖皮质激素受体（GR），而GR是预后不良的标志物，并且GR信号通路会降低肿瘤对化疗的敏感性。瑞拉可兰（Relacorilant）是一种新型的选择性GR拮抗剂（SGRA），能够恢复肿瘤对细胞毒性化疗的敏感性。白蛋白结合型紫杉醇是铂耐药性卵巢癌患者中疗效最高的疗法之一；由于使用时不需要糖皮质激素预处理，因此它是与瑞拉可兰联合使用的合理搭档。基于ROSELLA研究结果，瑞拉可兰联合白蛋白紫杉醇已于2026年3月获FDA批准，成为铂耐药卵巢癌患者（既往接受过1-3线治疗且包含贝伐珠单抗）的新标准治疗方案。

 

ROSELLA研究在全球14个国家117家中心开展，入组标准包括：经组织学确诊的上皮性卵巢癌、原发性腹膜癌或输卵管癌；ECOG体能状态评分为0或1分；末次铂类治疗后6个月内出现疾病进展，但排除对初次铂类治疗无反应或在初次铂类治疗中不到1个月即进展的患者；既往接受过1～3线治疗；且必须曾使用过贝伐珠单抗治疗。381例铂耐药卵巢癌患者按1:1随机分配至瑞拉可兰（150 mg口服给药）联合白蛋白紫杉醇组或白蛋白紫杉醇单药组。双重主要终点为盲态独立中心评审评估的无进展生存期（PFS）及总生存期（OS）。分层因素包括前线治疗线数及地区。

 

研究设计

 

两组患者基线均衡。实验组和对照组的中位年龄分别为61和62岁；43.1%和44.6%的患者既往接受过3线治疗；60.6%和62.2%既往使用过PARP抑制剂；约12%携带BRCA1/2突变。所有患者均接受过贝伐珠单抗治疗。

 

最终OS分析的中位随访时间为24.8个月。瑞拉可兰联合组中位OS为16.0个月，对照组为11.9个月，组间差异达4.1个月（HR=0.65，95%CI:0.51-0.83，P=0.0004）。去年ASCO发布的初次分析中，PFS同样达到统计学显著改善（HR=0.70，P=0.0076）。因此，ROSELLA研究的双重主要终点（PFS与OS）均获得具有统计学及临床意义的阳性结果。亚组分析进一步表明，OS获益在全部预设亚组中方向一致，包括原发性铂耐药患者（HR=0.61）、既往PARP抑制剂经治患者（HR=0.70）等人群。ROSELLA是首个在铂耐药卵巢癌全人群中无需生物标志物筛选即取得OS显著获益的III期试验。

 

瑞拉可兰联合白蛋白紫杉醇组的平均治疗暴露时间为24.5周，长于对照组的19.3周，提示联合方案并未因毒性而缩短治疗时长。≥3级不良事件发生率联合组为74.5%，对照组为59.5%，主要由中性粒细胞减少驱动。然而经暴露时间校正后，中性粒细胞减少及贫血的发生率在两组间相似。周围神经病变发生率两组相近（19.1%vs 17.4%）。严重不良事件方面，发热性中性粒细胞减少症共5例：实验组4例（2.1%），对照组1例（0.5%）；脓毒症共5例：实验组3例（1.6%），对照组2例（1.1%）。Kaplan-Meier曲线直观显示，两组因不良事件导致治疗中止的时间进程完全重叠（HR=1.00，95%CI:0.50-2.00），且均低于10%，证实瑞拉可兰的加入未增加治疗中止风险。研究中381例受试者中无肾上腺功能不全发生，且无瑞拉可兰相关致死性不良事件。

 

Alexander Olawaiye：去年ASCO会议上公布ROSELLA研究时，仅有无进展生存数据达到成熟。截至2026年1月，总生存数据已经成熟，我们随后花费两个月时间进行了数据分析。我们非常欣喜地看到OS结果同样为阳性——在铂耐药卵巢癌中获得了0.65的风险比，这一结果是前所未有的，意味着死亡风险降低了35%，非常令人印象深刻。

 

该OS数据与既往报道的PFS趋势一致。事实上，在数据成熟前的期中分析节点，总生存期风险比为0.69。此次的最终OS数据甚至优于中期分析所见。

 

Q:What updated data from the ROSELLA trial were presented at the 2026 SGO Annual Meeting?And do these updates align with the trends previously reported for progression-free survival and interim overall survival?

 

Alexander Olawaiye:Yes.When ROSELLA was presented last year at ASCO，the PFS endpoint was the only data that had matured.As of January 2026，the overall survival data became mature，and we spent the next two months analyzing those data.We are delighted that the OS results are also positive，with the overall survival endpoint being met with a hazard ratio of 0.65 in platinum-resistant ovarian cancer.This is unprecedented，representing a 35%reduction in the risk of death.It is very impressive.

 

It aligns with previously reported trends for PFS.As a matter of fact，the interim OS hazard ratio before data maturity was 0.69.This final OS data looks even better than what we observed at the interim analysis.

Alexander Olawaiye：安全性数据并未发生变化。在最终总生存期分析节点，其安全性特征与我们主要分析（primary analysis）时观察到的情况相符。未发现新的安全性信号，无瑞拉可兰相关致死性不良事件。事实上，本研究中观察到的大多数不良事件均归因于白蛋白紫杉醇，且与其已知的毒性特征完全吻合。

 

我所展示的数据要点之一聚焦研究方案的耐受性：我们核查了因不良事件而中止治疗的患者数量。两个治疗组Kaplan-Meier曲线高度重合，这意味着研究药物瑞拉可兰并未导致治疗中止率上升。此外，治疗中止事件整体并不常见。瑞拉可兰试验组与对照组在治疗中止率方面未见差异。

 

Q:The balance between efficacy and safety is critical.How would you assess the overall tolerability of the relacorilant combination regimen?

 

Alexander Olawaiye:The safety data remain unchanged.The safety profile at the time of final OS analysis is consistent with what we observed at the primary analysis.No new safety signals were identified，and there were no relacorilant-related fatal adverse events.Really，most of the adverse events observed in this study are attributable to nab-paclitaxel and are aligned with its well-established toxicity profile.

 

One of the data points I presented specifically addressed this:we examined the number of patients who discontinued treatment due to adverse events.The Kaplan-Meier curves overlay，which means the investigational agent relacorilant，did not contribute to increased treatment discontinuation.By the way，treatment discontinuation was infrequent.There was no difference in treatment discontinuation between the experimental arm(with relacorilant)and the control arm.

Alexander Olawaiye：这正是ROSELLA研究所确立的新范式。糖皮质激素受体拮抗联合化疗正是ROSELLA研究的核心。如各位所知，三周前，该方案已获美国食品药品监督管理局批准。因此，它现已成为铂耐药卵巢癌新的标准治疗方案。我们希望将本试验的结果拓展至更多研究和更多癌种，运用相同的策略来治疗其他癌症。

 

Q:Glucocorticoid receptor signaling plays a key role in chemotherapy resistance.Does the success of the ROSELLA trial suggest that GR antagonism could become a novel strategic paradigm for overcoming chemoresistance?

 

Alexander Olawaiye:It has precisely become that.The combination of glucocorticoid receptor antagonism with chemotherapy is the core of our study.As you know，three weeks ago，this regimen was approved by the FDA.Therefore，it now represents a new standard of care for platinum-resistant ovarian cancer.We hope to extend the result of this trial into further studies and more cancer types，employing the same strategy to treat other cancers.

 

Alexander Olawaiye：KEYNOTE-B96试验也在2026 SGO会议上公布了新数据，该试验采用帕博利珠单抗联合紫杉醇和贝伐珠单抗治疗铂耐药卵巢癌。这是一项阳性结果试验，且该方案已获美国食品药品监督管理局批准。这标志着我们首次拥有获准用于卵巢癌治疗的免疫肿瘤药物。既往免疫疗法在铂耐药卵巢癌中并未显示出有意义的疗效。然而，KEYNOTE-B96试验表明，通过将免疫肿瘤药物（此处为帕博利珠单抗）与恰当的配伍药物联用，我们能够为患者带来切实的获益。令人振奋的是，针对铂耐药卵巢癌患者，我们现已拥有两种新方案可用。

 

Q:Many great clinical trials were presented at SGO 2026.Which particular presentation captured your interest the most?

 

Alexander Olawaiye:The KEYNOTE-B96 trial，which uses pembrolizumab combined with paclitaxel and bevacizumab for platinum-resistant ovarian cancer，was also presented.It is a positive trial，and the regimen is already FDA-approved.This marks the first time we have an immuno-oncology agent approved for ovarian cancer therapy.Previously，immunotherapy had not demonstrated meaningful efficacy in this disease.However，this trial shows that by combining an immuno-oncology agent(in this case，pembrolizumab)with the appropriate drug，we can achieve meaningful benefit for patients.It is exciting that we now have two new regimens available for patients with platinum-resistant ovarian cancer.