SGO 2025

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第56届美国妇科肿瘤学年会（SGO 2025）于2025年3月14-17日在西雅图盛大召开。作为全球范围内最权威的妇科肿瘤学术会议之一，SGO年会为业内同道提供交流最新研究成果和临床经验的平台，展示具有创新性及前沿视角的观点和思路。

 

会上，比利时鲁汶大学医院Toon Van Gorp教授团队开展的一项III期MIRASOL（GOG 304）研究的最终OS分析结果入选全体科学会议，该研究旨在比较索米妥昔单抗（MIRV）与研究者选择的化疗（ICC）在治疗叶酸受体α（FRα）阳性、铂类耐药卵巢癌疗效及安全性。在会议现场，《肿瘤瞭望》特邀Toon Van Gorp教授接受专访，分享MIRASOL研究长期随访数据及未来展望，特此整理，以飨读者。

 

 

Toon Van Gorp教授：首先，我认为无论激素受体阴性或阳性，一旦被确诊为铂耐药卵巢癌（PROC）后，患者预后极差，总生存期约为12~13个月。对此类患者，无论给予任何化疗方式，总有效率（ORR）仅为10%~20%。基于当下临床现状，我们很高兴抗体偶联药物（ADC）的出现，整体提高了PROC的总有效率，为PROC患者带来了希望，MIRASOL研究正是证明了这一点。

 

Prof.Toon Van Gorp：So I think，first of all，whether it’s for the receptor of positive or negative cancer，as soon as the patient is diagnosed with platinum-resistant ovarian cancer，the prognosis is very poor.So usually，these patient has an overall survival rate of about 12 to 13 months.And whatever chemotherapy we give，the overall response rates are usually also very low，somewhere between 10 to 20%，whatever we give as chemotherapy.I’m actually quite happy that with the new ADC that we can probably make this overall response rate higher，and probably also the survival better.And this has shown now with this study.

 

Toon Van Gorp教授：早在2023年美国临床肿瘤学会（ASCO）年会上首次公布的MIRASOL研究数据已展现了mirvetuximab（MIRV）令人鼓舞的疗效。中位随访13.1个月时，该研究结果显示与研究者选择的化疗方案相比，接受MIRV治疗的患者的无进展生存期（PFS）和总生存期（OS）均显著改善，客观缓解率（ORR）也更具优势。但两个关键问题随之涌现，第一，延长随访时间后疗效是否持续？其次，长期安全性是否依然良好？

 

针对这些疑问，我们开展了中位随访30.5个月进一步分析，这是铂耐药卵巢癌全球研究中最长的随访时间之一。结果令人振奋，首先，与研究者选择的化疗（ICC）相比，生存数据显示出持续获益，MIRV组死亡风险降低了32%（风险比，0.68；95%置信区间，0.54-0.84；P=0.0004）；MIRV组中位总生存期为16.85个月（95%置信区间，14.36-19.78）vs.13.34个月（95%置信区间，11.37-15.15）；值得一提的是，Kaplan-Meier生存曲线早期即出现分离，并随时间推移持续拉开差距，显示mirvetuximab持久的疗效。此外，评估其他研究终点中，无进展生存期（PFS）、客观缓解率（ORR）、中位缓解持续时间（mDOR）、第二次无进展生存期（PFS2）均显示出显著获益。由此可见，随着随访时间的延长，我们持续观察到与2023年公布的第一次分析结果一致的显著获益。

 

其次，非常重要的是，我们观察到延长随访时间并未出现任何新的安全信号。MIRV组严重不良事件较少，三级以上的不良事件、导致停药的不良事件也较少。

 

化疗所致不良反应导致停药的患者数是MIRV组的两倍，由此可见，对于PROC患者，MIRV不仅能带来更持久的生存获益，其安全性也显著优于传统化疗方案。

 

Prof.Toon Van Gorp：Yeah，I firstly want to emphasize that we already had a very positive trial when it was first presented in 2023 at ASCO.Of course，whenever you do a trial like the first analysis was after 13.1 months with an improved progression for your survival overall survival.And an objective response rate in the favor of mirvetuximab over investigated choice chemotherapy.So that’s an excellent result.But what you want to know that if it’s continue when you do a longer follow up，or you still continue to see this benefit?And the second question is that will there be any additional safety signals when we do a longer follow up time of these patient?

 

So that’s why we did a new analysis after 30.5 months.This is one of the longest follow up times in any of the global studies of platinum resistant ovarian cancer.What we saw in this analysis，it was that we have continued to see an improved overall survival with mirvetuximab，with the Hazard Ratio of 0.68.This means the 32%reduction in the risk of death.So that’s really good.Also，when we look at the median overall survival was 16.9 months for mirvetuximab and 13.3 months for investigator choice chemotherapy.So a clear difference and also something which is very important is that the fact that the curves split was very early and the keeps being separated when we continue the longer follow up，they do not come together.So this means that there is a very prolonged benefit of using mirvetuximab for the overall survival.When we look at the other end points，like Progression-Free Survival，Objective Response Rate，Duration of Response，PFS2 were all in favor of mirvetuximab.So with this prolonged follow up time，we keep on seeing the same result as what we saw for the first analysis in 2023.Also，something which is very important is that we didn’t see any new safety signals when we used mirvetuximab.There were less serious adverse events，less grade three or higher adverse events for mirvetuximab and also less adverse events that lead to the discontinuation of the treatments.And so when you look at the numbers of patients，it’s almost twice the number of patients that had to discontinue the treatment when they received chemotherapy.So this means that mirvetuximab is not only a very good drug in effectiveness due to the very nice efficacy results.But it’s also a very safe drug to use when you compare it to the chemotherapy.

 

Toon Van Gorp教授：目前，MIRV已被美国食品药品监督管理局（FDA）、欧洲药品管理局（EMA）批准应用于临床实践，尽管我不太确定它在世界其他地区的获批情况。但可以确定的是，MIRASOL研究结果表明MIRV作为治疗FRα阳性、铂耐药卵巢癌的最佳治疗药物应在临床实践中占有一席之地，有望作为此类患者的标准治疗手段。长期随访分析数据更加证明了这一点，在观察到持续获益的同时未观察到任何新的安全信号。而且即使在首次疾病进展后继续使用MIRV，患者仍能持续获益。

 

Prof.Toon Van Gorp：Mirvetuximab has already approved for a very long time in US，and it’s now also approved in the Europe，but I’m not really sure about the rest of the world.But it’s clear that’s Mirvetuximab is deserves a place as the most best treatment for patients with for the FRalpha-positive，platinum-resistant ovarian cancer.It should be the standard treatment，as the long term follow up analysis is confirming this.So I think this is the confirmation of something that we already knew，actually.But it is especially reassuring that we don’t see any new safety signals，so that we can see the benefit is very prolonged，even after the first progression when Mirvetuximab used.Afterwards，we still see that the benefit is prolonged.

 

Toon Van Gorp教授：目前，免疫疗法在卵巢癌领域并未获得显著成功，尽管相关研究进展展现了微弱的积极信号，但缺乏令人振奋的研究结果，因此，免疫治疗在卵巢癌领域应用并不广泛，相比之下，MIRV作为抗体药物偶联物（ADC），疗效远优于免疫疗法和PARP抑制剂，个人认为其完全有作为卵巢癌一线治疗选择的临床潜力，特别是对于FRα阳性的卵巢癌患者。

 

值得注意的是，在FRα阳性PROC治疗领域，目前尚未有其他治疗手段可替代。这种独特优势体现于尽管多项临床研究正在开展，但MIRV仍是目前唯一获批用于卵巢癌的ADC药物，其疗效优于传统化疗。

 

Prof.Toon Van Gorp：So when we looked at immunotherapy，I don’t think immunotherapy has been a big success in ovarian cancer to say the least.I don’t think we have very positive trials.There are maybe some minor signals.But I don’t think that immunotherapy is used a lot in ovarian cancer.So Mirvetuximab as an ADCs is much better than immunotherapy and the PARP inhibitors.I think they deserve their place in first line，especially for the FRalpha-positive tumors.That’s without any discussion break up and no doubt about it.But there are not having any space for them in the platinum-resistant ovarian cancer.So I think that’s the position that we’re talking about has right now is quite unique.We don’t have any competitors at the moment.Even if there are some studies ongoing，but at this moment，this is the only ADC which is approved in ovarian cancer.It’s better than chemotherapy.So like I said，I think this is the very strong position at the moment，and I think that everybody who has the tumor，which is followed FRalpha-positive，should receive the Mirvetuximab.

 

Toon Van Gorp教授：这是一种非常出色的治疗药物。我认为我们不应局限于铂耐药卵巢癌领域，该药物应向铂敏感卵巢癌领域拓展，甚至可能进入一线治疗。目前针对其线数前移和铂敏感卵巢癌领域相关临床研究的开展正在进行中，我期待这种强效药物能够治愈更多患者，或在铂敏感卵巢癌治疗中可展现显著延长患者PFS的优势。尽管尚未获得相关结果，但我对此充满信心并翘首以待，因为我相信，卵巢癌治疗的未来必将一片光明。

 

Prof.Toon Van Gorp：This is such a good treatment.I don’t think we need to stay in platinum-resistant ovarian cancer.I think the drug should move to platinum sensitive disease.And even maybe also in frontline，there are studies ongoing in both frontline and also platinum sensitive disease.So I hope that this very powerful drug will also be able to maybe cure more patients or they might cause a longer progression-Free survival in platinum sensitive disease.We don’t have these results yet，but I’m really hopeful，and I’m really looking forward to the future because I think the future is really bright.