AbbVie (NYSE: ABBV) today announced the final analysis of the confirmatory Phase 3 MIRASOL trial evaluating the efficacy and safety of ELAHERE (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy. At 30.5 months median follow-up, treatment with ELAHERE continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator's choice (IC) chemotherapy.®1 Ovarian cancer patients often present with late-stage disease and are historically first treated with platinum-based chemotherapy, which they may become resistant to and require another therapy, such as ELAHERE.

艾伯维公司（纽约证券交易所代码：ABBV）今天宣布了MIRASOL 3期确证试验的最终分析结果，该试验评估了ELAHERE（mirvetuximab soravtansine-gynx）与化疗相比对叶酸受体α（FRα）阳性耐铂卵巢癌（PROC）女性患者的疗效和安全性。在30.5个月的中位随访中，与研究者选择（IC）的化疗相比，ELAHERE治疗在无进展生存期（PFS）和总生存期（OS）方面仍有显著改善。

"Ovarian cancer can be devastating, and when cancer cells stop responding to chemotherapy patients may feel hopeless about their journey. The data presented today reinforce the importance of ELAHERE as a transformative therapy for patients with limited options," said Svetlana Kobina, MD, PhD, vice president, oncology medical affairs, AbbVie. "We remain steadfast in our commitment to bring forward innovative therapies that improve the lives of patients with difficult-to-treat cancers."

“卵巢癌可能是毁灭性的，当癌细胞对化疗停止反应时，患者可能会对自己的生命之路感到绝望。艾伯维公司肿瘤医学事务副总裁、医学博士Svetlana Kobina表示："今天公布的数据加强了ELAHERE作为一种变革性疗法对选择有限的患者的重要性。“我们将继续坚定不移地致力于推出创新疗法，改善难治癌症患者的生活。

In the United States, ovarian cancer is the leading cause of death from gynecological cancers.3 Each year, approximately 20,000 women are diagnosed.4 Unfortunately, most patients develop platinum-resistant disease, which is difficult to treat.5 In this setting, single-agent chemotherapies are associated with minimal survival benefit while adding significant toxicity burden

在美国，卵巢癌是妇科癌症的主要死因。3 每年约有 20,000 名妇女被确诊为卵巢癌。4 不幸的是，大多数患者会发展为铂类耐药疾病，难以治疗。5 在这种情况下，单药化疗对患者的生存获益极小，同时会增加很大的毒性负担。

The Phase 3 MIRASOL study included 453 patients with high-grade serous epithelial PROC whose tumors express high levels of FRα and had been treated with up to three prior therapies.1 Key findings from the 30.5-month median follow-up include:

MIRASOL 3 期研究纳入了 453 例高级别浆液性上皮性 PROC 患者，这些患者的肿瘤表达高水平的 FRα，并曾接受过最多三种治疗：

ELAHERE treatment achieved superior efficacy versus IC chemotherapy, with a median PFS of 5.59 months versus 3.98 months, representing a 37% reduction in the risk of tumor progression or death (HR 0.63; [95% CI: 0.51, 0.79]) and a higher objective response rate of 41.9% versus 15.9%. Superior and clinically meaningful overall survival for patients receiving ELAHERE (median 16.85 months) compared to IC chemotherapy (median 13.34 months), representing a 32% reduction in the risk of death (HR 0.68 [95% CI: 0.54, 0.84]). Other endpoints included safety and duration of response (DOR), which were consistent with the primary data analysis at 13.1-months median follow-up.

与 IC 化疗相比，ELAHERE 疗效更佳，中位 PFS 为 5.59 个月对 3.98 个月，肿瘤进展或死亡风险降低 37%（HR 0.63；[95% CI：0.51, 0.79]），客观反应率为 41.9% 对 15.9%。 与IC化疗（中位数13.34个月）相比，接受ELAHERE治疗的患者总生存期（中位数16.85个月）更长，且具有临床意义，死亡风险降低了32%（HR 0.68 [95% CI: 0.54, 0.84]）。 其他终点包括安全性和反应持续时间（DOR），与中位随访 13.1 个月的主要数据分析结果一致。

The most common treatment-emergent adverse events (TEAEs) occurring in at least 20% of patients in the ELAHERE arm were blurred vision, keratopathy, abdominal pain, fatigue, diarrhea, dry eye, constipation, nausea and peripheral neuropathy. Compared with IC chemotherapy, treatment with ELAHERE was overall associated with lower rates of grade ≥3 TEAEs, serious AEs and discontinuations due to AEs.

在ELAHERE治疗组中，至少有20%的患者出现了最常见的治疗突发不良事件（TEAEs），包括视力模糊、角膜病、腹痛、疲劳、腹泻、干眼症、便秘、恶心和周围神经病变。与IC化疗相比，使用ELAHERE治疗的≥3级TEAEs、严重AEs和因AEs导致的停药率总体较低。

"The final data showcase the significant improvement in overall survival benefit of treatment with ELAHERE compared to standard of care chemotherapy," said investigator and presenter, Toon Van Gorp, MD, PhD, Professor of Gynecologic Oncology, University of Leuven. "The significant improvements in survival, along with the well-characterized safety profile, reinforce ELAHERE as an emerging standard of care for difficult-to-treat ovarian cancer and warrants further study of this medicine in earlier treatment settings."

“研究者兼发言人、鲁汶大学妇科肿瘤学教授、医学博士Toon Van Gorp说："最终数据显示，与标准化疗相比，使用ELAHERE治疗可显著提高总生存率。“生存期的显著改善以及良好的安全性特征加强了 ELAHERE 作为治疗难治性卵巢癌的新兴标准疗法的地位，值得在早期治疗环境中进一步研究这种药物。

A separate analysis from the Phase 3 MIRASOL study evaluating the impact of [ELAHERE] treatment-emergent ocular events on patient-reported health-related quality of life (HRQoL), will be shared during an oral presentation March 17 at the SGO Annual Meeting scientific plenary session.

3期MIRASOL研究评估了[ELAHERE]治疗引起的眼部事件对患者报告的健康相关生活质量（HRQoL）的影响，该研究的另一项分析结果将在3月17日SGO年会科学全体会议上的口头报告中分享。

ELAHERE was granted full approval by the U.S. Food and Drug Administration in March 2024 and was approved by the European Commission in November 2024. Marketing Authorization Applications for ELAHERE are also under review in multiple other countries.

ELAHERE于2024年3月获得美国食品药品管理局的全面批准，并于2024年11月获得欧盟委员会的批准。ELAHERE在其他多个国家的上市许可申请也在审查中。

About the Phase 3 MIRASOL Trial MIRASOL is a randomized Phase 3 trial of ELAHERE versus investigator's choice (IC) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with PROC whose tumors express high levels of FRα, using the Ventana FOLR1 RxDx Assay, and who have been treated with up to three prior regimens. The primary endpoint of this trial is progression-free survival (PFS) by investigator assessment. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). The trial enrolled 453 patients. Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 39% had two prior lines of therapy, and 47% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%). Sixty-two percent of patients received prior bevacizumab; 55% received a prior PARP inhibitor.

关于 MIRASOL 3 期试验 MIRASOL是ELAHERE与研究者自选（IC）单药化疗（每周紫杉醇、聚乙二醇脂质体多柔比星或托泊替康）的随机3期试验。资格标准包括使用 Ventana FOLR1 RxDx 检测法检测肿瘤表达高水平 FRα 的 PROC 患者，且患者之前最多接受过三种方案的治疗。该试验的主要终点是研究者评估的无进展生存期（PFS）。主要次要终点包括客观反应率（ORR）和总生存期（OS）。该试验共招募了 453 名患者。根据患者既往接受过的治疗方案数量（14%的患者既往接受过一种治疗方案，39%的患者既往接受过两种治疗方案，47%的患者既往接受过三种治疗方案）和IC化疗进行了分层，其中紫杉醇是最常用的化疗方案（41%），其次是PLD（36%）和托泊替康（23%）。62%的患者之前接受过贝伐单抗治疗；55%的患者之前接受过PARP抑制剂治疗。