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- Health Canada has approved ELAHERE ® , the first novel therapy to demonstrate statistically significant and clinically meaningful improvements in overall survival (OS) compared to chemotherapy alone for patients with platinum-resistant ovarian cancer (PROC). 1
- ELAHERE ® received approval through Health Canada's Priority Review process, based on data from the pivotal MIRASOL Phase 3 trial, establishing it as a potential new standard of care for folate receptor alpha (FRα)-positive PROC). 1
- ELAHERE ® is the first and only Health Canada approved antibody-drug conjugate (ADC) targeting FRα, offering a new treatment option for a disease with the lowest survival rate among gynecological cancers in Canada .
Today, AbbVie (NYSE: ABBV) has announced that under the Priority Review process, Health Canada has approved ELAHERE ® (mirvetuximab soravtansine for injection), an antibody-drug conjugate (ADC), for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. 1
"Ovarian cancer poses many unique challenges for women. In addition to vague symptoms and late-stage diagnosis, many patients develop a resistance to current treatments that increases their risk of poor survival outcomes," said Tania Vrionis , CEO of Ovarian Cancer Canada, the only national health charity focused on supporting women facing ovarian cancer. "The approval of ELAHERE ® in Canada is not only welcome news for women in our community, but also a critically needed update to their care. This decision gives them another treatment option and can help improve outcomes for those who are no longer responding to surgery and chemotherapy."
"Platinum-resistant ovarian cancer is a challenging disease with limited effective therapies and a poor prognosis," said Dr. Shannon Salvador , President of the Society of Gynecologic Oncologists of Canada , Associate Professor at McGill University , and Director of the Gynecologic Oncology Subspecialty Residency Program. "This approval marks a critical advancement in the treatment of advanced ovarian cancer. ELAHERE ® has been shown to extend the survival of patients and offers a much-needed new option for those facing this form of gynecological cancer, which has the lowest survival rate in Canada ."
"This new treatment is the first in over a decade for this type of ovarian cancer and marks a major milestone for patients," said Rami Fayed, Vice President and General Manager of AbbVie Canada. "We take seriously our responsibility to research, develop and introduce therapies that impact patients' lives and AbbVie is committed to developing treatments for hard-to-treat cancers to help improve patients' outcomes and quality of life."
About The Phase 3 MIRASOL Trial
MIRASOL is a randomized Phase 3 trial evaluating the efficacy and safety of ELAHERE ® (mirvetuximab soravtansine for injection) versus investigator's choice (IC) of single-agent chemotherapy. Eligibility criteria included patients with PROC whose tumors express high levels of FRα, as determined using the Ventana FOLR1 RxDx Assay, and who have been treated with one to three prior systemic regimens. The trial enrolled 453 patients. The primary endpoint was progression-free survival (PFS) by investigator assessment, and key secondary endpoints included objective response rate (ORR) and overall survival (OS).
The OS hazard ratio (HR) was 0.67 (95% confidence interval [CI]: 0.50, 0.88; p=0.0046), representing a 33% statistically significant and clinically meaningful reduction in risk of death in the ELAHERE ® arm compared to the IC chemotherapy arm. The PFS HR was 0.65 (95% CI: 0.52, 0.81; p ® arm compared to IC chemotherapy. ORR in the ELAHERE ® arm was 42% (95% CI: 35.8%–49.0%) compared to 16% (95% CI: 11.4%–21.4%) in the IC chemotherapy arm. Additionally, 5% of patients in the ELAHERE ® arm achieved a complete response, versus 0% in the chemotherapy arm.
In this trial, serious adverse reactions occurred in 24% of patients treated with ELAHERE ® . The most common (≥ 2%) serious adverse events were pleural effusion (3%), abdominal pain (3%), intestinal obstruction (2%), ascites (2%) and small intestinal obstruction (2%).
About Ovarian Cancer
Ovarian cancer is the leading cause of death from gynecological cancers in Canada . 2 Each year, an estimated 3,000 women are diagnosed. 3 Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. 4 Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. 4 In this setting, standard of care chemotherapies with or without bevacizumab are associated with low response rates, poor prognosis, short durations of response, and significant toxicities. 5
About ELAHERE ®
ELAHERE ® (mirvetuximab soravtansine for injection) is the first and only FRα-targeted ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. Please consult the ELAHERE ® Product Monograph at https://www.abbvie.ca/en/our-science/products.html .
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 35 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, gynecology and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca . Follow AbbVie Canada on Instagram , or LinkedIn .
| References |
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| 1 ELAHERE (mirvetuximab soravtansine for injection) product monograph. AbbVie Corporation. Available at: https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/ELAHERE_PM_EN.pdf |
| 2 Statistics Canada. Trends in the incidence and mortality of female reproductive system cancers. 2015. Available at: https://www150.statcan.gc.ca/n1/pub/82-624-x/2015001/article/14212-eng.htm |
| 3 Canadian Cancer Society. Ovarian cancer statistics. 2024. Available at: https://cancer.ca/en/cancer-information/cancer-types/ovarian/statistics |
| 4 Wang, L., Wang, X., Zhu, X. et al. Drug resistance in ovarian cancer: from mechanism to clinical trial. Mol Cancer 23, 66 (2024). https://doi.org/10.1186/s12943-024-01967-3 |
| 5 Gonzalez-Ochoa E, Veneziani AC, Oza AM. Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer. Clin Med Insights Oncol. 2023 Jul 25;17:11795549231187264. doi: 10.1177/11795549231187264. PMID: 37528890; PMCID: PMC10387675. |
SOURCE AbbVie Canada
