^
Association details:
| Biomarker: | FOLR1 overexpression |
|---|---|
| Cancer: | Ovarian Cancer |
| Drug: | Elahere (mirvetuximab soravtansine-gynx) (Microtubule inhibitor, Folate receptor 1-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
1015 - Mirvetuximab Soravtansine Demonstrates Longer Overall Survival And Progression-Free Survival By Prior Lines Of Therapy Vs Chemotherapy In Platinum-Resistant Ovarian Cancer And High Folate Receptor Alpha Expression In The MIRASOL Trial
Published date:
09/18/2023
Excerpt:
453 PROC pts with high FRα expression (Roche FOLR1 Assay), 1-3 PLOT were randomized 1:1 to MIRV or IC: paclitaxel, pegylated liposomal doxorubicin, or topotecan….MIRV demonstrated a longer OS and PFS vs IC, regardless of the number of PLOT.
Trial ID:
Source:
Title:
1056 - Mirvetuximab Soravtansine Demonstrates Efficacy Over Investigator’s Choice Chemotherapy Regardless Of Prior PARPi Exposure In Phase III MIRASOL Trial
Published date:
09/18/2023
Excerpt:
453 PROC pts with high FRα expression with 1-3 priors were randomized 1:1 to MIRV or IC: paclitaxel, pegylated liposomal doxorubicin, or topotecan….MIRV is the first treatment to demonstrate both an OS and a PFS benefit compared to IC in a phase III trial in PROC.
Trial ID:
Source:
Title:
Phase III MIRASOL (GOG 3045/ENGOT-ov55) study: Initial report of mirvetuximab soravtansine vs. investigator's choice of chemotherapy in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression.
Published date:
05/25/2023
Excerpt:
453 PROC pts with high FRα expression (Roche FOLR1 Assay) with 1-3 priors were randomized 1:1 to MIRV 6 mg/kg...MIRV is the first treatment to demonstrate a PFS and OS benefit in PROC compared to IC.
DOI:
10.1200/JCO.2023.41.17_suppl.LBA5507
Trial ID:
Source:
Title:
Mirvetuximab soravtansine (MIRV) in patients with platinum-resistant ovarian cancer with high folate receptor alpha (FRα) expression: Characterization of antitumor activity in the SORAYA study.
Published date:
05/26/2022
Excerpt:
MIRV is the first biomarker-directed therapy demonstrating anti-tumor activity in pts with FRα high PROC. These results support the clinically meaningful impact MIRV has for pts with FRα high PROC, irrespective of prior therapies or dose modifications.
DOI:
10.1200/JCO.2022.40.16_suppl.5512
Trial ID:
Source:
Title:
ImmunoGen Announces Acceptance of Biologics License Application for Mirvetuximab Soravtansine in Ovarian Cancer by US Food and Drug Administration with Priority Review
Published date:
05/23/2022
Excerpt:
ImmunoGen...announced that the US Food and Drug Administration (FDA) has accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. The application has been granted Priority Review designation...
Source:
Title:
Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I
Published date:
03/02/2021
Excerpt:
Superior outcomes for MIRV over chemotherapy were observed in all secondary endpoints in the FRα high population including improved objective response rate (24% versus 10%)...Secondary endpoints consistently favored MIRV, particularly in patients with high FRα expression. MIRV showed a differentiated and more manageable safety profile than chemotherapy.
DOI:
10.1016/j.annonc.2021.02.017
Trial ID:
Source:
Title:
ImmunoGen Announces FDA Fast Track Designation for Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer
Published date:
06/18/2018
Excerpt:
ImmunoGen...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead program, mirvetuximab soravtansine. The designation is for the treatment of patients with medium to high folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer...
Source:
Title:
EFFICACY AND SAFETY OF MIRVETUXIMAB SORAVTANSINE IN CHINESE PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER WITH HIGH FOLATE RECEPTOR ALPHA EXPRESSION: RESULTS FROM IMGN853-301 (SORAYA CHINA) STUDY
Published date:
10/18/2023
Excerpt:
MIRV demonstrated consistent clinically meaningful antitumor activity and favorable tolerability and safety in Chinese patients with FRα-high PROC.
Source:
Title:
Efficacy and Safety of Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer With High Folate Receptor Alpha Expression: Results From the SORAYA Study
Published date:
01/30/2023
Excerpt:
SORAYA is a single-arm, phase II study evaluating efficacy and safety of MIRV in patients with PROC….ORR was 32.4% (95% CI, 23.6 to 42.2), including five complete and 29 partial responses. The median duration of response was 6.9 months (95% CI, 5.6 to 9.7)....MIRV demonstrated consistent clinically meaningful antitumor activity and favorable tolerability and safety in patients with FRα-high PROC who had received up to three prior therapies, including bevacizumab...
DOI:
10.1200/JCO.22.01900
Trial ID:
Source:
Title:
CLINICAL BENEFIT OF MIRVETUXIMAB SORAVTANSINE IN OVARIAN CANCER PATIENTS WITH HIGH FOLATE RECEPTOR ALPHA EXPRESSION: RESULTS FROM THE SORAYA STUDY
Published date:
09/12/2022
Excerpt:
Seventy-five patients (71%) experienced tumor reduction as their best response (Figure 1) and the disease control rate (DCR) was 51.4% (95% CI 41.5, 61.3). The confirmed ORR was 32.4% (95% CI 23.6, 42.2), the median duration of response was 6.9 months (95% CI 5.6, 8.1), and the median progression-free survival was 4.3 months (95% CI 3.7, 5.1)....MIRV demonstrated anti-tumor activity by tumor reduction and DCR in heavily pretreated patients with FRα-high PROC. These data support MIRV as a potential practice-changing, biomarker-driven therapy.
