EMA Accepts Application for Mirvetuximab Soravtansine in Ovarian Cancer

The FDA previously granted accelerated approval to mirvetuximab soravtansine as a treatment for patients with previously treated FRα–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in November 2022.

The European Medicines Agency (EMA) has accepted a marketing authorization application for mirvetuximab soravtansine-gynx (Elahere) as a treatment for those with folate receptor α (FRα)–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, according to a press release from ImmunoGen, Inc.¹

Supporting findings for the application came from the phase 3 MIRASOL trial (NCT04209855). According to data from a prior readout, mirvetuximab soravtansine produced a median overall survival (OS) of 16.46 months compared with 12.75 months in patients treated with investigator’s choice of chemotherapy (HR, 0.67; P = .0046).² Investigators also reported a median progression-free survival (PFS) of 5.62 months and 3.98 months in each respective arm (HR, 0.65; P <.0001).

Grade 3 or higher treatment-emergent adverse effects (TEAEs) affected 42% of patients in the mirvetuximab soravtansine arm vs 54% of those in the chemotherapy arm. Additionally, serious AEs occurred in 24% and 33% of patients in each respective arm, and TEAEs resulting in treatment discontinuation were reported in 9% and 16%. The mirvetuximab soravtansine arm raised no new safety signals in the MIRASOL trial.

“The acceptance of our [marketing authorization application] is another important regulatory milestone in the next chapter of [mirvetuximab soravtansine’s] story as we work diligently to deliver this new treatment option to patients with platinum-resistant ovarian cancer globally,” Michael Vasconcelles, MD, executive vice president of Research, Development, and Medical Affairs at ImmunoGen, said in the press release.¹ “We look forward to working closely with the EMA throughout the review process and to potentially bring this novel [antibody-drug conjugate] to Europe as early as 2024.”

The FDA previously granted accelerated approval to mirvetuximab soravtansine as a treatment for patients with previously treated FRα–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in November 2022.³ Supporting data for the accelerated approval came from the phase 3 SORAYA trial (NCT04296890), in which mirvetuximab soravtansine yielded an investigator-assessed overall response rate of 31.7% (95% CI, 22.9%-41.6%). Investigators also reported a median duration of response of 6.9 months (95% CI, 5.6-9.7).

References

1. ImmunoGen announces European Medicines Agency acceptance of marketing authorization application for mirvetuximab soravtansine in platinum-resistant ovarian cancer. News release. ImmunoGen, Inc. October 27, 2023. Accessed October 30, 2023. https://shorturl.at/pG069
2. ELAHERE® demonstrates overall survival benefit in the phase 3 MIRASOL trial in patients with FRα-positive platinum-resistant ovarian cancer. News release. ImmunoGen. May 3, 2023. Accessed October 30, 2023. bit.ly/42pdZ6h
3. ImmunoGen announces FDA accelerated approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. News release. ImmunoGen. November 14, 2022. Accessed October 30, 2023. https://bwnews.pr/3AayMyH