FDA Grants Full Approval to Elahere for Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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The FDA has granted a full approval to Elahere (mirvetuximab soravtansine-gynx) for adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who were previously administered one to three systemic treatment regimens.¹ The FDA granted accelerated approval to Elahere in November 2022 for this indication.²

Manufacturer ImmunoGen, Inc. was then acquired by AbbVie in November 2023 along with its flagship antibody drug conjugate (ADC) Elahere.³

"The full FDA approval of Elahere for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team,” Roopal Thakkar, MD, senior vice president, chief medical officer, global therapeutics, AbbVie, said in a press release. “Elahere is the first and only (ADC) approved in the US for this difficult-to-treat malignancy.”¹

The most fatal gynecological cancer, ovarian cancer, is often diagnosed in the late stage, with approximately 20,000 patients diagnosed annually and 13,000 deaths. Standard of care treatment is surgery and platinum-based chemotherapy; however, many patients develop difficult to treat platinum-resistant disease that reduces their response rates.

Among patients with the disease, Elahere produced significant anti-tumor activity, durability of response, and overall tolerability in the SORAYA trial. The trial’s primary endpoint of confirmed objective response rate (ORR) was met by 31.7% of patients administered the ADC, making Elahere the first targeted medicine to show a meaningful survival benefit in this patient population. Positive findings from the multicenter, open-label, active-controlled, randomized Phase III MIRASOL confirmatory trial were used to support the full approval for Elahere.

MIRASOL enrolled patients (n = 453) with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who were permitted prior administration of up to three lines of systemic therapy. Patients were randomly assigned at a 1:1 ratio to receive intravenous Elahere every three weeks compared with investigator's choice of chemotherapy including paclitaxel, pegylated liposomal doxorubicin, or topotecan. Treatment continued until disease progression or intolerable toxicity.

Elahere showed superiority in median overall survival at 16.5 months (95% CI, 14.5-24.6) compared with 12.7 months (95% CI, 10.9-14.4) with investigator's choice of chemotherapy (n = 226). Elahere was also found to improve progression-free survival at a median of 5.6 months (95% CI, 4.3-5.9) compared with 4.0 months (95% CI, 2.9-4.5) with investigator's choice of chemotherapy. Further, Elahere produced an ORR of 42% (95% CI, 36%-49%) compared with 16% (95% CI, 12%-22%) with chemotherapy (P < .0001). Among patients who responded to Elahere, 5% achieved a complete response and 37% achieved a partial response.

"As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, Elahere provides an effective new option for patients with folate receptor alpha positive tumors. These patients previously had very limited options and Elahere changes that," MIRASOL principal investigator Kathleen Moore, deputy director and associate director of clinical research at the Stephenson Cancer Center of The University of Oklahoma, said in a press release.¹

References

1. U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients. AbbVie. March 22, 2024. Accessed March 25, 2024. https://news.abbvie.com/2024-03-22-U-S-Food-and-Drug-Administration-FDA-Grants-Full-Approval-for-ELAHERE-R-mirvetuximab-soravtansine-gynx-for-Certain-Ovarian-Cancer-Patients

2. ImmunoGen. ImmunoGen Announces FDA Accelerated Approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian. News Release. November 15, 2022. Accessed March 25, 2024. https://www.businesswire.com/news/home/20221104005657/en

3. AbbVie to Acquire ImmunoGen, including its Flagship Cancer Therapy ELAHERE® (mirvetuximab soravtansine-gynx), Expanding Solid Tumor Portfolio. AbbVie. News release. November 30, 2023. Accessed March 25, 2024. https://news.abbvie.com/2023-11-30-AbbVie-to-Acquire-ImmunoGen,-including-its-Flagship-Cancer-Therapy-ELAHERE-R-mirvetuximab-soravtansine-gynx-,-Expanding-Solid-Tumor-Portfolio