HQ Team
November 15, 2022: Immunogen, one of the leading companies in the field of antibody-drug conjugates (ADCs) for the treatment of cancer, has got accelerated approval from the US Food and Drug Administration (FDA) for Elahare, a drug for treating advanced ovarian cancer.
The antibody drug can be used to treat adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Elahere is reportedly the first ADC to receive FDA approval for platinum-resistant disease.
Soraya clinical trial
Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the Soraya clinical trial.
The ADC carries FRα-binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4.
The SORAYA trial included 106 patients with platinum-resistant ovarian cancer whose tumors expressed high levels of FRα and who had been treated with one to three prior systemic treatment regimens – at least one of which included Avastin® (bevacizumab). The primary endpoint was confirmed ORR as assessed by investigator and the key secondary endpoint was DOR. Elahere demonstrated an ORR by investigator of 31.7%, including five complete responses. The median DOR was 6.9 months. Elahere safety was determined from three studies among a total of 464 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received at least one dose of Elahere (6 mg/kg adjusted ideal body weight (AIBW) administered intravenously once every 3 weeks).
ImmunoGen president and CEO Mark Enyedy said: “With an indication for use regardless of prior treatment with Avastin, we believe Elahere is positioned to become the new standard of care for patients with FRα-positive platinum-resistant ovarian cancer.
“Elahere’s accelerated approval is a testament to the decades of work dedicated to developing the next generation of ADCs and marks ImmunoGen’s transition to a fully-integrated oncology company and the start of an exciting new chapter for us as a leader in the development and commercialisation of innovative oncology products.”
The continual approval for ADC is subject to validation of its clinical benefit in a confirmatory trial.
The confirmatory, randomised MIRASOL trial has concluded subject enrolment with top-line findings anticipated early next year.
In February, the company signed a licensing agreement with Eli Lilly and Company, which obtained exclusive rights to conduct the research, development and marketing of ADCs.
