AbbVie’s Elahere (mirvetuximab soravtansine-gynx) has demonstrated consistent survival benefits in a subset of ovarian cancer patients, according to results from a confirmatory late-stage trial of the drug.
The phase 3 MIRASOL study compared the efficacy and safety of Elahere against chemotherapy in women with folate receptor alpha-positive platinum-resistant ovarian cancer.
The final data analysis comes after the European Commission and US Food and Drug Administration approved the drug in November and March last year, respectively.
At a median follow-up of 30.5 months, median progression-free survival was 5.59 months for Elahere and 3.98 months for investigator’s choice chemotherapy.
Elahere was also associated with a higher objective response rate compared to chemotherapy, at 41.9% versus 15.9%, and demonstrated a 32% reduction in the risk of death compared to chemotherapy.
Other endpoints included safety and duration of response, which AbbVie said were consistent with the trial’s primary data analysis.
Ovarian cancer is the leading cause of death from gynaecological cancers in the US, with approximately 20,000 cases of the disease diagnosed every year.
The majority of patients present with late-stage disease and will usually undergo surgery followed by platinum-based chemotherapy. However, most will eventually develop platinum-resistant disease, at which point standard-of-care single-agent chemotherapies are associated with low response rates, short durations of response and significant toxicities.
Elahere, which AbbVie gained access to last year through its $10.1bn acquisition of ImmunoGen, is an antibody-drug conjugate (ADC), a relatively new class of cancer drugs that combine the selectivity of antibodies with the potent cell-killing power of chemotherapy or other anti-cancer agents.
Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy ones.
Commenting on the latest results for the drug, Svetlana Kobina, vice president, oncology medical affairs at AbbVie, said: “Ovarian cancer can be devastating, and when cancer cells stop responding to chemotherapy patients may feel hopeless about their journey.
“The data presented today reinforces the importance of Elahere as a transformative therapy for patients with limited options.”