AbbVie Launches ELAHERE in Singapore for FRα-Positive Platinum-Resistant Ovarian Cancer

“Biomarker testing, including for FRα status, can help inform treatment decisions as targeted therapies become available for certain patient groups. In clinical practice, such testing may be performed at diagnosis or at the point of disease progression, depending on the patient’s condition and care plan,” he added.

Ovarian cancer is a malignant tumour that arises from the ovaries and adjacent structures such as the fallopian tubes or peritoneum.^[3] It is known as the deadliest gynaecological cancer because it is usually detected in its later stages of development and spread.^[4] First-line treatment for advanced ovarian cancer typically consists of surgery and platinum-based chemotherapy,^[5] but 70% of patients experience recurrence after initial therapy, and resistance to platinum therapy accumulates with repeated treatments.^[6],[7] As a result, about one in five patients relapse within six months of platinum therapy, progressing to platinum-resistant ovarian cancer (PROC).^[5],[8] These patients have limited treatment options,^[9] and many are physically frail from prior therapies.^[10] In addition to the physical burden, patients may experience emotional distress due to social isolation and side effects such as hair loss from prior treatments, which can negatively impact prognosis.^[11],[12]

In Singapore, ovarian cancer is the 6th most common cancer and the 6th most common cause of death from cancer in women (2019-2023). The age-standardised incidence rate for ovarian cancer increased from 10.8 per 100,000 in 1998-2002 to 12.2 per 100,000 in 2019-2023. The five-year (2019-2023) age-standardised relative survival rate for ovarian cancer is 45.3%, much lower than other female cancers such as breast (84.2%), uterus (73.3%) and cervix (62.4%).^[13]

“Ovarian cancer can be devastating, taking women away from precious moments with their family, disrupting careers and the many other important contributions that women make to society.” said Rama V, ASEAN General Manager, AbbVie Pte Ltd. “The availability of ELAHERE provides a much needed clinically meaningful option for patients who receive the distressing news their ovarian cancer has returned, fearing what’s next in their treatment journey after they’ve developed platinum-resistance.”

“We are pleased that this availability brings the innovative therapeutic benefits of antibody-drug conjugate therapy to address a major unmet need for patients with platinum-resistant ovarian cancer. AbbVie is developing innovative approaches based on targeted therapy in ovarian cancer, a disease where early diagnosis and treatment remain difficult. And we will continue our efforts to improve treatment outcomes across all stages of ovarian cancer and to create a healthier tomorrow for women,” said Kenneth Sim, ASEAN Medical Director, AbbVie Pte Ltd.

In approximately one third of people living with ovarian cancer, the folate-receptor alpha (FRα) biomarker is highly expressed (≥75% of tumour cells with ≥2+ membrane staining intensity). To determine biomarker status, patients can be tested with Roche’s VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay at diagnosis or at the first sign of resistance to platinum-based chemotherapy. AbbVie collaborated with Roche Diagnostics on the newly approved immunohistochemistry (IHC) companion diagnostic test to identify patients who may be eligible for ELAHERE. 

The marketing authorisation of ELAHERE is supported by data from MIRASOL: a global, Phase 3 open-label, randomised, controlled trial.

• Trial patients were 18 years of age or older with disease that had progressed while on or after one to three lines of previous therapy. Patient tumours had to express high levels of FRα ≥75% of tumour cells with ≥2+ membrane intensity), assessed using the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. The primary endpoint was investigator-assessed progression-free survival (PFS). Key secondary endpoints included objective response rate (ORR) and overall survival (OS).
• Results presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO) demonstrated a 37% reduction in the risk of tumour progression or death in patients treated in the ELAHERE arm compared with the investigator’s choice (IC) chemotherapy arm, which represented an improvement in PFS [HR 0.63 (95% CI: 0.51, 0.79; p<0.0001)].
• ELAHERE also demonstrated improvement in OS compared with IC chemotherapy, representing a 32% reduction in the risk of death in the ELAHERE arm in comparison to the IC chemotherapy arm [HR 0.68 (95% CI: 0.54, 0.84; p=0.0004)].
• The most common adverse reactions with ELAHERE were blurred vision, nausea, diarrhea, fatigue, abdominal pain, keratopathy, dry eye, constipation, vomiting, decreased appetite, peripheral neuropathy, headache, asthenia, increased aspartate aminotransferase and arthralgia. The most commonly reported serious adverse reaction was pneumonitis.