NICE recommends first-in-class FRα ADC in platinum-resistant ovarian cancer

This is a further step towards biomarker-driven treatment in ovarian cancer.

AbbVie recently announced that the National Institute for Health and Care Excellence (NICE) has recommended ELAHERE® (mirvetuximab soravtansine) as a monotherapy treatment option for eligible adults with folate receptor-alpha (FRα) positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three lines of systemic treatment, in its Final Draft Guidance (FDG).¹ 

This recommendation marks an important step forward in the treatment of PROC, where there has been no advancement in access to innovative treatments in 20 years.^2,3

Across the UK, more than 40,000 women are living with ovarian cancer, and each year over 6,000 more women in England and Wales are diagnosed. ^[vii],[viii] In England and Wales, two thirds of people living with ovarian cancer are diagnosed late at stage 3 or 4, when the cancer is difficult to treat.⁷

PROC is the term used when the cancer progresses or recurs within six months of completing treatment with a platinum-based chemotherapy and it is estimated that up to 70% of patients will eventually relapse and become platinum resistant over time.^4,5 PROC is severe and debilitating, with median overall survival being approximately one year.^[ix],[x] This makes people living with PROC one of the most underserved groups in ovarian cancer, facing limited options, high relapse rates, and poor outcomes.^2,9,[xi]

“For those with FRa-positive platinum-resistant ovarian cancer, today marks a landmark moment. Being told that platinum-based chemotherapy is no longer working can bring anxiety and uncertainty, particularly when the disease is at an advanced stage, where time and options are limited. This recommendation is the first in over twenty years to offer the ovarian cancer community an additional choice at a critical stage, with the potential to make a real difference to patients and their families,” said Victoria Clare, Chief Executive Officer, Ovacome.

The NICE FDG recommendation is based on data from MIRASOL; a global phase 3, open-label, randomised, controlled trial.⁶ In MIRASOL, the median progression free survival (PFS, the primary endpoint of the trial) for patients who received mirvetuximab soravtansine  (n=227) was 5.62 months compared with 3.98 months for those who received chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan)  (n=226) [HR 0.65, 95% CI 0.521-0.808, p<0.001].⁶ Overall survival (a secondary endpoint) was significantly longer for those patients who received mirvetuximab soravtansine than those who received chemotherapy (median, 16.46 months vs. 12.75 months; HR 0.67; 95% CI, 0.50-0.89; P=0.005).⁶ This is the first time a significant benefit in both PFS and OS has been demonstrated in FRa-positive PROC for over two decades.

“NICE’s recommendation of mirvetuximab soravtansine is an important milestone, helping to ensure eligible women with FRα-positive platinum resistant ovarian cancer can access this therapy. For the first time in over twenty years, this new treatment offers the potential to extend survival where effective options have been limited. Mirvetuximab soravtansine is designed to target and help kill cancer cells expressing high levels of a biomarker called folate receptor. Having access to novel treatments such as mirvetuximab soravtansine, is vital, offering patients more options where few have existed and supporting a more tailored approach to care for ovarian cancer patients,” said Professor Susana Banerjee, UK lead for the MIRASOL trial, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust, London and Professor in Women’s Cancers, the Institute of Cancer Research, London.

Mirvetuximab soravtansine is a targeted antibody-drug conjugate (ADC) for cancers that express high levels of a protein on the surface of cancer cells known as folate receptor alpha (FRα).^[xii] The FRα protein is a biomarker that is commonly overexpressed on ovarian tumours and minimally expressed on normal tissues.⁶ FRα acts as a biomarker, meaning it provides biological information about the tumour that helps to determine whether certain therapies are likely to be effective.^[xiii] Mirvetuximab soravtansine may stop the cancer cells from growing and can help to stop the disease from spreading.¹²

Roughly 80% of recurrent epithelial ovarian cancer has FRα on the surface of its cancer cells, and approximately 32%-36% of ovarian cancer cells have FRα-high expression.^6,[xiv],[xv] Biomarker testing is becoming an important part of modern cancer care, as it identifies changes in tumour genes and proteins, such as FRα, that influence how a cancer behaves and may respond to certain treatments.^[xvi] To determine if people are eligible for treatment with mirvetuximab soravtansine, a test must be done to assess FRα biomarker status. This can be done at diagnosis, relapse, or at the first sign of resistance to platinum-based chemotherapy.^[xvii]

“NICE’s Final Draft Guidance (FDG) positive recommendation of mirvetuximab soravtansine is an important milestone for people living with platinum‑resistant ovarian cancer, an area of significant unmet need. As the first FRα biomarker‑targeted therapy for this population, we remain committed to working with healthcare authorities to help ensure eligible patients across the UK can access mirvetuximab soravtansine.” said Rachael Millward, Medical Director, AbbVie UK.

References:

Source: AbbVie

Image: Canva 

Staff Writer