EU starts review of first-line Enhertu for breast cancer
Breast cancer assayed with anti HER-2 antibody.
The EMA has started its review of Daiichi Sankyo and AstraZeneca's Enhertu as a first-line therapy for HER2-positive breast cancer, setting up a possible approval later this year.
The two companies have filed Enhertu (trastuzumab deruxtecan) for approval for use in combination with pertuzumab for newly-diagnosed patients with unresectable or metastatic HER2-positive breast cancer, based on the results of the DESTINY-Breast09 study.
That showed a significant 44% reduction in the risk of disease recurrence or death compared to the current first-line standard of care, based on trastuzumab, pertuzumab and taxane chemotherapy known as THP.
DESTINY-Breast09 is also comparing the anti-HER2 antibody-drug conjugate (ADC) as a monotherapy against THP, but, so far, the data has not revealed any benefit over the comparator arm.
Daiichi and AZ already have approval for this indication in the US, which came in last month, and the frontline indication could help them overshoot their ambition to grow Enhertu into a $5 billion-a-year brand. For AZ, achieving that will also be an important part of its strategy of driving sales to $80 billion-plus by 2030.
The FDA's clearance made the regimen the first new first-line option in more than a decade, and could be a stepping stone to even earlier use in neoadjuvant and adjuvant settings, potential uses that are respectively being tested in the DESTINY-Breast11 and DESTINY-Breast05 studies and generated data at last year's ESMO cancer conference. Daichi and AZ are preparing to file for perioperative use of Enhertu in earlier-stage HER2-positive breast cancer on the strength of the two studies.
Already a blockbuster therapy for advanced breast cancer and other indications like gastric cancer, Enhertu made revenues of $3.58 billion in the first half of this year, up 31% on the same period of 2024, which puts it on course to get close to the $5 billion sales target in the full year – even before earlier-line use starts to kick in.
In Europe, approximately 557,000 cases of breast cancer are diagnosed annually, with more than 144,000 deaths. HER2-positive metastatic breast cancer is an aggressive disease that affects 15% to 20% of patients with advanced-stage disease.
While HER2 targeted therapies have improved outcomes, prognosis remains poor, with most patients experiencing disease progression within two years of first-line treatment with THP, while one in three patients do not receive any treatment following first-line therapy due to disease progression or death.
