EMA awards double validation for Daiichi Sankyo and AstraZeneca’s cancer ADC

Two marketing authorisation applications for Daiichi Sankyo and AstraZeneca’s jointly developed Dato-DXd (datopotamab deruxtecan) have been greenlighted by the European Medicines Agency (EMA), in two distinct cancer types.

One application is for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment. This submission was based on results from the Phase III TROPION-Lung01 trial (NCT04656652). Lung cancer patients treated with Dato-DXd were compared to those taking the chemotherapy drug docetaxel, the current standard of care.

The other application is for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2-negative breast cancer who have progressed on and are not suitable for endocrine therapy and received at least one additional systemic therapy. This application was based on results from the Phase III TROPION-Breast01 trial (NCT05104866).

Results from both trials indicated that Dato-DXd significantly improved progression-free survival compared to chemotherapy in both cancer types.

It’s been a positive start to the year for the companies regarding Dato-DXd. In February, the US Food and Drug Administration (FDA) accepted Dato-DXd’s filing for review for the treatment of patients with locally advanced or metastatic NSCLC who have received prior systemic therapy. A decision is anticipated later this year, with a Prescription Drug User Free Act (PDUFA) date scheduled for 20 December 2024. The companies have also submitted a biologics license application to the FDA for breast cancer treatment.

Dato-DXd is a TROP2-directed antibody-drug conjugate (ADC). TROP2 is a protein highly expressed in many types of lung and breast cancers.

Daiichi Sankyo’s three lead ADCs, which it is developing with pharma partners—Enhertu (trastuzumab deruxtecan), patritumab deruxtecan (HER3-Dxd), and Dato-Dxd—are expected to hold a significant chunk of the ADC market. The combined global sales of these three drugs are predicted to reach $13bn by 2029, according to GlobalData’s Intelligence Centre.

GlobalData is the parent company of Pharmaceutical Technology.

In the announcement accompanying the validations, executive vice president for oncology R&D at AstraZeneca Susan Galbraith said: “Today’s dual validation of our applications in lung and breast cancers brings this potential medicine a meaningful step closer to redefining treatment expectations for patients with two of the most common cancers in Europe.”