It is shaping up to be a big year for AstraZeneca in lung cancer treatments. Following another approval win for its blockbuster immunotherapy drug Tagrisso (Osimertinib) in non-small cell lung cancer (NSCLC), another drug could be on the way later this year.

The US Food and Drug Administration (FDA) has accepted for review Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) for the treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy, as per a 19 February press release.

The outcome of the FDA’s decision will only be known later this year, with a Prescription Drug User Free Act (PDUFA) date set for 20 December 2024. 

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

The drug has demonstrated positive results in the Phase III TROPION-Lung01 trial (NCT04656652), which Daiichi Sankyo sponsored with collaboration from AstraZeneca. Lung cancer patients treated with Dato-DXd were compared to those taking the chemotherapy drug docetaxel, the current standard of care.

Whilst the trial met one of the dual primary endpoints of progression-free survival, interim analysis of data indicated that the other endpoint of overall survival did not meet statistical significance. The companies said that the overall survival will be assessed again at the final analysis.

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The companies have submitted a biologics licence application to the FDA for breast cancer treatment too, following positive results in the Phase III TROPION-Breast01 trial (NCT05104866).

Daiichi Sankyo and AstraZeneca entered a global collaboration to jointly develop and commercialise Dato-DXd in July 2020. The companies also jointly developed Enhertu (trastuzumab deruxtecan) – approved in the US for NSCLC in 2022.

The NSCLC market is largely dominated by MSD’s Keytruda (pembrolizumab), which saw $25bn in global sales last year. AstraZeneca’s Tagrisso – the pharma’s biggest selling drug – meanwhile, was approved for patients with EGFR-positive NSCLC patients in combination with chemotherapy on the same day as Dato-DXd was accepted for review. Tagrisso and Enhertu are expected to add competition to the cancer market with more approvals – GlobalData’s Pharma Intelligence Centre forecasts $7.4bn and $9.9bn in annual sales for the two drugs respectively by 2029.

Across 15 global markets, the NSCLC market is predicted market to reach over $45.4bn in total by 2031, according to a report by GlobalData.

GlobalData is the parent company of Pharmaceutical Technology.

Daiichi Sankyo’s global head of R&D, said: “We endeavour to make datopotamab deruxtecan the first TROP2-directed antibody drug conjugate approved to treat patients with nonsquamous non-small cell lung cancer after disease progression on prior systemic therapy.”