Company: AZN
Filing Date: 2025-06-24
Form Type: 6-K
Source: 0001654954-25-007315
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-06-24
Form: 6-K
Chunk 2
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. The median DoR was 6.5 months (95% CI: 4.2-8.4).

The safety profile of Datroway was evaluated in a pooled analysis of 125 patients in the TROPION-Lung05, TROPION-Lung01 and TROPION-PanTumor01 trials. The safety profile observed across these trials was consistent with the known profile of this medicine with no new safety concerns identified.

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

AstraZeneca and Daiichi Sankyo are evaluating Datroway alone and with Tagrisso (osimertinib) in other advanced or metastatic EGFR -mutated NSCLC settings in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

Financial considerations

Following approval in the US, an amount of $45 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the locally advanced or metastatic EGFR -mutated NSCLC indication. Sales of Datroway in the US are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from July 2020 .

#### Notes

#### Advanced non-small cell lung cancer
Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. 1 Lung cancer is broadly split into small or non-small cell lung cancer, the latter accounting for about 87% of cases. 2 Approximately 10 to 15% of patients with NSCLC in the US and Europe, and 30 to 40% of patients in Asia have an EGFR mutation. 3,4 The majority of EGFR mutations occur in tumours of nonsquamous histology. 5 TROP2 is a protein broadly expressed in the majority of NSCLC tumours. 6

For patients with tumours that have an EGFR mutation, the established 1st-line treatment in the metastatic setting includes EGFR -directed therapy with or without platinum-based chemotherapy. 7 While these therapies have improved outcomes in earlier lines of treatment, most patients eventually experience disease progression and receive subsequent therapies. 8-11

#### TROPION-Lung05
TROPION-Lung05 is a global, multicentre, single-arm