Datopotamab deruxtecan is comprised of a TROP2-targeting antibody conjugated to a TOP1-inhibitor payload. Image: Getty Images/ wildpixel

New data from the TROPION-Lung01 trial show datopotamab deruxtecan treatment led to greater overall survival (OS) than docetaxel chemotherapy in a group of non-small cell lung cancer (NSCLC) patients.

The TROP2-directed antibody-drug conjugate (ADC) is being developed by Daiichi Sankyo and AstraZeneca. Results from the Phase III trial’s (NCT04656652) final OS analysis were presented yesterday (9 September) at the 2024 World Conference on Lung Cancer.

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The global, multicentre trial enrolled 590 adults with locally advanced or metastatic NSCLC who had undergone at least one prior line of therapy. Although OS was not significantly improved with datopotamab deruxtecan compared to chemotherapy in the overall cohort, there was a significant mean improvement of 2.3 months among the nonsquamous disease subgroup of 14.6 months with the ADC versus 12.3 months with chemotherapy.

This data builds upon TROPION-Lung01 results presented at the 2023 European Society for Medical Oncology Congress, which showed a clinically significant increase in progression-free survival with datopotamab deruxtecan versus docetaxel for nonsquamous NSCLC patients.

Entering into collaboration in July 2020, Daiichi Sankyo and AstraZeneca have jointly advanced datopotamab deruxtecan development in more than 20 trials, including seven Phase III trials in lung cancers and five in breast cancers. Datopotamab deruxtecan is not the only instance where both companies have collaborated. The two partners successfully developed and launched the HER2-directed ADC Enhertu (trastuzumab deruxtecan), which is approved for certain types of breast cancer and NSCLC.

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In March this year, the European Medicines Agency (EMA) granted marketing authorisation to datopotamab for treating nonsquamous NSCLC and HER2-negative breast cancer, based on results from the TROPION-Lung01 and TROPION-Breast01 trials (NCT05104866), respectively. A parallel approval application in NSCLC is currently under review with the US Food and Drug Administration (FDA), with a Prescription Drug User Free Act date set on 20 December 2024.

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According to a GlobalData report, the NSCLC market, valued at $30.7bn in 2021, is set to grow to $45.4bn by 2031. The space is dominated by Keytruda (pembrolizumab), marketed by MSD, and AstraZeneca’s own Tagrisso (osimertinib mesylate), which are predicted to generate $28.6bn and $6.4bn in 2024 global sales, respectively. GlobalData estimates datopotamab deruxtecan will bring in $6bn in annual global sales by 2030.

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Ken Takeshita, Global Head of Research and Development at Daiichi Sankyo, said the TROPION-Lung01 data would support the company’s comprehensive development program, which will also include an evaluation of TROP2-directed ADC as a combination treatment for earlier lines of therapy in NSCLC.