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AstraZeneca and Daiichi Sankyo announced that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) to their Trop2-targeted antibody-drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with EGFR tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy.According to the press release, this is the first time datopotamab deruxtecan has received Breakthrough Therapy Designation.

This timeFDAThe granting of Breakthrough Therapy Designation is primarily based onTROPION-Lung05Clinical2Phase trial data, and addTROPION-Lung01Clinical3Supporting data for the Phase trial. This year, the American Society of Clinical Oncology (ASCO) Annual Meeting AnnouncedTROPION-Lung05Partial results of the trial show,18Patients with target brain lesions who have been treated for locally advanced or metastatic diseaseNSCLCThe patient's intracranial (IC) Objective Response Rate (ORR) for22%（95% CI：6–48），ICDisease Control Rate (DCR) for72%（95% CI：47–90）。18Among the patients,10Name (56%) The total diameter of brain tumors decreased.

The previously announced results of the TROPION-Lung01 Phase 3 clinical trial showed that, compared to the current standard of care docetaxel, patients with locally advanced or metastatic NSCLC who received datopotamab deruxtecan demonstrated a statistically significant improvement in one of the dual primary endpoints, progression-free survival (PFS). These patients had previously received at least one prior therapy. The safety profile of datopotamab deruxtecan was consistent with findings observed in other ongoing trials, with no new safety concerns identified.

Datopotamab deruxtecanIs a targetedTrop2TheADC。Through Daiichi Sankyo's proprietaryDXd ADCTechnical Design.Datopotamab deruxtecanBy a humanized anti-Trop2Monoclonal antibodies, with multiple topoisomerasesIInhibitor Payload (DXd) Generated by conjugation through a cleavable tetrapeptide linker.

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References:

[1] Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer. Retrieved December 9, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/datopotamab-deruxtecan-granted-breakthrough-therapy-designation-us-patients-previously-treated-advanced-egfr-mutated-non-small-cell-lung-cancer.html

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