Daiichi Sankyo and AstraZeneca Submits New BLA for Accelerated Approval of Non-Small Cell Lung Cancer (NSCLC)
Wednesday, November 13, 2024
Daiichi Sankyo and AstraZeneca have submitted a Biologics License Application (BLA) for accelerated approval in the U.S. for datopotamab deruxtecan (Dato-DXd) as a treatment for adult patients with advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
Lung cancer remains a major global health challenge, with non-small cell lung cancer (NSCLC) accounting for around 80% of all lung cancer cases. Approximately 30-40% of NSCLC patients in Asia have an EGFR mutation, making it a significant target for treatment.
However, many patients eventually experience resistance to EGFR TKIs and require chemotherapy. Datopotamab deruxtecan, a targeted TROP2-directed ADC, could provide a promising new treatment option for these patients.
The companies have voluntarily withdrawn a previous BLA for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC, following data from the TROPION-Lung01 phase 3 trial.
This decision to submit the new BLA for EGFR-mutated NSCLC and withdraw the earlier one was based on feedback from the U.S. Food and Drug Administration (FDA).
The new BLA is supported by data from the TROPION-Lung05 phase 2 trial, as well as results from the TROPION-Lung01 phase 3 and TROPION-PanTumor01 phase 1 trials. A new pooled analysis from TROPION-Lung05 and TROPION-Lung01 will be presented at the European Society for Medical Oncology (ESMO) Asia 2024 Congress.
Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate (ADC), developed by Daiichi Sankyo and being jointly developed with AstraZeneca.
TROPION-Lung05 is a global phase 2 trial evaluating datopotamab deruxtecan in patients with advanced or metastatic NSCLC with genomic alterations, who have progressed after receiving at least one platinum-based chemotherapy and one tyrosine kinase inhibitor (TKI).
The trial aims to evaluate the objective response rate (ORR) and other secondary endpoints, including progression-free survival (PFS) and overall survival (OS). It enrolled 137 patients across Asia, Europe, and North America.
TROPION-Lung01 is a phase 3 trial comparing datopotamab deruxtecan with docetaxel in adult patients with advanced or metastatic NSCLC who have already received prior treatment. It enrolled approximately 600 patients globally, with primary endpoints focused on PFS and OS. The trial’s results were presented at major oncology conferences.
Additionally, datopotamab deruxtecan is being evaluated in combination with AstraZeneca’s EGFR TKI osimertinib in two ongoing phase 3 trials, TROPION-Lung14 and TROPION-Lung15, for advanced or metastatic EGFR-mutated nonsquamous NSCLC.
Datopotamab deruxtecan is part of Daiichi Sankyo’s ADC pipeline and is being investigated in over 20 clinical trials across various cancers, including NSCLC and breast cancer.
Source: daiichisankyo.com
