The experimental drug datopotamab deruxtecan, also known as Dato-DXd, has achieved Breakthrough Therapy Designation (BTD) in the United States. It targets adult patients who suffer from locally advanced or metastatic non-small cell lung cancer (NSCLC) that exhibits epidermal growth factor receptor mutations and whose disease has worsened after receiving an EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy treatment.
The US Food and Drug Administration’s Breakthrough Therapy Designation aims to expedite the development and regulatory assessment of promising new drugs for serious illnesses that lack adequate treatments. To qualify, the drug must show encouraging preliminary clinical outcomes that significantly improve upon the current treatment options.
This BTD was granted following an analysis of data from the TROPION-Lung05 Phase II and TROPION-Lung01 phase III trials. The findings, involving patients who had prior treatments for EGFRm NSCLC, were recently showcased at the European Society of Medical Oncology (ESMO) Asia 2024 Congress, marking the first BTD for datopotamab deruxtecan.
AstraZeneca’s oncology R&D executive VP Susan Galbraith commented on the designation, stating, “This recognition confirms datopotamab deruxtecan as an innovative, potential therapy for EGFR-mutated lung cancer patients who desperately need new treatment approaches after exhausting current options. We are dedicated to supporting these patients and anticipate offering this cutting-edge treatment to enhance their care.”
Dr. Ken Takeshita from Daiichi Sankyo emphasized the importance of this approval, “The FDA’s designation highlights the critical demand for novel therapies to benefit those battling previously treated EGFR-mutations in NSCLC with depleted options. Datopotamab deruxtecan promises better patient outcomes, and we eagerly collaborate with the FDA to expedite its availability.”
Datopotamab deruxtecan is a TROP2-guided DXd antibody drug conjugate (ADC) conceived by Daiichi Sankyo and is being co-developed with AstraZeneca.
Both companies recently forwarded a Biologics License Application seeking to accelerate US approval to treat adults with EGFRm NSCLC who have previously undergone systemic treatment regimes including EGFR-directed therapies.
In 2022 alone, approximately 2.5 million globally were diagnosed with lung cancer, with NSCLC constituting nearly 80% of cases. Additionally, 10-15% of NSCLC cases in the US and Europe, and 30-40% in Asia, display EGFR mutations.
The initial treatment for EGFR-mutant tumours is often an EGFR-TKI. Despite initial success, progression during or post-EGFR-TKI requires additional treatments, often leading to chemotherapy.
Protein TROP2 is predominantly expressed within the NSCLC tumour category, yet there is no approved ADC targeting TROP2 for lung cancer.
Trials like TROPION-Lung05 and TROPION-Lung01 evaluate datopotamab deruxtecan effectiveness across different settings, including monotherapy and combined cancer treatments. These trials engage patients on diverse parameters including the progression-free survival (PFS), overall survival (OS), and more.
AstraZeneca and Daiichi Sankyo’s innovative partnership aims to push boundaries in oncology by introducing medications that address resistant and advanced cancer stages. AstraZeneca, through collaborations, remains at the frontier of cancer research and treatment, pursuing a vision to ultimately eradicate cancer as a life-threatening illness.