NSCLC is the most common type of lung cancer, and prognosis is particularly poor for patients with metastatic disease as only about 6-10% will be alive five years after diagnosis. Approximately 2-4% of patients with NSCLC have a HER2 mutation.
The FDA granted BTD based on data from the ongoing Phase II DESTINY-Lung01 trial currently testing ENHERTU, a HER2-directed antibody drug conjugate (ADC), in patients with HER2-mutant (HER2m) metastatic NSCLC, and data from the Phase I trial published in Cancer Discovery.
An interim analysis from DESTINY-Lung01will be presented during the 2020
The overall safety and tolerability profile of ENHERTU in the ongoing DESTINY-Lung01 trial is consistent with that seen in the phase 1 trial. The most common adverse events to date (n=42) are gastrointestinal and hematological including nausea, alopecia, anemia, decreased appetite and decreased neutrophil count. There have been five cases of drug-related interstitial lung disease (ILD) and pneumonitis in patients with HER2 mutant NSCLC, all of which were grade 2. There have been no ILD-related deaths.
This is the third BTD granted for ENHERTU in the
ENHERTU recently received accelerated approval in the
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in
By harnessing the power of four scientific platforms Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory and Immunology. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
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