Officials with the FDA have granted breakthrough therapy designation to trastuzumab deruxtecan (Enhertu, AstraZeneca and Daiichi Sankyo) for the treatment of HER2-mutant metastatic non-small cell lung cancer (NSCLC), according to a press release.
Trastuzumab deruxtecan is a HER2-directed antibody drug conjugate that is already approved in the United States for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2-based regimens.
NSCLC, the most common form of lung cancer, has poor prognosis for patients with metastatic disease, with only approximately 6-10% of patients alive 5 years after diagnosis, according to AstraZeneca. Approximately 2-4% of patients with NSCLC have a HER2 mutation.
The breakthrough designation for NSCLC is based on data from the ongoing phase 2 DESTINY-LUNG01 clinical trial, which is evaluating trastuzumab deruxtecan in patients with HER2-mutant metastatic NSCLC, and data from the phase 1 trial published in Cancer Discovery.
In the DESTINY-LUNG01 study, the primary end point is overall response rate, with key secondary end points of duration of response, disease control rate, progression-free survival, and overall survival. The overall safety and tolerability profile of trastuzumab deruxtecan in the ongoing trial is consistent with that seen in the phase 1 study.
Results from an interim analysis from DESTINY-LUNG01 will be presented during the 2020 American Society of Clinical Oncology ASCO20 Virtual Scientific Program.
“Today’s news is very welcome as we continue to evaluate the potential of Enhertu to help patients with this devastating type of lung cancer,” José Baselga, executive vice president, R&D Oncology, said in a statement. “Targeted treatments and immunotherapies are demonstrating tremendous advancements, but there remains an unmet medical need for patients with HER2 mutations who are not benefiting from such therapies or for those whose cancer continues to progress.”
1. Enhertu granted Breakthrough Therapy Designation in the US for HER2-mutant metastatic non-small cell lung cancer. News Release. AstraZeneca; May 18, 2020. Accessed May 19, 2020. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/enhertu-granted-breakthrough-therapy-designation-in-the-us-for-her2-mutant-metastatic-non-small-cell-lung-cancer.html#!