Enhertu (DS-8201) is indicated for the treatment of previously treated patients with HER2-mutant unresectable or metastatic non-small cell lung cancer, an indication for which it has been granted Priority Review designation by the U.S. FDA. On April 19, 2022, AstraZeneca announced that it and Daiichi Sankyo had received a notification of acceptance from the FDA for their supplemental Biologics License Application (CLPA) for Enhertu. If approved for this new indication, Enhertu will become the first targeted therapy for HER2-mutant metastatic non-small cell lung cancer.
The remission rate was 55%, and the survival time was 17.8 months.
At last year's World Conference on Lung Cancer, researchers presented the latest findings of their study on Enhertu for the treatment of non-small cell lung cancer. The results of the DESTINY-Lung01 trial (NCT03505710) showed an overall response rate of 61.9%, with a complete response rate of 2.4% and a disease control rate of 90.5%. At a median follow-up of 8 months, the median progression-free survival was 14 months. The median duration of response and overall survival have not yet been reached.
This year, researchers updated the data from the Phase III DESTINY-Lung01 trial, with a follow-up period of 13.1 months. Among 91 patients with metastatic HER2-mutant non-small cell lung cancer, the overall response rate reached 55%, and the disease control rate improved again to 92%. These patients included some refractory cases, such as those with brain metastases, and those who had received multiple treatment regimens, including various immune checkpoint inhibitors. Similarly, this drug is characterized by rapid response and long duration of efficacy. The median response time was only 1.5 months, the median duration of response was 9.3 months, the median progression-free survival was 8.2 months, and the median overall survival was 17.8 months.
This is one of the clinical trials of HER2 inhibitors (including ADC drugs) for treating non-small cell lung cancer that has enrolled a relatively large number of patients and shown significant efficacy.
Among patients with HER2 amplification, the overall response rates for dacomitinib, trastuzumab + pertuzumab, and T-DM1 regimens were 0%, 24%, and 43%, respectively, showing a significant difference. The newly released data for DS-8201 represents a slight improvement over T-DM1, demonstrating equally stable and excellent performance.
The new generation of ADC drugs has clearly become the future direction of treatment for HER2-positive non-small cell lung cancer.
