On April 5, 2024, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior systemic therapy and have no satisfactory alternative treatment options. Efficacy was evaluated in 192 previously treated patients with unresectable or metastatic HER2-positive solid tumors who participated in three multicenter trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02. All three trials excluded patients with a history of interstitial lung disease/pneumonia requiring steroid treatment or those with interstitial lung disease/pneumonia and clinically significant cardiac disease at screening. Patients with active brain metastases or an ECOG performance status greater than 1 were also excluded. Treatment continued until disease progression, death, withdrawal of consent, or unacceptable toxicity. The primary efficacy outcome measure in all three trials was confirmed objective response rate, and another efficacy outcome was duration of response. All results were assessed by independent central reviewers according to RECIST v1.1. In DESTINY-PanTumor02, the objective response rate was 51.4%, with a median duration of response of 19.4 months. In DESTINY-Lung01, the objective response rate was 52.9%, with a median duration of response of 6.9 months. In DESTINY-CRC02, the objective response rate was 46.9%, with a duration of response of 5.5 months. The prescribing information includes a boxed warning to alert healthcare professionals to the risk of interstitial lung disease and embryo-fetal toxicity.
Clinical oncology specialist Dr. Li Yu Chung, Jacky recommends that all solid cancers (including lung cancer, head and neck cancer, gastrointestinal cancer, hepatobiliary and pancreatic cancer, and gynecological cancer) undergo IHC (immunohistochemistry) testing for HER2 protein expression in order to find new treatment options for patients with advanced cancer.
