Trastuzumab Deruxtecan Receives Chinese Approval in HER2+ Breast Cancer
Adult patients with previously treated unresectable or metastatic HER2-positive breast cancer in China can now receive treatment with trastuzumab deruxtecan.
China’s National Medical Products Administration has approved trastuzumab deruxtecan (T-DXd; Enhertu) monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received 1 or more prior anti-HER2 therapies, according to a press release from Daiichi Sankyo and AstraZeneca.1
"This approval marks an important day for the breast cancer community in China as patients with HER2-positive metastatic breast cancer continue to need additional treatment options," according to an expert from Institute Cancer Hospital of the Chinese Academy of Medical Sciences.
The approval was based on data from the phase 3 DESTINY-Breast03 trial (NCT03734029) in which T-DXd yielded a 72% reduction in the risk of disease progression or death compared with trastuzumab emtansine (T-DM1; Kadcyla; HR, 0.28; 95% CI, 0.22-0.37; P <.000001). Additionally, the median progression-free survival (PFS) was not reached (95% CI, 18.5-not evaluable [NE]) with T-DXd vs 6.8 months (95% CI, 5.6-8.2) with T-DM1.
“This approval marks an important day for the breast cancer community in China as patients with HER2-positive metastatic breast cancer continue to need additional treatment options,” Binghe Xu, MD, professor and director of the Department of Medical Oncology at Cancer Hospital and Institute Cancer Hospital of the Chinese Academy of Medical Sciences, said in the press release. “Despite initial treatment, patients with HER2-positive metastatic breast cancer will often experience disease progression, demonstrating the importance of early systemic disease control and the potential for [T-DXd] to help eligible patients with metastatic breast cancer.”
Patients (n = 524) who enrolled were treated with 5.4 mg/kg of T-DXd or T-DM1.
The safety profile of T-DXd in DESTINY-Breast03 yielded no new signals and was comparable with those reported of the agent in previous clinical trials. The most common adverse effects in the trastuzumab deruxtecan arm included nausea (75.9%), fatigue (49.4%), and vomiting (49.0%).
The FDA previously approved T-DXd for unresectable or metastatic HER2-low breast cancer in August 2022.2 The approval was supported by data from the phase 3 DESTINY-Breast04 trial (NCT03734029), in which T-DXd produced a statistically significant and clinically meaningful improvement in overall survival vs chemotherapy.
References
- ENHERTU® approved in China for patients with HER2 positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens. News release. Daiichi Sankyo and AstraZeneca. February 24, 2023. Accessed February 27, 2023. bit.ly/3ECrd5R
- FDA approves first targeted therapy for HER2-low breast cancer. News Release. FDA. August 5, 2022. Accessed August 5, 2022. https://bit.ly/3BNUxWy
Treatment Combinations for HER2-Positive Breast Cancer
March 7th 2013As part of our coverage for the 30th Annual Miami Breast Cancer Conference, we bring you an interview with Dr. Mark Pegram, director of the breast cancer program at the Stanford Women’s Cancer Center and codirector of the molecular therapeutics program. Dr. Pegram will be discussing the potential for novel HER2 combination therapies at the conference.
