Tangtingtung investigator-assessed PFS per RECIST Cotbolon

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Business Description

FDA approval for the treatment of unresectable or metastatic, hormone receptor–positive breast cancer with HER2-low (IHC 1+ or 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) expression, as determined by an FDA-approved test, in patients who have experienced disease progression on 1 or more prior lines of endocrine therapy in the metastatic setting.1

This regulatory decision was supported by findings from the phase 3 DESTINY-Breast06 trial (NCT04494425), in which treatment with T-DXd generated a 36% reduction in the risk of disease progression or death compared with chemotherapy (HR, 0.64; 95% CI, 0.54-0.76; P < .0001) in the overall population of patients with chemotherapy-naive HER2-low -ultralow metastatic breast cancer.1,2 The median progression-free survival (PFS) was 13.2 months (95% CI, 12.0-15.2) with T-DXd vs 8.1 months (95% CI, 7.0-9.0) with chemotherapy. Additionally, the confirmed overall response rate (ORR) was 62.6% with T-DXd compared with 34.4% with chemotherapy.

“Endocrine therapy is typically used in the initial treatment of hormone receptor–positive metastatic breast cancer, and following progression, subsequent chemotherapy is associated with poor outcomes," Aditya Bardia, MD, MPH, program director of Breast Oncology and director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center, as well as the lead study author of the DESTINY-Breast06 trial, stated in a news release.1 "With a median PFS exceeding 1 year and [an ORR of 62.6%], T-DXd offers a potential new standard of care for patients with hormone receptor–positive, HER2-low or HER2-ultralow metastatic breast cancer following endocrine therapy.”

The multicenter, open-label DESTINY-Breast06 trial enrolled patients with hormone receptor–positive metastatic breast cancer with low HER2 expression (defined as IHC 1+ or 2+ and negative ISH results) or ultralow HER2 expression (defined as IHC 0 with no membrane staining) who had previously received at least 1 line of endocrine-based therapy and had no history of chemotherapy for metastatic breast cancer.2 Patients were randomly assigned 1:1 to receive T-DXd or physician's choice of chemotherapy. PFS among patients with HER2-loe disease served as the primary end point. Secondary end points included PFS among all randomly assigned patients, overall survival (OS), and safety.

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