Table 4.

Summary of clinical trials that led to FDA approval of T-DXd.

Trial	DESTINY-BREAST01 (Trastuzumab Deruxtecan in Metastatic HER2-Positive Breast Cancer Previously Treated with T-DM1)
Group	Experimental Therapy (intention to treat)
Treatment	T-DXd (5.4 mg/Kg)
Sample Size	n = 184
Median Progression-Free Survival	16.4 months
Overall Response	60.9%
Drug-related Grade ≥ 3 adverse events	57.1%
Trial	DESTINY-BREAST03 (Phase III Clinical Trial) (Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer)
Groups	Experimental Therapy	Control Arm
Treatment	T-DXd	T-DM1
Sample Size	n = 261	n = 263
Progression-Free Survival at 12 Months	75.8%	34.1%
Overall Response	79.7%	34.2%
Drug-related Grade ≥ 3 Adverse events	45.1%	39.8%
Trial	DESTINY-BREAST04 (Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer)
Groups	Experimental Therapy	Control Arm
Treatment	T-DXd	Physician’s Choice 1
Sample size	n = 373	n = 184
Median Progression-Free Survival	9.9 months	5.1 months
Overall Survival	23.4 months	16.8 months
Drug-related Grade ≥ 3 adverse events	52.6%	67.4%

¹ Physician’s choice of therapy included: capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel.