Table 4:

Studies with T-DXd Currently Accruing/Ongoing in Tumors that are HER2-Positive, HER2-Low or Those with HER2 Activating Mutations (22)

Studies	Disease Area	Phase	Study Details
HER2-positive
DS8201-A-U301 (DESTINY-Breast02)	Breast Cancer	3	Randomized, 2-arm, open-label study to compare the safety and efficacy of T-DXd versus the investigator’s choice of trastuzumab/capecitabine or lapatinib/capecitabine in subjects with HER2-positive, unresectable, and/or metastatic breast cancer previously treated with T-DM1.
DS8201-A-U302 (DESTINY-Breast03)	Breast Cancer	3	Randomized, 2-arm, open-label study to compare the safety and efficacy of T-DXd versus T-DM1 in subjects with HER2-positive, unresectable, and/or metastatic breast cancer previously treated with trastuzumab and taxane.
DS8201-A-U305 (DESTINY-Breast05)	Breast cancer	3	Randomized, open-label, active-controlled study of T-DXd versus T-DM1 in patients with high-risk HER2 positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes following neo-adjuvant therapy. High risk defined based on inoperable cancer at disease presentation (clinical stages T4, N0–3, M0 or T1–3, N2–3, M0) or operable at presentation (clinical stages T1–3, N0–1, M0) with positive pathological node status (ypN1–3) after neo-adjuvant therapy.
DS8201-A-U205 (DESTINY-Gastric02)	Gastric or GEJ adenocarcinoma	2	Single-arm, open-label, single-arm study of T-DXd in HER2-positive, unresectable or metastatic gastric or GEJ adenocarcinoma subjects who progressed on or after a trastuzumab-containing regimen.
D967LC00001 (DESTINY-Gastric03)	Gastric or GEJ adenocarcinoma	1B/2	Open-label study to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity in participants with HER2 overexpressing (IHC 3+ or IHC 2+/ISH+) locally advanced or metastatic, unresectable gastric cancer
DS8201-A-J203 (DESTINY-CRC01)	Colorectal cancer (CRC)	2	Single-arm, multicenter, open-label, 3-cohort study to investigate the safety and efficacy of DS-8201a in HER2-expressing advanced CRC subjects
DS8201-A-U105	Breast or urothelial cancer	1B	Single-arm, open-label, 2-part, multiple-dose study of T-DXd in combination with nivolumab in subjects with HER2-expressing advanced breast and urothelial cancer. Also enrolling HER2-low breast and urothelial cancer
DS8201-A-U106	Breast or non-small cell lung cancer (NSCLC)	1B	Single-arm, open-label, 2-part, multiple-dose study of T-DXd in combination with pembrolizumab, an anti-PD-1 antibody, in subjects with locally advanced/metastatic breast or NSCLC. Also enrolling HER2-low breast cancer and NSCLC, and HER2-mutant NSCLC
D967VC00001 (DESTINY-PanTumor02)	Solid tumors (urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors)	2	Single-arm, open-label, multi-cohort, study to evaluate the efficacy and safety of T-DXd for the treatment of selected HER2-expressing tumors. Also enrolling HER2-low tumors
HER2-low disease
DS8201-A-U303 (DESTINY-Breast04)	Breast Cancer	3	Randomized, 2-arm, open-label, active-controlled study to compare the safety and efficacy of T-DXd versus the physician’s choice of capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel, in subjects with HER2-low, unresectable, and/or metastatic breast cancer.
D9670C00001 (DESTINY-Breast06)	Breast Cancer	3	Randomized, open-label study of T-DXd versus investigator’s choice chemotherapy (capecitabine, paclitaxel, or nab-paclitaxel) in HER2-low, hormone receptor positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
HER2-mutations
DS8201-A-U204 (DESTINY-Lung01)	Non-small cell lung cancer (NSCLC)	2	Single-arm, open-label, 2-cohort, Phase 2 study to investigate the safety and efficacy of T-DXd in subjects with HER2-overexpressing or HER2- mutated NSCLC.