Advances in Antibody-Drug Conjugates in the Treatment of HER2-Positive Breast Cancer

Figures & data

Table 1 Trials of T-DXd That Have Updated Date

Study (NCT Number)	Population	Setting	Experimental Arm	Primary End Points	Secondary End Point	Adverse Reactions ≥ Grade 3
DS8201-A-J101 (NCT02564900)^Citation31	HER2-low MBC	No prior HER2-targeted therapy	T-DXd	cORR (ICR): 37.0% cORR (by investigator): 44.4%	cDCR (ICR): 47% cDCR (by vestigator): 45% mDOR: 10.4 months mPFS: 11.1 months mOS: 29.4 months	63.00%
DS8201-A-J101 (NCT02564900)^Citation74	HER2+ MBC	Prior T-DM1	T-DXd	cORR (by investigator): 59.5%	CR: 3% PR: 57% SD: 34% PD: 5% cDCR: 93.7% mTTR: 1.6 months mDOR: 20.7 months mPFS: 22.1 months	50.00%
DS8201-A-U105 (NCT03523572)^Citation75	HER2-expressing MBC or advanced urothelial cancer	-	T-DXd in combination with nivolumab	cORR (HER2+ cohort, by ICR): 59.4% cORR (HER2-low cohort, by ICR): 37.5%	DCR (HER2+ cohort): 90.6% DCR (HER2-low cohort): 75.0% mPFS (HER2+ cohort): 8.6 months mPFS (HER2-low cohort): 6.3 months	43.80%
DESTINY-Breast01 (NCT03248492)^Citation34,Citation76	HER2+ MBC	Prior T-DM1	T-DXd	cORR (by ICR): 61.4%	mDOR: 20.8 months mPFS: 19.4 months mOS: 24.6 months DCR: 97.3% CR: 6.5% PR: 54.9% SD: 35.9% PD: 1.6%	-

Table 2 Trials of T-DXd That is on Going

Study (NCT-number)	Population	Setting	Experimental Arm	Control Arm	Primary End Points	Secondary End Point
DESTINY-Breast02 (NCT03523585)^Citation77	HER2+ MBC	On or after T-DM1	T-DXd	Investigator’s choice	PFS (by BICR)	OS ORR DOR PFS (by investigator) CBR
DESTINY-Breast03 (NCT03529110)^Citation78,Citation79	HER2+ MBC	Prior trastuzumab and a taxane	T-DXd	T-DM1	PFS (by BICR)	PFS (by investigator) cORR DOR OS
DESTINY-Breast04 (NCT03734029)^Citation80	HER2-low MBC	Prior chemotherapy	T-DXd	Investigator’s choice	PFS (by BICR)	PFS (by investigator) OS ORR DOR (by BICR) DOR (by investigator)
DESTINY-Breast05 (NCT04622319)^Citation81	Primary BC with residual invasive disease	After neoadjuvant therapy	T-DXd	T-DM1	IDFS (by nvestigator)	OS IDFS DRFI BMFI
- NCT04553770^Citation82	HER2-low, HR+ EBC	After neoadjuvant therapy	T-DXd ± anastrozole	-	pCRrate	Incidence of adverse events Molecular changes in tumor biomarkers ORR Biomarker analyses
DESTINY-Breast06 (NCT04494425)^Citation83	HR+, HER2-low MBC	≥ 2 prior lines of endocrine therapy have not received chemotherapy or any anti-HER2 therapy for metastatic disease	T-DXd	Investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, or capecitabine)	PFS (HER2-low, by BICR)	PFS (HER2 low, by investigator) PFS (intent-to-treat, by BICR) OS (HER2 low) OS (intent-to-treat) ORR (by BICR) ORR (by investigator) DOR (by BICR) DOR (by investigator)
DESTINY-Breast07 (NCT04538742)^Citation84	HER2+ MBC	Part 1: ≥2 lines of treatments Part 2: No prior treatment for MBC	T-DXd or in combination with other anti-cancer agents	-	AEs SAEs	ORR PFS PFS2 DOR OS
DESTINY-Breast08 (NCT04556773)^Citation85	HER2-low MBC	-	T-DXd in combination with other anti-cancer agents	-	AEs SAEs	ORR DOR PFS (by investigator) OS
DESTINY-Breast09 (NCT04784715)^Citation86	HER2+ MBC	No prior chemotherapy or HER2-targeted therapy for MBC	Arm A (T-DXd + placebo) Arm B (T-DXd + pertuzumab) Arm C (THP)	-	PFS (by BICR)	PFS (by investigator) OS ORR DOR PFS2
TUXEDO-1 (NCT04752059)^Citation87	HER2+, newly diagnosed or progressing BM	Progressing BM with radiological progression after prior local therapy, prior exposure to trastuzumab and pertuzumab	T-DXd	-	RR (intracranial, by RANO):83.3%	RR (extracranial) PFS OS Safety Quality-of-life
DEBBRAH (NCT04420598)^Citation88	(1) HER2+ MBC with non-progressing BM (2) HER2+ or HER2-low MBC with asymptomatic BM (3) HER2+ MBC with progressing BM (4) HER2-low MBC with progressing BM (5) HER2+ or HER2-low MBC with LMC	(1) Prior radiotherapy and/or surgery (2) Prior untreated (3) Prior local treatment (4) Prior local treatment (5) Not required	T-DXd	-	PFS OS ORR	Additional efficacy outcome Safety
HER2CLIMB-04 (NCT04539938)^Citation89	HER2+ MBC	Prior 2 or more anti-HER2-based regimens	T-DXd + tucatinib	-	cORR	DOR PFS DCR OS
DS8201-A-U106 (NCT04042701)^Citation90	HER2+/HER2-low MBC	Prior T-DM1/Prior have exhausted treatments that can confer any clinically meaningful benefit	T-DM1 + pembrolizumab	-	cORR	DOR DCR PFS TTR OS
HER2-PREDICT (NCT04257162)^Citation91	Metastatic/advanced cancer	Treated with T-DXd	T-DXd		HER2 mRNA cut-point predictive of T-DXd response

Table 3 The Approved and Investigational Anti-HER2 ADCs

Drug	ADC main parts 1) Monoclonal antibody 2) Payload 3) Linker	Drug-antibody ratio (DAR)	Study (NCT-number)	Population and setting	Efficacy	Adverse events grade≥3
Trastuzumab emtansine	1) DM1 2) Trastuzumab 3) N-maleimidomethyl cyclohexane-1-carboxylate (MCC)	3.5^Citation92	EMILIA (NCT00829166)	HER2+ MBC; Prior trastuzumab and a taxane	PFS: 9.6 months^Citation17 mOS: 29.9 months	Diarrhoea Fatigue AST increased ALT increased Anaemia Peripheral neuropathy Hypokalaemia Neutropenia Thrombocytopenia
Trastuzumab deruxtecan	1) DXd 2) A humanized HER2-targeted antibody 3) Cysteine-maleimide	8	DESTINY-Breast01 (NCT03248492)	HER2+ MBC; Prior Trastuzumab emtansine	cORR: 61.4% DOR: 20.8 months mPFS: 19.4 months mOS: 24.6 months DCR: 97.3%^Citation33	Anemia Decreased lymphocyte count Fatigue Vomiting Constipation Decreased appetite Diarrhea Aopecia Hematologic Interstitial lung disease^Citation93
SYD985	1) Trastuzumab 2) Duocarmycin 3) Vc-seco-DUBA	2^Citation42	TULIP (NCT03262935)	HER2+ MBC; ≥2 previous regimens or T-DM1	mPFS (by blinded central review): 7.0 months mPFS (by investigator): 6.9 months months OS: Unknown ORR: No significant difference HRQoL: No significant difference	Eye disorders Respiratory disorders
			-(NCT02277717)	HER2+/HER2 low/Triple-negative MBC; Prior ≥ 3 HER2-targeting regimens	ORR (HER2+): 33% PFS (HER2+): 9.4 months ORR (HER2-low): 27% ORR (Triple-negative): 40%	Neutropenia Cnjunctivitis
XMT-1522	1) HT-19 2) AF-HPA 3) Dolaflexin ADC platform^Citation48	10~15	- (NCT02952729)	HER2+ MBC; Prior all standard of care therapies	DCR (at dose of 16 or 21.3 mg/m2): 83% (5/6) DCR (at doses less than 16 mg/m2): 25% (3/12)	No
A166	1) Trastuzumab 2) Monomethyl auristatin F derivative 3) Valine citrulline	Unknown	- (NCT03602079)	HER2+/HER2-amplified MBC;-	PD: 41% (11/27) SD: 33% (9/27) PR: 26% (7/35)	Unknown
RC48-ADC	1) Hertuzumab 2) Monomethyl auristatin E (MMAE) 3)maleimidocaproyl(mc)^Citation52	4	- (NCT02881138)	HER2+ MBC;-	PR: 57.1% (8/14) SD: 28.6% (4/14)	Leucopenia AST elevation Neutropenia
			- (NCT03052634)	HER2+ MBC; Prior trastuzumab/chemotherapy	DCR: 96.7% (29/30) CBR (1.5 mg/kg): 26.7% (8/30) CBR (2.0mg/kg): 46.7% (14/30) ORR (trastuzumab-naive): 57.1% (17/30) ORR (trastuzumab-pretreated): 33.3% (10/30)	Neutropenia Leucopenia AST elevation ALT elevation
MM-302	1) A HER2-targeted antibody 2) Liposomal doxorubicin 3) Unknown	Unknown	- (NCT01304797)	HER2+ MBC;-	RR (MM-302 ≥ 30 mg/m2): 12% mPFS: 7.6months mPFS(MM-302 + trastuzumab + cyclophosphamide): 10.6 months	Constipation Cough Decreased appetite Diarrhea Dyspnea Fatigue Nausea Neutropenia Stomatitis Vomiting Cardiac failure
			HERMIONE (NCT02213744)	HER2+ MBC; Prior trastuzumab, and anthracycline-naive	Failed to find any clinical benefit	Unknown
MEDI4276	1) A tubulysin-based microtubule inhibitor (MMETA) 2) A bivalent biparatopic antibody 3) Engineered cysteines with a maleimide-bearing mc-Lys protease cleavable linker	4^Citation94	- (NCT02576548)	HER2+ breast or gastric cancer; Prior trastuzumab, pertuzumab, and T-DM1, either alone or in combination	CR: (0.5 mg/kg; breast): 1/43 PR: (0.6 /0.75mg/kg; breast): 2/43 SD: 28% (12/43)	Increased AST Increased ALT Diarrhea Increased blood bilirubin
PF-06804103	1) Aur0101 2) Anti-HER2 immunoglobulin G1 antibody 3) Anti-HER2 immunoglobulin G1 antibody	4^Citation95	- (NCT03284723)	HER2+ BC or HER2+ GC; Prior HER2-targeted therapy	ORR (≥ 3mg/kg): 52.4% (11/21)	Arthralgia Neuropathy Myalgia Fatigue Osteomuscular pain
ARX788	1) A cytotoxic tubulin inhibitor, Amberstatin (AS269) 2) A humanized HER2 targeting mAb 3) pAF-hydroxylamine-PEG4	2^Citation96	- (NCT03255070)	HER2+ MBC; Prior pertuzumab and other HER2-directed therapies	Trial is ongoing	Trial is ongoing
			- (NCT02512237)	HER2+ MBC; rior a HER2 targeting therapy	Unknown	Unknown
ALT-P7	1) Monomethyl auristatin E (MMAE) 2) trastuzumab biobetter HM2 3) Cysteine-maleimide	2^Citation62	- (NCT03281824)	HER2+ MBC; Prior ≥ 2 anti-HER2 treatment	DCR: 77.3% (17/22) Median PFS: 6.2 months	Febrile neutropenia Thrombocytopenia Hyperbilirubinemia Myalgia Hyponatremia
DHES0815A	1) Pyrrolo benzodiazepine monoamide (PBD-MA) 2) A monoclonal HER-2 targeting antibody 3) Unknown	Unknown	- (NCT03451162)	HER2+ MBC; Prior ≥ 2 chemotherapy regimens	cORR: 86% (10/14) cCRR (at dose of 1.2 mg/kg): 7% (1/14)^Citation97	Blepharitis Eye pain Photophobia
BAT8001	1) A maytansine derivative 2) A trastuzumab biosimilar 3) Cysteine-3AA	Unknown	- (NCT04189211)	HER2+ MBC;-	ORR: 41.4% (12/29) DCR: 82.8% (24/29)	thrombocytopenia aspartate aminotransferase increased γ-glutamyl transferase increased alanine aminotransferase increased diarrhea

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