sacituzumab govitecan

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Stem definition	Drug id	CAS RN
humanized origin	5391	1491917-83-9

Stem definition

Drug id

CAS RN

humanized origin

5391

1491917-83-9

Description:

Molecule	Description
Molfile Synonyms: sacituzumab sacituzumab govitecan sacituzumab govitecan-hziy trodelvy IMMU-132 TROP-2-SN-38 hRS7-SN-38-ADC	Sacituzumab govitecan-hziy is a Trop-2-directed antibody-drug conjugate. Sacituzumab is a humanized antibody that recognizes Trop-2. The small molecule, SN-38, is a topoisomerase I inhibitor, which is covalently attached to the antibody by a linker. Pharmacology data suggest that sacituzumab govitecan-hziy binds to Trop-2-expressing cancer cells and is internalized with the subsequent release of SN-38 via hydrolysis of the linker. SN-38 interacts with topoisomerase I and prevents re-ligation of topoisomerase I-induced single strand breaks. The resulting DNA damage leads to apoptosis and cell death. Sacituzumab govitecan-hziy decreased tumor growth in mouse xenograft models of triple-negative breast cancer Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Molfile

Synonyms:

sacituzumab
sacituzumab govitecan
sacituzumab govitecan-hziy
trodelvy
IMMU-132
TROP-2-SN-38
hRS7-SN-38-ADC

Sacituzumab govitecan-hziy is a Trop-2-directed antibody-drug conjugate. Sacituzumab is a humanized antibody that recognizes Trop-2. The small molecule, SN-38, is a topoisomerase I inhibitor, which is covalently attached to the antibody by a linker. Pharmacology data suggest that sacituzumab govitecan-hziy binds to Trop-2-expressing cancer cells and is internalized with the subsequent release of SN-38 via hydrolysis of the linker. SN-38 interacts with topoisomerase I and prevents re-ligation of topoisomerase I-induced single strand breaks. The resulting DNA damage leads to apoptosis and cell death. Sacituzumab govitecan-hziy decreased tumor growth in mouse xenograft models of triple-negative breast cancer

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Date	Agency	Company	Orphan
April 4, 2020	FDA	IMMUNOMEDICS INC
Nov. 22, 2021	EMA	GILEAD SCIENCES IRELAND UC

Date

Agency

Company

Orphan

April 4, 2020

FDA

IMMUNOMEDICS INC

Nov. 22, 2021

EMA

GILEAD SCIENCES IRELAND UC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Disease progression	4243.78	32.35	1320	10791	155295	90461041
Neutropenia	967.99	32.35	508	11603	224396	90391940
Inappropriate schedule of product administration	629.89	32.35	334	11777	149599	90466737
Weight fluctuation	600.99	32.35	184	11927	19565	90596771
Death	561.78	32.35	472	11639	456079	90160257
Diarrhoea	385.22	32.35	543	11568	938647	89677689
Febrile neutropenia	244.97	32.35	188	11923	158161	90458175
Neutrophil count decreased	219.47	32.35	130	11981	71402	90544934
Neutropenic colitis	207.84	32.35	57	12054	4086	90612250
Metastases to central nervous system	166.90	32.35	69	12042	17473	90598863
Neutrophil count abnormal	131.97	32.35	40	12071	4088	90612248
Asthenia	122.50	32.35	239	11872	533512	90082824
Thrombocytopenia	115.90	32.35	141	11970	208584	90407752
Myelosuppression	113.24	32.35	77	12034	53514	90562822
Colitis	94.91	32.35	77	12034	69865	90546471
Heart rate increased	87.85	32.35	91	12020	112811	90503525
Metastases to liver	84.72	32.35	51	12060	28756	90587580
General physical condition abnormal	84.19	32.35	30	12081	5081	90611255
Pneumonitis	80.55	32.35	58	12053	44112	90572224
Febrile bone marrow aplasia	78.29	32.35	34	12077	9704	90606632
Weight decreased	74.93	32.35	160	11951	379750	90236586
Product preparation issue	67.63	32.35	21	12090	2325	90614011
Haematotoxicity	58.27	32.35	30	12081	12505	90603831
Anaemia	56.62	32.35	137	11974	352665	90263671
Cholinergic syndrome	56.30	32.35	14	12097	682	90615654
Haemoglobin abnormal	54.51	32.35	24	12087	7076	90609260
Metastases to meninges	54.33	32.35	20	12091	3715	90612621
Constipation	51.68	32.35	115	11996	280280	90336056
Mucosal inflammation	47.60	32.35	48	12063	57577	90558759
Product preparation error	46.09	32.35	24	12087	10237	90606099
Drug hypersensitivity	44.50	32.35	5	12106	463604	90152732
SARS-CoV-2 test positive	41.50	32.35	23	12088	11105	90605231
Drug intolerance	40.14	32.35	6	12105	447585	90168751
Cell death	39.48	32.35	15	12096	3040	90613296
COVID-19	38.98	32.35	76	12035	168767	90447569
Arthralgia	38.23	32.35	29	12082	778493	89837843
Alopecia	35.99	32.35	146	11965	494925	90121411
White blood cell count decreased	35.90	32.35	73	12038	167036	90449300
Neutropenic sepsis	35.79	32.35	25	12086	18105	90598231
Breast cancer metastatic	34.96	32.35	23	12088	15109	90601227
Septic shock	34.42	32.35	49	12062	84111	90532225
Metastases to bone	34.40	32.35	28	12083	25477	90590859
Condition aggravated	33.52	32.35	19	12092	595526	90020810

MedDRA adverse event term

Likelihood ratio

Likelihood ratio threshold

Patients taking drug having adverse event

Patients taking drug not having adverse event

Patients not taking drug having adverse event

Patients not taking drug not having adverse event

Disease progression

4243.78

32.35

1320

10791

155295

90461041

Neutropenia

967.99

32.35

508

11603

224396

90391940

Inappropriate schedule of product administration

629.89

32.35

334

11777

149599

90466737

Weight fluctuation

600.99

32.35

184

11927

19565

90596771

Death

561.78

32.35

472

11639

456079

90160257

Diarrhoea

385.22

32.35

543

11568

938647

89677689

Febrile neutropenia

244.97

32.35

188

11923

158161

90458175

Neutrophil count decreased

219.47

32.35

130

11981

71402

90544934

Neutropenic colitis

207.84

32.35

12054

4086

90612250

Metastases to central nervous system

166.90

32.35

12042

17473

90598863

Neutrophil count abnormal

131.97

32.35

12071

4088

90612248

Asthenia

122.50

32.35

239

11872

533512

90082824

Thrombocytopenia

115.90

32.35

141

11970

208584

90407752

Myelosuppression

113.24

32.35

12034

53514

90562822

Colitis

94.91

32.35

12034

69865

90546471

Heart rate increased

87.85

32.35

12020

112811

90503525

Metastases to liver

84.72

32.35

12060

28756

90587580

General physical condition abnormal

84.19

32.35

12081

5081

90611255

Pneumonitis

80.55

32.35

12053

44112

90572224

Febrile bone marrow aplasia

78.29

32.35

12077

9704

90606632

Weight decreased

74.93

32.35

160

11951

379750

90236586

Product preparation issue

67.63

32.35

12090

2325

90614011

Haematotoxicity

58.27

32.35

12081

12505

90603831

Anaemia

56.62

32.35

137

11974

352665

90263671

Cholinergic syndrome

56.30

32.35

12097

682

90615654

Haemoglobin abnormal

54.51

32.35

12087

7076

90609260

Metastases to meninges

54.33

32.35

12091

3715

90612621

Constipation

51.68

32.35

115

11996

280280

90336056

Mucosal inflammation

47.60

32.35

12063

57577

90558759

Product preparation error

46.09

32.35

12087

10237

90606099

Drug hypersensitivity

44.50

32.35

12106

463604

90152732

SARS-CoV-2 test positive

41.50

32.35

12088

11105

90605231

Drug intolerance

40.14

32.35

12105

447585

90168751

Cell death

39.48

32.35

12096

3040

90613296

COVID-19

38.98

32.35

12035

168767

90447569

Arthralgia

38.23

32.35

12082

778493

89837843

Alopecia

35.99

32.35

146

11965

494925

90121411

White blood cell count decreased

35.90

32.35

12038

167036

90449300

Neutropenic sepsis

35.79

32.35

12086

18105

90598231

Breast cancer metastatic

34.96

32.35

12088

15109

90601227

Septic shock

34.42

32.35

12062

84111

90532225

Metastases to bone

34.40

32.35

12083

25477

90590859

Condition aggravated

33.52

32.35

12092

595526

90020810

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	88.05	44.57	43	470	185660	42435162
Sepsis	59.54	44.57	34	479	199300	42421522
Neutropenic sepsis	50.79	44.57	15	498	15931	42604891
Neutropenic colitis	47.70	44.57	11	502	4459	42616363
Disease progression	46.79	44.57	26	487	143630	42477192
Colitis	45.31	44.57	18	495	46554	42574268

MedDRA adverse event term

Likelihood ratio

Likelihood ratio threshold

Patients taking drug having adverse event

Patients taking drug not having adverse event

Patients not taking drug having adverse event

Patients not taking drug not having adverse event

Febrile neutropenia

88.05

44.57

470

185660

42435162

Sepsis

59.54

44.57

479

199300

42421522

Neutropenic sepsis

50.79

44.57

498

15931

42604891

Neutropenic colitis

47.70

44.57

502

4459

42616363

Disease progression

46.79

44.57

487

143630

42477192

Colitis

45.31

44.57

495

46554

42574268

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Disease progression	1862.88	29.40	714	8644	243320	110336621
Neutropenia	604.67	29.40	381	8977	374239	110205702
Weight fluctuation	563.70	29.40	162	9196	21983	110557958
Inappropriate schedule of product administration	331.79	29.40	209	9149	203428	110376513
Diarrhoea	327.70	29.40	438	8920	1139067	109440874
Death	288.30	29.40	323	9035	698546	109881395
Neutrophil count decreased	203.81	29.40	127	9231	120814	110459127
Febrile neutropenia	148.24	29.40	157	9201	316610	110263331
Neutropenic colitis	140.10	29.40	44	9314	8021	110571920
Metastases to central nervous system	118.03	29.40	51	9307	22766	110557175
Myelosuppression	114.96	29.40	81	9277	94259	110485682
Heart rate increased	92.66	29.40	85	9273	143749	110436192
Asthenia	84.31	29.40	182	9176	688817	109891124
Alopecia	81.18	29.40	125	9233	364628	110215313
Colitis	80.99	29.40	68	9290	102255	110477686
Metastases to liver	72.00	29.40	42	9316	35344	110544597
Weight decreased	65.76	29.40	131	9227	467926	110112015
Neutrophil count abnormal	60.91	29.40	21	9337	5111	110574830
Thrombocytopenia	50.57	29.40	99	9259	348786	110231155
Product preparation issue	47.58	29.40	15	9343	2764	110577177
Constipation	46.46	29.40	97	9261	357689	110222252
Weight increased	42.44	29.40	103	9255	419541	110160400
White blood cell count decreased	41.94	29.40	72	9286	229318	110350623
Fatigue	40.47	29.40	206	9152	1215752	109364189
Anaemia	39.93	29.40	119	9239	546967	110032974
Febrile bone marrow aplasia	38.91	29.40	22	9336	17443	110562498
Nausea	37.44	29.40	204	9154	1235486	109344455
Breast cancer metastatic	35.99	29.40	18	9340	11163	110568778
Energy increased	32.16	29.40	12	9346	3662	110576279
SARS-CoV-2 test positive	31.56	29.40	19	9339	16916	110563025
Metastases to bone	31.52	29.40	24	9334	31348	110548593
Haemoglobin abnormal	30.42	29.40	15	9343	9023	110570918
Flashback	29.66	29.40	7	9351	435	110579506

MedDRA adverse event term

Likelihood ratio

Likelihood ratio threshold

Patients taking drug having adverse event

Patients taking drug not having adverse event

Patients not taking drug having adverse event

Patients not taking drug not having adverse event

Disease progression

1862.88

29.40

714

8644

243320

110336621

Neutropenia

604.67

29.40

381

8977

374239

110205702

Weight fluctuation

563.70

29.40

162

9196

21983

110557958

Inappropriate schedule of product administration

331.79

29.40

209

9149

203428

110376513

Diarrhoea

327.70

29.40

438

8920

1139067

109440874

Death

288.30

29.40

323

9035

698546

109881395

Neutrophil count decreased

203.81

29.40

127

9231

120814

110459127

Febrile neutropenia

148.24

29.40

157

9201

316610

110263331

Neutropenic colitis

140.10

29.40

9314

8021

110571920

Metastases to central nervous system

118.03

29.40

9307

22766

110557175

Myelosuppression

114.96

29.40

9277

94259

110485682

Heart rate increased

92.66

29.40

9273

143749

110436192

Asthenia

84.31

29.40

182

9176

688817

109891124

Alopecia

81.18

29.40

125

9233

364628

110215313

Colitis

80.99

29.40

9290

102255

110477686

Metastases to liver

72.00

29.40

9316

35344

110544597

Weight decreased

65.76

29.40

131

9227

467926

110112015

Neutrophil count abnormal

60.91

29.40

9337

5111

110574830

Thrombocytopenia

50.57

29.40

9259

348786

110231155

Product preparation issue

47.58

29.40

9343

2764

110577177

Constipation

46.46

29.40

9261

357689

110222252

Weight increased

42.44

29.40

103

9255

419541

110160400

White blood cell count decreased

41.94

29.40

9286

229318

110350623

Fatigue

40.47

29.40

206

9152

1215752

109364189

Anaemia

39.93

29.40

119

9239

546967

110032974

Febrile bone marrow aplasia

38.91

29.40

9336

17443

110562498

Nausea

37.44

29.40

204

9154

1235486

109344455

Breast cancer metastatic

35.99

29.40

9340

11163

110568778

Energy increased

32.16

29.40

9346

3662

110576279

SARS-CoV-2 test positive

31.56

29.40

9339

16916

110563025

Metastases to bone

31.52

29.40

9334

31348

110548593

Haemoglobin abnormal

30.42

29.40

9343

9023

110570918

Flashback

29.66

29.40

9351

435

110579506

Source	Code	Description
ATC	L01FX17	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates
CHEBI has role	CHEBI:35610	antineoplastic agent

Source

Code

Description

ATC

L01FX17

ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates

CHEBI has role

CHEBI:35610

antineoplastic agent

Disease	Relation	SNOMED_ID	DOID
Triple negative breast neoplasms	indication	706970001

Disease

Relation

SNOMED_ID

DOID

Triple negative breast neoplasms

indication

706970001

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
DNA topoisomerase 1	Enzyme	P11387	TOP1_HUMAN	BINDING AGENT			DRUG LABEL	DRUG LABEL
Tumor-associated calcium signal transducer 2	Tumour-associated antigen	P09758	TACD2_HUMAN	ANTIBODY BINDING	Kd	9.58	DRUG LABEL	DRUG LABEL
IgG receptor FcRn large subunit p51	Membrane receptor	P55899	FCGRN_HUMAN	ANTIBODY BINDING	Kd	6.71	DRUG LABEL

Target

Class

Pharos

UniProt

Action

Type

Activity value
(-log[M])

Mechanism
action

Bioact source

MoA source

DNA topoisomerase 1

Enzyme

P11387

TOP1_HUMAN

BINDING AGENT

DRUG LABEL

Tumor-associated calcium signal transducer 2

Tumour-associated antigen

P09758

TACD2_HUMAN

ANTIBODY BINDING

9.58

DRUG LABEL

IgG receptor FcRn large subunit p51

Membrane receptor

P55899

FCGRN_HUMAN

ANTIBODY BINDING

6.71

DRUG LABEL

External reference:

ID	Source
D10985	KEGG_DRUG
M9BYU8XDQ6	UNII
1796566-95-4	SECONDARY_CAS_RN
4039353	VANDF
4039354	VANDF
C4086837	UMLSCUI
CHEBI:755547	CHEBI
CHEMBL3545262	ChEMBL_ID
91668186	PUBCHEM_CID
DB12893	DRUGBANK_ID
CHEMBL3707405	ChEMBL_ID
10097	INN_ID
C000608132	MESH_SUPPLEMENTAL_RECORD_UI
8253	IUPHAR_LIGAND_ID
871700000	SNOMEDCT_US
871701001	SNOMEDCT_US
871812009	SNOMEDCT_US
10418	INN_ID
333695	MMSL
38376	MMSL
38377	MMSL
d09554	MMSL
018344	NDDF
2360231	RXNORM

Source

D10985

KEGG_DRUG

M9BYU8XDQ6

UNII

1796566-95-4

SECONDARY_CAS_RN

4039353

VANDF

4039354

VANDF

C4086837