Development and clinical application of anti-HER2 monoclonal and bispecific antibodies for cancer treatment

Yu, Shengnan; Liu, Qian; Han, Xinwei; Qin, Shuang; Zhao, Weiheng; Li, Anping; Wu, Kongming

doi:10.1186/s40164-017-0091-4

Experimental Hematology & Oncology

Table 1 Completed clinical trials of anti-HER2 monoclonal antibodies

From: Development and clinical application of anti-HER2 monoclonal and bispecific antibodies for cancer treatment

Drug	Identifier	Disease	Phase	Status	Treatment arms	Endpoints
Trastuzumab	NCT01450696 (HELOISE)	HER2+ gastric cancer	3	Completed	a. Capecitabine + cisplatin + trastuzumab (6 mg/kg) b. Capecitabine + cisplatin + trastuzumab (10 mg/kg)	OS a. 12.5 months b. 10.6 months C_trough increased in high dose trastuzumab
Trastuzumab	NCT01041404 (ToGA)	HER2+ advanced gastric cancer	3	Completed	a. Trastuzumab + fluoropyrimidine + cisplatin b. Fluoropyrimidine + cisplatin	OS a. 13.8 months b. 11.1 months
Pertuzumab	NCT00545688 (NeoSphere)	HER2+ breast cancer	2	Completed	a. Trastuzumab + docetaxel b. Trastuzumab + docetaxel + pertuzumab c. Trastuzumab + pertuzumab d. Pertuzumab + docetaxel	pCR a. 29.0% b. 45.8% c. 16.8% d. 24.0% PFS a. 81% b. 86% c. 73% d. 73% DFS a. 81% b. 84% c. 80% d. 75%
Pertuzumab	NCT00567190 (CLEOPATRA)	HER2+ metastatic breast cancer	3	Completed	a. Pertuzumab + trastuzumab + docetaxel b. Placebo + trastuzumab + docetaxel	OS a. 56.5 months b. 40.8 months PFS a. 18.7 months b. 12.4 months
Pertuzumab	NCT00976989 (TRYPHAENA)	HER2+ breast cancer	2	Completed	a. Pertuzumab + trastuzumab + FEC b. Pertuzumab + trastuzumab + docetaxel + FEC c. Pertuzumab + trastuzumab + docetaxel + carboplatin	pCR a. 61.6% b. 57.3% c. 66.2% CCR a. 50.7% b. 28.0% c. 40.3%
Pertuzumab T-DM1	NCT00951665	HER2+ locally advanced/metastatic breast cancer	1/2	Completed	a. T-DM1 3.6 mg/kg (Q3W) + paclitaxel 80 mg/m² (QW) b. T-DM1 3.6 mg/kg (Q3W) + paclitaxel 80 mg/m² (QW) + pertuzumab (Q3W)	Total ORR: 50.0% Total CBR: 56.8% Total incidence of grade 3 or worse AEs: 77.3%
Pertuzumab T-DM1	NCT00951665	HER2+ locally advanced/metastatic breast cancer	1/2	Completed	a. T-DM1 3.6 mg/kg (Q3W) + paclitaxel 80 mg/m² (QW) b. T-DM1 3.6 mg/kg (Q3W) + paclitaxel 80 mg/m² (QW) + pertuzumab (Q3W)	Total ORR: 50.0% Total CBR: 56.8% Total incidence of grade 3 or worse AEs: 77.3%
T-DM1	NCT01641939 (GATSBY)	HER2+ advanced gastric cancer	2/3	Completed	a. T-DM1 (2.4 mg/kg) b. Standard taxane therapy	Median follow-up a. 17.5 months b. 15.4 months OS a. 7.9 months b. 8.6 months Incidences of grade 3 or more AEs a. 60% b. 70%
T-DM1	NCT01120184 (MARIANNE)	HER2+ locally advanced/metastatic breast cancer	3	Completed	a. Trastuzumab + taxane b. T-DM1 + pertuzumab c. T-DM1 + placebo	Response rate a. 67.9% b. 59.7% c. 64.2% PFS a. 13.7 months b. 14.1 months c. 15.2 months Incidence of grade 3 or worse AEs a. 54.1% b. 45.4% c. 46.2%
T-DM1	NCT00829166 (EMILIA)	HER2+ locally advanced/metastatic breast cancer	3	Completed	a. T-DM1 b. Capecitabine + lapatinib	ORR a. 43.6% b. 30.8% PFS a. 9.6 months b. 6.4 months OS a. 30.9 months b. 25.1 months Incidence of grade 3 or worse AEs a. 57% b. 41%
T-DM1	NCT01419197 (TH3RESA)	HER2+ breast cancer	3	Completed	a. T-DM1 b. Treatment of physician’s choice	OS a. 22.7 months b. 15.8 months PFS a. 6.2 months b. 3.3 months Incidence of grade 3 or worse AEs a. 40% b. 47%
MM-302	NCT02213744 (HERMIONE)	HER2+ locally advanced/metastatic breast cancer	2/3	Completed	a. MM-302 + trastuzumab b. Chemotherapy of physician’s choice + trastuzumab	OS a. 13.8 months b. 11.1 months

The details of Table 1 derived from http://clinicaltrials.gov/
FEC, 5-fluorouracil, epirubicin, cyclophosphamide, CCR clinical complete response, Q3W every three weeks, QW every week, CBR clinical benefit, rateC _trough trastuzumab serum trough concentration, ORR objective response rate

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ISSN: 2162-3619

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