Table 1.
Agent | Brand name | Approval | Indication | Trial population | Trial results |
---|---|---|---|---|---|
MYL-1401O | Ogivri | December 2017 | Adjuvant early stage and metastatic breast cancer, metastatic gastric or GEJ adenocarcinoma | Metastatic breast cancer (n = 500) | MYL-1410 versus trastuzumab: Noninferior ORR: 69.6% versus 64% (HR 1.09; CI 95% 0.95–1.24)12,13 |
CT-P6 | Herzuma | December 2018 | Adjuvant early stage and metastatic breast cancer | Early stage breast cancer (n = 549) | CT-P6 versus trastuzumab: noninferior pCR 46.8% versus 50.4% (risk ratio 0.92)17,18 |
SB3 | Ontruzant | January 2019 | Adjuvant early stage and metastatic breast cancer, metastatic gastric or GEJ adenocarcinoma | Early stage breast cancer (n = 800) | SB3 versus trastuzumab: Equivalent in breast pCR 51.7% versus 42.0% (adjusted ratio 1.259)20 |
PF-05280014 | Trazimera | March 2019 | Adjuvant early stage and metastatic breast cancer, metastatic gastric or GEJ adenocarcinoma | Metastatic breast cancer (n = 707) | PF-05280014 versus trastuzumab: Equivalent in breast ORR 62.5% versus 66.5% (RR for ORR 0.94)24 |
ABP980 | Kanjinti | June 2019 | Adjuvant early stage and metastatic breast cancer, metastatic gastric or GEJ adenocarcinoma | Early stage breast cancer (n = 725) | ABP980 versus trastuzumab: pCR 48% versus 41% (risk ratio 1.188)28 |
GEJ, gastroesophageal junction; HR, hazard ratio; ORR, Overall Response Rate; pCR, pathological complete response; RR, risk ratio.