Quantum Leap Healthcare Collaborative

Agent Information Sheet

Widely hailed as the future of phase II drug development, the adaptive I-SPY 2 platform trial has set a new benchmark for
Close
Close
I-SPY Trial Manuscript
<- Back to All Agents

Trastuzumab emtansine (TDM-1) + pertuzumab

Trade Name:
Kadcyla
Company:
Status:
Graduated
Treatment Protocol:
T-DM1 was an ErbB2/EGFR/ErbB3 dimerization inhibitor. T-DM1 was administered at 3.6 mg/kg once every 3 weeks with Pertuzumab at 840 mg (loading dose) and a 420 mg (thereafter) once every 3 weeks for 12 total weeks. This regimen is followed by AC (q2w or q3w) for 4 weeks.
Date Entered I-SPY:
June 3, 2013
Date Left I-SPY:
August 17, 2015
No. Participants in Arm:
54
Graduating Subtypes:
HER2+, HR-HER2+, HR+HER2+
Agent Description:

Trastuzumab emtansine, also known as ado-trastuzumab emtansine, is an antibody-drug conjugate consisting of the monoclonal antibody trastuzumab (Herceptin) linked to the cytotoxic agent emtansine (DM1). Trastuzumab alone stops growth of cancer cells by binding to the HER2/neu receptor, whereas DM1 enters cells and destroys them by binding to tubulin. Trastuzumab binding to Her2 prevents homodimerization or heterodimerization (Her2/Her3) of the receptor, ultimately inhibiting the activation of MAPK and PI3K/AKT cellular signalling pathways. Because the monoclonal antibody targets HER2, and HER2 is only over-expressed in cancer cells, the conjugate delivers the toxin specifically to tumor cells.

Notes:
Final pCR Probabilities:
Primary Manuscript:
 
abstractpdfview original