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Related Experiment Video

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High-Content Screening Assay for the Identification of Antibody-Dependent Cellular Cytotoxicity Modifying Compounds

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Trastuzumab emtansine: first global approval.

Anita Ballantyne¹, Sohita Dhillon

¹Adis R & D Insight, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754 Auckland, New Zealand. dru@adis.com

|April 27, 2013

Summary

Trastuzumab emtansine, a HER2 antibody-drug conjugate, combines trastuzumab

Area of Science:

Oncology
Pharmacology
Biotechnology

Background:

Trastuzumab emtansine is a HER2 antibody-drug conjugate developed through collaboration between Genentech and ImmunoGen.
It links Genentech's trastuzumab antibody to ImmunoGen's anti-mitotic agent, mertansine (DM1).
The conjugate leverages trastuzumab's anti-HER2 activity and mertansine's targeted intracellular delivery as a tubulin polymerization inhibitor.

Purpose of the Study:

To summarize the development milestones of trastuzumab emtansine.
To highlight its first approval for treating HER2-positive metastatic breast cancer.
To detail its mechanism of action and therapeutic applications.

Main Methods:

Development of a HER2 antibody-drug conjugate (trastuzumab emtansine).

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Utilizing a non-reducible thioether linker (SMCC/MCC).

Clinical development across various stages and indications for HER2-positive cancers.

Main Results:

Trastuzumab emtansine (Kadcyla™) launched in the USA as second-line monotherapy for HER2-positive metastatic breast cancer.
Filed for approval in the EU and Japan for the same indication.
Ongoing Phase III trials for first- and third-line metastatic HER2-positive breast cancer, and Phase II/III for HER2-positive gastric cancer.

Conclusions:

Trastuzumab emtansine represents a significant advancement in targeted cancer therapy.
Its development milestones led to its first approval for a specific patient population with metastatic breast cancer.
The drug combines targeted antibody therapy with potent cytotoxic delivery.