HER2 Support Group Forums - View Single Post - How Are You Doing On T-DM1?

schoonder · 04-25-2011, 08:13 AM

KDR,

In addition to information you seek from participating Board members, on May 18 ASCO will publish abstracts of their early June annual meeting. T-DM1 items of interest will be:

Abstract #TPS102
MARIANNE: A phase III, randomized study of trastuzumab-DM1 (T-DM1) with or without pertuzumab (P) compared with trastuzumab (H) plus taxane for first-line treatment of HER2-positive, progressive, or recurrent locally advanced or metastatic breast cancer (MBC).
Paul A. Ellis, MD
Poster: 36D
________________________________________
Abstract #TPS116
EMILIA: A phase III, randomized, multicenter study of trastuzumab-DM1 (T-DM1) compared with lapatinib (L) plus capecitabine (X) in patients with HER2-positive locally advanced or metastatic breast cancer (MBC) and previously treated with a trastuzumab-based regimen.
Sunil Verma, MD
Poster: 38B
________________________________________
Abstract #605
A semi-physiologic population pharmacokinetic/pharmacodynamic (PK/PD) model of thrombocytopenia (TCP) characterizing the effect of trastuzumab-DM1 (T-DM1) on platelet counts in patients with HER2-positive MBC.
Brendan C. Bender, MS
Poster: 9G
________________________________________
Abstract #633
Pharmacokinetic and pathophysiologic covariates influencing treatment outcomes with T-DM1 in patients with HER2-positive metastatic breast cancer (MBC).
Manish Gupta, PhD, FCP
Poster: 13C

Both Emilia and Marianne are worldwide evaluation. Mid 2012 Roche plans to submit Marianne results to FDA for product approval. This then would be latest official status of product.

In closing, I believe that if either phase III trial proofs so superior in performance to current standard of care, Roche would seek to discontinue the evaluation and allow all participants to transfer into the T-DM1 arm; if memory serves me right this is exactly what happened with GSK's Tykerb.

04-25-2011, 08:13 AM	#2
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: How Are You Doing On T-DM1? KDR, In addition to information you seek from participating Board members, on May 18 ASCO will publish abstracts of their early June annual meeting. T-DM1 items of interest will be: Abstract #TPS102 MARIANNE: A phase III, randomized study of trastuzumab-DM1 (T-DM1) with or without pertuzumab (P) compared with trastuzumab (H) plus taxane for first-line treatment of HER2-positive, progressive, or recurrent locally advanced or metastatic breast cancer (MBC). Paul A. Ellis, MD Poster: 36D ________________________________________ Abstract #TPS116 EMILIA: A phase III, randomized, multicenter study of trastuzumab-DM1 (T-DM1) compared with lapatinib (L) plus capecitabine (X) in patients with HER2-positive locally advanced or metastatic breast cancer (MBC) and previously treated with a trastuzumab-based regimen. Sunil Verma, MD Poster: 38B ________________________________________ Abstract #605 A semi-physiologic population pharmacokinetic/pharmacodynamic (PK/PD) model of thrombocytopenia (TCP) characterizing the effect of trastuzumab-DM1 (T-DM1) on platelet counts in patients with HER2-positive MBC. Brendan C. Bender, MS Poster: 9G ________________________________________ Abstract #633 Pharmacokinetic and pathophysiologic covariates influencing treatment outcomes with T-DM1 in patients with HER2-positive metastatic breast cancer (MBC). Manish Gupta, PhD, FCP Poster: 13C Both Emilia and Marianne are worldwide evaluation. Mid 2012 Roche plans to submit Marianne results to FDA for product approval. This then would be latest official status of product. In closing, I believe that if either phase III trial proofs so superior in performance to current standard of care, Roche would seek to discontinue the evaluation and allow all participants to transfer into the T-DM1 arm; if memory serves me right this is exactly what happened with GSK's Tykerb.