T-DM1 Compassonate Use

[Joe]

T-DM1 Expanded Access Program

We have had several posts from members who were disappointed that they were
ineligible for trastuzmab-DM1 (T-DM1) clinical trials. We met with several
representatives of Genentech while at ASCO to discuss your concerns.

Here is some information about T-DM1 trials that may be helpful:

The current T-DM1 phase III trial is open to enrollment now for patients who have had
no prior treatment with Tykerb (Lapatinib) and / or Xeloda (Capecitabine). The two
Phase II trials that have been fully enrolled are no longer available for patients.
However, Genentech is committed to opening new trials to address patients’ needs;
another Phase II trial of T-DM1 is due to open within the month. In addition, Genentech
has recently opened a Phase I/II trial of T-DM1 combined with Pertuzumab that will
enroll up to 60 patients:

http://clinicaltrials.gov/ct2/show/NCT00875979?term=pertuzumab+TDM1&
recr=Open&rank=1

Each trial will have slightly different inclusion / exclusion criteria, but neither have
restrictions on what prior treatment(s) patients may have received provided they have
not been given T-DM1 or T-DM1 and Pertuzumab.

During our conversation, it was clear that Genentech understands your frustrations. We
discussed the following possible steps, and will keep you posted as we learn more.

1. Expanded Access – We all agreed that it is premature to offer T-DM1 for
compassionate use at this time as the Phase III trial has only recently opened for
recruitment and the results from the second phase II trial are not yet available.
However Genentech will consider launching an Expanded Access Program after
it accumulates sufficient data warranting this.

Additional Clinical Trials –Genentech will provide us with the location of new trials as
they are opened for recruitment.

Warmest Regards
Joe

[Jean]

Joe,
This is good news...thank you for always being on top of things.

Jean

[Kim in DC]

thanks Joe for your support

Kim

[runtolive]

kim.. how are you doing in your trial..

still good i hope..

run to live

[Ceesun]

Why are tykerb xeloda patients excluded? Ceesun

[StephN]

Ceesun -

I KNOW of people in the T-DM1 trial in Idaho who HAVE had Tykerb/Xeloda, so am figuring there are several trials underway with DIFFERENT admittance criteria.

This is why it is confusing even the oncologists who can't seem to keep track of them. It would be nice if there was a list of each trial and a simplified synopsis for each.

I know in my limited experience I have never seen such a wide variety of trials for ONE drug in investigational phases.

[hutchibk]

Push Genentech at every turn to open this to Compassionate use!

[schoonder]

Reading the articles under which the FDA operates I would think that plenty of data have been captured (not all made public) from the T-DM1 phase II trials in 3rd line setting to justify compassionate use of this drug.
Don't believe companies and oncologists are overly eager to take on the additional paperwork to document unapproved drug's performance that is required by such program.

[Sandra in GA]

Thank you so much Joe. You are appreciated.
Sandra

[julierene]

My onc just told me last week, I still wasn't eligible.

[Ceesun]

thanks for this very clear explanation....and Steph, Yes, I thought I read somewhere that tykerb use was not an exclusion though I think it is here in Detroit at Karmanos. Thanks for this info to all! Ceesun