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