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Old 02-22-2009, 12:53 PM   #1
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Genetech's upcoming plans with T-DM1


Genentech has disclosed the following in terms of the T-DM1 development plans:
  • They plan to initiate a Phase III trial evaluating T-DM1 as a second-line treatment for HER2-positive metastatic breast cancer (MBC) in the first half of 2009. We have disclosed that the initiation of Phase III testing with T-DM1 triggers a milestone payment to ImmunoGen.
  • They have initiated a Phase II trial in August 2008 that evaluates T-DM1 as a third-line treatment for this cancer, another potential route to market for T-DM1.
  • They have initiated a Phase II trial comparing T-DM1, given as a single agent, to Herceptin (trastuzumab) plus Taxotere (docetaxel) as a first-line treatment for this cancer; and
  • They plan to start a Phase Ib trial in the first half of 2009 to evaluate T-DM1 given in combination with their pertuzumab compound (this one excites me for Caryn who responded VERY well to the DM1 but got thrown off because her body didn't handle the higher dose well)
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Old 02-23-2009, 06:40 PM   #2
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Location: Central Coast, CA
Posts: 3,207
Eric, I like the sound of that pertuzumab trial as well - blocking more pathways is definitely a good thing, and if they can do so with a lower dose of the DM1...that might also be a good thing!
Chris in Scotts Valley
June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?"
9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++
10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response!
04/05 - 4/07 Herception every 3 wks, Continue NED
04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial
06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin
01/08 Progression in liver
02/08 Begin (TDM1) trial
08/08 NED! It's Working! Continue on TDM1
02/09 Continue NED
02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED
12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver
07/11 - 11/11 Herceptin/Xeloda -not working:(
12/11 Begin MM302 Phase I trial - bust:(
03/12 3rd times the charm? AKT trial

5/12 Scan shows reduction! 7/12 More reduction!!!!
8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!)
9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3
11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc
11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go.
2/13 Gemzar/Carbo/Herceptin - no go.
3/13 TACE procedure
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Old 02-24-2009, 06:39 AM   #3
Mary Anne in TX
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Location: San Antonio, TX
Posts: 2,357
This really does sound terrific!!!
MA in TX.
Grateful for each and every day....

Diag. 12/05 at age 60
Stage II, Grade 3, 4.5 cm primary tumor
ER/PR- Her2 +3 strongly positive
Her2 by FISH 7.7 amplified
vascular invasion
Ki67 20% borderline
Jan - March '06 Taxotere/Adriamycin X 3 to try to shrink tumor - it grew
April '06 Rt Modified Radical Mas, 7 of 9 nodes positive
April - Aug. '06 Herceptin/Taxol/Carboplatin X 8 (dose dense)
Sept - Dec. '06 Navelbine/Herceptin x 8 (dose dense)
Radiation & Herceptin Jan. 22 - March 1, 2007
Finished Herceptin Dec. 10 '08! One extra year.
Port removed August, 2012.
8 1/2 years since diagnosis! 5 1/2 Years NED!
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Old 02-24-2009, 06:51 AM   #4
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Location: I live in Christmas, MI - located on the shores of Lake Superior.
Posts: 606
Very interesting and sounds promising for a lot of people.

10/03 Radical Mastectomy 3 cm tumor - 1/17 Nodes Stage II B, Her 2 +++ ER-/PR- 11/03 4 AC 4 Taxol 12/05 Stage IV - Lung met , Bone mets - Carbo, Taxotere, Herceptin 9/06 - 2 cm brain tumor 10/06 - Tumor removal surgery - Herceptin Halted 12/06 gamma knife tumor base.1/07 Navelbine/Herceptin 4/07 Rads to R femur 5/07 Stereotactic - new 2 cm brain tumor 4/07 Start Xeloda 5/07 Tykerb added 7/07 Brain MRI clean 10/07 .055 cm brain met found. 12/07 Stereotactic -1 cm brain tumor Start Tykerb 11/07 Abraxane/Herceptin 5/08 Cisplatin, Gemcitabine/Herceptin 6/08 Stereotactic to 1cm 9/08 Stereotactic repeat (growth). 11/08 Pet Scan Good but new tiny met on L lung/dead Brain surgery (no cancer cells found/scar tissue) 1/09 Chemo restarted 2/09 Pet Scan Bad - R larger very active/active L active lymph nodes both sides of chest MRI- mets slight increase 2/09 Start Doxil/Tykerb Treatment
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Old 02-25-2009, 10:18 AM   #5
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Genentech's T-DM1 vs Tykerb/Xeloda phaseIII trial is now accepting candidates.
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