news on trastuzumab-dm1/ itsa GO
 

Genentech announced it made a Phase III "go" decision to study Trastuzumab-DM1 (T-DM1) as a potential second-line treatment for HER2-positive metastatic breast cancer.

In the third quarter of 2008, the company initiated enrollment in two Phase II studies of T-DM1 as potential first-line and third-line treatments for patients with HER2-positive metastatic breast cancer.

run to live

also using tdm1 in a phase 1 trial with pertuzumab...

now 5 trials will be enrolling shortly using tdm1.

they also expect to file for an accelerated approval based on positive data from the newly announced phase 3 trial, and the phase 2 trial for patients who have failed tykerb.

Wow - I'd love to hit this with tm1 AND pertuzumab - that is very exciting!

I just love logging into this forum! There is so much hope and positive news, emotions and science, everything coming together to make us come alive everyday!
Thanks you all.

that phase 1 trial is supposed to start sometime in the first half of 2009. should be a very quick trial.. about a year. then a p2, another year. then a pivotal trial..starting late 2010 /2011/ approval in 2012.

imo tras-dm1 will begin to get approval across the board starting in mid to late 2010... 3rd line, 1st line, 2nd line.. etc.. then in combo with pertuz.../ and later avastin, xeloda etc..

run

new gtrastuzumab-dm1 data from sabc
 

On December 12, 2008, interim clinical data from a trastuzumab-DM1 (T-DM1) Phase II trial were presented by study investigators at the San Antonio Breast Cancer (SABC) Symposium being held in San Antonio, TX. T-DM1 comprises ImmunoGen's DM1 cell-killing agent linked to Genentech's HER2-targeting antibody, trastuzumab, and is being developed by Genentech under a collaboration agreement with ImmunoGen.

The interim data reported were from the T-DM1 Phase II trial that began in July 2007. The trial is designed to evaluate T-DM1, administered at 3.6 mg/kg every 3 weeks, in approximately 100 efficacy-evaluable patients with HER2-positive metastatic breast cancer that progressed on treatment with HER2-directed therapy plus chemotherapy.

It was reported today that 112 patients were enrolled in this study, and that 107 of these patients were efficacy evaluable.

At the time of data cut-off for presentation (8/29/08), the patients had a median follow up of 4.4 months (19 weeks). Final results are expected to be available in 2009 when all patients have at least 6 months of follow-up.
Baseline demographic, disease characteristics and prior therapy information were reported for the 112 patients enrolled. All of these patients had metastatic disease, with 68.7% having at least 3 distinct metastatic sites.

They all had previously been treated with trastuzumab (Herceptin) plus chemotherapy, with a median time on trastuzumab of 76.6 weeks.

Additionally, 55.4% of these patients also had received lapatinib (Tykerb) plus chemotherapy. The median duration of treatment with lapatinib among the patients who had received it was 26.3 weeks. Approximately two-thirds (67.9%) of the patients had received prior anthracycline therapy.

At the time of data cut-off for presentation, the 112 patients had received a median of 5.0 cycles of T-DM1. Two patients discontinued treatment due to adverse events considered to be possibly related to the study drug. Three of the 112 patients were dose-reduced from 3.6 mg/kg to 3.0 mg/kg for tolerability reasons, and these three patients were still receiving T-DM1 at the time of data cut-off.

The efficacy section of the presentation reported two types of findings: the overall objective response rate (Overall ORR) and the confirmed objective response rate (Confirmed ORR). The Overall ORR includes all complete responses (CRs) and partial responses (PRs) reported, whereas the Confirmed ORR includes only those CRs and PRs that were able to be confirmed with two consecutive scans taken at least 4 weeks apart. (Reasons a response would not be confirmed include that the data cut-off occurred before it could be confirmed, that the patient withdrew from the study before it could be confirmed, and that it was not sustained long enough to be confirmed.)

Among the entire 107 efficacy evaluable patients, the Overall ORR was 39.3% and the Confirmed ORR was 27.1%, with an explanatory note included that these findings include 19 patients who only had one post-baseline tumor assessment (i.e., they had not had the absolute minimum number of assessments needed to confirm a response). Thus, results were also reported for just those patients who had either had at least 6 months of follow-up or had discontinued treatment prior to the data cut-off date. Among these 76 patients, the

Overall ORR was 43.4% and the Confirmed ORR was 38.2%. Other activity information presented was:

Sixty of the efficacy evaluable patients previously were treated with lapatinib. The activity of T-DM1 in these patients was found to be consistent with that in the entire study population (Overall ORR of 38.3%; Confirmed ORR of 21.7%).
? One of the inclusion criteria for the study is that patients have metastatic breast cancer that is HER2-positive (FISH+ and/or IHC3+). However, among the 86 efficacy evaluable patients where HER2 expression could be confirmed centrally, it was found that only 74.4% were HER2-positive by these criteria. Among the 64 patients confirmed to be HER2-positive, the Overall ORR was 50.0% and the Confirmed ORR was 34.4%.

The presentation conclusions include that T-DM1 shows single agent activity in patients with previously treated HER2-positive breast cancer, including patients previously treated with trastuzumab and with lapatinib, and appears to be well tolerated at the dose and schedule used.

Question regarding Herceptin. I've just started Herceptin (every 3 weeks) for a year. I've read that there is a study currently being done to determine if continuing for a 2nd year is beneficial. Asked my onco. and she said that she should know better by the time I am almost at the end of my year, next November. I do not have metatastic cancer so my question is, does it mean if your cancer has not spread that this study or continuing for a 2nd year would not apply? Or, is there a separate study?
Hope someone has an answer to this question.
Happy Holidays to All,
robindhttp://her2support.org/vbulletin/images/icons/icon3.gifhttp://her2support.org/vbulletin/ima...ons/icon14.gifhttp://her2support.org/vbulletin/images/icons/icon7.gifhttp://her2support.org/vbulletin/ima...ons/icon12.gif

I tried to find out that very thing in San Antonio, but did not find anyone who said to do more than a year. I did 2 1/2 years and would like to have done more, but insurance finally wouldn't go further. Did anyone else hear anything different? ma

Mary Anne in Texas;

I don't know very much about the study and am so new with Herceptin.
However, I know a woman (42) stage 4, will be on Herceptin for the rest of her life.
You mentioned your insurance company has stopped covering your continuing with Herceptin...that just doesn't seem right. Can you appeal that decision, can your treatment center (oncologist) get involved?
However, and I don't know if you mentioned you are taking a aromotose inhibitor like Femara or Arimidex, perhaps the Herceptin you were being given did the necessary job it was supposed to and you are good to go.
Sorry I haven't been much help.
Best to you,
robind

Hi -
I heard last week that my cancer center in Seattle is in the final phase of agreement to participate in the T-DM1 trials.

Do not know the details as to WHICH trial or phase, but might find out in the next few days when I go back. Just heard that they have patients lined up to enroll.

Hello StephN,
I don't exactly know what the T-DMI trials stands for. However, I am thinking that this is not the trial I was referring to. I'm thinking that because this is an ongoing trial which results should be in by next Nov. approximately with a decision to possibly offer a woman an additional year on Herceptin beyond the standard year.
What does NED stand for? I don't know some or most of the abrieviations that are used.
I like what you say - live in the moment.
Have a wonderful holiday season.
robind

StephN,
I looked up T-DMI, know what it stands for.

Hi runtolive;
With regard to the trials of Herceptin, it appears that this from what you say only applies to Her2+ with metastatic cancer.
Is this correct as far as you know? I ask because I do not have metastatic cancer, had 1 positive lymph node. When I asked my oncologist, her response was that the study that is being done - the result/data should be in just as I will be completing Herceptin next Nov. I sort of got the impression that there is a possibility that I will continue on Herceptin for an additional year should the data prove that it is beneficial. There was no discussion with regard to my not having metastatic cancer. So, now I am quite confused. I will not see my oncologist till the end of January so cannot ask for more clarification.
And, good for you that you know as much as you do, where do you find all of this important information? Or, better question, how???
Thanks for clarifying...
Happy Holidays to you filled with good health for the New Year.
robind

you are at the very beginning of a long journey.. herceptin.. is for her2 +++ breast cancer.. you are being treated in the initial stages.. newly diagnosed..

the tras-dm1, tdm1, super herceptin, etc is currently only is phase trials prior to actual approval.. in a few years it will be likely approved at the beginning of the journey , instead of the so late in the game is it is today.

tdm1 is available to patients in a phase 2 and soon phase 3 drug study format. you are evaluated against the current standard of care.

in the metastatic setting..

the two phase 2 trials running currently are 3rd line after tykerb/xeloda failure.
and phase 2.... 1st line tras-dm1 vs herceptin / taxotere

robin.. this forum.. is a fabulous resource for patients. please contribute whenever you can..

run

Hi run;
I do not understand what you mean. I am stage 2, er & pr positive and 1 sentinal node positive. I was diagnosed last May, and finished 8 rounds of chemo (Nov.28) last 4 was taxol & Herceptin. My question to you is do these trials only pertain to metastatic cancer and is there really super herceptin? What exactly is that? Not heard of this before???
If I am understanding you correctly, you do not know of a study being done to see if women taking Herceptin will benefit if they receive an additional year?
Thanks for the education, much appreciate your reply. robind

herceptin -dm1 is only for MBC patients.. or relapsed patients.
tdm1, herceptin-dm1.. is commonly known as super herceptin.

i dont about the benefits of an additional year..

run

Thanks for replying and clarifying.