TDM-1 in the news

[waterdreamer]

Hi,

Tomorrow, there will be a short article in the New York Times, which discusses TDM-1. There will also be a clip on NBC Nightly News on Sunday June 3rd, 2012 at around 5:30 - 6:30 or later, depending on what celebrity is hogging the news that day.

Wishing everyone a great weekend.

Best wishes
Fern

[sarah]

Here's the article: (hope Dr. Lambert and ImmoGene make some of the money!)

ASCO starts soon!!!


http://www.nytimes.com/2012/06/01/business/a-new-class-of-cancer-drugs-may-be-less-toxic.html?ref=health&pagewanted=print

May 31, 2012
A New Class of Cancer Drugs May Be Less Toxic

By ANDREW POLLACK (http://topics.nytimes.com/top/reference/timestopics/people/p/andrew_pollack/index.html)

Fern Saitowitz’s advanced breast cancer (http://health.nytimes.com/health/guides/disease/breast-cancer/overview.html?inline=nyt-classifier) was controlled for about a year by the drug Herceptin and a toxic chemotherapy (http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/chemotherapy/index.html?inline=nyt-classifier) agent. But her hair fell out, her fingernails turned black and she was constantly fatigued.
She switched to an experimental treatment, which also consisted of Herceptin and a chemotherapy agent. Only this time, the two drugs were attached to each other, keeping the toxic agent inactive until the Herceptin carried it to the tumor (http://health.nytimes.com/health/guides/disease/tumor/overview.html?inline=nyt-classifier). Side effects, other than temporary nausea and some muscle cramps (http://health.nytimes.com/health/guides/symptoms/muscle-cramps/overview.html?inline=nyt-classifier), vanished.
“I’m able to live a normal life,” said Ms. Saitowitz, 47, a mother of two young children in Los Angeles. “I haven’t lost any of my hair.”
The experimental treatment, called T-DM1, is a harbinger of a new class of cancer (http://health.nytimes.com/health/guides/disease/cancer/overview.html?inline=nyt-classifier) drugs that may be more effective and less toxic than many existing treatments. By harnessing antibodies (http://health.nytimes.com/health/guides/test/antibody-titer/overview.html?inline=nyt-classifier) to deliver toxic payloads to cancer cells, while largely sparing healthy cells, the drugs are a step toward the “magic bullets” against cancer first envisioned by Paul Ehrlich, a German Nobel laureate, about 100 years ago.
“It’s almost like we’re masking the chemotherapy,” said Dr. Edith Perez, a breast cancer specialist at the Mayo Clinic in Jacksonville, Fla.
One such drug, Adcetris, developed by Seattle Genetics, was approved last August to treat Hodgkin’s lymphoma (http://health.nytimes.com/health/guides/disease/hodgkins-lymphoma/overview.html?inline=nyt-classifier) and another rare cancer. T-DM1, developed by Genentech, could reach the market next year. Data from a large clinical trial of T-DM1 is expected to attract attention at the annual meeting of the American Society of Clinical Oncology this weekend in Chicago.
Numerous other companies, from pharmaceutical giants to tiny start-ups, are pursuing the treatments, which are known variously as antibody-drug conjugates, armed antibodies or empowered antibodies. “I don’t think there is a major pharma or a midsized pharma with interest in cancer that doesn’t have a program or isn’t scrambling to put one together,” said Stephen Evans-Freke, a managing general partner at Celtic Therapeutics, an investment firm that recently committed $50 million to create a new company, ADC Therapeutics, to develop antibody-drug conjugates.
About 25 such drugs from a variety of companies are in clinical trials, according to Alain Beck, a French pharmaceutical researcher who closely tracks the field. Genentech alone has eight in clinical trials besides T-DM1, and another 17 in earlier stages of development.
Many of the drugs use technology from either Seattle Genetics, based in Bothell, Wash., or ImmunoGen of Waltham, Mass., which supplied the toxin and linker used in T-DM1.
The armed antibodies do not work for all patients and they are not totally free of side effects. T-DM1, for instance, can lower blood platelet levels. The drugs are also likely to be expensive. Adcetris costs more than $100,000 for a typical course of treatment.
Biotechnology drugs called monoclonal antibodies, like Herceptin, Rituxan and Erbitux (http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/erbitux_drug/index.html?inline=nyt-classifier), are already mainstays of what is called targeted cancer therapy. These laboratory-produced molecules mimic the antibodies made by a person’s immune system to fight infection. But instead of attacking pathogens these antibodies attach to specific proteins on the surface of cancer cells.
But antibodies by themselves have a limited ability to kill tumors (http://health.nytimes.com/health/guides/disease/tumor/overview.html?inline=nyt-classifier). So the antibodies are usually given with more conventional cell-killing chemotherapy drugs, which cause side effects because they can also attack healthy cells.
The new approach chemically attaches a toxin to the antibody, increasing its killing power while reducing the need to give toxic drugs separately. After the antibody binds to a cancer cell, it is taken inside the cell like a Trojan horse, and the toxin is released.
While armed antibodies are sometimes likened to guided missiles with toxic warheads, they actually cannot guide themselves to tumors.
Rather, they float through the bloodstream, bumping against various cells. But they stick only to the cells bearing the target protein.
“These are like floating sea mines,” said K. Dane Wittrup, a professor of chemical and biological engineering at the Massachusetts Institute of Technology. “But when they end up in a particular harbor, they blow up.” Less than 1 percent of the drug actually makes it to the tumor, he estimated.
The antibody used in Adcetris, which binds to a protein on malignant cells called CD30, had little effect on cancer when tested alone, even at doses 20 times as high as used now. But when linked to a toxin, it shrank tumors in 75 percent of those with Hodgkin’s lymphoma.
Aimee Blaine, a petroleum engineer from Bakersfield, Calif., who has had Hodgkin’s lymphoma since 2004, was virtually out of options after traditional chemotherapy and a stem cell (http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/stemcells/index.html?inline=nyt-classifier) transplant failed to cure her disease.
But four days after taking Adcetris in a clinical trial, the unbearable itching (http://health.nytimes.com/health/guides/symptoms/itching/overview.html?inline=nyt-classifier) that accompanied her disease vanished, she said.
Eventually, so did the cancer. Ms. Blaine, 40, has been in remission since her last dose in January 2011 and recently returned to work for the first time in seven years.
Like Herceptin, T-DM1 binds to what is known as the HER2 protein and is meant to treat only the roughly 20 percent of breast cancer cases characterized by an abundance of that protein.
In one trial involving 137 women, including Ms. Saitowitz, T-DM1 proved both more effective and less toxic than a combination of Herceptin and the chemotherapy drug docetaxel as an initial treatment for metastatic breast cancer.
Those who received T-DM1 went a median of 14.2 months before their disease worsened, compared with 9.2 months for those getting the two-drug combination. Yet only 46 percent of the T-DM1 patients suffered a severe side effect, half the rate of the other group.
At the cancer conference, researchers will present results of a pivotal trial involving nearly 1,000 women. Though armed antibodies are easy to envision, it has taken more than three decades to make them practical, with many failures along the way.
With the first armed antibody to reach the market, Mylotarg, the toxin sometimes fell off the antibody prematurely, causing side effects. Approved in 2000 to treat acute myeloid leukemia, Mylotarg was removed from the market by its manufacturer, Pfizer, in 2010 after new studies showed it did not prolong lives and had safety problems.
Since then, two antibodies linked to radioactive isotopes have been approved to treat non-Hodgkin’s lymphoma — Bexxar from GlaxoSmithKline and Zevalin from Spectrum Pharmaceuticals. These drugs, while effective, are more cumbersome to use than antibodies linked to chemical toxins.
Researchers first tried to use existing chemotherapy drugs as the payloads, but they were simply not toxic enough. That is because less of a drug gets to the tumor when carried on an antibody than when the drug floods the body by itself.
Seattle Genetics and ImmunoGen use toxins that are hundreds of times as potent as typical chemotherapy agents. They are too toxic to be given by themselves.
The linkers have proved even trickier to develop since they must keep the toxin attached to the antibody while in the bloodstream, but then release the toxin inside the cancer cell.
Dr. John Lambert, executive vice president for research and development at ImmunoGen, will be in the audience at the cancer conference as the fruits of 30 years of work are presented.
“To get to this point is an indescribable feeling, actually,” he said.

[waterdreamer]

Hi Sarah,

Thanks for posting this. The picture is of me and some of the interview that Andy Pollack, did with me.

Best wishes
Fern

[sarah]

well Fern you look beautiful and so glad the TDM1 is working its magic for you. Your family must be pleased also. Great piece and nice to read the reactions from a real person going through it and hear you say the side effects are less than old fashioned chemo.
I lived in LA for many years, loved it, have good friends still there. we lived in Laurel Canyon in a very countrylike setting with deer, coyotes and rattle snakes!
By any chance are you being treated at St Joseph's??? Just asking because I have a dear friend there.
Keep posting about how it goes. All very exciting and hopeful.
Health and Happiness
hugs and love
sarah

[waterdreamer]

Hi Sarah,

I am being treated at the Jonsson Comprehensive Cancer Center, home to Dr Dennis Slamon. My doctor is Dr Sara Hurvitz, who I think is an amazing doctor.
I had a met to the brain, while on TDM-1 and being a lead researcher, she asked for an exception. It was granted, the brain met was radiated, and I continued on TDM-1.
I am now on a cross over from the trial, and because of what happened to me, part of the protocol is to allow women on the cross over to continue on TDM-1 even if they get a brain met, provided that the brain met is treated with radiation.
This may be good news for anyone currently on TDM-1. However, I do understand that the protocols for each trial are different.

I live in West Hills, closer to Topanga Canyon, and am so grateful to have the treatment UCLA is able to provide, available to me.

NBC Nightly News also did an interview with me, and it will air Sunday evening.

The New York Times will also be doing another article on TDM-1 in the upcoming weeks.

Thanks again.


Best wishes
Fern

[StephN]

Dear Fern -
GREAT P.R. for you, the drug and many more who are waiting so impatiently for approval for this drug.

We need more info like that to pressure the FDA.

As Sarah says, keep us posted on you and TDM-1 news you find.

Two young children - good for you!

[waterdreamer]

Hi Steph,

Two young children, and recently divorced. The other interview, is actually tonight on NBC Nightly News and not on Sunday.

Best wishes
Fern

[yanyan]

Hi Fern,
It is a beautiful picture of you on the news! I am very happy to hear that you are doing well on TDM1. We are praying it will be soon be available for people that need it !

[Del]

And the results of the EMILIA trial are being presented at the ASCO conference Sun afternoon. Exciting times! Now hopefully the ball keeps rolling!!

[MJsHusband]

Hi Fern,
My wife, MJ, and I watched you on NBC news tonight here in Washington, D.C. Did they change it from Sunday to Friday or will it also be on Sunday as well? It was very inspiring! ~Greg

[waterdreamer]

Hi Greg and MJ,

First of all congratulation on your marriage, wishing you decades of health and happiness.

They aired the show tonight instead of Sunday, but here are the links to it, on NBC as well as a web only interview.


http://video.msnbc.msn.com/nightly-news/47653323

http://video.msnbc.msn.com/nightly-news/47653323/#47653323/#47652878

Thank you for your kind words.

Best wishes
Fern

[Ellie F]

Thanks Fern
I am hoping to be able to use the links here in England. So pleased you are doing so well.Thanks for the continued updates.
Ellie

[Redwolf8812]

Thanks! I posted the link to the article on my Facebook page.

- Penny

[MJsHusband]

Thanks Fern. We had a great wedding. Jamaica was amazing.

[chrislmelb]

Thanks for the links to your interviews Fern. They are talking about it on TV here in Australia tonight also.

[michka]

An article about TDM1 yesterday in a very popular French newspaper! I hope there will be a lot of articles in Europe so TDM1 will be announced fast.

Here is the link for French speaking friends.
http://www.leparisien.fr/laparisienne/sante/une-arme-plus-efficace-conte-le-cancer-avance-du-sein-03-06-2012-2030209.php
Michka

[Cheryl D]

Read this in the papers in Melbourne today, it is all very exciting.
Hope it gets to the ladies that need it a.s.a.p.
Cheers,
Cheryl

[sarah]

Fern, It is fair that you get to be the lucky one!! you're a good spokesperson and come across well.
I am sorry to hear you're divorced with 2 young kids, 10 and 6, makes it more difficult I'm sure but you sound so positive and strong.
Looking forward to hearing more about your journey on this amazing drug.
health and happiness
hugs sarah

[Soccermom]

Fern, I too have posted the Video on my FB page. Your journey and current status speak so well to the efficacy of TDM-1. Hopefully with such press the powers that be will make the drug available to all who need it.

Best wishes for continuing on this path!
Marcia

[waterdreamer]

Thank you so much for all your kind words. I said that it is not "fair that I get to be the lucky one" because this drug needs to be approved asap, so that all our her2+ sisters and brothers can benefit. I also said it, because with a her2+ cancer, we have more targeted treatments than other cancers, and I look forward to others with different types of cancers being as lucky as we are, in terms of treatment options.

[caya]

Big news story here about TDM1 today on Global TV news ( my younger daughter Cassie works there on The Morning Show) - Apparently one of Toronto's big cancer hospitals, Sunnybrook, is involved in the large 900 woman worldwide TDM1 clinical trial, and this was reported here on the evening news. Very very promising results, the dr. and health reporter both said that once the US FDA approves this wonderful drug, it will be available to all.

Hope the FDA moves quickly, so that all our Her2 sisters (and brothers) can have access to it.

all the best
caya

[phil]

Our T DM-1 story , Part2 , aired on Boston Ch. 5 ABC, wcvb.com , sewrch under herceptin t dm-1 or lorraine heidke-mccartin. Too short , but every bit of pr counts. Fern, This FDA hates this negative pr, we need to keep it up !

[Laurel]

Fern,

I loved your interviews!

[bejuce]

Hi Fern,

Just saw the interview, thanks for posting!!!! I met Dr. Hurvitz at a DoD research grant panel last year and loved her. She is so passionate about helping her patients, you are lucky to have her by your side. She got me an appt. with Dr. Slamon and I feel honored and privileged to have met him. A wonderful team you have there.

Good luck with everything and may TDM-1 continue to work for you!!

Marcia