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Old 05-30-2015, 08:04 PM   #1
Lani
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Thumbs up breaking news from ASCO--new drug penetrates BBB , effectively combines w TDM1,is new

alternative for Stage IVs running out of alternatives!

PUBLIC RELEASE: 29-MAY-2015
ONT-380 has stage IV HER2+ breast cancer patient 'worrying about normal stuff again'
UNIVERSITY OF COLORADO DENVER

IMAGE
IMAGE: AT ASCO 2015, VIRGINIA BORGES, M.D., M.M.SC., AND COLLEAGUES REPORT PROMISING CLINICAL TRIAL RESULTS OF ONT-380 AGAINST HER2+ BREAST CANCER. view more

CREDIT: UNIVERSITY OF COLORADO CANCER CENTER

Promising clinical trial results presented at the American Society for Clinical Oncology (ASCO) Annual Meeting 2015 show activity of the investigational anti-cancer agent ONT-380 against HER2+ breast cancer, in one case specifically against brain metastases and in another case in overall survival of heavily pretreated HER2+ breast cancer patients.

"I am thrilled to have been able to offer this therapy to a patient in her early 40s. She didn't have any other great treatment options that we would have expected to have any meaningful impact, especially on her brain. Now she's been on the study over a year. The mets in her body are gone and the brain lesion has shrunk down to a little nubbin. She's living a normal life, fretting about the family business and how the kids are doing - normal stuff," says Virginia Borges, MD, MMSc, director of the Breast Cancer Research Program and Young Women's Breast Cancer Translational Program at the University of Colorado Cancer Center and one of the study's authors.

Both sets of results being presented are from ongoing phase 1b clinical trials of ONT-380, one in combination with the drug TDM-1, and the other in combination with capecitabine and/or trastuzumab. Women on these studies include those whose disease had progressed after at least two previous rounds of therapy (sometimes including previous drugs used to target HER2).

In the first study of ONT-380 with TDM-1, all 8 evaluable patients experienced more than 50 percent reduction in primary brain tumor size.

"This drug has the potential to be the long-awaited, needed therapy that targets brain metastases in HER2+ brain cancer, and could even someday be used to prevent brain metastases in the first place," says Borges.

The second study presents overall response rates from a similar, ongoing phase 1b clinical trial of ONT-380 with capecitabine and/or trastuzumab. Of 8 heavily pretreated patients enrolled on the study, 4 showed partial response (reduction in tumor size of more than 30 percent), 2 achieved stable disease, and 2 progressed.

In about 25 percent of the 1-in-8 women who will develop breast cancer during their lifetimes, the HER2 gene creates an abnormal amount of HER2 protein, which acts as a "receptor" for human epidermal growth factor. The presence of more HER2 receptors allows a cell to trap more growth-promoting hormones, which tells the cell to grow in an out-of-control, cancerous way.

ONT-380, invented by Array Biopharma in Boulder, CO and now being developed by Oncothyreon in Seattle, WA, is a small molecule inhibitor of the HER2 growth factor receptor. The drug works by targeting the HER2 "tyrosine kinase" - a link in the chain of communication that allows HER2 receptors to signal the growth of the cell. The fact that it is a small molecule means the drug is able to pass through the blood-brain barrier to act against brain metastases of the disease. HER2+ breast cancer is more likely to affect younger women and also more likely than other breast cancers to metastasize specifically to the brain.

"Usually we expect the results of a phase 1 clinical trial to give us data that we can use to guide the results of future treatments. This is a great case in which, for many of these patients, the results were immediate. There are women who are alive today because of this drug," Borges says.

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Old 07-31-2015, 02:45 PM   #2
agness
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Re: breaking news from ASCO--new drug penetrates BBB , effectively combines w TDM1,is

I wonder if I'm a candidate. Thanks.
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  • Dx 2/14 3b HER2+/HR- left breast, left axilla, internal mammary node (behind breast bone). Neoadjuvant TCHP 3/14-7/2. PCR 8/14 LX and SND. 10/21-12/9 Proton therapy to chest wall.
  • Dx 7/20/15 cerebellar met 3.5x5cm HER2+/HR-/GATA3+ 7/23/15 Craniotomy.
  • 7/29/15 bone scan clear. 8/3/15 PET clean scan. LINAC SRS (5 fractions) Sept 2015. 9/17/15 CSF NED, 9/24/15 CSF NED, 11/2/15 CSF NED.
  • 10/27/15 atypical uptake in right cerebellum - inflammation?
  • 12/1/15 Leptomeningeal dx. Starting IT Herceptin.
  • 1/16 - 16 fractions of tomotherapy to cerebellum, break of IT Herceptin during rads, resume at 100 mg weekly
  • 3/2016 - stable scan
  • 5/2016 stable scan
  • 7/2016 pseudoprogression?
  • 9/2016 more LM, start new chemo protocol and IV therapy treatment with HBOT
  • 11/2016 Cyberknife to temporal lobe, HBOT just prior
  • 12/2016 - lesions starting to show shrinkage
  • 8/2017 - Stable since Dec 2016. Temporal lobe lesion gone.
  • Using TCM, naturopathic oncology, physical therapy, chiro, massage, medical qigong, and energetic healing modalities in tandem. Stops at nothing.
  • Mother of 2 boys - ages 7 and 10 (8/2017) and a lovely partner with lots to live for.
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Old 09-25-2015, 11:37 AM   #3
marvass
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Re: breaking news from ASCO--new drug penetrates BBB , effectively combines w TDM1,is

Thanks Lani we will hearr a lot on this
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Old 09-25-2015, 08:40 PM   #4
caya
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Re: breaking news from ASCO--new drug penetrates BBB , effectively combines w TDM1,is

Wonderful news.
Thanks for sharing, Lani.

all the best
caya
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ER90%+/PR 50%+/HER 2+
1.7 cm and 1.0 cm.
Stage 1, grade 2, Node Negative (16 nodes tested)
MRM Dec.18/06
3 x FEC, 3 x Taxotere
Herceptin - every 3 weeks for a year, finished May 8/08

Tamoxifen - 2 1/2 years
Femara - Jan. 1, 2010 - July 18, 2012
BRCA1/BRCA2 Negative
Dignosed 10/16/06, age 48 , premenopausal
Mild lymphedema diagnosed June 2009 - breast surgeon and lymph. therapist think it's completely reversible - hope so.
Reclast infusion January 2012
Oopherectomy October 2013
15 Years NED!!
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Old 09-26-2015, 01:05 PM   #5
Donna H
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Re: breaking news from ASCO--new drug penetrates BBB , effectively combines w TDM1,is

So glad to hear research is ongoing. This sounds very promising to combat brains mets. Thanks for sharing!
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Old 09-29-2015, 09:44 AM   #6
annettchen
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Re: breaking news from ASCO--new drug penetrates BBB , effectively combines w TDM1,is

Thanks Lani, this website and your posts specifically are always a source of hope!
Thank you so much for spending your time researching and sharing!
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Annette
----------------------------------------
03/2014: Diagnosed with ER/PR-, HER2+++ MBC (bone mets, oligometastatic)
04/2014: Started 6 cycles of "PHD" (Perjeta, Herceptin, Docetaxol)
07/2014: Finished 6 cycles of PHD; restaging; 2 bone mets are sclerotic - looks like Herceptin and Perjeta is working
10/2014: STABLE!
01/2015: STABLE!
04/2015: STABLE!
08/2015: STABLE!
12/2015: BRAIN METS. BODY STABLE.
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