nanoknife IRE for pancreatic cancer

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RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Wed Jan 20, 2016 09:45 PM

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Everyone,

Bambi, a google search will show IRE being performed by a surgical team at JHopkins.

The annual ASCO meeting begins Friday, January 22. I expect to report on new developments of value.

The early release of outcomes for a TTFields Phase-2 trial appears below. This non-invasive, minimal-adverse-effect treatment doubled Overall Survival and Progression Free Survival in advanced unresectable PC patients.

TTFields induces electric fields within tumors to reduce the rate of cancer cell division (growth) – this could be an important therapy to follow.

A TTFields trial is still open, principally in Spain, Switzerland and soon Germany.  See
https://clinicaltrials.gov/show/NCT01971281

More when other papers are released. For quick definitions of words download

http://wordweb.info/.

PhilipJax

Novocure Presents Phase 2 PANOVA Results at ASCO GI Suggesting Tumor Treating Fields Therapy Plus Chemotherapy may be Safe as First-Line Treatment and Improve Survival of Patients with Advanced Pancreatic Cancer

January 20, 2016

http://www.fiercemedicaldevices.com/press-releases/novocure-

Progression free survival and overall survival of patients treated with Tumor Treating Fields combined with gemcitabine were more than double those of gemcitabine-treated historical controls Of the evaluable tumors, 30 percent had partial response and another 30 percent had stable disease

Novocure will present data on Friday, Jan. 22, 2016, from its ongoing phase 2 PANOVA clinical trial at the American Society of Clinical Oncology 2016 Gastrointestinal Cancers Symposium in San Francisco showing that Tumor Treating Fields (TTFields) therapy plus first-line chemotherapy gemcitabine is tolerable and safe in patients with advanced pancreatic cancer.

The data also suggest improved survival and response rate among patients who received TTFields therapy with gemcitabine compared to a historical control of patients who received gemcitabine alone.

The first cohort of the prospective, single-arm study included 20 patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received chemotherapy or radiation therapy prior to the clinical trial. The primary endpoint measured the incidence and severity of treatment-related adverse events.

As a result of TTFields therapy, 10 patients experienced treatable contact dermatitis. No serious adverse events related to TTFields were reported. Fourteen patients reported serious adverse events unrelated to TTFields therapy.

A phase 3 study of the efficacy and safety of nab-paclitaxel plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer published in October 2013 in the New England Journal of Medicine1 showed that patients who received gemcitabine alone experienced a median progression free survival of 3.7 months, a median overall survival of 6.7 months, a median one-year survival of 22 percent, and a response rate of 7 percent. See

http://www.nejm.org/doi/full/10.1056/NEJMoa1304369

In relation to these reported results for gemcitabine alone, PANOVA patients who received TTFields therapy plus first-line gemcitabine experienced a median progression free survival of 8.3 months compared to 3.7 months, a median overall survival of 14.9 months compared to 6.7 months, and a median one-year survival of 55 percent compared to 22 percent.

Thirty percent of the evaluable tumors had partial responses compared to 7 percent with gemcitabine alone and another 30 percent had stable disease. The PANOVA trial includes a second cohort testing TTFields plus gemcitabine and nab-paclitaxel in an additional 20 patients.

Preclinical models have demonstrated increased cancer cell sensitivity when TTFields therapy is combined with taxane-based chemotherapies, such as nab-paclitaxel. "The phase 2 results are promising," said Fernando Rivera, MD, PhD, the study's principal investigator and a Senior Medical Oncologist at the Santander University Hospital in Spain.

"Given these first cohort results and the synergistic effect that was demonstrated in preclinical models when TTFields therapy was combined with taxane-based chemotherapies, I am even more optimistic about what the second cohort will show when nab-paclitaxel is added to the treatment regimen." "We are pleased by these results," says Asaf Danziger, Novocure's CEO. "Over the last 15 years, in all of our preclinical and clinical research we have observed that the physical, antimitotic effect of TTFields is consistent regardless of cancer type.

Based on these data we will accelerate planning of a phase 3 clinical trial in pancreatic cancer."

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate.

TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Wed Jan 20, 2016 10:08 PM

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Everyone,

A search of Clinical Trials shows several active IRE studies in the US, Netherlands and China.  See
https://clinicaltrials.gov/ct2/results?term=&recr=&rslt=&type=&cond=pancreatic&intr=irreversible+electroporation&titles=&outc=&spons=&lead=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&rcv_s=&rcv_e=&lup_s=&lup_e=

Two of the trials are at the U of Texas Health Science Center at Houston.

PhilipJax

RE: nanoknife IRE for pancreatic cancer

by dshell17 on Thu Jan 21, 2016 03:56 PM

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Just had my 10 month post nanoknife surgery from April 1st and scan was all clear! Still NED!!!

Thanks to Dr.Martin I am still alive!

RE: nanoknife IRE for pancreatic cancer

by bambi99d on Thu Jan 21, 2016 04:06 PM

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Thanks for the reply. It's interesting because I took my Mother to Johns Hopkins in March of 2011 to their clinic. When I brought up the NanoKnife they completely disregarded it and blew it off. She went to have the procedure at another hospital. It's a bit ironic they are now using it for PC 5 years later. 

RE: nanoknife IRE for pancreatic cancer

by Jkelly on Thu Jan 21, 2016 10:18 PM

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I am almost 4 1/2 years post IRE/Nanoknife. Thanks to Dr. Martin, my superhero!??

RE: nanoknife IRE for pancreatic cancer

by Jkelly on Thu Jan 21, 2016 10:23 PM

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I am almost 4 1/2 years post IRE/Nanoknife. Thanks to Dr. Martin, my superhero!!!

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Thu Jan 21, 2016 11:31 PM

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Everyone,

Excellent news, Jkelly.  IRE patients should consider contacting the local press to describe their experiences.  A news story would inform others of a valuable therapy almost unknown, even to physicians.

Incidentally, AngioDynamics, the NanoKnife® manufacturer has just begun developing the “next generation” IRE device.

ObamaCare’s tax on new devices had halted the development program. But, Congress’s recent nullification of the tax reawakened the development program.

An example of how government central-control destroys the best healthcare system on earth.

PhilipJax

RE: nanoknife IRE for pancreatic cancer

by Jkelly on Fri Jan 22, 2016 02:28 AM

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Hello PhilipJax, Last April, Dr. Martin, Elise Tedeschi and myself went to New York and did a media release. It was released to various areas around the country. I'm hoping that it brought more awaremess to this procedure, but I still wish we could do more. Thanks to David Shell, the "Nanoknife Surgery Warrior" Facebook page is a great place for individuals to find out information and ask questions about the IRE/Nanoknife procedure from individuals who have gone through the procedure. PhilipJax,Thanks for all you do!

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Fri Jan 22, 2016 05:19 PM

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Everyone,

Thanks Jkelly. Perhaps other survivors should contact the local press to spread the word.

There are 2 reports today from 2016 ASCO GI symposium.

The Demcizumab trial, described below, is still active at 39 centers and is available only to previously-untreated patients (although prior IRE is not excluded).  See
https://clinicaltrials.gov/show/NCT02289898

In the second story, note the value of treatment at major centers (which I would define as those highly-rated by US News).

PhilipJax

Demcizumab Plus Standard of Care Yields Median Overall Survival of 12.7 Months

 

January 22, 2016: 08:30 AM EThttp://money.cnn.com/news/newsfeeds/articles/globenewswire

OncoMed Pharmaceuticals Inc. announced updated survival data from the company’s Phase 1b clinical trial of demcizumab (anti-DLL4, OMP-21M18) at the Gastrointestinal Cancers Symposium.

The Phase 1b dose-escalation and expansion study assessed the safety, biomarker, and anti-tumor activity of demcizumab and gemcitabine plus Abraxane®(paclitaxel protein-bound particles for injectable suspension) (albumin bound) in 32 previouslyuntreated patients with advanced pancreatic cancer.

Demcizumab in combination with chemotherapy had an acceptable safety profile.  The updated Kaplan-Meier estimated medianprogression-free survival was 7.1 months and median overall survival was 12.7 monthsfor the patients who received the demcizumab-gemcitabine-Abraxane combination.  Current standard-of-care treatment for advanced pancreatic cancer with gemcitabine and Abraxane, based on Phase 3 data, has median progression-free survival of5.5 months and median overall survival of 8.5 months.1

“Pancreatic cancer remains a difficult-to-treat tumor and patients with this disease are in need of new and improved treatment options.  We are very encouraged by the safety and early efficacy results observed in our Phase 1b clinical trial of demcizumab in pancreatic cancer,” said Jakob Dupont, M.D., OncoMed’s Chief Medical Officer.  “In this updated data set from our Phase 1b study of demcizumab plus standard of care in thirty-two patients with pancreatic cancer, we are pleased to see the median overall survival extend beyond 12.5 months.  Overall, the safety, response, progression-free and overall survival data observed in our single-arm Phase 1b clinical study support our ongoing Phase 2 randomized YOSEMITE clinical trial for the treatment of first-line metastatic pancreatic cancer.”

A randomized Phase 2 “YOSEMITE” trial infirst-line pancreatic cancer patients with metastatic disease is currently being conducted at more than 50 centers in the U.S., Canada, Europe and Australia.  Approximately 200 patients will be randomized into one of three study arms.  Patients in Arm 1 will receive standard-of-care gemcitabine plus Abraxane plus placebo.  Patients in Arm 2 patients will receive standard of care plus one course of demcizumab 3.5 mg/kg every two weeks for six doses (70 days).  Patients in Arm 3 will receive standard of care with demcizumab for two courses.  OncoMed expects to complete enrollment of the Phase 2 trial in 2016 and data from this trial is anticipated in early 2017. 

Additional Phase 1b Results
In total 56 subjects were enrolled in this Phase 1b trial.  The first 24 subjects received the double of demcizumab and gemcitabine and after a protocol amendment 32 subjects received demcizumab (in a truncated fashion) with the new standard of care of gemcitabine plus Abraxane.

Fourteen of the 28 (50%) evaluable patients who received the demcizumab-gemcitabine-Abraxane combination had a RECIST partial response (unconfirmed) and 11 achieved stable disease, resulting in a clinical benefit rate of 89 percent.

Demcizumab and gemcitabine plus Abraxane were generally well tolerated with fatigue, nausea and vomiting being the most common drug related toxicities.  Truncated demcizumab therapy (i.e. 70 days of therapy) appears to prevent the onset of late cardiopulmonary toxicity, as none of the 32 patients treated in this manner developed heart failure or pulmonary hypertension.  Pharmacodynamic analyses demonstrated clear down regulation of Notch pathway gene expression at the Phase 2 dose of demcizumab. 

These data are being presented today in a poster titled “A Phase 1b study of the anti-cancer stem cell agent demcizumab (DEM) and gemcitabine (GEM) +/- nab-paclitaxel in patients with pancreatic cancer” (Abstract 341), during Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract.  OncoMed previously presented data on demcizumab’s safety, response rates and preliminary survival benefit from the Phase 1b study during the 2015 ASCO Annual Meeting.  Results presented today provide eight months of additional follow-up on survival benefit.

About Demcizumab (anti-DLL4, OMP-21M18)
Demcizumab is a humanized monoclonal antibody targeting Delta-like Ligand 4 (DLL4), a key member of the Notch signaling pathway.  Based on preclinical studies, demcizumab appears to have a multi-pronged mechanism of action: halting cancer stem cell growth and reducing cancer stem cell frequency, disrupting angiogenesis in the tumor and augmenting anti-tumor immune responses by decreasing tumor myeloid-derived suppressor cells (MDSCs).

Demcizumab is currently being studied in two randomized Phase 2 clinical trials.  The YOSEMITE trial is testing demcizumab with gemcitabine plus Abraxane versus gemcitabine plus Abraxane in first-line advanced pancreatic cancer patients.

Patients interested in learning more about participating in a demcizumab clinical trial may learn more by calling 1-866-914-7347 or emailing oncomed@emergingmed.com.

Please see the company's website atwww.oncomed.comfor additional information.

1Von Hoff, et al; “Increased Survival in Pancreatic Cancer with nab-paclitaxel plus Gemcitabine,” N Engl J Med 2013; 369:1691-1703

 

Pancreatic Cancer: Adjuvant Therapy at High-volume Centers Associated With Better Survival

Jason Hoffman, PharmD, RPh| January 22, 2016 |http://www.cancertherapyadvisor.com/pancreatic-cancer/pancre

Both median and 5-year overall survivalafter adjuvant therapywas statistically superior at high-volume centers compared with community centers in patients withresected pancreatic cancer, according to a study presented at the 2016 Gastrointestinal Cancers Symposium in San Francisco, CA.1

Although surgical outcomes for patients with resected pancreatic outcomes are known to be superior at high-volume centers, the impact of adjuvant therapy performed at high-volume centers is less understood. Therefore, researchers at Virginia Mason Medical Center in Seattle, WA, sought to examine the impact of site of adjuvant therapy administration on resected patients.

For the study, researchers analyzed data from 245 patients diagnosed with pancreatic cancer between 2003 and 2014 who had their tumors removed at a high-volume center. Of those,57% received adjuvant therapy at a high-volume center and 43% were treated by a community oncologist.

Patient characteristics were similar between arms with respect to tumor stage and size, nodal status, resection margins, and average distance travelled to the high-volume center. However, researchers found that patients treated at community centers were older by about an average of 5 years than those treated at high-volume centers (P < .01).

Results showed that median overall survival was high-volume centers was 44 months compared with 28 months at community centers (P < .01), and 5-year overall survival was 38.6% and 24.8%, respectively (P < .01).

“Our study supports the use of high-volume centers for all adjuvant therapy components for pancreatic cancer treated with curative intent,” the authors concluded. “Ongoing investigation of patterns of care and their impact on overall survival in pancreatic cancer is warranted.

Reference

  1. Mandelson MT, Picozzi VJ. Resected pancreatic cancer (PC): impact of adjuvant therapy (Rx) at a high-volume center (HVC) on overall survival (OS) [abstract]. J Clin Oncol. 2016;34(suppl 4S; abstr 191).

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Sat Jan 23, 2016 02:36 PM

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Everyone,

Another report from ASCO GI 2016. The immunotherapy Indoximod, when used with gemcitabine/nab-paclitaxel, shows promise, and a surprising “complete response”. However, the study is far from complete, and the patients are few. So, in the end the early results may be shown to be incorrect.

The trial is still open. 50 of the total 80 patients have already been enrolled.

There are 9 study locations in the US.  See
https://clinicaltrials.gov/show/NCT02077881

PhilipJax

NewLink's indoximod combo shows 42% response rate in early-stage pancreatic cancer study; shares up 3% after hours

Jan 22 2016, 16:49 ET | By:Douglas W. House, SA News Editorhttp://seekingalpha.com/news/3047266-newlinks-indoximo

Resultsfrom a Phase 1b/2 clinical trial assessing NewLink Genetics'indoximod plus gemcitabine/nab-paclitaxelin patients with metastatic pancreatic cancer showed encouraging durable responses with a delayed pattern and a42% objective response rate (ORR), including one complete response. The data will be presented today at the 2016 Gastrointestinal Cancers Symposium in San Francisco.

The results were generated from 12 evaluable patients out of 50 enrolled to date. The target enrollment in the Phase 2 portion is 80. The ORR was 42% (n=5/12) with one complete responder. The smallnumber of patientsnotwithstanding, this handily beat the 23% ORR in the IMPACT study which established gemcitabine/nab-paclitaxel as the standard of care for metastatic pancreatic cancer.

Indoximodis an orally available small molecule that inhibits an enzyme called indoleamine 2,3-dioxygenase (IDO), a central regulator of local and systemic immunosuppression that allows tumors to avoid the body's immune response.

NewLink Genetics Presents Phase 1b Data of Indoximod in Combination with Gemcitabine/Nab-Paclitaxel for Patients with Metastatic Pancreatic Cancer That Show Encouraging Durable Responses with Delayed Pattern

http://www.sec.gov/Archives/edgar/data/1126234/0001126234160

AMES, Iowa, January 22, 2016 -- NewLink Genetics Corporation today presents data that describe a combination therapy of indoximod, an IDO pathway inhibitor, plus gemcitabine/nab-paclitaxel, for patients with metastatic pancreatic cancer.

This combination immunotherapeutic approach was well tolerated and shows encouraging durable responses with a delayed pattern and a 42 percent objective response rate, including one complete response (CR), according to data presented at the 2016 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco.

“The preliminary overall response rate is certainly promising, but I am particularly intrigued by the pattern of delayed and durable responses potentially suggesting an immune mediated mechanism of action,” said Nathan Bahary, MD, PhD, Associate Professor in the Division of Oncology and Medical Director of the Pancreatic Cancer Program at the University of Pittsburgh Medical Center, and principal investigator of the study.

These data come from the Phase 1b portion of the trial that included 12 patients who were evaluable for a response. To date, this Phase 1/2 trial has enrolled 50 patients, with a target enrollment of 80 patients in the Phase 2 portion.

In the Phase 1b portion of the trial, the combination therapy with indoximod had an objective response rate of 42 percent (5/12), including one CR. The MPACT study, which established gemcitabine/nab-paclitaxel as standard of care for patients with metastatic pancreatic cancer, demonstrated an objective response rate of 23 percent.

These data are being presented today at ASCO GI, during Poster Session B (12:30-2:00PM and 5:30-7:00PM), “Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract,” correspond to abstract number 452 entitled, “Results of the Phase 1b Portion of a Phase 1/2 trial of the Indoleamine 2,3-dioxygenase Pathway (IDO) Inhibitor Indoximod plus Gemcitabine/Nab-Paclitaxel for the Treatment of Metastatic Pancreas Cancer.”

 

 

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