A Diary of A Mesowarrior Things Are Moving Very Slowly To Get a Drug For #Mesothelioma


The latest on Keytruda I know its still for Skin Cancer but we now need more trials and Comination trials so we can get it out there as a treatment for mesothelioma Immunatherapy is here and we need more money for research into these drugs So keep backing Mesothelioma UK and Cancer research to fund these trials and encourage the drug companies but our next hurdle is getting NICE to sanction these very costly drugs Or even get the Insurance Companies to count the cost of the drugs into Compensation. We need to push the Lawyers on this one .http://medicalxpress.com/news/2016-05-immune-drug-deadly-skin-cancer.htm

Immune drug for deadly skin cancer shows long-term survival

Immune drug for deadly skin cancer shows long-term survival (Update)

May 18, 2016 by By Lindsey Tanner

A new kind of drug for the deadliest form of skin cancer helped some patients survive for at least three years, a study shows. It’s a remarkable advance for patients who until recently faced dismal chances of living for more than a few months.

About 40 percent of melanoma patients in the study were still alive three years later. The drug, which targets the immune system, was used to treat former President Jimmy Carter, who was diagnosed with melanoma that had spread to his brain.

“This is incredible,” Dr. Caroline Robert, the study’s lead author, said of the results released Wednesday. “I spend my time telling my residents that these patients would be dead if it was five years ago.”

The drug, Keytruda, is among a new class of genetically engineered antibody-based medicines. They block proteins that prevent the body’s disease-fighting immune system from attacking cancer cells. This immunotherapy approach is transforming treatment for several kinds of cancer with drugs that are often less toxic than chemotherapy.

The latest findings for Merck’s Keytruda (kee-TROO’-duh) are among the best long-term data ever for treating melanoma that has spread to other organs, Robert and other cancer experts said.

Keytruda, also known as pembrolizumab (pem-bro-LIZ’-uh-mab,) is one of the treatments Carter received after his diagnosis last year, and he has done well. Carter, 91, was seen beaming last weekend as he helped give an honorary humanities degree to rocker Gregg Allman at Georgia’s Mercer University, where Carter is a trustee.

The new results in 655 patients are a follow-up to research that led to the 2014 approval of Keytruda for advanced melanoma.

In addition to the 40 percent survival rate at three years, Robert said 85 patients remain cancer-free. “Of course it’s not enough,” but it raises hope for an eventual cure for the disease, she said.

Robert, a melanoma researcher at Gustave Roussy cancer center near Paris, has worked as a consultant for Merck and Bristol-Myers Squibb, which makes two other immunotherapy drugs approved for advanced melanoma. The newest drug, Opdivo, targets the same protein as Keytruda, while Yervoy targets a different protein.

Dr. Len Lichtenfeld, the American Cancer Society’s deputy chief medical officer, said the new Keytruda research “is a big deal.”

“Looking to the future, these treatments are going to be used earlier in the course of this disease,” sometimes combined with other immunotherapy drugs, Lichtenfeld said.

The Keytruda study was released at a news briefing organized by the American Society of Clinical Oncology in advance of the group’s annual meeting next month in Chicago.

The American Cancer Society estimates that almost 77,000 people will be diagnosed with melanoma this year and that 10,000 will die from the disease. It’s much less common than other skin cancers and much more aggressive and likely to spread to other organs. The earliest sign is often a large misshapen or unusually colored mole that grows in size.

Yervoy, approved in 2011, has the longest-term data of the three drugs, with an eight-year survival rate of about 20 percent, said Dr. Thomas Gajewski, a University of Chicago immunotherapy expert.

He said success with Keytruda echoes what he’s seen in melanoma patients at his center. They receive IV infusions of the drug for an hour every few weeks for an indefinite time unless they develop severe side effects, which he said are rare. Rashes and internal inflammation are the most common side effects and they are reversible if the drug is stopped. The yearly cost is more than $100,000, a higher price than some conventional cancer drugs.

Some insurers pay for the treatment, which Gajewski called “a game-changer” for melanoma, allowing many patients to return to work and live productive lives.

In other immunotherapy developments, a new drug was approved Wednesday for bladder cancer, and Opdivo was approved Tuesday for another cancer, Hodgkin lymphoma.

A list of the trials for 2016 is at this link and funny enough the list covers Australia.

https://www.centerwatch.com/clinical-trials/listings/location/international/Australia/North%20Ryde

We havent got a petition running in UK as we are governed by so many ;laws and we just would not get pass NICE  Or best hope is for fast Track and The Promised Saatchi Bill.

Just came up with the very latest report on Keytruda

Final Overall Survival Data from KEYNOTE-006 To Be Presented at ASCO; KEYTRUDA, the First Anti-PD-1 Monotherapy to Demonstrate Overall Survival Compared to Ipilimumab, Shows Continued Benefit with Longer Follow-Up

KEYNOTE-001 Findings Show Continued Benefit in Response Rates, Duration of Response, and Include New Three-Year Overall Survival Data for KEYTRUDA

http://www.newschannel10.com/story/32008560/new-keytruda-pembrolizumab-data-from-keynote-006-and-keynote-001-in-advanced-melanoma-including-updated-survival-data-to-be-presented-at-2016-asco

Lou Williams has a petition for keytruda onto the PSB List although Keytruda hasnt gone through all trials there it has been liscenced and on is on the PSB list for Melonoma.

Australia http://asbestosaustralia.blogspot.co.uk/2016/05/keytruda-fast-track-mesothelioma-pbs.html?spref=fb

Lou says Trevor Grant and myself have on behalf of mesothelioma warriors in Australia sent a letter to the CEO of MSD/Merck who manufacture Keytruda in response to the letter that I received above from Hon Sussan Ley.
Please continue to sign my petition to get Keytruda (and other immunotherapy drugs) fast tracked on to the PBS for Mesothelioma and 30 other rare cancers.  I believe that once are successful in getting Keytruda on to the PBS for all to access as another treatment in Mesothelioma then it will follow for other cancers.  It is getting closer and with a bit more pushing we will succeed.  This cancer is deadly, lethal, aggressive and we simply do not have time to waste!  In unity we can do this!

Lou Williams's profile photo

Rod Smith Of Bernie Banton has a completely different Petition running to get Australia to Trial More Drugs as for some reason they do not get included into to many trials.

We need your support!  The Bernie Banton Foundation is lobbying the Australian Government, via the Health Minister, the Hon. Sussan Ley, to fund trials of drugs with the potential to treat rare diseases, and to reform the Pharmaceutical Benefits Scheme (PBS) application requirements that currently make it impractical for pharmaceutical companies to apply to have valid drugs listed on the PBS.

In Australia, drug trials for treating many rare diseases are almost non-existent, as drug companies find it is not financially viable to conduct trials, due to the relative small number of sufferers compared to more common diseases, such as melanoma.  Not only are trials an important part of helping find cures, and are necessary to obtain data to build a case to justify a drug being listed on the PBS, importantly, they also give sufferers hope – where often none exists!

The Government needs to step up and fund treatment trials for asbestos cancers and other rare and less common diseases! 

Drugs not listed on the PBS for treating asbestos cancer and other rare diseases are prohibitively priced, this often preventsdesperate sufferers with no other treatment options from accessing them!

A good example of the unfairness of the system is where a drug; that has demonstrated benefits, in extending and giving better quality of life, to some sufferers of the rare terminal asbestos cancer, mesothelioma; has been listed on the PBS for treating melanoma – which we think is fabulous!  This means melanoma sufferers pay only up to $38 per treatment, whilstmesothelioma and other rare cancer sufferers are paying between $5,000 and $10,000 per treatmentfor the same drug! 

What’s important to understand is; pharmaceutical companies are often not even attempting to apply to list drugs, with promise to treat rare diseases, onto the PBS, as the application requirements are too demanding and can’t be met in a practical time frame, due to the small number of sufferers involved and the lack of trial data.

The current PBS application requirements disadvantage sufferers of rare diseases – it must be overhauled!

Industry based discussion papers have made a convincing case on how the PBS application requirements could be changed to allow valid drug applications to be fast tracked onto the PBS, without losing the integrity of the system.   All that is needed is for the government to see the need for change and the will to do so!

https://www.change.org/p/to-the-federal-minister-for-health-give-sufferers-of-asbestos-cancer-and-other-rare-diseases-hope-and-a-chance-to-survive-fund-trials-and-change-the-application-requirements-to-allow-valid-drugs-to-be-fast-tracked-onto-the-pbs-application-process

The whole problem is that its the first drug we have had for Mesothelioma. Its always been palliative care only and we have now got a glimmer of hope at last and we want and need it now.

The USA have had trials for some time and with a 22% response. We need more trials. Verestem have come onto the scene as well  and are working with Merck. So many are working hard to make it happen.

VERASTEM REPORTS FIRST QUARTER 2016 FINANCIAL RESULTS
BOSTON–(BUSINESS WIRE)–May 9, 2016– Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer, today reported financial results for the first quarter ended March 31, 2016, and also provided an overview of certain corporate developments.

“To date in 2016, Verastem has announced two new clinical collaborations with world-class organizations, includingMerck KGaA and Pfizer, and Washington University in St. Louis and Merck & Co., to further elucidate the potential of FAK inhibition to enhance the efficacy of PD-(L)1 inhibitors in patients with pancreatic and ovarian cancer,” said Robert Forrester, President and Chief Executive Officer of Verastem. “The data generated from these trials will continue to inform the ongoing development of our anti-cancer therapeutics which reduce cancer stem cells and modulate the local tumor microenvironment to allow both cancer treatments and the immune system to do their job more efficiently. We’ve had a strong start to 2016 with the announcement of these clinical collaborations in addition to attracting key strategic hires on the development team, including Dr. Greg Berk as Chief Medical Officer and Dr. Toyin Shonukan as Vice President of Clinical Development, to oversee and execute on our ongoing and future studies. We are well financed with approximately $100 million in available capital and we look forward to keeping you updated in the coming quarters on our progress.”

First Quarter 2016 and Recent Highlights:

Focal Adhesion Kinase Inhibition Program

  • Clinical Collaboration with Pfizer and Merck KGaA to Evaluate Combination of VS-6063 and Avelumab in Ovarian Cancer – In March 2016, the companies announced a clinical trial collaboration agreement to evaluate the combination of Verastem’s focal adhesion kinase (FAK) inhibitor VS-6063 and Pfizer and Merck KGaA’s anti-PD-L1 immunotherapy avelumab. Verastem has previously reported initial signs of clinical activity in patients with ovarian cancer when VS-6063 is used in combination with paclitaxel. Under the terms of the agreement, the parties will conduct a planned Phase 1/1b clinical trial evaluating escalating doses of the combination of VS-6063 and avelumab as a potential treatment option for patients with advanced ovarian cancer.
  • Washington University in St. Louis Initiated a Clinical Study of VS-6063 in Combination with Merck & Co.’s Pembrolizumab and Gemcitabine in Pancreatic Cancer – In January 2016, Verastem announced the initiation of a Phase 1 dose-escalation study at Washington University to evaluate its FAK inhibitor VS-6063 in combination with Merck & Co.’s anti-PD-1 immunotherapy pembrolizumab and gemcitabine in patients with pancreatic cancer. The trial builds upon preclinical research conducted by Dr. David Denardo, presented at several conferences in late 2015 and early 2016, demonstrating the ability of FAK inhibition to increase the efficacy of checkpoint inhibition in the reduction of tumor volume and overall survival in models of pancreatic cancer. This Phase 1 clinical trial is currently enrolling and is anticipated to enroll approximately 50 patients with advanced pancreatic cancer.
  • Presented Scientific Data Supporting FAK Inhibition in Combination with Immunotherapy at Key Medical Meetings – During the first quarter of 2016, Verastem presented data in support of its new development programs focused on advancing its FAK inhibitors in combination with immune-oncology agents and other current and emerging standard of care cancer treatments. Data were presented at several medical and scientific meetings, including the 2016 American Academy of Cancer Research (AACR), the Society for Gynecologic Oncology’s 2016 Annual Meeting on Women’s Cancer, the Keystone Symposium on Cancer Pathology, the Keystone Symposium on Stem Cells and Cancer, and Immunotherapy World 2016.
  • Presented Clinical Data from the Window of Opportunity Study at iMig 2016 – In May 2016, the Company announced results from the ongoing open-label, single-center, neoadjuvant Window of Opportunity study evaluating tolerability, along with biomarker and tumor volume response to VS-6063 (400mg BID) following either 12 days (Cohort 1) or 35 days (Cohort 2) of treatment in surgically-eligible patients with malignant pleural mesothelioma. Data analysis from Cohort 1 and Cohort 2 showed that VS-6063 was generally well tolerated with early signs of tumor reduction observed, with six of the twenty patients demonstrating an encouraging tumor reduction after brief treatment with VS-6063.
  • Development of VS-4718 Continues in Solid Tumors – Dosing continues in a Phase 1 dose escalation trial evaluating single-agent VS-4718 and a Phase 1 clinical trial evaluating VS-4718 in combination with gemcitabine and Abraxane® is currently ongoing. Following results from the dose escalation trial, an expansion cohort of VS-4718 + Gemcitabine/Abraxane® vs Gemcitabine/Abraxane® alone in patients with pancreatic cancer is planned.

Dual PI3K/mTORC1/2 Inhibition Program

  • Confirmatory Recommended Phase 2 Dose and Expansion Cohorts – The maximum tolerated dose of single-agent VS-5584 has been reached in a Phase 1 study, and the recommended Phase 2 dose (RP2D) is being confirmed. Reductions in pharmacodynamic markers of PI3K and mTOR activity and clinical activity has been observed in some tumor types.

http://phx.corporate-ir.net/phoenix.zhtml?c=250749&p=irol-newsArticle&ID=2166539&highlight=

We will be looking for the latest reports at

INTERNATIONAL SYMPOSIUM ON MALIGNANT MESOTHELIOMA: SAN FRANCISCO AND CHICAGO

Following our conference in Houston on May 20, the 2016 International Symposium on Malignant Mesothelioma will continue with one-day conferences in San Francisco on September 16 and Chicago on October 7.

Each conference will be a one-day event starting at 8:30am and ending around 6:30pm, including breakfast, lunch, and a cocktail hour, plus coffee breaks throughout the day. Each will feature top mesothelioma experts, professionally-moderated support sessions, and numerous opportunities for socialization.

TOPICS
covered at each location by different speakers
• Mesothelioma Research – What’s on the Horizon
• Clinical Trials for the Newly Diagnosed and Beyond
• Radiation Therapy New Techniques and New Ways to Incorporate into Treatment Modalities
• Surgery: How Do We Improve Outcomes
• Immunotherapy Options
• Introduction to Regional Centers of Excellence
• Do Your Genes Put You at Risk

 

SPEAKERS
San Francisco
invited speakers• Thierry Jahan, MD, University of California San Francisco
• Courtney Broaddus, MD, University of California San Francisco
• David Jablons, MD, University of California San Francisco
• Andrew Lowy, MD, University of California San Diego
• Lyudmila Bazhenova, MD, University of California San Diego
• Gleneara Bates, PhD, Meso Foundation
Chicago
invited speakers• Hedy Kindler, MD, University of Chicago
• Sam Armato, MD, University of Chicago
• Kiran Turaga, MD, University of Chicago
• Dennis Wigle, MD, Mayo Clinic
• Aaron Mansfield, MD, Mayo Clinic
• Tobia Peikert, MD, Mayo Clinic
• Daniel Raymond, MD, Cleveland Clinic
• James Stevenson, MD, Cleveland Clinic
• Wickii Thambiah Vigneswaran, MD, Loyola University
• Arkadiusz Dudek, MD, University of Minnesota Medical Center
• Gleneara Bates, PhD, Meso Foundation

The first conference as part of the 2016 International Symposium on Malignant Mesothelioma will take place in Houston on May 20.

http://www.curemeso.org/site/c.duIWJfNQKiL8G/b.8578185/k.F0D0/INTERNATIONAL_SYMPOSIUM_ON_MALIGNANT_MESOTHELIOMA.htm

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