Join Team Kennett at Breathe Deep DC 2014

29 Aug

Team Kennett,

Last fall, thanks to what some may call a minor obsession with local meteorologist Doug Kammerer, I inadvertently became aware of an event called Breathe Deep DC – a fundraising walk around the National Mall for lung cancer. The event was organized by a group named LUNGevity, which I had also never heard of, to raise funds for critical lung cancer research, education, and support for patients and caregivers. Despite my reluctance at that point to participate in cancer-related causes, the day before the event, I decided to register and walk.

I still don’t know exactly what made me decide to walk last year. Maybe I had finally realized it was time I become more involved in fighting back against this awful disease, or maybe I just wanted a chance to meet Doug. Either way, I am grateful to have participated in last year’s Breathe Deep event as I met a number of amazing survivors and caregivers, helped raise critical awareness and funding, and also had the privilege of meeting Andrea Ferris, the President of LUNGevity. This encounter has led to almost a year of personal involvement with LUNGevity and their efforts to combat lung cancer.

The 2014 Breathe Deep DC walk is on November 2nd. October 26th will mark the two-year anniversary of my diagnosis when I was told I had one to two years to live. I have been the recipient of some of the very medical breakthroughs and ground-breaking developments LUNGevity is supporting and working to help fund.

breathe-deep

Because we have been able to enjoy many more quality-filled days together as a family, it’s time we give back. Sheila and I have formed a Breathe Deep team and would love to have you join us. If you are interested in raising money for a great cause and/or going for a nice fall walk in our nation’s capital, please take a look at the links below. If you have any questions, feel free to email me at chip (dot) kennett (at) gmail (dot) com.

Thanks in advance for your consideration.

Regards,
Chip

Out of the Blue

9 Aug

“Momma, you are going to die and go to heaven before me, right? Because you are older than me.”

Yes, that’s probably right, bud.

“But you’ll still be my Momma.”

That’s right, Joe. I will always be your Momma. Even when I am in heaven.

“And then when I go to heaven one day, you’ll still be my Momma.”

That’s right.

“And when I was growing inside of your belly, you were my Momma and now you are my Momma and when I am all grown up, you’ll still be my Momma!”

Joe, that is right. I will ALWAYS be your Momma, my sweet boy.

“How do you get to heaven?”

Well, just your soul goes up to heaven. Our bodies will stay here on earth, because they don’t work anymore.

“What is a soul?”

The soul is the part of me that makes me Momma. The part that makes me laugh, that makes me do silly things, that makes me your Momma and different from all of the other Mommas. You soul is not a body part like your arm or your heart. It’s a part of your body that we can’t see that just makes us who we are. Does that make sense, bud?

“Ohhhh, I know what you are talking about! But why don’t our bodies go to heaven with us?”

Because God gives us new bodies when we get to heaven.

“Even old people?”

Oh, yes, old people get new, young bodies and very sick people get new, healthy, strong bodies in heaven.

“Why do we get new bodies?”

Because our bodies here on earth don’t work anymore. When you die, your ears no longer hear, your eyes no longer see, your heart no longer beats, your mouth no longer eats food, so when your soul gets to heaven, it gets a new body.

“Then where does your body that doesn’t work anymore go?”

It returns to the earth. Ashes to ashes and dust to dust. When God made us, he scooped up a handful of dirt, breathed life into it and created man, so when our body dies and our soul goes up to heaven, our body here on earth that doesn’t work anymore will return to the earth and it will then become vitamins and nutrients for the flowers and trees and grass.

“God made us out of dirt?? That’s funny.”

I know!! That is pretty silly, isn’t it?

“Is God the size of a giant?”

No, I think God is probably just the size of a grown-up, but he is as strong as a giant!

“Did God ever live on earth?”

No, he has always lived in heaven, so that is why he sent his son, Jesus, to earth to tell us all about God.

“Is Jesus as strong as God?”

No, I don’t think so, but he is still very, very strong. God is the one who created all of the heavens and the earth, but when Jesus lived here on earth, he did all kinds of cool tricks like part the ocean and multiply loaves of bread to feed all those people, so that’s how we know he is very strong.

“Is Santa Claus as strong as God and Jesus?”

No, no, now Santa Claus is very strong and can certainly hear and see us, but here is the difference. Santa Claus only creates toys and needs all of those elves to help him, whereas God created EVERYthing all by himself. All of the animals, the oceans, the fish, all of the planets and stars. Everything. And Santa Claus goes on vacation when it’s hot outside. He really gets busy and starts paying close attention to us when it starts to get cold outside, but God listens to us every single day.

“What country is heaven in?”

Well, all of the countries all over the world share one great, big heaven.

“But, Momma, how is that going to work, because people from different countries speak different languages? How are we going to be able to understand each other?”

Well, those are good questions. Maybe God has a universal language in heaven.

“What does that mean?”

Maybe God just has everybody speak the same language in heaven…please be English, please be English, please be English…or maybe when God gives us our new bodies it will come with these big and really smart brains, and we will know how to speak all the different languages so we will know how to talk to each other so we can all be friends.

“Do all of the countries have just one hell for the bad guys?”

Yes, that’s right.

“So, you can either live on earth or heaven or hell?”

Yes, but everybody starts off on earth. When you are born and you are a baby, you live on earth, and then when you die you either go to heaven or hell.

“Ya, the bad guys go to hell and all the good guys go to heaven.”

Mmmmm…ya, it’s sort of like that, bud.

“But once you go to live in heaven, you cannot return to earth.”

That’s exactly right. Once you go to heaven, you live there forever. You ask very, very good questions, Joe. Do you have any more questions for Momma?

“Ya. Um, Momma, can you snuggle with me for a couple of more minutes?”

You bet, bud. I would love to snuggle with my boy.

my view from morning snuggles

my view from morning snuggles

I was so grateful to have that conversation with Joe on Sunday night. I am even more grateful that the help of our social worker, pastors, and family therapist, and my own limited research of children’s developmental stages at different ages and what they are capable of understanding about illness and death, all helped prepare me for that moment. I am grateful that just that very morning, I had prayed for words. I didn’t pray for a miracle that morning for God to ultimately heal Chip’s body but instead for me to always be able to find the right and truthful words when I need them to try to explain all of this to our kids.

And sometimes that makes me feel guilty, but I sit through all of these doctors appointments, I read all of these articles and protocols for different drug trials, and I read the pathology reports from our scans, so sometimes I just have to leave the praying for a miracle up to others, because I am too bogged down in the details and intricacies of this disease to be able to pray that particular prayer anymore. I am too busy praying our alarm clock goes off in the morning so Chip doesn’t miss his biopsy scheduled at 7 AM at Johns Hopkins. I pray we both don’t die in a car wreck on the outer loop of the Capital Beltway driving to Baltimore early one morning. I pray for good labs so we can receive our infusion and for the chemo to not make Chip feel too badly. I pray for bowel movements. For us to remain on schedule and there to not to be any traffic so we can make it back home in time to pick up the kids from daycare and that I don’t have to text a friend asking him or her to pick the kids up, which would most certainly alarm them. At night I pray for Chip’s breathing so I, too, can breathe more easily. I pray for restful and restorative sleep. I pray for good trips home and for “normal” visits with our friends and family. I pray for more quality-filled days together as a family. I pray for my own mental strength and physical health, and I continue to pray for the words. The words to help explain all of this to the kids when I don’t really understand it myself. I pray I don’t screw all of this up too badly.

I also pray Chip and I will rear affectionate children, because they have witnessed their parents be openly affectionate with each other. I pray Crosby will learn from her Daddy how a man is supposed to respect and treat a woman. I pray Joe will learn how to be a gentleman, how to be compassionate, how to be a team player and how to lose, and how to be a friend by witnessing Chip’s actions. I pray they will bear witness to our authenticity and commitment to one another in this marriage. I pray they will know the true character of their Daddy, flaws and all, because that is what makes him so genuine and perfect and real. I pray they will remember and always know their Daddy.

I am grateful for the sense of peace that washed over me as I lay there snuggled up next to my boy that night, and I continue to pray for sustained moments of peace and understanding for us all.

– Sheila

Prevent Cancer Foundation Webcast

16 Jul

In response to his recent Congressional testimony, Chip has been asked by the Prevent Cancer Foundation to participate in a webcast to discuss funding cancer research. View it live tomorrow at preventcancerwebcast.org; details below. (For those who are interested and can’t watch live, the webcast will be available after the event in the group’s archive at the same link.)

webcast_savethedate3

Tuesday’s Briefing and Wednesday’s Hearing

7 May

On Sunday afternoon, I received an e-mail from Jeff Allen, the Executive Director of Friends of Cancer Research, the organization that hosted the Breakthrough Therapies Designation Briefing held in the Senate today, asking if Chip or I would be interested in serving on the panel to discuss our personal experience on LDK 378, now known as Zykadia, since this drug was designated as a breakthrough therapy drug by the FDA last week. I was happy to do it if being on tap for two days in a row was going to be too much for him, but Chip didn’t hesitate for a second. He happily agreed to serve on the panel. As a panelist, Chip testified about his participation in the trial and what it meant to him and our family to have had a solid 7 1/2 month stretch of “health” and normal living.

briefing

Prior to today’s briefing, the panelists and moderator had an opportunity to meet with Senator Bennet (D-CO) who, along with Senator Hatch (R-UT) and Senator Burr (R-NC), introduced the “Advancing Breakthrough Therapies for Patients Act” in the Senate last spring.

What does Breakthrough Therapy Designation mean? In total laymen’s terms, after animal testing is done, drugs go through three different phases:

  • Phase 1–A small group of qualifying candidates (the criteria and protocol for each clinical trial is unique) receive the drug to determine proper dosage levels, how long it takes your body to metabolize the drug and any side effects are recorded. The number of subjects typically ranges from 20 to 80.
  • Phase 2–Barring unacceptable toxicity levels and once the proper dosage is determined, the drug then moves into the expansion phase. Chip entered the LDK378 trial in Phase 2. The pharmaceutical company wants to get the drug to as many qualifying candidates as possible to determine if the drug is indeed effective in treating the targeted disease, and any short-term side effects are further documented. Only a couple of hospitals or cancer centers will execute a particular clinical trial at any given time, hence patients quite often having to travel for treatment, because there are thousands of clinical trials for all diseases being conducted across the nation at once, so not all hospitals can conduct all trials. Typically, the number of subjects in Phase 2 studies ranges from a few dozen to about 300. If there is substantial evidence the drug is having an effect on the disease, and more specifically over other comparable or existing treatments, the drug moves ahead to Phase 3.
  • Phase 3–More information is gathered regarding the safety and effectiveness of the drug, they study different populations and dosages and study the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people.

Breakthrough Therapies allows a drug, if designated by the FDA, to skip Phase 3 and move directly to the market, so now every ALK+ patient across the U.S. has access to this drug. Both of us being from small, rural towns, it has never been lost on either Chip or me how fortunate we are to now live where we do and to have access to such great medical centers like Johns Hopkins in Baltimore and Fox Chase Cancer Center in Philadelphia that are conducting these clinical trials.

View the Breakthrough Facts Handout for more information.

The FDA approved LDK378 to “break through” to the market by skipping Phase 3, because unfortunately, those with non-small cell lung cancer who are ALK+, are being treated for longevity and quality of life, so they just need this drug. They aren’t worried about potential long-term side effects of the drug or how it interacts with Lipitor, for example. Or in some instances, it may be a drug treating an older population or children that can’t withstand the side effects of traditional chemo, aren’t of child-bearing age, etc., so there is no need for a drug that has proven to be effective in treating their type of disease, to go through all of this additional testing. To think that a potential ALK+ NSCLC patient from Marks, MS, or Conway, NH, could now receive this drug in part to the clinical trial Chip was one of 164 to participate in is really amazing.

It truly meant much to both of us to be able to say thank you to so many in the Senate, the FDA, healthcare providers, pharmaceutical companies and various cancer organizations today for all of the work they have been doing that we are directly benefiting from; likewise, I think it was equally as rewarding for them to attach a name and face to a real person who is a husband and father just trying to live a quality-filled life. We repeatedly heard the message today that they were doing it all for us. For real people like US. Wow.

Tomorrow’s hearing in the Senate Special Committee on Aging regarding The Fight Against Cancer: Challenges, Progress, and Promise in which Chip is testifying, begins at 2:15 PM EST and will be streamed live from the Committee’s website. Riveting television, I know, but many of you have asked how to watch, so if you are indeed interested, click on http://www.aging.senate.gov/hearings/the-fight-against-cancer-challenges-progress-and-promise for your viewing pleasure. The Committee typically leaves a recording of their hearings up on their website, too, so you can watch it later, as well. It is recommended you use Chrome or Firefox as your browser instead of Internet Explorer.

Wish us luck!

– Sheila

 

And this is also happening…

2 May

hopeThe LUNGevity Foundation is hosting their annual HOPE Summit in Arlington this weekend (see more on the LUNGevity website), so Chip and I are going to do a sophisticated dance, i.e., juggle with the kids and various commitments this weekend so Chip can attend as much of this as possible. Please don’t judge me if I place Crosby on one of those child leashes you see on kids at Tysons I, not II obviously, at tee ball in the morning, because Crosby is convinced she is a four-year-old little boy who has every much of a right to the field as her big brother.

Sunday, May 4, 2014
10:15-11:00am
Immunology 101 and Clinical Trials

On Sunday morning, our oncologist at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Dr. Julie Brahmer, is presenting on the immunotherapy trial Chip is currently enrolled in, so he is specifically looking forward to learning more about that and other advances being made in lung cancer research.

A big, big thanks to Andrea Ferris, President and Chairman of LUNGevity, for her vision, her determination and all of the support she has provided to Chip over the last six months.

– Sheila

So…THIS is happening!

1 May

… and was officially just noticed in the Senate:

SENATE SPECIAL COMMITTEE ON AGING

Bill Nelson, Chairman
Susan M. Collins, Ranking Member

WITNESS LIST

The Fight Against Cancer: Challenges, Progress, and Promise

May 7, 2014

2:15 PM

Dirksen Room 562

  • Harold E. Varmus, MD, Director, National Cancer Institute, National Institutes of Health
  • Valerie Harper, Actress and Cancer Survivor
  • Thomas Sellers, PhD, MPH, Director, H. Lee Moffitt Cancer Center and Research Institute
  • Mary Dempsey, Assistant Director and Co-Founder, The Patrick Dempsey Center for Cancer Hope and Healing
  • Chip Kennett, Advocate and Cancer Survivor

Most cancer diagnoses occur in those aged 65 and older, and this portion of the population is rapidly growing. In addition, because of advances in research, a huge number of diagnosed individuals now “live with cancer.” New treatments for diseases that were once fatal means someone diagnosed at a young age, for instance, now will “age” with cancer, either living with cancer for a period of many years or fighting cancer and surviving earlier in life and aging with the impact of those treatments. Still another subset of those are fighting cancers that are still as-yet incurable and rely on the absolute latest of clinical trials to prolong their lives until a cure can be found. Clearly, both the advances and the demographics of those with cancer has changed since even the last Senate hearing on cancer six years ago.

This hearing will highlight each one of these factors and why innovations in cancer research are so important to confronting this trend, while also illustrating the progress that has been made against cancer because of the dedicated work of researchers, clinicians, patients, and advocates. In addition to stressing the importance of federal funding through the National Institutes of Health and the National Cancer Institute, witnesses will also cover the specific areas of treatment and survivorship.

Witnesses:

1) Dr. Harold Varmus, Director, The National Cancer Institute (NCI). Dr. Varmus will provide an update on the Federal government’s work to get the latest advances to patients.

2) Thomas A. Sellers, PhD, MPH: Executive Vice-President and Director, Moffitt Comprehensive Cancer Center, Tampa, FL. Dr. Sellers will present research progress and challenges from the ground.

3) Mary Dempsey, Director, The Patrick Dempsey Cancer Center for Hope and Healing in Lewiston, Maine. Ms. Dempsey will talk about the services and supports needed today by cancer patients outside of medical treatment including help with finances, caregiver support, emotional and nutrition counseling, etc…and the trends she sees most often today from her vantage point and where we could improve.

4) Valerie Harper, a celebrity and survivor with Leptomeningeal carcinomatosis (LC), a rare complication of cancer in the brain. Ms. Harper has survived nearly a year after her prognosis.

5) Bayard W. Kennett (Chip). Chip is an advocate, survivor and former Collins/Congressional staffer battling Stage IV terminal ALK+ non-small cell lung cancer. Chip will speak about his diagnosis and living with an extremely recalcitrant form of an already difficult to treat stage IV lung cancer.


Gulp!! I mean, Chip and I actually know better than to agree to do something like this, but when one of our good friends and former colleague of mine, Rachel Pryor, shot me an e-mail about a month ago wanting to know if she could pick my brain on a hearing she wanted to do in the Committee, I enthusiastically said yes. She and I met for coffee at Peregrine (my new fave!!) one morning and spent a solid three hours crying, laughing, discussing life and of course, this hearing. One thing led to another, and the next thing we knew, Senators Susan Collins and Bill Nelson invited Chip to testify.

Anybody who has ever worked on the Hill usually adds to NEVER testify before a House or Senate Committee to their bucket list, but as Chip said, being invited is way better than being subpoenaed to testify. Four years ago, Chip was writing hearing questions for Senator Collins and staffing her at hearings, and on Wednesday, he will find himself on the opposite side of the dais answering questions from the Senator and other members of the Senate Aging Committee.

I am super proud of Chip for wanting to do this. As I’ve told a few people, he is on the panel with some really big names like Harold Varmus and Valerie Harper…you know, Mary Tyler Moore! Chip kindly informed me that Mary Tyler Moore was actually Mary Tyler Moore, and Valerie Harper was Rhoda on The Mary Tyler Moore Show to which I rolled my eyes and mockingly threw up some air quotes while mouthing “details…”

– Sheila

FDA Approves LDK 378

30 Apr

Chip and I are thrilled to have learned the Novartis trial drug he was on from March 28, 2013, to January 26, 2014, at Fox Chase Cancer Center in Philadelphia received breakthrough approval from the FDA yesterday. To think Chip was one of only 163 patients enrolled in this clinical trial is pretty astonishing.

We are so grateful for our proximity to Philadelphia from Washington, D.C., and that we had access to this trial and the means to travel every couple of weeks to receive this drug that provided him and our family with nine months of quality-filled days. To think Chip played a role in helping others who share the ALK+ genetic mutation to now have access to this drug is incredibly rewarding. You can read the related press release below.

Chip and I are also looking forward to attending a briefing in the Senate next week as guests of the Senate Special Committee on Aging, where the FDA Director, Janet Woodcock, will speak specifically about this drug. Details on the briefing follow.

– Sheila


Novartis gains FDA approval for Zykadia(TM), first therapy for patients with ALK+ NSCLC previously treated with the ALK inhibitor crizotinib

  • Zykadia (ceritinib) demonstrated an overall response rate of 54.6% in patients with ALK+ metastatic NSCLC who have no other treatment option[1]
  • Median duration of response to Zykadia was 7.4 months; patients in study started treatment with metastases, including brain (60%), liver (42%) and bone (42%)[1]
  • ALK+ NSCLC is driven by a rearrangement of the ALK gene, which is responsible for cancer cell growth in 2-7% of patients with NSCLC[2]
  • Approval follows FDA Breakthrough Therapy designation; regulatory application submitted in the EU and filings underway with other health authorities worldwide

Basel, April 29, 2014 – Novartis announced today that the US Food and Drug Administration (FDA) has approved Zykadia(TM) (ceritinib, previously known as LDK378) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib[1]. The approval of Zykadia addresses an unmet medical need for patients with this type of lung cancer who have progressed on prior therapy.

“Zykadia represents an important treatment option for ALK+ NSCLC patients who relapse after starting initial therapy with crizotinib,” said lead investigator Alice T. Shaw, MD, PhD, Massachusetts General Hospital Cancer Center, Boston. “This approval will affect the way we manage and monitor patients with this type of lung cancer, as we will now be able to offer them the opportunity for continued treatment response with a new ALK inhibitor.”

Lung cancer is the leading cause of cancer death worldwide. The most common type of lung cancer is NSCLC, accounting for 85-90% of all cases[3]. Of those, 2-7% are driven by a rearrangement of the ALK gene, which increases the growth of cancer cells and can be identified by a molecular test of the cancer tumor[2]. Despite significant treatment advances for patients with ALK+ NSCLC, disease progression is often inevitable and more options are needed.

The approval of Zykadia is based on a pivotal trial that included 163 patients with metastatic ALK+ NSCLC who progressed on or were intolerant to treatment with crizotinib. The most common sites of metastases in the patient population studied were brain (60%), liver (42%) and bone (42%)[1].

Among previously-treated patients, Zykadia achieved an overall response rate (ORR) of 54.6% [95% CI, 47-62%] and a median duration of response (DOR) of 7.4 months [95% CI, 5.4-10.1 months][1]. The most common adverse reactions (incidence of at least 25%) were diarrhea, nausea, elevated transaminases, vomiting, abdominal pain, fatigue, decreased appetite and constipation[1].

“The approval of Zykadia less than three and a half years after the first patient entered our clinical trial exemplifies what is possible with a highly focused approach to drug development and strong collaboration,” said Alessandro Riva, MD, President, Novartis Oncology ad interim and Global Head, Oncology Development and Medical Affairs. “The dedication of clinical investigators, patients, the FDA and others has enabled us to bring this medicine to patients in need as swiftly as possible.”

Zykadia is an oral, selective inhibitor of ALK, an important therapeutic target in lung cancer. ALK is a gene that can fuse with other genes to form an aberrant “fusion protein” that promotes the development and growth of cancer cells[4],[5]. Zykadia is one of the first medicines to be approved following FDA Breakthrough Therapy designation, which was received in March 2013 due to the significance of results observed in the pivotal trial and the serious and life-threatening nature of ALK+ NSCLC. Additional regulatory submissions for Zykadia are underway worldwide, with an application currently filed in the European Union.

[Full press release with references]


Briefing on Breakthrough Therapies: Science and Progress at the FDA

A Friends of Cancer Research Congressional Briefing on the Progress of the FDA’s Breakthrough Therapies Program

Sponsored by:

Senator Michael Bennet (D-CO), Senator Orrin Hatch (R-UT), Senator Richard Burr (R-NC)

May 6, 2014 1:30pm-2:30pm 902 Hart Senate Office Building,

Panelists:

· Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA)

· Ellen Sigal, Ph.D., Chair & Founder, Friends of Cancer Research

· Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development, Roche

· Urte Gayko, Ph.D., Senior Vice President of Global Regulatory Affairs, Pharmacyclics

· Moderator: Kate Rawson, Senior Editor, The RPM Report

Event Summary:

The FDA began implementing the Breakthrough Therapies Program in the summer of 2012, following the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA). After a speedy rollout, many stakeholders were quick to draw attention to the benefits that a Breakthrough Designation offers, namely, increased communication between drug sponsors and high-ranking FDA officials over the course of development, and an “all hands on deck” approach to drug review. In fact, in just two years, 178 requests for Breakthrough Designation have been submitted, 41 designations have been granted, and 5 drugs have been approved from the program.

In order to allow for the continued success and growth of the FDA’s Breakthrough Therapies Program, this briefing will convene expert stakeholders to explore key lessons learned and strategies for future application of this critical initiative.

· An hour-long briefing on Capitol Hill to evaluate the progress of the FDA’s Breakthrough Therapies Program, identifying how partnerships between government and industry have facilitated the development and review of the most urgently needed treatments.

· This briefing will also allow stakeholders to discuss lessons learned through participation in the program, including how Breakthrough Therapy designation has influenced the development of specific products.

· The briefing will aim to address how the Breakthrough Therapies Program can grow and evolve to encourage even more expeditious development and review of treatments that demonstrate significant improvements over existing options.

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