ASH Abstract: Factors That Influence Patient Treatment Decision Making in the Era of Novel Agents and my Trip to Serbia

Today in the Conference Coverage section of the CLL Society website, we’ve posted a summary and link to the ASH abstract we wrote based on the results from our Reader Poll in the Q1 2016 issue of The CLL Tribune where we asked you about what was important to you when making treatment decisions for your CLL. You can view my article and see the abstract here.

Leaving on a jet plane. Economy class. Red-eye. Tight connection in Germany. Leave on one day, arrive the next in Belgrade. Landing at the Nicolas Tesla Airport.

This is another familiar story as I’m packing my bags to attend the 2016 CLL Horizons meeting in Serbia this week. I will serve as faculty and part of the steering committee for the newly forming CLL Advocacy Network, a global network of organizations representing people with CLL. The main goal of this first CLL Horizons conference is to build capacity for international patient advocacy organizations to support people affected by CLL.

In addition to getting ready to getting ready for the next ASH meeting, we’re also working on the content for the next issue of The CLL Tribune. If you have a question for our Ask The Doctor section, you can submit it here. No question is too silly to ask and you can be sure others have the same questions. 

Patient and Caregiver Support Meetings

November 7th @ 6:00 pm in Indianapolis, the CLL and Indolent Blood Cancers Support Group will be meeting. See more information here.

If you’re aware of other CLL Patient Support Group meetings, let us know and we’ll post them. Thanks!

Post-ASH CLL Patient Educational Forum at City of Hope

We're excited to announce that on Saturday, December 17th, in partnership with City of Hope Medical Center and the Leukemia and Lymphoma Society, the CLL Society will be hosting the second annual Post-ASH CLL Educational Forum at City of Hope. Dr. Tanya Siddiqi will be presenting on the latest data on Diagnosis and Frontline Treatment and Dr. Steven Rosen will present on Relapsed Disease and Novel Therapies. You can access the flyer here and pre-registration is requested. We look forward to seeing you there.

Patient Education Meetings

From time to time, we will make you aware of in-person Patient Education meetings coming up for those of us affected by CLL and lymphoma, specifically:

·      Wednesday, November 16^th at 6 PM at the Hilton Minneapolis/St. Paul Airport – Mall of America in Bloomington, MN: The Lymphoma Research Foundation will be hosting Updates on Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma as part of their Ask the Doctor series. Dr. Timothy Call, from the Mayo Clinic is the featured speaker. You can find out more information and register here. Dinner will be served and there is no charge to attend.

·      Friday, November 18^th from 7:30 AM to 2:15 PM at the Hilton Hotel City Avenue in Philadelphia, PA: The Abramson Cancer Center in partnership with the Leukemia and Lymphoma Society will be hosting 9th Focus on Leukemia, Lymphoma, Myeloma and Bone Marrow/Stem Cell Transplantation Conference. Dr. Anthony Mato is the featured speaker for the CLL Workshop. You can find out more information and register here.

·      Wednesday, December 14^th at 6 PM at the Washington Marriott Georgetown in Washington DC: The Lymphoma Research Foundation will be hosting Updates on Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma as part of their Ask the Doctor series. Dr. Chaitra S. Ujjani from Georgetown University Hospital is the featured speaker. You can find out more information and register here. Dinner will be served and there is no charge to attend.

Heads Up! The CLL Society has become aware of a series of unbranded (no specific drug discussion) patient education meetings coming up in November. CLL patients will share their personal stories, and local CLL experts will be providing a talk on the basics of CLL. A complimentary meal will be provided and parking is free. You are welcome to bring a guest.

One member of the CLL Society will be at each meeting to show a brief video and give a talk about the impact support and education groups have had on their CLL journey. We will provide practical tips and support for setting up a local CLL group and will stay afterwards to meet with attendees who may be interested in participating in a support group in those areas. We look forward to meeting you there. The next 3 confirmed meetings are:

·      Thursday, November 10^th in Metairie, LA. More details in the flyer. Access it here.

·      Thursday, November 15^th in Independence, OH. More details in the flyer. Access it here.

·      Wednesday, November 16^th in Austin, TX. More details in the flyer. Access it here.

In the meantime….

Stay strong.

We are all in this together.

Brian Koffman, MD

11/7/16

http://cllsociety.org

Top 10 list for lymphoma and an important CLL survey

Dr. Leonard is a great teacher and this week we share his top 10 list of what we need to know about lymphoma on our nonprofit's website: http://cllsociety.org.

Remember that any cancer that arises from a lymphocyte is a lymphoma, that of course includes us, so this is a relevant discussion.

While not specific to CLL, it helps us see where our brand of lymphoma fits in and reviews overriding principles in lymphoma management. Well worth a look. And it’s fun. 

If you haven’t completed our 5 minute survey on how you choose your therapy, please, please join the 300+ who already have and help us generate some strong data to share with CLL researchers, doctors, payers, and industry and make our voices heard. Industry and doctors and payers love data.

Stay strong.

We are all in this together.

Brian 

Survey to help Canadian CLL (chronic lymphocytic leukemia) Patients

If you have CLL could you please read the below and consider taking a 10 minute survey to help patients in Canada.
The Canadian regulatory system for the approval of new medicines is very similar to Australia, but different than in the USA. Lymphoma Canada It is currently preparing submissions to their decision makers for the following treatments:
· Ibrutinib (Imbruvica) for patients with previously untreated CLL for whom fludarabine based treatment is considered inappropriate
· Ventetoclax (ABT – 199) for patients with relapsed/refractory CLL
Lymphoma Canada like Lymphoma Australia can survey patients and caregivers to provide data to regulators on the side effects and quality of life experienced by those on current therapies and how a new therapy may improve the quality of life for patients. This information can then help the regulators better understand the value of new therapies for patients and their families.
HOW CAN ANY CLL PATIENTS HELP?
Please complete the survey below for Lymphoma Canada. You do not need to live in Canada to complete this survey.
The survey will be open until midnight (Pacific Time- Canada) on Wednesday, April 20th and should only take 10 minutes of your time.
You may access the survey by clicking the link below.
https://www.surveymonkey.com/r/SRWKYMX

Patient Survey, New CLL support groups, Life at the Beach, and Living Well with CLL (chronic lymphocytic leukemia)

Friends, 
It’s been a very busy year and this week I spent a few days away from my patients and my online and live support group efforts just walking, reading, and resting at a nearby state park on the beach. It was wonderful! 
As I prepare to speak at a symposium at the 2016 European Hematology Association Congress in Copenhagen in June, I am asking you to please consider completing our Reader Poll [https://asktellq12016.questionpro.com/] on how we patients and caregivers make decisions about therapy. It takes less than 5 minutes to complete. Many thanks to the 190 folks who have already done so!  We’ll present the aggregated results in a future issue of The CLL Tribune.
In our live support group efforts, we are forming 2 new patient and caregiver support meetings: Charlotte, NC and Tampa FL.  
• If you live in Charlotte, NC and are interested, please complete the online survey to indicate your preferences for days and times. [https://charlottegroup.questionpro.com/]
• If you live in Tampa, FL and are interested, please complete the online survey to indicate your preferences for days and times. [https://tampa.questionpro.com/]
We look forward to getting started. For those interested in getting a CLL support group going on the west side of the LA Basin, or in attending our Orange County group that meets at UCI, or the group that meets at City of Hope, please send us an email at support@CLLSociety.org and we will provide you with the necessary information.
Find out about other’s experiences with support groups in the Support area of the Living Well with CLL section of the website. [http://cllsociety.org/living-well-with-cll/support/] Teresa Altemeyer wrote a great article in the latest issue of The CLL Tribune about The Value of Support Groups – A Personal Perspective about how she was asked by her CLL specialist to facilitate a support group in Indianapolis, Indiana and the positive effect it had on her life. Check it out. [http://www.cllsociety.org/newsletter/quarter-1-2016-volume-2-issue-1/living-well-with-cll-quarter-1-2016-volume-2-issue-1/value-support-groups-personal-perspective/]

Busy Few Weeks and a Therefore Rather Ironic Article on Fatigue in CLL (chronic lymphocytic leukemia) by Dr. Estrov

Hi Friends,

It’s been a busy few weeks.

Last week was exciting as we marked the first year since we launched our website, published our first 2016 issue of The CLL Tribune, and fielded a short survey in our Reader Poll on how we patients and caregivers make decisions about our therapy. I hope to present the results at a symposium at the 2016 European Hematology Association Congress in Copenhagen in June, so I am asking you to please complete it. It takes less than 5 minutes. Many thanks to the 78 folks who have already done so!

Two weeks ago in Anaheim, I spoke in front of more than 550 patients and caregivers on behalf of LLS at their southern Californian Blood Conference. My topic was “How to be your own advocate”. It was a great privilege, in every way, to be able to give such a talk after 10 years of dancing with my CLL.

On April 2^nd, the CLL Society had an active table sharing CLL information and resources at the LRF Lymphoma Workshop in Manhattan Beach.

Both meetings had superb CLL breakout sessions, in Anaheim by Dr. Tanya Siddiqi of City of Hope, and in Manhattan Beach by Dr. Herbert Eradat of UCLA. Thanks to them both for donating their time.

At both meeting we collected signatures for those interested in getting a CLL support group going on the west side of the LA Basin. It you missed the meetings and are interested, please send us an email at support@CLLSociety.org and we will make you aware of our interest survey when it launches.

This week in the 2015 Conference Coverage section of the CLL Society website, we have posted an interesting article written by Dr. Zeev Estrov from MD Anderson Cancer Center describing the abstract they presented at ASH 2015 focused on exploring treatment options to address CLL fatigue. 

You can see a summary and view our interview on the website.

We are also gathering interest in forming 2 new patient and caregiver support meetings: Charlotte, NC and Tampa FL.

If you live in Charlotte, NC and are interested, please complete the online survey to indicate your preferences for days and times.

If you live in Tampa, FL and are interested, please complete the online survey to indicate your preferences for days and times. We look forward to getting started.

In the meantime….

Stay strong.

We are all in this together.

Brian Koffman, MD

Volunteer Medical Director of the CLL Society

http://cllsociety.org

Last chance for the CLL (chronic lymphocytic leukemia) Survey and the News About the Agreement between Gilead and Ono

We are taking down the survey at midnight tonight Pacific Time, so if you haven't completed it, please let us know what will be important to you in a CLL website and support groups.

Here is the link to the survey: https://cllsociety.questionpro.com

And thanks so much to the over 400 of you that completed the survey and the many who have made a donation to the CLL Society Inc. to jumpstart our process.

                                  


Finally I want to share this press release from Gilead:

ONO  AND  GILEAD  ANNOUNCE  EXCLUSIVE  LICENSE  AGREEMENT  TO  DEVELOP  BTK  INHIBITOR,  ONO-4059,  FOR  THE  TREATMENT  OF

B-CELL  MALIGNANCIES  AND  OTHER  DISEASES

-- Companies will Collaborate Jointly on Global Development of ONO-4059 --

Osaka, Japan, and Foster City, CA, December 18, 2014 - ONO PHARMACEUTICAL CO., LTD. (“ONO”) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the companies have entered into an exclusive license agreement for the development and commercialization of ONO-4059, ONO’s oral Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies and other diseases.  Under the terms of the agreement, Gilead will pay ONO an upfront payment plus additional payments based upon achievement of certain development, regulatory and commercial milestones.  The companies will collaborate jointly on global development of ONO-4059.  Gilead will have exclusive rights to develop and commercialize ONO-4059 in all countries of the world outside of Japan, South Korea, Taiwan, China and the Association of Southeast Asian Nations (ASEAN) countries, where ONO retains development and commercialization rights.  

ONO-4059 is a selective, once-daily, oral inhibitor of BTK, which has been shown to play a role in the survival and proliferation of malignant B-cells.  ONO has presented preliminary Phase 1 data showing clinical activity in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) at several scientific conferences.  ONO and Gilead plan to develop ONO-4059 for the treatment of B-cell malignancies and other diseases as a monotherapy and in combination with approved and investigational agents, including combinations with kinase inhibitors in Gilead’s portfolio. 

“We are pleased to partner with Gilead to accelerate worldwide development and commercialization of ONO-4059,” said Gyo Sagara, ONO’s President, Representative Director and Chief Executive Officer.  “Our goal is to bring better therapeutic options as quickly as possible for the patients with B-cell malignancies or other diseases in the world, and we believe we can fulfill the goal by pursuing the development of ONO-4059 with Gilead.”

“With this agreement, Gilead now has compounds targeting four unique signaling pathways associated with B-cell malignancies – PI3K delta, Syk, JAK and BTK,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer.  “In addition to evaluating ONO-4059 in combination with standards of care, we believe there is an opportunity to combine this compound with Gilead’s other kinase inhibitors with a goal of achieving more pronounced and more durable response rates.  We look forward to working with ONO to move the ONO-4059 development program forward as quickly as possible.”

About ONO PHARMACEUTICAL

ONO PHARMACEUTICAL, headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. It focuses especially on the diabetes and oncology areas.  For more information, please visit the company’s website at http://www.ono.co.jp/eng/index.html.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.  The company’s mission is to advance the care of patients suffering from life-threatening diseases.  Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Gilead Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including risks that the parties will be unable to develop and commercialize ONO-4059, as a potential monotherapy and in combination with other therapies, for the treatment of B-cell malignancies or other diseases.  These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.  The reader is cautioned not to rely on these forward-looking statements.  These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, as filed with the U.S. Securities and Exchange Commission.  All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

###

This is good news as we need more options and Gilead is a smart company that has a strong track record on getting new and important drugs approved. It also has other small molecules including idelalisib that might make sense in combination therapies. The market seems to approve of the move as this joint effort should increase the likelihood we will be seeing ONO-4059 become commercially available.

Ibrutinib is a great BTK inhibitor and has set the bar very very high in terms of its response rates and tolerability, but still it won't be the right choice for all patients due to some intolerance or adverse outcomes or lack of efficacy, so having another Bruton Tyrosine Kinase inhibitor option is something all patients should want.

And waiting in the sidelines is Acerta's ACP-196- no data to report yet, but the buzz about this new BTK inhibitor is very promising.

Abbvie, Janssen, Pharmacyclics and others are looking at new non-chemo combos in trials in the hope of going from control to cure. More on these trials and plans soon.

2014 was a great year for those with CLL. 2015 may be even better.

Happy Holidays to all.

ASCO 2014: Dr. O'Brien Discusses Improved Trial Designs, CT Scans and the role of Chemo-immunotherapy In Frontline Therapy in CLL (chronic lymphocytic leukemia)

I am back from ASH 2014 with some informative video interviews from Drs. Hillmen, Byrd, Burger, Wiestner, Kipps. Sharman, Roberts, Pagel, and Kay. The congress was a huge success and I will be reporting on the important abstracts and news over the next few months first here and then on our new website for the CLL Society Inc.

I also am very excited with the video interviews from ESH in Greece including ones with Furman, Porter, Hallek, Stilgenbauer, Wu, and Brown.

But first I have to share this fourth and final thoughtful audio interview with Dr. Susan O'Brien despite all its hisses and pops.

We pick up on the issue of ethical trial design from the third part of her interview on the issue of equipoise. If you missed part 3 or part 1 or 2, please enjoy by clicking on the numbers.

In this segment, Dr. O'Brien and I discuss the place of CT scans in clinical trials and in the real world of CLL therapy. Her answer is not black or white but is balanced and well considered.

Next Dr. O' Brien gives as a nuanced response to the question of what might be the possible role for chemo-immunotherapy in and out of trials.

Spoiler alert: Consider FCR frontline if you are young, healthy, mutated, and trisomy 12. But only under those circumstances>

 Here is Dr. O'Brien



More soon from ASH and ESH.

And thanks to the well over 300 of you that have completed our survey. If you haven't done it yet, please, take a few minutes to add your voice to the others as to what are your particular unmet needs in living with CLL. We are building the nonprofit CLL Society Inc. in response to those needs.

We will be taking the survey offline in one week on December 19, so please don't delay.

Here's the link.

And a very special thanks to those of you who have generously given a tax deductible donation to help us with our website construction and developing our CLL specific support groups.

More details to follow soon after we have analyzed the survey results.

We still are welcoming any contribution, large or small. At the suggestion of several of you, we have added a donate button at the top of the blog and on our placeholder website for the CLL Society Inc.

Thanks for all your help.

We are all in this together.

                                           

Why Patients Need to Be Heard At Medical Congresses on not just CLL (chronic lymphocytic leukemia) but on All Important Medical Issues

I was asked by friends to help with a campaign to ensure that the voice of informed patients be heard more loudly, more clearly and more often at large medical congresses such as ASH and ASCO. To that end, I shot a series of very short videos, starting with this one that introduces who I am and how I got involved in traveling the world, teaching my fellow patients and physicians about my disease, CLL and how patients approach their medical decisions.

Me in front of bleach painting by my son, Will Koffman

This video effort is directed at doctors, and is an important but smaller piece of my larger work that focuses on providing us patients with the best possible resources to educate and support ourselves in dealing with our largely incurable cancer.

So here is my first "ask".

Please complete this survey to help me and a team of patients, nurses and doctors across the world to meet the unmet needs of the CLL community.  It will take you less than 5 minutes to do.

We plan to start by constructing the most patient friendly, robust and relevant CLL specific website. 

We don't plan to step on the toes of the other great websites out there and replicate what already exists, but to make something different, deeper, and more accessible and searchable. Please remember that our goal is to meet the unmet needs of our community.

Next, we are going to build a facilitated network of CLL specific support groups across the country, linked by the mother website and a common goal to make sure we are all getting the best possible care for our particular circumstances.

We can't do this alone and we already have a strong team of folks in place: doctors, nurses, researchers, advocates and patients, many of whom you already know and respect from the videos hosted on this blog and/or their ubiquity in the CLL forums and other helpful sites.

Truth is that the CLL world has changed radically in the last few years, and what needs to done has outgrown the capacity of this humble blog. It will slowly morph back to my telling my own story and sharing my opinions, but in order to teach and support my fellow CLL patients, a IRS approved nonprofit 501(c)3, The CLL Society Inc. (EIN # 46-4131354) will largely be doing the heavy lifting, starting with designing a web presence from the ground up.

Stay strong. We are all in this together.

CLLPAG Niagara Falls Conference and Survey

Paul Henderson and Me

Every Canadian knows Paul Henderson. He is the hockey player who scored the most famous iconic winning goal ever, finding the back of the net in the dying seconds of the Summit Series in 1972 against the Russians, a defining event in Canadian identity.  For non Canadians, think Olympic Gold, the Word Cup, Wimbledon, the Masters, the SuperBowl and the World Series all wrapped into one. His goal surpassed all that. Turns out Paul is a sweet guy who is not shy about using his fame to help others who share his diagnosis of CLL. We met at the CLLPAG conference.

The CLLPAG conference in Niagara Falls was wonderful in so many ways, and not just for meeting a hockey idol.

First it was great to see so many old friends and make new ones in the CLL community.

As I have said before, if it wasn't for the downside, everyone would want cancer.

People may have left with different levels of understanding of their disease, but everyone left with a clear and strong sense that they were not in this alone. It was an enormous group hug for everyone involved.

That said, it was not just about feeling good. The world class and world wide faculty presented both the medical basics and the latest for a crowd of over 200 that included many newbies and more than a few pros.

Patients and patient advocates addressed the cold and complex psychological, social, financial, and political realities of the disease and its cost in the broadest sense of the word.

Still, the overall sense was hopeful. The CLL world is changing very fast, for the better.

Thanks to Deborah and all the volunteers and faculty who all donated their time. Amazing success.

I will leave for my next post an update on the promising new science, my vision for the future, and a reprise of my own presentation. Actually, that will take a few posts.

Before that I need your help.

As part of an effort to bring together an more informed and participatory patient group, I am surveying fellow cancer patients and their caregivers  about what they would want on their smart phone or IPAD or computer in an app to have with them at all times when dealing with their malignancy.

So please, please complete a very brief online form at http://www.virtualcancerbuddy.com/ if you didn't do one already at the conference. You don't need to have been to CLLPAG or even have CLL to share your needs. You just need to be a cancer patient or a caregiver of a cancer patient.

We are truly and eternally all in this together.

Language

This is verbatim from my friend Arlene on the survey. She is right, of course.

The words used for each choice probably has a bearing on the outcome.

The "gentle treatment" answer was somewhat nuanced and contained a reasonable medical strategy whereas the "aggressive treatment" answer was all metaphor and did not outline a medical reason to proceed.

The gentle treatment answer appears to leave more options open. The thought is that if the Gandhi approach starts to look like it's not going to work, one can then take the other approach, blow war trumpets, load the ammunition, and strike with deadly force.

No results yet on bone marrow biopsy, though Dr. Forman thought they might be back as soon as Thursday.

I always have the irrational worry that the delay means the news is not good. Crazy thinking. I will do better.

The Year of the Flood

I am always a little sad and lost when I finish a great book, a book that has swept me away to a different world. This time it was to the dystopic future of Margaret Atwood's The Year of the Flood, a companion text to Oryx and Crake. My oldest daughter lent me this Canadian writer's latest and gave it a hearty thumbs up. Thank you.

Like a vacation or an insight, a finely crafted piece of writing can change how you look at everything.

Atwood's writing is such a gift. and even though the pictures she painted were dank and squalid, it was hard to leave, and the taint of the story stays with me.

If you do decide to pick up the book, read Oryx and Crake first.

On another topic all together, the latest CLICK Here for SURVEY results are now 3 to 1 in favor of the slow gentle path. Still not too late to vote.