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Mayo Clinic Rochester Publishes Updated Multiple Myeloma Survival Rates!

12/23/2018

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When I was first diagnosed with multiple myeloma 13 years ago, I conducted a search of the available information on which facilities had the best survival rates.  To my total surprise I found very little information.  Mayo clinic published their data and it was disappointing at just 33 MONTHS, the consolidated National Cancer Institute's data base mirrored the Mayo information.  The only other published information I found was for The Myeloma Institute at UAMS.  They published a life expectancy of an average of 7 years.  I was treated at Mayo and they got my myeloma under control, but I chose to have the majority of my treatment at UAMS, hoping for the extra 4 years.  Now being nearly 13 years post diagnosis, I think choosing a treatment facility on a data driven basis was a great decision.   Now fast forward to 2018 and Mayo Clinic's myeloma survival  has made quantum leaps. Transplant eligible patients (whether they have a transplant or not) can expect to be alive for more than 10 YEARS.  I just updated the Mayo data on the web site www.myelomasurvival.com and state the following:

Mayo Clinic(Dr. Vincent Rajkumar), Rochester, MN - The Mayo Clinic published an update of their myeloma survival rates for transplant eligible patients  and posted it on line  12/3/2018.  They reported Overall Survival (OS).   OS includes death from all causes and The SEER data is based on Relative Survival which excluded non myeloma deaths.   The Mayo Relative Survival rates are 95.9% at 2 years versus the SEER rate of 72% and 89.8% at 4 years versus the SEER rate of 57.7%  When compared to the SEER rate you are 6 times more likely to die in 2 years and 4.1 times more likely to die in 4 years at the average SEER facility than if you were under the care of the Mayo, Rochester.  You can see a graph of the data if you CLICK HERE. This data is reflected in an OS study of 518 consecutive transplant eligible patients seen at Mayo Clinic. An outline of Mayo's risk adapted treatment template called mSmart can be found at the attached link: http://www.msmart.org/

As noted, Mayo and most programs provide their data as Overall Survival(OS), and the National Cancer Institute adjusts the data to exclude the non myeloma deaths.  This measure is called Relative Survival(RS), so to make a comparison of Mayo's information to that listed on the NCI SEER data base, I have adjusted the Mayo data to reflect Relative Survival.  The graph  below is this comparison.
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Some very eye opening observations include 1) 17.2% of patients do not survive the first year if treated at the average SEER facility, whereas less than 1% of Mayo's patients do not survive year one.   This huge difference in surviving the first year is a major element in overall survival.  2) The difference or spread in the two lines widens with time, so the improvement over the average SEER facility also improves. 

In addition if there is to be any true cure, the Mayo graphs slope need not flatten but be less than or equal to the slope of the Social Security Life Tables.  If the blue line continues to run parallel or the gap between the blue and gray line does not get larger, this I might argue is the definition of cure.  What this means is the remaining population of myeloma patients is dying at a pace less than or equal to the national average of all people. 

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With all the new treatments now being used by the top myeloma facilities and the outstanding CAR T, BiTE, ADC  and other clinical trials available to their patients, these rates for Mayo most likely will improve.   These improved rates would be expected to be duplicated at other top academic centers of excellence.  Continued  improvement in myeloma life expectancy is not an if, but more likely WHEN! 

The Christmas and Holiday Gift to mankind is the mSmart template published by Mayo Clinic(CLICK HERE) which outlines the process they go through to reach these excellent survival rates.  If the local hematologist/oncologist throughout the world are able to follow this template for treatment and supportive care the myeloma survival throughout the world may improve significantly.  This is the only open source treatment template widely available.  The next step will be individualized myeloma care based on the Health Tree being co-developed by Dr. Rafael Fonseca of Mayo and Myeloma Crowd.



Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1
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Best Of The Best Myeloma Abstracts For ASH2018! Dr. Shaji Kumar of Mayo Rochester Selects His Top 5!

12/21/2018

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There  are 828 abstracts listed for multiple myeloma for ASH 2018.  If you want to know which abstracts are most important why not ask some of the most talented myeloma specialists in the world.  And  that is just what we did.  Dr. Shaji Kumar was kind enough to list his top 5 in there order of importance

Dr. Kumar is the Professor of Medicine,  Mayo Clinic College of Medicine, Consultant, Division of Hematology, Medical Director, Cancer Clinical Research Office, Mayo Clinic Rochester, Minnesota.  Dr. Shaji Kumar’s research team evaluates the in vitro activity of novel drugs that, based on their mechanisms of action, are likely to have activity in the setting of myeloma. Promising drugs are brought into the clinic through early-stage clinical trials in Phase I or II studies. Dr. Kumar conducts National Institutes of Health-funded research on translation of novel therapeutic targets in multiple myeloma, understanding the mechanism of disease progression from monoclonal gammopathy of undetermined significance to active myeloma, and mechanisms of high risk disease. He also receives funding from the Multiple Myeloma Research Foundation to study the relationship between molecular profiles, treatment regimens for patients with multiple myeloma and outcomes and various clinical trials in relapsed multiple myeloma. 

One of the his many achievements includes his work with other US myeloma specialists, Dr. Noopur Raji, and Dr. Sundar Jagannath and several from India to provide a myeloma treatment template for India much like the mSmart program in the USA.  It is called the Consensus in the Management of Multiple Myeloma in India. To view CLICK HERE.

Dr. Kumar's Top 5 in there order of importance are as follows.  Click on the abstract number or the title to go directly to the expanded  abstract explanation.


1) Abstract LBA-2 - Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA)

Phase 3 trial of upfront Dara

2) Abstract 301 - Maintenance Therapy with the Oral Proteasome Inhibitor (PI) Ixazomib Significantly Prolongs Progression-Free Survival (PFS) Following Autologous Stem Cell Transplantation (ASCT) in Patients with Newly Diagnosed Multiple Myeloma (NDMM): Phase 3 Tourmaline-MM3 Trial

First randomized trial of a PI maintenance

3) Abstract 1010 - Treatment with AMG 420, an Anti-B-Cell Maturation Antigen (BCMA) Bispecific T-Cell Engager (BiTE®) Antibody Construct, Induces Minimal Residual Disease (MRD) Negative Complete Responses in Relapsed and/or Refractory (R/R) Multiple Myeloma (MM) Patients: Results of a First-in-Human (FIH) Phase I Dose Escalation Study

New immune modality, the preliminary results appear exciting

4) Abstract 955 - Updated Analysis of a Phase 1, Open-Label Study of LCAR-B38M, a Chimeric Antigen Receptor T Cell Therapy Directed Against B-Cell Maturation Antigen, in Patients with Relapsed/Refractory Multiple Myeloma

This trial has excellent responses and the follow up gives some sense of the durability



5) Abstract 305 - Efficacy and Feasibility of Dose/Schedule-Adjusted Rd-R Vs. Continuous Rd in Elderly and Intermediate-Fit Newly Diagnosed Multiple Myeloma (NDMM) Patients: RV-MM-PI-0752 Phase III Randomized Study

Importance of dose modification in elderly

Dr. Kumar, thank you for all you do for the myeloma patient community throughout the world.





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ASH 2018 - After CAR T What Is The Next BIG Area For Myeloma Treatment Progress? ADC(Antibody Drug Conjugates)?

12/20/2018

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Although CAR T has just made it to the clinic after more than 10 years of being studied in ASH abstracts, the explosion in the number of new CAR T abstracts bodes well for many more FDA approvals.  If you  look at the data from the 2018 abstracts you can see an almost identical explosion in abstracts for Antibody Drug Conjugates (ADC).  The graph which follows shows the beginning of the same exponential growth which was exhibited by the growth in CAR T abstracts.  
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Antibody Drug Conjugates (ADCs) are monoclonal antibodies (mAbs) attached to biologically active drugs by chemical linkers. By combining the unique targeting of mAbs with the cancer-killing ability of cytotoxic drugs, ADCs allow sensitive discrimination between healthy and diseased tissue.   Some patient friendly articles on ADCs can be seen if you CLICK HERE or HERE. 

A lot has been written about ADC's recently, and some of the most interesting revolved around the new Glaxo Smith Kline ADC GSK2857916.   This drug has shown twice the the Overall Response Rate (ORR) than did Daratumumab as a single agent in clinical trial.   GSK2057916 had a ORR of 60% and Darzalex had a 29% ORR.  At the time 29% was a giant leap forward. 
Not to be left behind Daratumumab has been turned into a AWC(Anitbody Warhead Conjugate) by the biotech company Actinium Pharmaceuticals, Inc.(ATNM)  This AWC showed a 10 fold improvement in myeloma cell death in vivo vs. Darzalex alone.  Finally, Takeda has a new CD38 antibody called TAK-079 and they are partnering with the biotech Molecular Templates(MTEM) to manufacture what they call a ETB(Engineered Toxin Bodies).  All use the same technique to link a toxin to an antibody with a linker.

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ADC is on the same trajectory as CAR T was just 3 years ago.  If you look at the graph to the left, ADC is tracking identical to CAR T and we can expect to see continued exponential growth for ADC abstracts with FDA approvals to follow. 

Targeted therapy has been touted as the future of cancer treatment, but not until recently have we had such a rush of new developments.  Large companies like GSK, Takeda, and Jannsen, small companies like Juno and Kite, and micro companies like Actinium, and Molecular Templates are changing the course of myeloma treatment more focused on the myeloma cancer cell target.  If Cytoxin and Melphalan are the shotgun approach to cancer care, CAR T and ADC are the one shot one kill approach to care!


Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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ASH 2018 Is An Amazing CAR show!  Chimeric Antigen Receptor(CAR)

12/17/2018

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It is interesting to note that just 10 years ago in 2009 there was just 9 CAR T abstracts in a total of 5176 total abstracts presented at ASH 2009.  It has also taken 10 years to get just 2 FDA approved CAR T treatments approved.  However for ASH 2018 there are 423 CAR T abstracts or 47 times as many.  As can be seen in the following graph the growth has been exponential.  It takes between 10 and 15 years to bring a drug from lab to clinic, so we can hope new CAR T approvals will also be exponential. 
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The data in this graph is from a search from the ASH abstract listing for the last 10 years.  You can find the 2018 listing if you CLICK HERE. CAR T seems to be a recent development, however it has been well over 10 years in the making.  There has been a lot of excitement around CAR T, but as can be seen from the growth in abstracts, this looks to be just the tip of the iceberg
New trials with multiple antigens targeted are being developed, as are many more antigens being identified as targets.  Not to be left behind, multiple myeloma has had a similar explosion in the number of new abstracts.
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As you might remember, myeloma represents just 1.8% of all cancers and historically has had more than it's share of the new drugs which have been developed.  The same holds true for the percentage of myeloma CAR T abstracts.  Of the 423 CAR T abstracts, 104 of them are myeloma CAR T abstracts, or 25% of the total.  This represents 14 times as many abstracts as one might expect based on the myeloma patient volume.  Recently Dr. Vincent Rajkumar recently presented a listing of 8 CAR T abstracts which he found of interest.  Dr. Rajkumar is one of the finest myeloma specialists, and his focus on CAR T helps to signify how very important this targeted treatment has become for the future of myeloma treatment.  His list is below and it you CLICK on the red Abstract Number it will go directly  to the ASH abstract.




1) Abstract 955 - Updated Analysis of a Phase 1, Open-Label Study of LCAR-B38M, a Chimeric Antigen Receptor T Cell Therapy Directed Against B-Cell Maturation Antigen, in Patients with Relapsed/Refractory Multiple Myeloma
Update of known CAR-T LCARB38M: results look similar to bb2121 with median PFS of 15 months. We need more follow up to know what % patients have enduring responses.

2) 2nd gen” BCMA CAR-Ts - for want of a better term: All show promising activity. Problem is going to be how they make it to FDA approval. 
Abstract 956 - Durable Remission Achieved from Bcma-Directed CAR-T Therapy Against Relapsed or Refractory Multiple Myeloma
Abstract 1012 - Efficacy and Safety of P-Bcma-101 CAR-T Cells in Patients with Relapsed/Refractory (r/r) Multiple Myeloma (MM)
Abstract 960 - Low Dose of Human scFv-Derived BCMA-Targeted CAR-T Cells Achieved Fast Response and High Complete Remission in Patients with Relapsed/Refractory Multiple Myeloma
Abstract 959 - Clinical Responses and Pharmacokinetics of MCARH171, a Human-Derived Bcma Targeted CAR T Cell Therapy in Relapsed/Refractory Multiple Myeloma: Final Results of a Phase I Clinical Trial

2b) Abstract 1011 - Fully Human Bcma Targeted Chimeric Antigen Receptor T Cells Administered in a Defined Composition Demonstrate Potency at Low Doses in Advanced Stage High Risk Multiple Myeloma
Defined CD4 CD8 composition BCMA CAR-T: Interesting idea. Not sure if there will be a real advantage. Need more data to decide.

3)  Abstract 1009 - Tandom Autologous Transplantation and Combined Infusion of CD19 and Bcma-Specific Chimeric Antigen Receptor T Cells for High Risk MM: Initial Safety and Efficacy Report from a Clinical Pilot Study
Combined CD19 - BCMA CAR-T: another interesting idea and may overcome some resistance pathways.

4) Abstract 1014 - Safety and Efficacy of Multiantigen-Targeted T Cells for Multiple Myeloma
Multi-antigen targeting CAR-T: one step further than dual CD 19 BCMA targeting CAR-T. Interesting and may be another way to overcome resistance

5) Abstract 591 - ALLO-715, an Allogeneic Bcma CAR T Therapy Possessing an Off-Switch for the Treatment of Multiple Myeloma
Allogeneic CAR-T - May fulfill potential of off the shelf CAR-T in future preclinical study

6) Abstract 590 - NKG2D-CAR Transduced Primary Natural Killer Cells Efficiently Target Multiple Myeloma Cells
CAR-NK: I guess this is CAR-Tish and can be included in this list!

7) Abstract 1013 - T Cells Expressing Anti B-Cell Maturation Antigen Chimeric Antigen Receptors for Plasma Cell Malignancies
There’s one more CAR-T abstract I found interesting but didn’t know whether it was a “2nd gen CAR-T” or a consecutive patient series with an existing CAR-T.


Thank You Dr. Rajkumar for your leadership in the patient fight to survive this deadly disease.

Another new treatment approach which is becoming more and more important is the use of Antibody Drug Conjugates(ADC).  I plan on providing a similar evaluation of this very important new treatment approach in my next ASH 2018 Myeloma Crowd article. 

Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1
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    Author

    Gary R. Petersen
    [email protected]
    CLICK HERE for my myeloma journey

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