Myeloma Today - Spring 2022

Volume 22 Number 2 Spring 2022

Myeloma Today A publication of the International Myeloma Foundation

CARVYKTI CAR-T Immunotherapy ™

The FDA grants approval to a second CAR T-cell therapy for patients with relapsed or refractory myeloma PAGE 5

Also in this edition: } 2022 Brian D. Novis Research Grants } Bispecific Antibodies in Myeloma Members of the myeloma community help fund four important myeloma research projects

The next wave of immunotherapy options for patients with myeloma is in the pipeline

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This edition of Myeloma Today is supported by Amgen • Bristol Myers Squibb • Janssen Oncology • Karyopharm Therapeutics • Takeda Oncology

Connect. Be Informed. Take Charge.

UPDATED AND INTERACTIVE RESOURCES AT A GLANCE covid19.myeloma.org The latest information on COVID-19 variants and vaccination for myeloma patients

infoline.myeloma.org Contact the IMF InfoLine with your myeloma-related questions and concerns

A Message from the IMF President & CEO NEWLY APPOINTED IMF President & CEO Yelak Biru looks ahead to the future of the IMF Watch Now

videos.myeloma.org

diversity.myeloma.org Diversity and inclusion are integral aspects of the myeloma community

medications.myeloma.org Learn about FDA-approved therapies for myeloma

“Living Well with Myeloma” Webinar: Learn about managing your side effects, including peripheral neuropathy Watch Now

publications.myeloma.org •B ooklets that explain myeloma therapies and more •T ip cards on topics important to myeloma patients •G uide to Myeloma Acronyms and Abbreviations

support.myeloma.org Robin Tuohy

•G uide to Myeloma Terms and Definitions

rtuohy@myeloma.org

will help you find a multiple myeloma support group

•M yeloma Today Winter 2021/2022 edition

Take advantage of the hyperlinks in Myeloma Today by signing up for the digital edition at subscribe.myeloma.org, where you can also sign up to receive alerts about IMF events, webinars, teleconferences, and advocacy actions, as well as our e-newsletter Myeloma Minute.

And engage with us on social media! /myeloma

@IMFMyeloma

A Message from the IMF Founder and the IMF Chairman Dear Reader, At the beginning of the COVID-19 pandemic, there was real concern that being infected would be life-threatening. Back then, best protections were still unknown and unavailable.

as available as possible, including Evusheld™ monoclonal antibody shots as a preventive and Paxlovid™ as an early treatment option.

The availability of these will increase in the coming months.

Now, with the Omicron surge fading, we are in a much better position. However, we must remain alert for the emergence of new variants of concern (VOC), as classified by the Centers for Disease Control and Prevention (CDC).

The good news is that tracking metrics have been put in place and many communities have come up with strong response plans to protect against infection and to institute early treatment.

B oth mobile and fixed vaccination sites will be maintained on an ongoing basis. This is helpful for myeloma patients.

The COVID-19 pandemic has had a devastating impact, particularly on poor and vulnerable communities. In Los Angeles County, the following seven metrics were put in place to assess the status of COVID-19 in the community and to serve as the basis for decision-making:

1. COVID-19 variants – The goal is to have less than 5% new variants in tested samples. As of this writing in April 2022, no VOC is beyond the 5% level. However, recent wastewater analyses are raising concerns.

2. Emergency room visits – The goal is to have fewer than 5% COVID-19-related emergency room visits each week. Currently, this is still below 5% but needs close monitoring.

3. L ow-income areas – In low-income areas, the goal is to have fewer than 100 cases per 100,000 people.

4. Nursing homes – Nursing homes have many vulnerable individuals in close contact, which is why they are considered to be high-risk environments. The goal is to have fewer than 11 COVID-19 outbreaks every week.

5. K -12 schools – For K-12 schools, the goal is to have fewer than 4 outbreaks each week.

6. Homeless shelters – Homeless shelters have the same goal as nursing homes: fewer than 11 COVID-19 outbreaks each week.

7. Workplaces – For workplaces, the goal is to have fewer than 100 outbreaks at work sites each week.

The above parameters help gauge the level of COVID-19 in the community and there have been significant improvements in Los Angeles County. They illustrate the day-to-day challenges of monitoring on a global basis.

To respond to any increase in COVID-19 infections in the community, Los Angeles County also has a five-point plan.

W orkplaces are required to report 3 or more cases within a 14-day period.  Free COVID-19 testing is available.  A key goal, which is very important to myeloma patients, is to make helpful preventive and treatment options

Susie Durie and Dr. Brian G.M. Durie receive a joint 2019 Honorary Doctorate for Scientific Excellence from the Vrije Universiteit Brussel

 S urveillance is a key aspect of VOC. The intention is to analyze 15–25% of COVID-19 samples and to increase testing of wastewater samples.

Right now, there is concern because reports from both the US and Europe indicate an uptick in COVID-19 cases, including the BA.2 variant and perhaps the Deltacron variant (a mix of Delta and Omicron). There was an increase in new cases in the UK. In several locations in the US, there has been a 1,000% increase in COVID-19 found in wastewater samples.

From what we have learned about COVID-19 – including monitoring, testing, and treatments – the outlook has dramatically improved for myeloma patients. If vaccinated and boosted, the risk of having severe COVID-19 is quite low. With the addition of Evusheld, a high-level of protection is feasible.

Stay alert in your community. If COVID-19 metrics are increasing, be especially cautious during all situations of risk with groups, particularly indoors. Masks remain a key line of defense for myeloma patients and are strongly recommended even if mask-wearing is not mandated. Take maximum precautions to protect yourself.

We are hoping for a much better Spring and Summer. Staying safe is the best way to have opportunities to do more. Plan your vacation and travel when the situation is right. Be cautious, but there is no need to panic!

Warm regards,

Susie Durie IMF Founder Director, Global Patient Initiatives

Dr. Brian G.M. Durie IMF Chairman Chief Scientific Officer

This free issue of Myeloma Today© (Volume 22, Number 2) is dated April 15, 2022. Myeloma Today© is a quarterly (Spring, Summer, Fall, and Winter) publication of the International Myeloma Foundation, located at 4400 Coldwater Canyon Avenue, Suite 300, Studio City, CA 91604 USA

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Scientific & Clinical

#W H

DR E RE IS

JOE

Bispecific Antibodies

The next wave of immunotherapy in myeloma is coming!

By Dr. Joseph Mikhael IMF Chief Medical Officer

In the Spring 2020 edition of Myeloma Today, my column focused on the topic of immunotherapy in myeloma. Employing one’s immune system in the fight against cancer has since become standard practice in many diseases and is becoming a critical part of myeloma therapy. Two CAR T-cell therapies have been approved for myeloma by the US Food and Drug Administration (FDA), and at least 10 new agents are being developed!

Bispecific antibodies have two targets. Think of them as a drug that has two arms – one to grab on to the myeloma cell and the other to directly engage a key immune cell, usually a T cell or natural killer (NK) cell, to help destroy the myeloma cell. In fact, currently there are trispecifics in development that have three arms, two to hook on to the myeloma cell and one to engage the immune cell. This unique approach is really a combination of two strategies at the same time:

CD3

binding domain

binding domain

myeloma cell

tumor surface antigen

T or NK cell cytotoxic granules released by the T or NK cell

infrequently as monthly. In contrast, CAR T-cell therapies are given once, then patients are off treatment for an extended period.

All drugs come with risks, and we have seen similar side effects in both monoclonal antibodies and cellular therapies:

1. A monoclonal antibody that targets myeloma cells and induces the immune system to destroy the myeloma cell – sometimes called “humoral” immunity.

C ytokine release syndrome (CRS) – This uncontrolled immune reaction occurs with all of the bispecifics in development. It is less severe than what we see with CAR T-cell therapy, but at present still requires hospitalization for at least the first dose for close monitoring.

2. A monoclonal antibody that engages a local immune cell to directly kill the myeloma cell – sometimes called “cellular” immunity.

N eurological toxicities – We have seen neurological effects of these drugs. As we learn more about them, we anticipate this to be less of an issue.

Bispecific antibodies, therefore, have many advantages when compared other humoral and cellular approaches: D ual treatment – By using both the humoral and cellular pathways together, they can leverage different aspects of the immune system. Dual treatment strategies are very important in myeloma.  “ Off the shelf” – Cellular approaches like CAR T-cell therapy require that we collect T cells from patients, manufacture the CAR T cells, and then re-infuse them several weeks later.

Bispecifics engage the immune cells in the body directly, and therefore can be directly given to patients “off the shelf.” D ifferent targets – We are constantly discovering more antigens on the surface of myeloma cells, and bispecifics can be engineered to latch on to different antigens while still engaging immune cells. We are most familiar with B-cell maturation antigen (BCMA) but now we can target other antigens, such as GPRC5D and FcRH5. B roader use – Many myeloma patients may not be fit enough for CAR T-cell therapy but would likely be eligible for bispecifics. Furthermore, we anticipate being able to deliver these therapies in the community and not only in cellular therapy centers – something very important for patients who cannot access one of these centers.

The key disadvantage to bispecifics is that they must be given on an ongoing basis. They range in dosing, both intravenous (IV) and subcutaneous (SQ), from as frequently as weekly to as 4

bispecific antibody BCMA

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 I nfections – As the immune system is affected with these drugs, patients are at higher risk of infection, and this must be watched closely. O ther drug-specific side effects – Unique features have been seen with each agent. For example, skin, nail, or hair effects must be considered.

Bispecific antibodies are not yet approved by the FDA as they are still in development, but there may be approvals in 2022 in the relapsed/refractory setting. It is exciting to see that so many bispecific antibodies which engage T cells are being tested in clinical trials, including teclistamab, talquetamab, cevostamab, elranatamab, AMG 701, REGN 5758, ABBV-338, and CC-93269. And more are on the way!

I am particularly interested in NK-cell engagers as it appears their risk of CRS is even lower than with bispecifics, which may reduce the need for hospitalization. Some approaches are combining these agents with therapies currently in use for myeloma.

Bispecifics are coming soon, and many of us in the myeloma community are very excited about being able to help our patients with these treatments. MT

Stay tuned for Dr. Mikhael’s next #WHEREISDRJOE column and contact the IMF InfoLine for help with your myeloma-related questions and concerns. Phone lines are open 9 a.m. to 4 p.m.

(Pacific) Monday through Friday at 1.800.452.CURE in the US and Canada or 1.818.487.7455 worldwide. You can also email InfoLine@myeloma.org to submit your query electronically. info@myeloma.org

myeloma.org

Scientific & Clinical

CARVYKTI™ CAR T-Cell Therapy Approved by the FDA

By Dr. Brian G.M. Durie IMF Chairman of the Board

On February 28, the US Food and Drug Administration (FDA) approved Carvykti™ (ciltacabtagene autoleucel or cilta-cel) for the treatment of adults with relapsed or refractory myeloma who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

The FDA approval is based on data from the phase Ib/II CARTITUDE-1 clinical trial, in which cilta-cel elicited an overall response rate (ORR) of 97.9% among 97 treated patients.

removal of BCMA-expressing cells, thereby removing the myeloma cells.

Carvykti is the second personalized B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell immunotherapy approved for myeloma. Carvykti works by recognizing and binding to BCMA, a protein that is found almost universally on myeloma cells. This leads to the

Carvykti is currently only administered at certified treatment centers. The infusion should take no more than 2.5 hours to receive. The appropriate use of Carvykti is supported by the Carvykti Risk Evaluation and Mitigation Strategy (REMS) program. MT

Carvykti is delivered as a one-time intravenous infusion, manufactured for each individual patient using the patient’s own T cells. The patient’s T cells are collected, genetically modified to recognize and attack BCMA on the surface of the myeloma cells present in that patient, and then infused back into the patient. T cells are a type of white blood cell that plays a central role in the immune system.

What does this mean for patients with myeloma?

“We’re harvesting the patient’s T cells from the peripheral blood and training them to kill the patient’s own cancer cells; we’re putting a new gene into the nucleus of the T cell that activates that T cell and directs it to the myeloma. There have been many advances in the field of myeloma over the last 5 to 10 years, and the use of immunotherapies has been a great success.

Cilta-cel is unique in that it has two single-domain binding antibodies that bind to BCMA and the intracellular signaling domain. CARTITUDE-1 evaluated heavily pretreated patients, who had had received a median of 6 prior lines of therapy. A single infusion of cilta-cel could provide deep and durable responses in this relapsed or refractory patient population, with a manageable safety profile. Responses deepened over time from the 1-year follow-up, and 60.5% of patients are still progression-free at 2 years.

CAR T-cell therapies in myeloma are the next frontier, and the next 5 to 10 years are going to bring even more substantial advancements as we move into the next generation of immunotherapies. Initially, we’ve focused on BCMA but in the future there are also going to be CAR T cells targeting other receptors on the myeloma cell surface. I think that in order to cure people with myeloma by using CAR T-cell therapeutics we’re going to have to use more than one target. That’s the future of myeloma, and the future is bright for all patients with relapsed or refractory myeloma.”

Thomas G. Martin, MD Helen Diller Family Comprehensive Cancer Center University of California, San Francisco

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Scientific & Clinical

2022 IMF Brian D. Novis

Members of the myeloma community

By Suzanne Battaglia IMF Senior Director, Member Events

Since 1994, the IMF has funded more than 150 of the most promising myeloma research projects by talented investigators from the leading institutions around the world. The IMF’s commitment to supporting important myeloma research has improved patient outcomes and brought us closer to fulfilling our mission – a cure.

The Brian D. Novis Research Grants, established in memory of the IMF’s co-founder, are traditionally awarded at a “Living Well with Myeloma” patient presentation held during the annual meeting and exposition of the American Society of Hematology (ASH). This year, the presentations took place online.

The Brian D. Novis Research Grants are made possible by the proceeds from the IMF Member Fundraisers program. We are grateful to all the individuals whose support of myeloma research makes these grants possible. This year, one 2022 Senior Research Grant is being funded at $80,000 and three 2022 Junior Research Grants are being funded at $50,000 each.

SENIOR GRANT AWARD Xabier Agirre, PhD Center for Applied Medical Research University of Navarra, Spain Dr. Agirre’s research is focused on deciphering the epigenomic mechanisms of transformation from monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) to symptomatic multiple myeloma (MM). While the transformation from MGUS-SMM to MM has been well characterized at the genetic level, the modifications that do not alter the genetic code but give rise to changes in gene expression (epigenome) have not been studied thus far. Dr. Agirre and colleagues will characterize the epigenome of the transformation from MGUSSMM to MM in order to identify potential aberrations that will lead to the development of new therapeutic strategies for the treatment of patients with MM.

Laughs 4 Life Dr. Agirre’s research is funded by Kent Oliver’s Laughs 4 Life fundraiser. Kent was diagnosed with myeloma in 2015 at age 34. “At that time, my wife Candace and I had a newborn and a toddler.

Hearing the words ‘myeloma’ and ‘incurable’ left me feeling stunned.” In 2016, after Kent recovered from his stem cell transplant, he and Candace hosted their very first myeloma awareness event, a comedy show with a dinner and an afterparty.

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“It was a way to say thank you to those who made my personal journey tolerable.” About 900 people took part in the first Laughs 4 Life, and the Olivers raised enough money to fund an IMF Senior Grant.

They’ve now hosted four events and funded four Senior Grants. Each year the show has grown, and it has become a summer highlight in their hometown of Hattiesburg, Mississippi.

Kent and Candace Oliver with daughters Annie and Charlotte, and the 2020 Senior Grant recipient Dr. Mikhail Nikiforov

JUNIOR GRANT AWARDS Martina Chiu, PhD University of Parma, Italy Dr Chiu’s research is dissecting the nutritional interaction between myeloma and mesenchymal stromal cells.

Myeloma cells consume large amounts of the amino acid glutamine and create a peculiar low-glutamine/high-glutamate microenvironment in the bone marrow of patients. Thus, other cell populations in the bone marrow undergo glutamine shortage and are forced to synthesize the amino acid for the myeloma cells. Therefore, bone marrow stromal cells acquire a pro-tumor behavior.

Therefore, drugs that limit glutamine consumption of cancer cells or glutamine production and secretion by stromal cells are expected to hinder progression of myeloma. This project aims to produce new insights about the interaction between myeloma cells and other cell populations of the bone marrow, revealing novel targetable pathways.

The Czerkies Memorial Golf Outing Dr. Chiu’s research is funded by the Czerkies Family. In 2000, Carolyn Czerkies passed away from complications brought on by myeloma. In 2008, her sons Craig, David, and Scott Czerkies organized the first fundraiser as a tribute to their mom and to benefit the efforts of the IMF’s research program. Then, in November 2018, their dad, Edward Czerkies, passed away at the age of 81 after a courageous fight with prostate cancer.

The annual Czerkies Memorial Golf Outing honors the memory of both parents. Over the past 13 events, the Czerkies Memorial Golf Outing has raised more than $410,000 with the generous info@myeloma.org

myeloma.org

Research Grant Awards fund important myeloma research

age 42. In 2021, with the support of other family members, Angie’s husband Chad and their son Damon organized the Angela (Dirks) Barto Memorial Golf Tournament in Stevens, Pennsylvania. Although this was their first event, their ambitious goal was clear from the start – raise enough funds to support an IMF research grant. The inaugural Angela (Dirks) Barto Memorial Golf Tournament raised almost $63,000!

Alessandra Romano, MD, PhD University of Catania, Italy

The Czerkies Family has raised more than $410,000 for myeloma research

donations from participants, sponsors, and volunteers. The 2021 Czerkies Memorial Golf Outing was one of the nation’s largest charity golfing events, with 145 golfers taking part in the outing in Bolingbrook, Illinois. The Czerkies brothers are funding their eighth myeloma research grant in 2022!

Leslie Crews, PhD University of California, San Diego The research by Dr. Crews is focused on tuning the innate immune myeloma microenvironment by modulating IRF4.

This project will endeavor to reprogram myeloma-associated macrophages while simultaneously eradicating malignant plasma cells through selective inhibition of IRF4 in preclinical myeloma models.

This research will contribute vital knowledge about the potential impact of anti-inflammatory macrophages on myeloma cell survival and their relevance to the treatment of cancer. It is anticipated that the results will be rapidly translated into improving treatments for patients with myeloma because the researchers will be exploring the mechanism of action of a state-of-the-art antisense therapeutic agentthat recently entered into clinical trials for myeloma. This project is potentially transformative for the diagnosis and treatment of myeloma because it has the potential to distinguish IRF4 antisense therapy as a two-pronged molecular targeting approach that could eradicate tumor cells along with reprogramming the tumor-supportive microenvironment.

Dr. Romano is focused on defining a novel function for the post-translational modification UFMylation in the adaptive response to arginine deprivation in myeloma. Myeloma cells can survive in arginine starvation, which is toxic for T cells, hampers immune function, leads to infections, disease progression, and refractory myeloma. Strong preliminary data revealed UFMylation, a new molecular mechanism used preferentially in secreting cells, for quick recycling of nucleotides and amino acids during arginine starvation.

This has never been described before in myeloma. Dr. Romano and colleagues aim to better understand how UFMylation works in myeloma, and if it is possible to target it to increase the effectiveness of Velcade® (bortezomib) and to identify the underlying mechanisms through which inhibition takes place.

Miles for Myeloma 5K Run/Walk Dr. Romano is a second-time recipient of the Brian D. Novis Junior Research Grants, having been awarded her first grant in 2017. In 2022, Dr. Romano’s research is being funded by the IMF’s Miles for Myeloma 5K Run/Walk event. Over the course of 14 years, Miles for Myeloma has funded 8 Brian D. Novis Grants!

Angela (Dirks) Barto Memorial Golf Tournament Dr. Crews’ research is funded by the Barto Family. Angie passed away in 2019, only two years after her myeloma diagnosis at “Pop’s Fight Is My Fight!” – one of 24 virtual Miles for Myeloma teams – raised over $46,000 for myeloma research

In closing, I would like to thank all the remarkable individuals whose support of the IMF’s research program makes these grants possible. Brian Novis would often say, “One person can make a difference, but two can make a miracle.” His message continues to resonate loud and clear. MT 1.800.452.CURE toll-free in USA and Canada

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Special Event

More Successful Than Ever: 30 Million

The IMF’s 2022 Myeloma Action Month inspires the

By Robin Tuohy IMF Vice President, Support Groups

As the 2022 Myeloma Action Month came to a close, the International Myeloma Foundation (IMF) was unwavering in achieving its goals. By encouraging individuals and groups to take actions that have a positive impact on the myeloma community, the IMF succeeded in increasing awareness of myeloma and in inspiring a culture of hope and resilience among myeloma patients worldwide.

While Myeloma Action Month has grown over the years, the heart of its focus remains the same: (1) to increase awareness of myeloma and its signs, symptoms, and tests to lead to earlier diagnosis; (2) to increase funding for research; (3) to amplify the outreach of myeloma support groups. These objectives are all geared to help myeloma patients and care partners all over the world.

The IMF is proud to report that the myeloma community went above and beyond when it came to taking action and making a difference. Undeterred by the COVID-19 pandemic, myeloma commu­nities in 46 nations took part in the Myeloma Action Month move­ment, reaching more than 30 million people.

Yelak Biru, IMF President & Chief Executive Officer and a 26-year myeloma survivor, is truly elated at the success of this year’s campaign: “Throughout the 2022 Myeloma Action Month, the IMF focused on encouraging engagement through the theme, #MYelomaACTION. Each of us has a role in advancing the art and science of cancer care in general, for better outcomes for myeloma in particular.”

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Robin Tuohy and Susan Dunnett, PhD (University of Edinburgh, Scotland) lead a Resilience Workshop with members of myeloma support groups in Bismarck, ND and Sioux Falls, SD

In 2009, the IMF launched March as Myeloma Awareness Month to shed light on this little-known cancer. By 2016, the IMF elevated the annual campaign to Myeloma Action Month, with the added purpose of encouraging individuals and groups to take actions that positively impact the myeloma community as a whole.

2022 Myeloma Action Month was all about taking action to make a positive difference. Participants in this year’s campaign were able to join the movement by uploading photos of their chosen action at the Myeloma Action Month website mam.myeloma.org, using the hashtag #MYelomaACTION, and sharing their “action” photos on Twitter, Instagram, Facebook, and LinkedIn. To further increase awareness about the disease, the Myeloma Action Month website also featured 31 IMF Stats and Facts about myeloma.

With so many countries joining the #MYelomaACTION movement this year, Myeloma Action Month social badges were translated into 12 languages, and individuals and groups across the globe shared their actions, posts, and photos.

info@myeloma.org

myeloma.org

People Reached Across 46 Nations

global myeloma community to take action 31 days of inspiring actions Creative members of the myeloma community contributed immensely to the success of Myeloma Action Month this year, through their inspiring posts on the Myeloma Action Month website.

For 31 days, the Myeloma Action Month advent calendar was filled with posts of actions taken by members of the myeloma community to draw attention to the disease and to encourage others to share their own actions.

IMF Support Groups: in full force for MAM 2022 This year, IMF Support Groups were able to empower each other by encouraging their members to join in, take action, and help increase awareness of myeloma at their virtual support group meetings. Additionally, IMF Support Groups launched their own “actions” for Myeloma Action Month.

The IMF sent a care package to each myeloma support group leader to help with their local community outreach.

The IMF Support Group Team – Nancy Bruno, Kelly Cox, Jon Fitzpatrick, Kelley Sidorowicz, and me – led online sessions with 80 support groups to Dr. Joe Mikhael, IMF Chief Medical share IMF resources and to Officer, raised funds for the IMF by provide technical support. running in the Arizona desert

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Support Group leader and myeloma patient Tanjua Mays held an Awareness Day in the Park in Ocala, FL

The Lake Norman Myeloma Support Group held its second annual fundraiser to benefit the IMF’s research program.

The event took place on March 31 at Kickback Jack’s in Mooresville, NC. Kelley Sidorowicz, IMF Regional Director of Support Groups, created Mind and Body guided audio meditations and yoga videos that are available at wellness.myeloma.org (continues on next page)

Chattanooga Support Group leader and patient Linda Huguelet shared her experience and answered questions in a segment on Local 3 News, and Myeloma Action Month was declared in Tennessee’s Hamilton County!

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Special Event MAM 2022 – CONTINUED FROM PAGE 9 The IMF is thankful for each support group leader who works during Myeloma Action Month and throughout the year to ensure that their local myeloma community has the resources, information, and opportunity to share and learn. Knowledge is Power!

Active sponsor participation

March was declared Myeloma Action Month in Walker County, GA

In Italy, Associazione Italiana contro le Leucemie, linfomi e mieloma Onlus (AIL) – an organization that raises public awareness of blood diseases – held a myeloma patient webinar.

In South Korea, the Korean Blood Disease & Cancer Association (KBDCA) produced several videos for myeloma patients, including one with Dr. Ki Hyun Kim of the Korean Multiple Myeloma Working Party (KMMWP). These videos are available on KBDCA’s YouTube channel.

In China, a series of lectures on myeloma were produced for viewing in real time and for replay.

In Hong Kong, a program explaining myeloma to the general public was produced and aired.

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South Carolina support group leader and myeloma survivor Tiffany Williams has been at the forefront in raising myeloma awareness and shining a light on health disparities

Sponsor participation this year exceeded expectations with their active engagement in social media. The IMF is grateful to the following sponsors for supporting Myeloma Action Month this year: 2seventy bio, Amgen, Binding Site, Bristol Myers Squibb, GSK, Janssen Pharmaceutical Companies of Johnson & Johnson, Karyopharm Therapeutics, Pfizer, Regeneron, Sanofi, and Takeda Oncology.

With the overwhelming success of this year’s Myeloma Action Month, IMF Vice President of Marketing Peter Anton had this to say: “I am thrilled that we have been able to grow this campaign year over year into a powerful global movement, capturing the hearts and minds of the collective myeloma community, and sharing hope and resilience. Every #MYelomaACTION makes a difference to amplify awareness, support, and education about myeloma to help those in need.”

Thanks to the kind and generous contributions of individuals and groups, the IMF is delighted to announce that the 2022 Myeloma Action Month made an enormous difference in building a powerful mosaic of activity for every myeloma patient, care partner, nurse, doctor, and advocate – thus, fortifying the myeloma community’s collective hope, understanding, and resilience. MT

For more information about finding a local myeloma support group, or launching one in your area, please contact Robin Tuohy at rtuohy@myeloma.org.

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Advocacy

Cancer Drug Parity Act Update

Patients must have access to oral cancer therapies

By Robin Levy IMF Senior Director, Public Policy & Advocacy

Improving access to lifesaving medications for myeloma patients is a long-standing commitment of the International Myeloma Foundation (IMF). For many years, the IMF Advocacy Team has focused on oral parity legislation, specifically the Cancer Drug Parity Act. This legislation would ensure that orally administered drugs – like many of the drugs used to treat myeloma – are covered by health insurers in the same way that they cover intravenous therapies. We are happy to share with you the major advancements we have made with this bill.

The IMF-led Coalition to Improve Access to Cancer Care (CIACC) has accomplished record progress with its work to advance oral parity legislation. The Cancer Drug Parity Act was brought up as a solution for patients during the COVID-19 pandemic, which helped make legislators aware of this issue. We received confirmation from groups representing medical professionals that, in cases where medically appropriate, cancer patients were being transitioned onto orally administered drugs in order to keep them safer at home.

The IMF Advocacy Team led CIACC members in conducting meetings about this issue with Members of the House and Senate, including with Leader McConnell’s Office and Leader Pelosi’s Office. Additionally, we sent letters to top policy makers about how the Cancer Drug Parity Act could help patients. The bill received traction in the COVID-19 legislative discussions, but it was not ultimately included in relief packages. Despite this, we were pleased with the increased support. At the end of the last Congress, the bill ended up with 170 House co-sponsors and 19 Senate co-sponsors. The increased visibility has greatly helped our efforts this Congress, specifically in the Senate, where our bill leads have reported even more traction.

The Cancer Drug Parity Act was reintroduced in the House in July 2021 (H.R.4385) and in the Senate in October 2021 (S.3080)

and support for both is steadily increasing. We have made significant progress on the legislation since its introduction. We are already at the same level of support in the Senate as where we ended last Congress. Senator Tina Smith (D-MN) and Senator Jerry Moran (R-KS), who are leading the bill in the Senate, have great optimism for the path forward. We are proud of the bipartisan nature of this legislation and the support we have garnered for it so far.

We need your help to advance this bill, and there are a few ways you can get involved. If you think this bill will have an impact on your treatment, please contact us at advocacy@myeloma.org to share your story. Congressional leaders have relayed to us that before they consider moving this bill forward, they need to understand more about how patients are being impacted by the current status quo. This specific bill has an impact on people with federally regulated ERISA insurance plans. If you have private insurance and are not on Medicare, you are likely someone who could benefit from the passage of the Cancer Drug Parity Act. MT

If you wish to contact your legislators directly or to learn more about our advocacy activities, visit advocacy.myeloma.org. To subscribe to the IMF Advocacy Newsletter, visit subscribe.myeloma.org.

To learn more about how you can help, contact our team at advocacy@myeloma.org. We welcome your engagement, questions, and ideas.

The Myeloma ACTION Team Needs YOU!

You can become an advocate for the myeloma community Join the Myeloma ACTION Team, also known as “Advocates Committed To Inspiring Others Nationwide!” Our team works together to strengthen support for legislation, build strong grassroots networks, and raise awareness of issues that affect myeloma patients. You will receive training, provide input, and undertake actions to advance policies that will help myeloma patients.

Myeloma patients and caregivers like you have helped advocate for increases in cancer research funding, ensuring that myeloma-specific research continues, oral drug parity, access to clinical trials, healthcare parities, COVID-19specific advocacy initiatives, and veterans’ issues. Joining the Myeloma ACTION Team will give you the opportunity to address the issues that are directly affecting you.

YOU can make a difference! advocacy@myeloma.org 1.800.452.CURE toll-free in USA and Canada

1.818.487.7455 worldwide

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Philanthropy

New IMF Clinical Database Will Answer Key Questions About Immunotherapies

Join the fight against myeloma by supporting novel research!

By Lynn K. Green, Ed.D. IMF Senior Vice President, Philanthropy

YOU can help the IMF collect and study important data to ensure that the right patient gets the right treatment at the right time!

Patients have always been the primary focus of the IMF’s mission: to improve the quality of life of myeloma patients while working toward prevention and a cure. Patients are at the center of all IMF initiatives, ranging from education to research that will enhance their quality of care and outcomes. IMF programs have made and continue to make significant advances and improvements in the lives of myeloma patients across our four founding principles: Research, Education, Support, and Advocacy.

Myeloma is the second-most common blood cancer diagnosed in the United States. It is a very complicated disease and must be approached from multiple directions to treat it successfully.

Recent advances in novel therapies have significantly improved the treatment outcomes for patients with myeloma; however, most myeloma patients eventually will become resistant to therapies and consequently relapse. This highlights an unmet need to develop better treatments to improve patient outcomes.

Novel immunotherapies B-cell maturation antigen (BCMA) is a term that is very relevant in myeloma. BCMA is an antigen that is present on nearly all myeloma cells, and it is being used as a target for myeloma therapies. An ideal target is one that is present on the myeloma cell but not on the healthy cells around it. That is one of the attractive features of BCMA – it is heavily expressed on cancer cells and allows the cancer cells to be targeted without affecting the good cells.

BCMA is a very special target on myeloma cells because many other targets disappear once the patient has received treatment.

BCMA stays preserved, which offers the opportunity over time to apply different types of BCMA drugs. In fact, there are three primary immunotherapies that target BCMA – antibody-drug conjugates (ADCs), bispecific therapy, and CAR T-cell therapy. As we look to the future, there will be the opportunity to match the right treatment to the right patient and at the right time.

IMF project ADCs, bispecifics, and CAR T-cell immunotherapies will transform the treatment landscape and patient outcomes in myeloma and will soon gain widespread use as part of routine clinical care. As immunotherapies are developed, both the optimal patient population for each treatment and the ideal sequence of each therapy will not be known; data will be needed to answer these questions. The IMF’s International Myeloma Working Group (IMWG) researchers will create the first GLOBAL clinical database study to prospectively collect data from patients with relapsed and/or high-risk disease who will be treated with immunotherapies. Data 12

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will be captured from the date of diagnosis and will be updated at least every 6 months. The study will include approximately 6,000 patients from study sites worldwide. The database will be housed in a secured FDA and HIPAA-compliant online format with restricted access. AXIOM, a leading provider of FDA-compliant clinical databases and data management services, will help to build and maintain the master electronic database.

Study goals The proposed database will permit the IMWG to examine both patient and disease characteristics to better understand the best candidates for each novel immunotherapy and to better understand how and in which sequence these therapies are best used in practice. The application of these novel therapies and the results achieved will help inform future research and clinical practice – in turn addressing the unmet need to identify more effective myeloma treatments to improve patient outcomes. Most importantly, the data will ensure that the right patient is getting the right treatment at the right time.

We’re making progress!

The IMF is making great strides in improving the outcomes for myeloma patients, and moving toward a cure. The IMWG provides a transformational platform for global myeloma experts to join forces. This revolutionary model fosters harmonization and collaboration between researchers and clinicians from multiple institutions, and offers a unique opportunity to make significant progress forward in the understanding and treatment of myeloma. In addition, the IMF’s Black Swan Research Initiative® (BSRI®) has taken the first steps to identify curative treatments in subsets of myeloma patients, as well as studying recurrent and resistant disease to develop novel treatment protocols. With these efforts, the IMF is changing the landscape of research and treatment of myeloma… but there is still work to be done. With dedicated philanthropic support, the IMF will change the trajectory of this disease. We hope that you will consider partnering with us to lead the way to a better future and a better today for myeloma patients and their families.

YOU could play a vital role in improving treatment of patients with myeloma by becoming a philanthropic partner with the IMF. Join us in finding the cure for myeloma by making a philanthropic contribution today! MT For more information, please contact Lynn Green at lgreen@myeloma.org or 1.334.332.0888. info@myeloma.org

myeloma.org

2022 Edition Patient Handbook for the Newly Diagnosed One of the most daunting aspects of being diagnosed with myeloma is learning about an unfamiliar disease that is quite complicated. The IMF’s Patient Handbook for the Newly Diagnosed provides an overview of myeloma, with a focus on getting the correct diagnosis and prognostic classification, the tests you really need, when to begin treatment, which issues to consider when selecting your treatment regimen, and supportive care measures to alleviate the physical and emotional impact of myeloma. You can request your FREE printed copy of this IMF publication, and download or read it online with hyperlinks to informative resources. Translated editions are available online in French, Italian, German, and Spanish.

publications.myeloma.org

You’ve got questions...

He’s got the answers.

#AskDrDurie

A weekly web series from the IMF

Selected recent topics:

What is multiple myeloma?

Will the COVID-19 pandemic ever end?

What are the treatment recommendations for bone disease in myeloma patients?

Can the new COVID-19 treatment Evusheld™ benefit myeloma patients?

What should myeloma patients know about mass spectrometry?

Does Pfizer’s antiviral pill used to treat COVID-19 infections benefit myeloma patients?

1.800.452.CURE toll-free in USA and Canada

1.818.487.7455 worldwide

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¡USTED NO ESTÁ SOLO!

Las Voces de Mieloma – Grupo Virtual

YOU ARE NOT ALONE

Virtual Support Group for Multiple Myeloma Families!

This support group for myeloma patients and caregivers who have young children offers strength and inspiration through education, empathy, empowerment, and encouragement. Educationally supported by the IMF, this group meets online monthly.

For more information, please visit: MMfamilies.support.myeloma.org

Un grupo de apoyo voluntario para pacientes interesados, se anima a los cuidadores, familiares y amigos a unirse a nosotros. Se trata de una excelente manera de conocer e interactuar con otros supervivientes y cuidadores para conocer los últimos avances en el tratamiento y la gestión del mieloma.

Para más información: lasvoces@imfsupport.org lasvoces.support.myeloma.org

¡SABER ES PODER! 14

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KNOWLEDGE IS POWER! info@myeloma.org

myeloma.org

INTERNATIONAL MYELOMA FOUNDATION Founder Brian D. Novis

Founder Susie Durie

Board of Directors Chairman Dr. Brian G.M. Durie Christine Battistini Andrew Kuzneski, III Yelak Biru Dr. Robert A. Kyle Prof. Dr. Mario Boccadoro Prof. Dr. Heinz Ludwig Loraine Boyle Dr. Edith Mitchell Susie Durie Charles Newman Martine Elias Dr. S. Vincent Rajkumar George T. Hayum Matthew Robinson Jason Katz Benson Klein E. Michael D. Scott IMF Executive Team Yelak Biru President & Chief Executive Officer Dr. Brian G.M. Durie Chief Scientific Officer Jennifer Scarne Chief Financial Officer Diane Moran Senior Vice President, Strategic Planning Lisa Paik Executive Vice President, Medical Affairs Daniel Navid Senior Vice President,Global Affairs

Lynn K. Green, Ed.D. Senior Vice President, Philanthropy lgreen@myeloma.org 334.332.0888

Dr. Joseph Mikhael Chief Medical Officer Lynn K. Green, Ed.D. Senior Vice President, Philanthropy Mimi Choon-Quinones, PhD, MBA Senior VP, Global Advocacy, Access, Policy & Research Peter Anton Vice President, Marketing Robin Tuohy Vice President, Support Groups

IMF Staff Betty Arevalo Karla Lemus Inventory Control Manager Assistant to Sr Director, Member Events Suzanne Battaglia Robin Levy Senior Director, Member Events Senior Director, Nancy Bruno Public Policy & Advocacy Regional Director, Support Groups Amirah Limayo Kelly Cox Senior Research Project Coordinator Director, Support Groups and Jason London Sr Dir, Regional Community Workshops Associate, MarCom & Web Danielle Doheny Jim Needham Director, Public Policy & Advocacy Publication Design Susie Durie Meghan O’Connor Director, Global Patient Initiatives Coordinator, Meetings & Programs Serdar Erdoğan Matthew Ohnsman Director, GMAN and European & Coordinator, Audio Visual Projects Middle Eastern Patient Programs Selma Plascencia Heather Fishman Director, Operations Donor Relations Annabel Reardon Jon Fitzpatrick Technology and Coordination, Senior Director, Support Groups Strategic Program Management Sherrie Guerrero Joy Riznikove Director, Human Resources Database Analyst Abigail Guzman Miko Santos Meeting Registration & Guest Relations Web Producer Brenda Hawkes Kelley Sidorowicz Director, Development Regional Director, Support Groups Paul Hewitt Sarah Solomon Coordinator, InfoLine Donor Relations Kevin Huynh Brando Sordoni Web Specialist Accounting & Distribution Marya Kazakova Rafi Stephan Editor-in-Chief, Publications Assistant to the President & Ilana Kenville Chief Executive Officer Assistant Director, Member Events Judy Webb Missy Klepetar Coordinator, InfoLine Coordinator, InfoLine Jonathan Weitz Phil Lange Accountant Donor Relations

imfteam.myeloma.org

1.800.452.CURE toll-free in USA and Canada

1.818.487.7455 worldwide

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International Myeloma Foundation 4400 Coldwater Canyon Avenue, Suite 300 Studio City, CA 91604 USA myeloma.org 800.452.CURE

Printed in USA © 2022 International Myeloma Foundation. All rights reserved.

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myeloma.org

Dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure.

2022 IMF Calendar of Events Due to COVID-19 policies, adjustments to the calendar will be made as needed.

Apr 27-May 1 Oncology Nursing Society (ONS) Annual Conference – Anaheim, CA

June 18

IMF Regional Community Workshop (RCW) New England – Virtual

Apr 28

IMF Nurse Leadership Board (NLB) Symposium at ONS – Anaheim, CA

June 23

IMF Living Well with Myeloma (LWM) Webinar – Virtual

May 7

IMF Regional Community Workshop (RCW) Mountain States – Virtual

June 25

IMF M-Power Community Workshop, Charlotte, NC – Virtual

May 14

IMF Patient & Family Webinar (PFW) – Virtual

July 7

IMF Best of ASCO & EHA Webinar – Virtual

May 21

IMF Regional Community Workshop (RCW) Midwest – Virtual

July 16

IMF Regional Community Workshop (RCW) South Atlantic – Virtual

July 23

IMF Regional Community Workshop (RCW) Pacific Southwest – Virtual

Aug 6

IMF Regional Community Workshop (RCW) East South Central – Virtual

Aug 20

IMF Patient & Family Webinar (PFW) – Virtual

June 3-7 American Society of Clinical Oncology (ASCO) Annual Meeting – Chicago, IL & Online June 9-12 European Hematology Association (EHA) Annual Congress – Vienna, Austria & Online June 16

Aug 25-27 International Myeloma Workshop (IMW) Annual Meeting – Los Angeles, CA

IMWG Conference Series Webinar – Virtual

LINK TO THE LATEST AT

events.myeloma.org

For information about international activities by IMF affiliates, please visit these websites:

Australia

myeloma.org.au

Canada

myelomacanada.ca

Israel

amen.org.il

Japan

myeloma.gr.jp

Latin America

mielomabrasil.org