HOUSTON & SEATTLE, December 17, 2024–Indapta Therapeutics, Inc., a privately held clinical stage biotechnology company developing next-generation cell therapies for the treatment of cancer and autoimmune diseases, announced today it has closed a $22.5 million round of new financing to accelerate the clinical development of its differentiated allogeneic Natural Killer (NK) cell therapy. Current investors RA Capital Management, LP, Leaps by Bayer, the impact investment arm of Bayer AG, Vertex Ventures HC, Pontifax, and the Myeloma Investment Fund, the venture philanthropy subsidiary of the Multiple Myeloma Research Foundation, completed the round.
“This funding will enable us to generate significant additional data in our ongoing trial of IDP-023 in cancer as well as initial data from our first trial in autoimmune disease,” said Mark Frohlich, Indapta’s CEO. “Preliminary results of IDP-023 in cancer are encouraging and we look forward to initiating our Phase 1 trial for multiple sclerosis in Q1 2025. This financing, together with our recently announced collaboration with Sanofi, highlights the promise of our differentiated platform.”
Read the full press release here.
Welcome to our final recap of the latest research on myeloma treatments presented at the American Society of Hematology (ASH) Annual Meeting in San Diego. Highlights from the final day included:
Let’s jump into the latest findings!
Researchers from Greece demonstrated that treatment with Darzalex can significantly delay the progression from smoldering multiple myeloma (SMM) to active disease in high-risk patients. Data from this abstract, simultaneously published in the New England Journal of Medicine (Dimopoulos et al.), showed that patients receiving Darzalex had a 51% lower risk of progression (that is the time until myeloma is detected) compared to those under active monitoring, the current standard of care after a median of more than 5 years of follow-up. The most common serious side effect in both arms was hypertension, affecting approximately 5%. Approximately 5% of patients in the Darzalex arm discontinued treatment.
High-risk SMM is an asymptomatic precursor to multiple myeloma, and early treatment strategies may improve outcomes for patients with a high risk of progression to active disease. The researchers emphasized that findings from this phase 3 trial specifically apply to patients with high-risk SMM. Future research will explore whether Darzalex alone or in combination with other medications could help prevent disease progression in patients with high-risk SMM.
Two abstracts showed that Sarclisa in combination with the current standard of care demonstrated significant treatment benefits in patients with newly diagnosed multiple myeloma (NDMM). Sarclisa is an anti-CD38 antibody in the same class as Darzalex and is administered intravenously.
The first abstract showed that Sarclisa in combination with Revlimid (lenalidomide), Velcade (bortezomib), and dexamethasone (Isa-VRd) induction therapy resulted in a 30% reduction in the risk of disease progression in transplant-eligible NDMM patients compared to VRd. Half of patients treated with Isa-VRd achieved minimal residual disease (MRD) negativity, indicating no detectable cancer cells, after 18 weeks of treatment. Side effects such as infections, diarrhea, and peripheral neuropathy were consistent with previous clinical trial findings of Isa-VRd.
In the next abstract, Dr. Orlowski and colleagues from MD Anderson Cancer Center reported that Isa-VRd induction therapy followed by maintenance with Isa-Rd demonstrated higher and sustained MRD negativity rates compared with the current standard of care in NDMM patients not eligible for a transplant. This analysis of the phase 3 study included 446 patients. Side effects of Sarclisa observed in this study were consistent with prior studies of Sarclisa and VRd.
Researchers conclude that Sarclisa-based quadruplets may represent an alternative new standard of care for patients with NDMM.
For patients with relapsed or refractory multiple myeloma considering treatment with Abecma (idecabtagene vicleucel), a CAR T-cell therapy, understanding factors that influence the effectiveness and side effects is important. Currently it is available for patients who have had two or more prior lines of therapy.
In a study of 108 patients, Dr. Hansen and researchers from the H. Lee Moffitt Cancer Center found that patients with high disease burden, such as advanced disease stage, and the presence of biomarkers of inflammation like ferritin and C-reactive protein before starting Abecma treatment were more likely to develop side effects such as neurotoxicity (ICANS). Patients who had extramedullary disease (ie, the presence of myeloma cells outside of the bone marrow) and those who had received prior treatment with a BCMA-targeting agent were less likely to have durable responses.
These findings highlight the importance of pre-treatment factors in shaping outcomes with ide-cel therapy and may help guide personalized approaches to optimize benefits while managing risks.
In the next abstract, researchers in the United Kingdom reported that treatment with Carvykti led to significantly higher rates of MRD-negativity in patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), compared to standard therapies of Pomalyst (pomalidomide), Velcade, and dexamethasone (PVd) or Darzalex, Pomalyst, and dexamethasone (DPd). Carvykti is currently available for patients who have had one or more prior lines of therapy. These findings further support the use of Carvykti patients with Revlimid-refractory MM.
Dr. Dima and researchers at the Cleveland Clinic Taussig Cancer Institute looked at how effective Tecvayli, a BCMA-targeting bispecific antibody, is for patients with relapsed/refractory multiple myeloma (RRMM) who previously received other BCMA-directed therapies like CAR T-cell therapy or antibody-drug conjugates (ADC). In this abstract, researchers found that while Tecvayli is effective for these patients, outcomes were generally better for those who hadn’t received prior BCMA treatments. Currently, it is available for patients who have had four or more lines of therapy.
Patients previously treated with BCMA-directed therapy had slightly lower response rates to and shorter median progression-free survival (PFS, time before the disease worsened) compared to for those without prior BCMA-directed therapies. The study also highlighted the importance of timing between BCMA-directed therapies. Patients who waited more than 9 months after their last BCMA-directed therapy before starting Tecvayli had better outcomes. Side effects like CRS and neurotoxicity (ICANS) were similar regardless of prior BCMA therapy; however, patients with prior BCMA-directed therapy were more likely to experience low platelet counts early in treatment. These findings suggest that Tecvayli is a valuable option for patients previously treated with BCMA therapies, and patients and caregivers should discuss the timing of starting Tecvayli with their healthcare team.
Dr. Tomasson and colleagues from the University of Iowa reported that Elrexfio, a bispecific antibody targeting BCMA, in combination with Kyprolis (carfilzomib) and dexamethasone shows promise for treating patients with RRMM. Currently, Elrexfio is available for patients who have had four or more lines of therapy.
In this abstract, researchers data from an early-phase study involving 12 patients, all of whom had received at least one or more prior lines of therapy. The most common side effects included fatigue, mild cytokine release syndrome (CRS), and low blood counts. Further studies ongoing will evaluate the benefits of Elrexfio combined with Kryprolis and dexamethasone in a larger population.
Researchers from Brazil reported that belantamab mafodotin combined with Velcade and dexamethasone (BVd) shows significant overall survival benefit, reducing the risk of death by 42% in multiple myeloma at or after first relapse compared to Darzalex with Velcade and dexamethasone (DVd). In this abstract, data was analyzed from 494 patients, of which 51% of patients had received 1 previous line of therapy, 52% had received prior Revlimid, while 34% of patients no longer responded to Revlimid; 28% had high-risk chromosomal abnormalities. The researchers note that additional studies will shed light on if BVd may be a potential new standard of care in MM at first relapse or later.
Cevostamab is an investigational bispecific antibody that targets FcRH5, a new target on myeloma cells. In this study of 167 heavily pretreated patients (between 2 and 18, with a median of 6), Dr. Richter and researchers at Mount Sinai found that cevostamab demonstrated good response rates. Patients who had not previously received BCMA-targeted therapies responded better than those who had. Almost all patients (96%) were resistant to all three standard treatment classes: proteasome inhibitors, immunomodulatory drugs (IMiDs), and anti-CD38 monoclonal antibodies. A majority (57%) of patients had received one or more prior BCMA-targeted therapy. Common side effects included CRS, low white blood cell counts, and fatigue. Further analysis will evaluate the use of cevostamab in larger trials.
CELMoDs are a new class of oral myeloma drugs that work like immunomodulators such as Revlimid and Pomalyst. They also stimulate the immune system and kill myeloma cells directly, even for myeloma that has become resistant to certain treatment. Researchers from Canada presented their findings from an early phase trial evaluating mezigdomide, an oral CELMoD, in combination with dexamethasone and either Velcade (Mezi-Vd) or Kyprolis (Mezi-Kd). In this study, 77 patients who have had one or more prior lines of therapy received Mezi-Vd and 27 patients received Mezi-Kd. The authors reported that Mezi-Vd and Mezi-Kd demonstrated high response rates and side effects such as low white blood cell counts, infections, and low platelet counts.
Researchers from Israel reported data from an early phase clinical study of HBI0101, an anti-BCMA CAR T-cell therapy. Their study included 84 patients, most of whom were triple class refractory, showed high response rates and MRD negativity rates in patients treated with HBI0101. Common side effects included CRS, low white blood cell, low red blood cell, and low platelet counts.
Dr. Freeman and researchers at the H. Lee Moffitt Cancer Center reported their findings from an early phase trial evaluating anitocabtagene autoleucel, another anti-BCMA CAR T-cell therapy. The trial included 58 patients with RRMM who have received at least three prior lines of treatment. Patients treated with anitocabtagene autoleucel achieved high response rates and MRD negativity rates. Common side effects observed were CRS, low white blood cell, low red blood cell, and low platelet counts.
Further analysis will evaluate the use of these new therapies in larger trials.
We hope you enjoyed our daily recap of the latest advances in myeloma treatment. Keep an eye on themmrf.org for future updates!
Welcome to the second day of our recap of the latest findings on myeloma treatments reported at the American Society of Hematology (ASH) meeting in San Diego.
Highlights from today included:
Let’s take a closer look!
Several abstracts highlighted promising results on the use of Tecvayli (teclistamab) in combination with other drugs for patients with newly diagnosed multiple myeloma (NDMM) and those who relapse after one or more line of treatment. Currently, it is available for patients who have had four or more lines of therapy.
In the first abstract, 49 patients with transplant-eligible NDMM were treated with Tecvayli in combination with Darzalex, Revlimid, and dexamethasone with or without Velcade (Tec-DRd) or (Tec-DVRd) as induction therapy. Researchers from Germany reported that 35 of 36 patients who completed at least 3 treatment cycles achieved minimal residual disease (MRD) negativity, indicating no detectable cancer cells. The most common side effects were infections and cytokine release syndrome (CRS), which presents as flu-like symptoms and is a common side effect of the bispecific antibodies. Further analysis will evaluate these combinations in larger trials.
Revlimid maintenance therapy after autologous stem cell transplantation (ASCT) has been the standard-of-care for transplant-eligible NDMM. However, patients eventually relapse, supporting the need for better strategies for maintenance therapy. In this abstract, researchers from Italy reported data from an early phase trial that Tecvayli with or without Revlimid could be safely given as maintenance therapy for 90 patients with transplant-eligible NDMM. Common side effects included infections, low white blood cell counts, CRS, cough, diarrhea, and fatigue. All patients enrolled in the study who received Tecvayli with or without Revlimid as maintenance therapy achieved MRD negativity. These findings support the ongoing study of Tecvayli alone or in combination with Revlimid as maintenance therapy.
In the next abstract, Dr. D’Souza and colleagues at the Medical College of Wisconsin showed that Tecvayli in combination with Darzalex and Pomalyst may lead to better responses, especially in patients with relapsed or refractory multiple myeloma (RRMM) who had one or more lines of therapy. Common side effects reported in this early phase trial of 27 patients with RRMM were infections, low white blood cell, red blood cell, and low platelet counts. The researchers concluded that, pending the results of a larger study, Tecvayli in combination with Darzalex and Pomalyst may be a new triplet therapy for early relapsed myeloma.
Etentamig (formerly ABBV-383) is a new bispecific antibody that targets B-cell maturation antigen (BCMA) that is being evaluated with monthly dosing from the beginning of treatment, unlike Tecvali and Elrexfio which are administered weekly through 24 weeks after initial step-up.
Dr. Rodriguez and colleagues at Mount Sinai presented results from an early phase trial of ABBV-383 combined with Darzalx and dexamethasone in this abstract. The study, which aimed to identify the best dosage of ABBV-383, included 60 patients who received 3 or more prior lines of therapy including a proteasome inhibitor and an immunomodulatory drug. Of this group 70% had received anti-CD38 mAb therapy. Most common side effects included low platelet, white blood cell, and red blood cell counts, CRS and fatigue. Their findings suggest that ABBV-383 in combination with Darzalx and dexamethasone is tolerable and early response rates were promising. Ongoing trials will offer more information on the potential use of ABBV-383 in RRMM.
In this abstract, Dr. Usmani and colleagues from Memorial Sloan Kettering Cancer Center showed belantamab mafodotin combined with VRd led to good response rates in patients with NDMM who are ineligible for transplant. Vision problems were the most common side effect. These side effects were managed by briefly stopping treatment or reducing the dose of belantamab mafodotin, allowing most patients to continue treatment. With these promising results, future studies will continue to evaluate the potential of belantamab mafodotin in patients with newly diagnosed disease.
In the final abstract, Dr. Foster colleagues at the University of Virginia reported that Darzalex in combination with Revlimid maintenance therapy resulted in better remission rates (MRD-negative) and longer disease control compared to Revlimid alone. The researchers evaluated data from the phase 3 AURIGA study that included 200 transplant-eligible NDMM patients who were MRD-positive after ASCT regardless of age, race, or risk profile. Findings from this trial revealed that maintenance therapy with Darzalex combined with Revlimid prolonged the time to disease progression across all subgroups of patients, including those with high-risk disease. Low white blood cell counts and infections were the most common side effects observed in this phase 3 trial of 200 patients with NDMM.
The researchers conclude that these results further support adding Darzalex to Revlimid maintenance therapy for patients with NDMM following stem cell transplant.
Be sure to come back tomorrow for our final day of updates in the treatment of myeloma at ASH 2024.
Welcome to our 2024 recap of the latest research on myeloma treatments reported at the American Society of Hematology (ASH) meeting that kicked off Saturday in San Diego. Highlights from today included:
Let’s dive in!
Autologous stem cell transplantation (ASCT) followed by Revlimid (lenalidomide) maintenance continues to be the standard of care for eligible patients with newly diagnosed multiple myeloma (NDMM). Currently, patients with myeloma typically stop maintenance therapy when their disease progresses, meaning there is no set timeframe to stop treatment. However, researchers are finding that patients with sustained (durable) minimal residual disease (MRD) negativity (that means that no myeloma cells were detected) may be able to safely stop maintenance therapy.
In this abstract, researchers from Greece found that maintenance therapy could be stopped for certain patients might be able to stop taking Revlimid maintenance therapy if they were consistently MRD-negative for 3 years. The study included 194 patients who received induction with proteasome inhibitor-based regimens (ie, regiments with Velcade or Kyprolis) and underwent ASCT.
The researchers conclude that sustained MRD negativity after ASCT and a completion of 3 years of Revlimid maintenance may guide the safe discontinuation of maintenance, but more study in clinical trials is needed.
In an analysis of data collected from the MMRF CoMMpass study, Dr. Shan and researchers at the Albert Einstein College of Medicine showed that those who relapse within 12 months of initial therapy have an overall survival (OS) of less than 24 months, regardless of the presence of high-risk features at diagnosis. Out of the 228 myeloma patients classified as functional high-risk myeloma, 63 did not have high-risk chromosomal features specifically–t(4;14), t(14;16), t(14;20), 1q amplification (amp1q), 17p deletion(del17p), or a p53 mutations. The researchers conclude that future studies are needed to confirm if functional high-risk status could be a useful tool for identifying patients who lack chromosomal changes with poor prognosis.
24-hour urine assessments are a key component of International Myeloma Working Group (IMWG) response criteria for myeloma and are requested in clinical trials even if not routinely used in real-world practice. Recent research has suggested a limited role for 24-hour urine assessment if serum immunofixation or free light chain testing is abnormal. In this abstract, Dr. Banerjee and colleagues at the University of Washington analyzed data from 636 patients in the phase 3 STaMINA trial. Outside of situations such as AL amyloidosis where 24-hour urine assessments remain critical or for patients with urine as their only measurable MM biomarker, our results support the removal of 24-hour urine assessments from future iterations of IMWG response criteria.
While there is no cure, the prognosis for myeloma patients has significantly improved, thanks to advances in treatments over the past 10-20 years. The life expectancy for multiple myeloma patients depends on several factors, including the stage of the disease, genetic factors, age, and overall health. One study followed patients for at least 15 years to look at patient- and disease-related factors that may identify those who have a better chance of living 15 years after their diagnosis.
Findings from one abstract of 323 patients in this study, 40 survived at least 15 years. What factors helped predict long-term survival?
Finally, the first day of ASH revealed some promising results on the use of iberdomide in the treatment of newly diagnosed patients who are not eligible for a transplant and those with intermediate and high-risk smoldering multiple myeloma (SMM), an early stage of myeloma that hasn’t yet caused symptoms but is identified by the presence of a serum monoclonal (M) protein of ≥3 g/dL and/or 10% to 60% clonal bone marrow plasma cells.
Iberdomide is a novel oral cereblon E3 ligase modulator (CELMoD™), which is like but more potent than Revlimid, with a dual function: activate the immune system and directly kill myeloma cells.
The first study, which included 75 patients enrolled in an early phase clinical trial, showed the addition of iberdomide combined with Darzalex (daratumumab) and dexamethasone was very effective, with 30 patients achieving MRD negativity.
The second abstract reported findings from an early phase trial that looked at the use of iberdomide alone or in combination with dexamethasone for the treatment of intermediate- or high-risk SMM). Of the 20 patients examined, Dr. Joseph and colleagues from Emory University found that 79% of those with intermediate- or high-risk SMM responded to iberdomide alone or in combination with dexamethasone. Common side effects included headache, abdominal cramping, dyspepsia, and insomnia.
Further studies will continue to evaluate iberdomide for the treatment of early-stages of disease.
Stay tuned tomorrow for additional updates from trials evaluating treatment of patients with newly diagnosed and relapsed/refractory disease.
Norwalk, Conn., December 6, 2024 – The Multiple Myeloma Research Foundation (MMRF®) today announced upcoming poster and oral presentations at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 7-10 in San Diego, CA. 36 presentations will feature data from the CoMMpassSM and Immune Atlas programs, further solidifying CoMMpass as the reference dataset for advancing multiple myeloma research. The findings shed light on the biology of high-risk multiple myeloma and the tumor immune microenvironment, driving novel insights into disease stratification and treatment strategies.
“Our mission is to deliver a cure for every myeloma patient, and we know that comprehensive, scalable research initiatives are the key to achieving that goal,” said Michael Andreini, President and CEO of the MMRF. “With CoMMpass, we have generated critical insights on distinct subtypes and high-risk genetic markers of multiple myeloma, which has translated to clinical trials and research to inform efforts that can optimize treatments for all myeloma patients.”
Data from CoMMpass and the Immune Atlas programs to be highlighted at ASH include insights demonstrating the unique tumor biology and immune microenvironment of high-risk patients, including:
“CoMMpass has been a cornerstone in advancing our understanding of the complex biology of multiple myeloma for over a decade,” said Jonathan Keats, Ph.D., Assistant Professor and Director of Bioinformatics and the Collaborative Sequencing Center at TGen, as well as a senior researcher involved in CoMMpass. “Through this program, we’ve made significant strides in understanding high-risk multiple myeloma, which is associated with poorer outcomes, and are paving the way for the development of more precise and effective therapies.”
About Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells that develops in bone marrow. It is the second most common blood cancer in the U.S., with 35,750 new cases and 12,590 deaths estimated to occur this year. New agents and therapies have resulted in better outcomes, but most multiple myeloma patients eventually relapse.
About CoMMpassSM
The MMRF CoMMpass study is a collaboration with clinical centers and patients with active multiple myeloma. It is one of the largest and most impactful research efforts in multiple myeloma, following over 1,100 patients across 76 centers for at least eight years. The study maps patients’ tumor genomic profile to clinical outcomes with the goal of developing a more complete understanding of both disease biology and the patient’s response to treatments. With its inclusion in more than 200 published or presented studies, CoMMpass represents the largest longitudinal genomic dataset in multiple myeloma and has led to groundbreaking discoveries that have transformed how researchers understand the biology of the disease. The MMRF continues to support the use of this resource and makes the CoMMpass data available to other researchers globally.
About the Multiple Myeloma Research Foundation (MMRF)
The Multiple Myeloma Research Foundation (MMRF) is the largest nonprofit in the world solely focused on accelerating a cure for each and every multiple myeloma patient. We drive the development and delivery of next-generation therapies, leverage data to identify optimal and more personalized treatment approaches, and empower myeloma patients and the broader community with information and resources to extend their lives. Central to our mission is our commitment to advancing health equity so that all myeloma patients can benefit from the scientific and clinical advances we pursue. Since our inception, the MMRF has raised over $600 million for research, opened nearly 100 clinical trials, and helped bring 15+ FDA-approved therapies to market, which have tripled the life expectancy of myeloma patients. To learn more, visit www.themmrf.org.
Media Contact:
Adam Silverstein
Scient PR
adam@scientpr.com
The Horizon Clinical Trials Program uses an adaptive platform designed to test multiple therapies simultaneously to determine the best combination, sequence, and duration of therapy to improve patient outcomes
Norwalk, Conn., December 4, 2024 – The Multiple Myeloma Research Foundation (MMRF®) announced today that the first patient had been enrolled in the first arm of its Horizon Clinical Trials Program. Horizon is an adaptive platform clinical trial being conducted across the Multiple Myeloma Research Consortium (MMRC®), a select group of academic medical centers and community-based clinics across the U.S. The MMRC Horizon trial will have multiple investigational arms to allow for simultaneous testing of multiple novel drugs and therapeutic approaches to determine the best combination, sequence, and duration of therapy in critical patient populations, including those with relapsed and refractory myeloma.
“The MMRC has a proven record of opening nearly 100 clinical trials and generating evidence to inform optimal treatment strategies for patients. Despite a multitude of approved therapies for multiple myeloma, patients and physicians still face complex questions around the most effective treatment combinations, sequencing, and duration,” said Michael Andreini, President and Chief Executive Officer of the MMRF. “The MMRF plays a vital role in building partnerships between companies, researchers, and patients to accelerate new treatments and improve patient outcomes. These collaborations provide meaningful insights on optimal treatment approaches that will make a meaningful difference for patients.”
The MMRF initiated the MMRC Horizon Clinical Trials Program to test therapies in critical patient populations, beginning in patients with relapsed and refractory myeloma. Horizon, through its design and multi-institutional cooperation, is set up to answer research questions that other types of trials lack the capabilities to pursue. The adaptive clinical trial design will use multiple arms to test different therapies, offering key advantages over traditional trials, including the flexibility to make prospectively planned modifications to certain elements of the study design to efficiently facilitate the development of more precise treatments. The first arm of Horizon is enrolling patients and will evaluate dosing approaches with Tecvayli (teclistamab), which is manufactured by Johnson & Johnson. For more information on the clinical trial visit our website or go to clinicaltrials.gov (NCT06171685).
“Johnson & Johnson is committed to advancing therapies for multiple myeloma across all stages of the disease,” said Imran Khan, MD, PhD, Vice President, Medical Affairs, Hematology, Innovative Medicine, Johnson & Johnson. “As a leader in multiple myeloma, we have a responsibility to continue to understand how our approved therapies can help patients in the clinical setting. We’re pleased to support the MMRF in conducting this research.”
“When I was first introduced to the Horizon clinical trial concept, I was on board immediately,” said Cindy Varga, MD, Atrium Health Levine Cancer Institute, MMRC Steering Committee member and Horizon investigator. “It is a truly unique platform as it allows us to test multiple new treatment strategies in a timely manner, significantly reducing the time it would take to obtain results. The benefit it offers myeloma patients cannot be emphasized enough.”
About Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells that develops in bone marrow. It is the second most common blood cancer in the U.S., with 35,750 new cases and 12,590 deaths estimated to occur this year. New agents and therapies have resulted in better outcomes, but most multiple myeloma patients eventually relapse.
About the Multiple Myeloma Research Foundation (MMRF)
The Multiple Myeloma Research Foundation (MMRF) is the largest nonprofit in the world solely focused on accelerating a cure for each and every multiple myeloma patient. We drive the development and delivery of next-generation therapies, leverage data to identify optimal and more personalized treatment approaches, and empower myeloma patients and the broader community with information and resources to extend their lives. Central to our mission is our commitment to advancing health equity so that all myeloma patients can benefit from the scientific and clinical advances we pursue. Since our inception, the MMRF has raised over $600 million for research, opened nearly 100 clinical trials, and helped bring 15+ FDA-approved therapies to market, which have tripled the life expectancy of myeloma patients. To learn more, visit www.themmrf.org.
Media Contact:
Adam Silverstein
Scient PR
adam@scientpr.com
How did you get involved with the MMRF?
When I was diagnosed with multiple myeloma in February 2021, I needed to find hope. Not just hope in an abstract sense, but real, tangible hope rooted in research, action and progress. That’s what the MMRF represents to me. Their dedication to funding research, accelerating treatments, and supporting patients gives me something to hold onto. I’ve made wonderful friends through MMRF too, so in a way, I feel like a part of the MMRF family.
Why did you choose to participate in the MMRF Walk/Run?
Walking has always been part of my life. I’ve walked with my walking partner, four mornings a week for 30 years. I walked with a dear friend who trained with me and walked with me on the Alaska trek, another MMRF fundraiser. And I have walked with beautiful friends who, even in the face of insurmountable odds, have shown me how to live with vitality, intention and connection. Walking isn’t just moving your legs—it’s a declaration that we are still here, still living, still showing up.
The MMRF Walk is more than a fundraising opportunity to me (although funding MMRF is more important today than ever). It’s about solidarity, community, and the choice to walk beside one another. I walk because I can. I walk for those who can’t. I walk toward a future where myeloma is no longer a life sentence.
The Spirit of Hope is given to “individuals/groups that inspire hope and show extraordinary commitment to the MMRF.” What does being given the award mean to you?
Hope is not passive. I don’t just sit back and wish for something better. Hope demands choice and action. It’s choosing, every day, to move forward, to invest in science, to believe in possibilities. Receiving this award is deeply humbling because I don’t see myself as doing anything extraordinary—I am simply choosing to keep walking, to keep showing up, to keep saying, “I’m not done yet.”
And it’s really not about me. The Spirit of Hope award is for every person who wakes up and chooses to go on, to care, to stand beside someone in their hardest moments. It belongs to my family, my friends, my medical team, my writing group, my clients and everyone needs to believe in a future without myeloma.
How have you found perseverance in light of obstacles? Please share any stories that have given you strength.
I have developed perseverance because of the people who walk with me.
My Thursday morning writing group, where we hold space for each other’s stories, healing the parts of us that long to be made whole.
John Waller, Ben Canales, and Jim Aikman, who captured our MMRF Alaska fundraiser on film. Watching John, who was himself living with stage 4 colon cancer, sprint up mountains, chase down bears and elk, laughing all the way, made a deep impression on me. It solidified my intention to persevere and live with vitality and intentionality.
My family—my children, my husband, my brothers, my mother, my extended family and dear friends—who have walked this road with me, helping me ward off the loneliness that pulls at all of us who live with cancer.
And I’ve learned something powerful: being vulnerable, telling the truth, and saying “I need you” is the path to the deepest connection. That connection sustains me. It is what enables me to keep going.
Do you have a favorite mantra, quote, lyric that gives you strength?
Yes. My mantra is simple, and it has been with me since way before my cancer diagnosis: “Just keep walking and the view will change.” No matter what today brings, I can take the next step, and the one after that, and the one after that. Before long, things change.
My daughters and I also love this Glennon Doyle quote: “We can do hard things.” Glennon reminds us that we’re all doing hard things every single day, like loving and losing; caring for children and parents; battling addiction, illness, and loneliness; struggling in our jobs, and in our relationships; setting boundaries; and fighting for what we value.
Anything to add?
Yes. This walk, this award, and this moment are part of something bigger. They are part of a conversation I want to have with the world—about presence, resilience, and the power of walking together. This is why I write. This is why I walk. And this is why I invite you to walk with me.
This award is presented at every Walk/Run to a patient, caregiver, or family who inspires hope through their resilience, perseverance, and dedication to the MMRF and its mission.
Learn more about the Spirit of Hope award and the 2025 recipients.
The final day of presentations at the International Myeloma Society (IMS) meeting in Brazil provided updates on the use of various treatments for patients with relapsed and refractory multiple myeloma. Let us break down the key findings for you…
Results of a large trial of Blenrep (belanatamab mafodotin), a treatment called an antibody-drug conjugate, included 302 patients who had tried at least one prior line of therapy, showed Blenrep in combination with Pomalyst and dexamethasone (B-Pd) lowered the risk of disease progression or death by 48% compared to Velcade (bortezomib), Pomalyst, and dexamethasone (VPd) (Dimopoulos M, NEJM 2024). Results from from this study were presented in two abstracts on Saturday:
Maintenance therapy with Revlimid (lenalidomide) is the standard of care following induction therapy and stem cell transplantation; however, Revlimid maintenance therapy can have side effects when given over a long period of time. In this study of 43 patients (Abstract OA-15), researchers evaluated if maintenance therapy can be stopped if patients are in minimal residual disease (MRD)-negative remission – that means doctors are not detecting cancer cells in the bone marrow or blood and patients don’t have any signs or symptoms of myeloma – after 3 years of Revlimid maintenance therapy. Researchers reported that 84% of patients maintained MRD-negative remission after 1 year of stopping Revlimid maintenance therapy. Ongoing studies are underway to better guide the decision to stop maintenance therapy in patients with MRD-negative remission.
CELMoDs are a new class of myeloma drugs that work like immunomodulators such as Revlimid and Pomalyst and are orally administered. They also stimulate the immune system and kill myeloma cells directly, even for patients whose myeloma has become resistant to certain treatment. This abstract (Abstract OA-29) evaluated the combination of mezigdomide, an oral CELMoD, tazemetostat, a small molecule that blocks a protein called EZH2 to kill myeloma cells, and dexamethasone in RRMM. Researchers hope that when mezigdomide and tazemetostat work together, they attack the cancer from different angles, making the treatment more powerful. Results from an early phase trial that included 13 patients treated with mezigdomide, tazemetostat, and dexamethasone responded to therapy. Additional results will be presented at future meetings.
Finally, results from a small trial of a new treatment for relapsed/refractory patients who have a chromosomal rearrangement called t(11;14) – sonrotoclax, similar to venetoclax, showed more than 75% of patients responded to the treatment in combination with dexamethasone. More than 20% had a complete response with two patients achieving MRD negativity, meaning no myeloma was detected even with the most sensitive tools. The most common side effects were fatigue and insomnia (28% of patients each) followed by gastrointestinal side effects (less than 20% of patients). Side effects were low-grade in more than 90% of patients, suggesting this may be a promising option for patients with this disease characteristic.
Please be sure to tune into our 2-hour webinar on Wednesday, October 9th from 10:00 AM–12:00 PM (ET) as myeloma experts recap each day’s clinical research and discuss what these findings mean for myeloma patients.
We look forward to more clinical updates in the months ahead!
The third day of presentations at the International Myeloma Society (IMS) meeting in Brazil offered a glimpse into the potential of new treatment strategies for patients with relapsed/refractory multiple myeloma (RRMM) and provided additional updates on quadruplet regiments for newly diagnosed multiple myeloma (NDMM).
Talvey (talquetamab), a GPRC5D-directed bispecific antibody, showed high response rates when used in different combinations, according to data from a pair of abstracts involving patients with RRMM who had received 1 or more prior lines of therapy.
An early phase trial (Abstract OA–01) that evaluated 77 patients who Talvey, Darzalex (daratumumab), Pomalyst (pomalidomide) led to high response rates. The most common side effects included loss of taste and dry mouth, as well as low white blood cell counts, and cytokine release syndrome (CRS), which presents as flu-like symptoms. This trial was notable for the fact that most patients had received an anti-CD38 antibody (94%) (Darzalex or Sarclisa) and Pomalyst (83%) prior to receiving this new triplet regimen. The findings suggest that combination Talvey, Darzalex and Pomalyst may be a potential treatment option even for those patients who had received Darzalex and/or Pomalyst and whose disease had eventually progressed.
In the next abstract (Abstract OA–03), researchers reported that Talvey combined with Tecvayli (teclistamab), a bispecific B-cell maturation antigen (BCMA)-targeted antibody, was safe and associated with high response rates in 94 patients with RRMM who received 3 or more prior lines of therapy. Infections, CRS, low white blood cell counts, and taste changes were the most common adverse effects; they were consistent with the side effects of each treatment and were manageable. Most notably, the combination treatment was very effective in treating extramedullary disease (EMD) which occurs when there are myeloma cells growing outside of the bone marrow. EMD has traditionally been difficult to treat with available therapies. Over 80 percent of patients still responded after 18 months, including patients with EMD. The combination is being studied in a larger trial to validate the results.
Researchers from Spain shared updates from CARTITUDE-4, the first randomized phase 3 study evaluating the efficacy and safety of Carvykti in 419 patients with RRMM that no longer responded to treatment with Revlimid (Abstract OA-65). Findings showed that treatment with Carvykti when compared to the standard of care (either Darzalex or Velcade combined with Pomalyst and dexamethasone) reduced the risk of death by 45%. These data continue to support the overall benefit-risk profile of Carvykti in patients with RRMM as early as after first relapse.
CAR T-cell therapy can be hampered by long production times that lead to significant delays in treatment. Thus, shortening CAR T-cell manufacturing time will enable patients with aggressive disease to receive treatment sooner. Several abstracts offered updates on recent advances in CAR T-cell therapy for RRMM.
Results from two new BCMA-directed (the same target as Abecma and Carvykti were presented:
P-BCMA- ALLO1, an off-the-shelf (meaning there is no waiting for the T-cells to be engineered and reinfused), BCMA-directed CAR T-cell therapy for RRMM was shown to have manageable side effects predominantly low white blood cell counts; CRS and neurologic side effects were lower grade than have been observed with the available CAR T-cell products in an early phase trial of 34 patients (Abstract OA-04). At the highest dose, 91% of patients responded. Ongoing studies will compare the response rates of this potential off-the-shelf CAR T-cell therapy for RRMM.
CAR T-cell therapies with mechanisms of action are also needed for patients who relapse following BCMA-directed therapy. An early phase clinical trial of 31 patients treated with BMS-986393, a GPRC5D CAR T-cell therapy, led to impressive response rates (96%) and side effects typical of GPRC5D-directed therapy (Abstract OA–08). Longer follow-up is needed as the median progression-free survival (PFS) – the time before the disease returned – had not been reached after almost 14 months of follow-up.
HDP-101, a new BCMA-directed antibody-drug conjugate (ADC) that has a different mechanism of action than Blenrep. Researchers reported that HDP-101 demonstrated encouraging safety and effectiveness in a small, early phase clinical trial of 18 patients with RRMM (Abstract OA–60). Future trials will evaluate the potential of this novel ADC for RRMM.
In the final abstract (Abstract OA-45), Dr Ashraf Badros from the University of Maryland and colleagues reported that minimal residual disease (MRD)-negativity rate more than doubled by 12 months when Darazlex was combined with Revlimid (D-R) in maintenance therapy compared to Revlimid alone, resulting in improvement in 30-month progression-free survival in patients with newly diagnosed multiple myeloma (NDMM) following stem cell transplant. Low white blood cell counts and infections were the most common side effects observed in this phase 3 trial of 200 patients with NDMM.
The researchers conclude that these results further support adding Darzalex to Revlimid maintenance therapy for patients with NDMM following stem cell transplant.
Be sure to come back tomorrow for our final day of updates in the treatment of myeloma at IMS 2024.
Welcome to the second day of our recap of the latest findings on myeloma treatments reported at the International Myeloma Society (IMS) meeting in Rio De Janeiro, Brazil. Today gave us important updates on new treatment combinations for newly diagnosed multiple myeloma (NDMM), particularly patients ages 65 years and older, as well as a new report on real-world experience with CAR T-cell therapy for relapsed/refractory multiple myeloma (RRMM).
Several abstracts presented on Thursday highlighted recent findings on approved and investigational treatment combinations for patients with NDMM ages 65 years and older.
In the first abstract (Abstract OA–51) Dr. Nisha Joseph from Emory University and colleagues reported that adults ages 65 and older greatly benefited from D-VRd in the real-world (outside of a clinical trial), with 95% of patients living disease-free 4 years after treatment compared to 65% who received VRd. Their real-world analysis included 420 patients with NDMM ages 65 and older who received a stem cell transplant.
The researchers conclude that other studies have shown inconsistent results, their data reflecting real-world clinical practice suggests that these patients can and do benefit from the addition of daratumumab upfront.
The second abstract (Abstract OA–52) researchers from France showed that adding weekly Velcade to Sarclisa plus Revlimid and dexamethasone (Isa-VRd) significantly increased the minimal residual disease (MRD) negativity (which means that no myeloma cells were detected) rate to 53% compared to 26% in patients who were treated with IsaRd (without Velcade). The BENEFIT study included 106 patients with NDMM ages 65-79 years who were not considered for a stem cell transplant. The findings further support Isa-VRd as a new standard of care for patients with NDMM who were deemed ineligible for a stem cell transplant, regardless of age.
While adding Darzalex or Sarclisa to standard of care triplet combinations has emerged as the new standard of care for patients with NDMM, ongoing clinical trials continue to evaluate other novel first-line treatment strategies, particularly for adults ages 65 and older and individuals with kidney disease. In this study (Abstract OA–55) of 75 patients who were deemed ineligible for a transplant, researchers from Spain reported that iberdomide (a next-generation immunomodulatory agent related to Revlimid and Pomalyst) when combined with Darzalex and dexamethasone (IberDd) was highly effective and had a manageable safety profile. Infections (84%) and low white blood cell counts (80%) were the most common side effects reported and were mostly low-grade. The trial included mostly older patients (median patient age was 75 years) and almost half of patients had mild kidney disease. The authors conclude that these data further support the continued evaluation of iberdomide in patients with NDMM.
The final abstract (Abstract OA-11) presented by Dr. Surbhi Sidana from Stanford University and colleagues revealed long-term follow up results on 236 patients with relapse/refractory multiple myeloma (RRMM) who received Carvykti (ciltacabtagene autoleucel), one of the CAR T-cell therapies that is FDA-approved. One unique aspect of their analysis was that 54% of the patients would not have met eligibility criteria for CARTITUDE-1, a clinical trial that led to the approval of Carvykti. Among the patients in their analysis were 14% who had prior BCMA therapy (which is the same target for Carvykti) and 4% who received prior bispecific antibodies (another type of immunotherapy).
Dr. Sidana and colleagues reported high levels of response rates among patients and side effects similar to those reported previously. Cytokine release syndrome or flu-like symptoms, neurological side effects, and infections were the most common side effects observed. These findings support that patients who received prior BCMA therapy or bispecific antibody may benefit from Carvykti.
Stay tuned tomorrow for what will be the biggest day of clinical trial updates in the treatment of myeloma at IMS 2024.
