Welcome back to our coverage of the 2025 ASCO Annual Meeting. On Day 2, researchers shared more promising updates about long-term results from large, ongoing clinical trials, new treatment combinations, and patient-friendly innovations in multiple myeloma care.
CAR T-Cell Therapy: Patients Cancer-Free After 5 Years
Long-term data were presented from the CARTITUDE-1 study of the CAR-T cell therapy Carvykti® (cilta-cel) in 97 heavily pretreated patients with relapsed or refractory myeloma.
- Five years after a single infusion of Carvykti, about 1 in 3 patients were still off treatment, living cancer-free.
- Close to 36% of these cancer-free patients were initially diagnosed with high-risk disease, including chromosomal alterations and myeloma tumors in different parts of the body (extramedullary disease).
- Researchers are looking beyond genetics to figure out what has helped stall disease progression for 5 years in these patients, including their T-cell makeup.
The MMRF’s new Translational Research Umbrella (TRU) Program asks similar questions to help us understand which patients respond to specific therapies and why. Combined efforts like CARTITUDE-1 and TRU will be key in understanding the long-term benefit of Carvykti and who can benefit the most.
Above all, these are some of the most positive results we’ve seen as a treatment for heavily pre-treated.
Strength with Newer Treatment Combinations
Yesterday, we highlighted how adding Darzalex® (daratumumab) to standard three-drug treatment helps patients who aren’t getting a transplant. Today, we heard similar long-term success in another group of patients who did receive a transplant.
- In the PERSEUS trial, newly diagnosed, transplant-eligible patients received Darzalex plus Velcade®(bortezomib), Revlimid® (lenalidomide), and dexamethasone (DVRd).
- These patients were more likely to reach and stay in MRD-negative status (no detectable cancer) for up to two years compared to those on Velcade, Revlimid, and dexamethasone alone.
- 95% of patients who stayed MRD-negative had a high chance of being cancer-free at four years.
We also saw more good news for Sarclisa® (isatuximab). A study of newly diagnosed patients found that adding Sarclisa to Kyprolis® (carfilzomib), Revlimid, and dexamethasone (Isa-KRd) led to:
- Greater percentage of high-risk patients with 2 or more chromosomal alterations reaching MRD-negativity compared to those on the triplet regimen (KRd) (62% vs 20%).
- Better long-term remission after one year (52% vs. 38%)
- No increase in side effects compared to the three drug combination
Given the improvement in outcomes and no significant side effects or impact on quality of life, this study and others from yesterday confirm that four-drug combinations are the standard of care treatment across different newly diagnosed patient populations.
From Bispecifics to Trispecifics
Day 2 also offered an exciting glimpse into potential new treatments on the horizon, including JNJ-5322, a new trispecific antibody that targets two regions of myeloma cells instead of one. This new therapy could be a particularly effective treatment for patients who have just relapsed after taking a proteasome inhibitor like Velcade, an immunomodulatory drug like Revlimid, or an anti-CD38 antibody like Sarclisa.
- 100% of relapsed/refractory patients in a phase I trial responded to the drug if they had not taken any other bispecific or CAR T-cell therapies.
- Side effects were similar to those seen in other bispecific antibody treatments and included cytokine release syndrome (CRS), infections, decrease in white blood cells, and taste loss.
Now that this Phase I trial discovered an optimal dose that minimizes side effects, we look forward to watching JNJ-5322 as it moves to the next stages of testing—Phase 2 and Phase 3 trials—where more patients can access the drug.
A New Way of Giving Sarclisa Offers New Possibilities for Patient Care
Today’s last study looked at a new way to give the medicine Sarclisa using a small, wearable device called an on-body delivery injector (OBI). This device sticks to the belly and uses a tiny needle to deliver the medicine. The goal of the study was to see if this new method works just as well as the current way of giving Sarclisa, which is through an IV drip.
- Both methods worked equally well, with 71% of patients responding in both groups. Side effects were also similar between the two groups.
- The study also found that patients wearing the injector had far fewer injection related reactions and reported higher satisfaction with the treatment than patients who received an IV infusion.
- Delivery of Sarclisa took only 20 minutes using the OBI.
The wearable injector may be used in the future to improve quality of life by making treatment more comfortable, convenient, and less disruptive to daily activities. One day, it could possibly be administered in a patient’s own home instead of a treatment center.
Moving forward, it will be important to figure out what can be done to minimize cost of this new device and increase everyone’s access to it.
We’re excited by the continued momentum in myeloma research that we’ve seen at ASCO 2025. For more updates, visit themmrf.org and follow along as we track the progress that brings us closer to a cure. In this table, we’ve highlighted the key findings that could make a real difference in treatment options for people with myeloma
We’re excited to share highlights from the first day of the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, one of the year’s most important events in cancer research.
This year, researchers from around the globe shared data on breakthrough research and treatment strategies, including 150 abstracts, posters, and presentations related to multiple myeloma. On Day 1 of ASCO, we were particularly encouraged by studies that showed progress for the following key areas of unmet need:
New Possibilities for Blenrep
Blenrep (belantamab mafodotin) is a type of cancer treatment that works by combining targeted therapy with chemotherapy.
One study looked at Blenrep combined with Pomalyst® (pomalidomide) and dexamethasone (BPd) in patients who had received at least one prior treatment that included Revlimid. This study found that more patients (25%) became MRD-negative—the deepest response measurable—when treated with BPd versus Pomalyst, Velcade® (bortezomib) and dexamethasone (PVd) (5%). The study also found that patients who did not become MRD-negative still benefitted more from BPd than PVd; 32% of patients who received BPd versus 5% of patients who received PVd had a very good partial response. Another study looked at some of the common eye problems caused by Blenrep. Researchers wanted to see if giving the drug less often could help reduce these side effects, especially in frail patients. The results were promising: patients still responded well to the treatment, even with fewer doses. Very few people—less than 1%—had serious vision problems like trouble driving or reading. When Blenrep was combined with the drugs Revlimid® (lenalidomide) and dexamethasone, it appeared to be a good treatment option for newly diagnosed myeloma patients who are too weak for a transplant. These results suggest that Blenrep could be a valuable option for patients who have few treatment choices left, especially since it’s an off-the-shelf therapy that doesn’t require a hospital stay. It may receive FDA approval as early as this summer.
Better Treatment for Newly Diagnosed High-Risk Patients
Some newly diagnosed patients, especially those with high-risk chromosomal alterations, may not respond to standard therapies, but data on new drug combinations are showing hope:
- Researchers looking for a better treatment for high-risk newly diagnosed patients with the 1q21+ chromosomal alteration found that adding Sarclisa® (isatuximab) to the standard treatment (Isa-VRd) showed promising results, including higher chances of a complete response – meaning more than 95% of plasma cells are eliminated from the bone marrow.
- In a separate study that included newly diagnosed myeloma patients with multiple chromosomal alterations and stage II or III myeloma, a four-drug combination of Sarclisa, Kyprolis® (carfilzomib), Revlimid, and dexamethasone helped 87% of high-risk patients become and stay cancer free—many for 1-2 years or longer. Importantly, this study also showed that doctors could reduce the frequency of Kyprolis dosing to once a week instead of twice and still get an effective response.
Both studies indicate that adding Sarclisa to treatment protocols for high-risk newly diagnosed myeloma patients could become a new standard of treatment for this hard-to-treat patient group.
For Patients Who Can’t Get a Transplant or May Not Want One: DVRd
We saw promising updated data continuing to confirm that adding Darzalex® (daratumumab) to the standard VRd combo (Velcade, Revlimid, dexamethasone)—known as DVRd—was shown to work better than VRd alone, particularly in patients who were not eligible to have a stem cell transplant or who are delaying a stem cell transplant.
The study found that treating with DVRd vs. VRd alone led to higher MRD-negative rates (60% vs. 39% MRD-negative rates) and better outcomes overall.
These results reinforce previous findings that DVRd is an important treatment option for patients who cannot or are not currently pursuing a stem cell transplant.
New Drugs and New Drug Combinations Show Promise
In a disease as complex as multiple myeloma, identifying new treatment options is key to moving toward a cure for each and every myeloma patient. It was encouraging to hear about the results of several studies focused on uncovering new treatment options.
- In an early study of relapsed and refractory patients, 75% of patients treated with ISB 2001, a trispecific antibody targeting BCMA and CD38, responded to the therapy—including patients who have received other BMCA-targeted and/or T-cell directed therapies. The most common side effects of this new treatment included infections, cytokine release syndrome, and a reduction in white blood cells. Only one patient discontinued treatment in this study. Overall, 60% of patients treated with ISB 2001 had a very good partial response or better – meaning there was a 90% decrease in M protein levels in their blood.
- Two other studies looked at combining linvoseltamab (a new, BCMA-directed bispecific antibody similar to Tecvayli® and Elrexfio®), with Velcade or Kyprolis, to see if they could enhance how well heavily-pretreated patients responded. In both studies, at least 50% of patients had a complete response—even if they had already tried other treatments. Common side effects included CRS, infections, and a reduction in white blood cells. In future clinical trials, these two treatment regimens will be measured up against standard of care therapies for relapsed/refractory patients.
Linvoseltamab is in late stage clinical trials and is expected to receive FDA approval later this year.
We’re hopeful about the progress shared on Day 1 of ASCO 2025—and we’ll be back tomorrow with more updates for the myeloma community. Stay tuned!
In this table, we’ve highlighted the key findings that could make a real difference in treatment options for people with myeloma.