ASH Annual Meeting 2025 Day 1: Promising Results Across the Myeloma Spectrum

The 67th ASH Annual Meeting is underway in Orlando, where more than 30,000 experts have gathered to share the newest research in multiple myeloma and other blood cancers. The MMRF team is here on the ground, connecting with leaders in the field and bringing you updates as they happen.

Over the next three days, we’ll highlight promising new research and key insights shaping the future of myeloma treatment, many of which align with MMRF’s strategic research priorities and address critical unmet patient needs.

On Day 1 of ASH, studies focused on addressing the unmet needs of high-risk patients as well as finding ways to improve existing standards of care for all patients along their journey.

To dive deeper into these findings and additional updates from ASH, read more below and join us for our Conference Highlights Webinar on December 17. Register here to hear from leading experts and stay informed on the latest advancements.

As a reminder, many of the studies being presented, particularly oral abstracts, are early in nature. While the results shared at ASH can be very strong and encouraging, much larger trials will need to be completed to confirm these initial findings, especially in patient populations that are representative of the real-world patient population in the U.S.

New CAR T Treatment Tested in High-Risk, Newly Diagnosed Patients

High-risk multiple myeloma is a more aggressive form of the disease, often marked by certain genetic changes, high levels of specific blood markers, or myeloma growing outside the bone marrow. A real-world study presented today reinforced that these high-risk features can make myeloma harder to treat and more likely to return sooner, highlighting the need for closer follow-up or additional therapy for these patients.

A small, phase 1 study presented early data on a potential new treatment for high-risk newly diagnosed patients who are not eligible for a stem cell transplant. Sixteen patients received an infusion of the CAR T-cell therapy eque-cel. All had a deep response within the first month, including complete responses and minimal residual disease (MRD) negativity, meaning no detectable myeloma using very sensitive tests. Most patients stayed MRD-negative for two years, keeping disease under control during this follow-up period.

Common side effects included CRS (cytokine release syndrome), low blood counts, and infections, but no cases of ICANS (Immune Effector Cell-Associated Neurotoxicity Syndrome) or other neurological toxicity were reported. While these results are promising, more patients and longer follow-up time are needed to confirm the benefits of eque-cel as an early treatment option for this high-risk group.

Improving Treatment Strategies for Newly Diagnosed Patients

New research shows real progress in treating people who are newly diagnosed with multiple myeloma. Three studies presented today look at different treatment approaches, including updated drug combinations, a CAR T-cell therapy that can be made in one day instead of weeks, and an immune-based treatment typically used for treating patients with relapsed/refractory disease.

• KRd leads to more complete and deeper responses than VRd in NDMM patients
  For newly diagnosed patients who may not be able to tolerate four drug treatments, what is the best way to ensure three drug combinations are still effective? One Phase 3 study of 250 patients compared two common triplet combinations for newly diagnosed multiple myeloma patients to see what works better: KRd (Kyprolis®, Revlimid®, dexamethasone) vs VRd (Velcade®, Revlimid®, dexamethasone). Both combinations worked well, but KRd led to more complete and deeper responses than VRd (see table below). This means that M protein levels were absent from the blood and plasma cells were not detectable in the bone marrow.

Side effects were similar between the two treatments: serious side effects occurred in about 7 in 10 patients on KRd and 6 in 10 on VRd, the most common of which were low white blood cell counts and infections. Patients treated with KRd had fewer nerve-related problems than VRd, but slightly more heart-related effects, while patients treated with VRd had more neuropathy than patients treated with KRd.

• “Next-day” CAR T-cell therapy shows strong results and may open door for shorter wait times
  A Phase 1 clinical trial tested a new CAR T-cell therapy for newly diagnosed patients that targets two proteins on the surface of myeloma cells—BCMA and CD19—instead of just one. All patients responded, and 97% had a complete response. While CRS was common side effect, it was manageable with treatment, and no patients had any serious nerve-related side effects. Importantly, this CAR T-cell therapy can be made overnight, rather than the typical timeframe of weeks seen with other CAR T therapies, potentially making the treatment available to those who need it sooner.
• Bispecific treatments brought in earlier along the patient journey
  With the hope of making therapeutic responses last longer, bispecific antibody treatments used for treating relapsed/refractory patients are now being tested as an alternative to traditional chemotherapy and stem cell transplant for newly diagnosed patients:
  • One such treatment is Linozyfic.™ In an early Phase 2 study, all 14 people treated had a deep response, and everyone tested was MRD-negative at six months. Side effects of Lynozyfic included infections, rash, bone pain, or low blood counts, which were mild for most patients.
  • Another is a combination of Tecvayli^® and Darzalex.^® Both Tecvayli and Darzalex are FDA-approved for patients with relapsed/refractory multiple myeloma; Darzalex is also approved for newly diagnosed patients when used in certain combination treatments. In a Phase 2 study of 37 newly diagnosed multiple myeloma patients ages 65 and older patients received this “all-antibody” combination as their initial therapy. Seventy-eight percent had a very good partial response or better after four treatment cycles, and eventually all patients responded. More than half (51%) had no detectable myeloma six months after starting treatment, and no patients experienced disease worsening. Common side effects included low blood counts and infections, which were mostly mild to moderate.

New CAR T-cell therapy shows promise in treating relapsed/refractory patients with limited options

A Phase 2 study tested anito-cel, a CAR T-cell therapy designed to more easily attach to myeloma cells using a small “hook”—a feature that may help reduce certain side effects seen with other CAR T-cell therapies. Key findings from 117 patients included:

• 97 percent responded, and 68 percent reached a complete remission or better, usually within about one month.
• Most patients remained cancer-free at the one-year mark.
• The most common side effects were low blood counts and mild to moderate cytokine release syndrome, which typically resolved quickly. Serious infections and neurological problems were uncommon.

These data suggest that anito-cel may offer strong, long-lasting control of myeloma, with manageable side effects, even for people whose disease has stopped responding to many other treatments.

We’re hopeful about the progress shared today at ASH—and we’ll be back tomorrow with more updates for the myeloma community.