Glossary:
Neutropenia: a drop in white blood cells.
Overall response rate (ORR): the proportion of patients who have a partial or complete response to therapy.
Complete response: the absence of detectable tumor in the patient's body.
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Cemsidomide Generates Results at Multiple Doses in Multiple Myeloma
May 7, 2025
Ryan Scott
Ryan Scott
Treatment with cemsidomide resulted in notable responses at multiple dose levels for patients with multiple myeloma
Treatment with cemsidomide resulted in notable responses at multiple dose levels, showing potential for a best-in-class profile, for patients with multiple myeloma, according to a news release from C4 Therapeutics, Inc., which shared updated data on the agent.
“2025 has been marked by focused execution across C4T to generate key data to optimize development plans across our clinical portfolio. With cemsidomide demonstrating compelling overall response rates (ORR) at multiple dose levels, including one patient with multiple myeloma at 100 micrograms [μg] who achieved a minimal residual disease negative complete response, we are prioritizing progressing cemsidomide to the next phase of development to realize its potential to be a best-in-class IKZF1/3 degrader,” Andrew Hirsch, president and CRO of C4 Therapeutics, said in the news release.
Cemsidomide is an investigational treatment for patients with multiple myeloma and the therapeutic agent has shown early results. In a recent phase 1 study evaluating different dose levels of cemsidomide, the treatment elicited a 50% ORR in those who received the highest dose of treatment at 100 μg. Notably, one patient achieved a complete response with no detectable disease. At the 75 μg dose, the ORR was 40%.
With dose escalation portion of the phase 1 study complete, next steps are underway, according to the news release. Feedback from the United States Food and Drug Administration (FDA) is expected by mid-year 2025, which is expected to support the initiation of the next phase of development in early 2026.
Based on these findings, the news release continues, the Company has made the decision to prioritize the continued development of cemsidomide.
“We remain focused on… advancing cemsidomide and pursuing our internal discovery pipeline focused on targets with a clear degrader rationale and compelling biology applicable to a broad range of therapeutic areas,” Hirsch concluded in the news release.
More Information on the Phase 1 Study and Multiple Myeloma Treatment
Early results from the phase 1 clinical trial show notable responses in patients with multiple myeloma, according to the news release. The dose-escalation portion of the study has been completed, and the 100 μg once-daily dose declared safe for additional evaluation. Ten additional patients will now be treated at this dose level to better understand the drug’s safety and efficacy.
Results from this group show that 50% of patients responded to treatment. Notably, one patient, who had previously progressed on two prior T-cell engager therapies, achieved a complete response with no minimal residual disease detected (measured by flow cytometry). No detection of minimal residual disease means no signs of cancer were found in the blood. In addition, 20 patients have received a 75 μg daily dose of cemsidomide. Among these 20 patients, the ORR was 40% as of April 30, 2025. According to the news release, these findings are important because many of the patients in the trial had already received therapies such as CAR-T or T-cell engagers.
Cemsidomide has so far been well tolerated, with side effects like neutropenia considered manageable.
Multiple myeloma, according to the American Cancer Society, is a type of blood cancer that develops in plasma cells. These cells are normally found in the bone marrow, the soft tissue inside bones where blood cells are produced; however, in people with multiple myeloma, plasma cells become cancerous and grow out of control. Based on outcomes for patients with this disease, this patient population represents an unmet need in the treatment landscape of hematological diseases, making ongoing investigations, such as this, important.
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