Trial results for elranatamab in patients with multiple myeloma were posted on ClinicalTrials.gov on 2025-06-27. The study compared elranatamab to standard of care using real-world data, showing a median progression-free survival of 10.58 months for elranatamab compared to 6.01 months in the Flatiron Health Database (p=0.0011).
Background
Multiple myeloma (MM) is a type of cancer that originates in plasma cells, which are white blood cells responsible for producing antibodies. The study aimed to understand the effectiveness of elranatamab for relapsed refractory multiple myeloma (RRMM), a condition where MM improves initially but then becomes resistant to treatment and recurs.
Trial design
The study (NCT06504524) enrolled 633 participants with multiple myeloma. It compared the effects of elranatamab against standard of care (SOC) therapies, utilizing real-world data from the TM-MM Database and the Flatiron Health Database.
Key results
The trial compared elranatamab (C1071003 Cohort A) against real-world data from the TM-MM Database and Flatiron Health Database for overall survival (OS), progression-free survival (PFS), and time to next treatment (TTNT).
- Overall Survival (OS):
- Against the TM-MM Database, median OS was 13.27 months for elranatamab versus 14.29 months for the database (HR: 1.128, 95% CI: 0.705 to 1.804, p=0.615).
- Against the Flatiron Health Database, median OS was 14.62 months for elranatamab versus 18.99 months for the database (HR: 1.18, 95% CI: 0.85 to 1.64, p=0.4429).
- Progression Free Survival (PFS):
- Against the TM-MM Database, median PFS was 13.01 months for elranatamab versus 9.00 months for the database (HR: 0.66, 95% CI: 0.39 to 1.115, p=0.12).
- Against the Flatiron Health Database, median PFS was 10.58 months for elranatamab versus 6.01 months for the database (HR: 0.52, 95% CI: 0.38 to 0.71, p=0.0011).
- Time to Next Treatment (TTNT):
- Against the TM-MM Database, median TTNT for elranatamab was not available ("NA") versus 12.06 months for the database (HR: 0.759, 95% CI: 0.337 to 1.71, p=0.503).
- Against the Flatiron Health Database, median TTNT for elranatamab was not available ("NA") versus 7.39 months for the database (HR: 0.38, 95% CI: 0.26 to 0.57, p=0.0001).
What this means
The results indicate that elranatamab demonstrated a statistically significant improvement in progression-free survival when compared to the Flatiron Health Database, with a median PFS of 10.58 months versus 6.01 months (p=0.0011). Similarly, a statistically significant improvement was observed for Time to Next Treatment against the Flatiron Health Database (p=0.0001). While overall survival did not show a statistically significant difference compared to either real-world database, the improvements in PFS and TTNT suggest potential benefits for patients with relapsed refractory multiple myeloma, particularly when considering real-world treatment patterns.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06504524, titled "A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany and US," were posted on 2025-06-27 on clinicaltrials.gov.