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CA057-003: Mezigdomide + dexamethasone in novel-novel combination for RRMM
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MEZI is a novel potent oral immunomodulatory drug, showing promising clinical activity with DEX. Preliminary results from the CA057-003 trial (NCT05372354) evaluating the safety and efficacy of MEZI + DEX (MEZId) plus novel-novel targeted triplet combination of TAX, BMS-986158, or TRAM in patients with RRMM who are intolerant or unsuitable for existing therapies (n = 56) were presented by Luciano Costa at the 66th ASH Annual Meeting and Exposition.1 |
| Key learnings |
| ≥1 DLTs were observed in 6.7%, 27.8%, and 10.5% of patients in the MEZId + TAZ, MEZId + BMS-986158, and MEZId + TRAM cohorts, respectively. All doses were well tolerated except DL3 in the MEZId + BMS-986158 cohorts. |
| Grade ≥3 neutropenia was experienced by 50.0%, 65.0%, and 80.0% of patients in the MEZId + TAZ, MEZId + BMS-986158, and MEZId + TRAM cohorts, respectively. No new safety signals were identified, and non-hematologic TEAEs were infrequent across all cohorts. |
| The ORR at all doses was 50.0%, 35.0%, and 75.0% in the MEZId + TAZ, MEZId + BMS-986158, and MEZId + TRAM cohorts, respectively. The pharmacodynamic activity of MEZI 1.0 mg was preserved in all combinations. |
| These preliminary findings suggest that MEZId in combination with TAZ, BMS-986158, or TRAM showed promising efficacy and a manageable safety profile, warranting further investigation. |
Abbreviations: DEX, dexamethasone; DL, dose level; DLT, dose-limiting toxicity; MEZI, mezigdomide; MEZId, mezigdomide plus dexamethasone; ORR, overall response rate; RRMM, relapsed/refractory multiple myeloma; TAZ, tazemetostat; TEAE, treatment-emergent adverse event; TRAM, trametinib.
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