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Pomalidomide/Daratumumab/Dexamethasone in Relapsed or Refractory Multiple Myeloma: Final Overall Survival From MM-014
Nizar J Bahlis1, Christy Samaras2, Donna Reece3
1University of Calgary, Calgary, AB, Canada.
Background:
Patients with relapsed or refractory multiple myeloma (RRMM) who have exhausted lenalidomide benefits require improved therapies. The 3-cohort phase 2 MM-014 trial (NCT01946477) explored pomalidomide in early lines of treatment for lenalidomide-exposed RRMM. In cohort B, pomalidomide plus daratumumab and dexamethasone (DPd) showed promising efficacy (median follow-up 28.4 months), as previously reported. Here, we report final overall survival (OS) in cohort B.
Methods:
Patients aged ≥ 18 years were treated in 28-day cycles: pomalidomide 4 mg orally daily from days 1 to 21; daratumumab 16 mg/kg intravenously on days 1, 8, 15, and 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 (cycle ≥ 7); and dexamethasone 40 mg (age ≤ 75 years) or 20 mg (age > 75 years) orally on days 1, 8, 15, and 22. The primary endpoint was ORR. OS and safety were secondary endpoints.
Results:
Among 112 patients enrolled, 85 (75.9%) had lenalidomide-refractory disease and 27 (24.1%) had lenalidomide-relapsed disease. At a median follow-up of 41.9 months (range, 0.4-73.1), median OS was 56.7 months (95% confidence interval, 46.5-not reached). Treatment-emergent adverse events related to, and leading to discontinuation of, pomalidomide, dexamethasone, or daratumumab occurred in 7 (6.3%), 9 (8.0%), and 6 (5.4%) patients, respectively.
Conclusion:
With long-term follow-up, our results show favorable OS with DPd. The safety profile was consistent with previous reports, with no new safety signals identified. IMiD agent-based therapy can still be considered in patients with RRMM who experience progressive disease on or after lenalidomide.
Insights
Pomalidomide, daratumumab, and dexamethasone (DPd) demonstrated favorable overall survival in relapsed or refractory multiple myeloma patients previously treated with lenalidomide. This combination therapy offers a viable option for patients progressing on or after lenalidomide-based treatments.
Area of Science:
- Hematology
- Clinical Oncology
- Pharmacology
Background:
- Relapsed or refractory multiple myeloma (RRMM) patients who have exhausted lenalidomide benefits need novel therapeutic strategies.
- The MM-014 trial investigated pomalidomide in early treatment lines for lenalidomide-exposed RRMM patients.
- Previous reports indicated promising efficacy for the pomalidomide, daratumumab, and dexamethasone (DPd) combination in cohort B.
Purpose of the Study:
- To report the final overall survival (OS) data for cohort B of the MM-014 phase 2 trial.
- To evaluate the long-term efficacy and safety of the DPd regimen in patients with lenalidomide-exposed RRMM.
Main Methods:
- Phase 2, 3-cohort trial (MM-014) including 112 patients with RRMM.
- Patients received pomalidomide, daratumumab, and dexamethasone over 28-day cycles with dose adjustments based on cycle number and patient age.
- Primary endpoint was objective response rate (ORR); secondary endpoints included overall survival (OS) and safety.
Main Results:
- Median overall survival (OS) was 56.7 months (95% CI: 46.5-NR) after a median follow-up of 41.9 months.
- Of 112 patients, 85 (75.9%) had lenalidomide-refractory disease and 27 (24.1%) had lenalidomide-relapsed disease.
- Treatment-emergent adverse events leading to discontinuation occurred in a small percentage of patients for each drug (pomalidomide 6.3%, dexamethasone 8.0%, daratumumab 5.4%).
Conclusions:
- The DPd regimen demonstrates favorable long-term overall survival in patients with RRMM who have progressed on or after lenalidomide.
- The safety profile of DPd is consistent with prior reports, with no new safety concerns identified.
- Immunomodulatory drug (IMiD)-based therapy remains a valid treatment option for patients with RRMM after lenalidomide failure.
