Analyzing the relationship of response and survival in patients with refractory or relapsed and refractory multiple myeloma (RRMM) treated with pomalidomide plus low-dose dexamethasone (POM + LoDEX) in the MM-003 trial.

Authors

null

Katja Weisel

University Hospital of Tuebingen, Tuebingen, Germany

Katja Weisel , Philippe Moreau , Craig J Gibson , Kevin W. Song , Owain Saunders , Lars Axel Sternas , Kevin Hong , Mohamed H. Zaki , Meletios A. Dimopoulos

Organizations

University Hospital of Tuebingen, Tuebingen, Germany, CHU de Nantes, Hotel Dieu—HME, Nantes, France, Celgene Corporation, Summit, NJ, Vancouver General Hospital, Vancouver, BC, Canada, BresMed Health Solutions, Sheffield, United Kingdom, National and Kapodistrian University of Athens, Athens, Greece

Research Funding

Pharmaceutical/Biotech Company

Background: RRMM patients (pts) previously exposed to bortezomib (BORT) and lenalidomide (LEN) have short overall survival (OS). The phase 3 MM-003 trial (NCT01311687) demonstrated significantly longer OS in RRMM pts treated with POM + LoDEX vs HiDEX (HR, 0.74 [95% CI, 0.56-0.97], P = .0285). This post hoc analysis investigated OS based on the response status of pts at different cycles. Methods: Landmark analyses at the start of cycles (C) 3, 5, and 7 were performed using Kaplan-Meier methods and unadjusted Cox regression models. Time-dependent survival analyses captured response status over time. For both approaches, survival of ptswith stable disease (SD) was compared to that of pts with progressive disease (PD) or overall response (OR; ≥ partial response). Results: At C3, 38.4% of pts (116/302) randomized to POM + LoDEX attained SD, 14.6% PD, and 19.2% OR; 28% had no response data, most due to early discontinuation. The median OS from randomization by response status at C3 was 15.3 mos for SD, 6.3 for PD, and 17.5 for OR. The difference in OS at C3 between pts with PD or SD was significant (P < .001); that between pts with OR or SD was not (P = .32). A similar pattern was observed at C5 and C7. The time-dependent survival model showed a lower risk of death for pts with SD or OR vs PD (HR, 0.27 [95% CI, 0.17-0.44] and HR, 0.06 [95% CI, 0.02-0.16], respectively). For the HiDEX arm, small pt numbers per group (due to the lower response rate, 2:1 randomization, and shorter OS vs POM + LoDEX) made interpretation challenging. Conclusions: In the POM + LoDEX group, pts with SD at C3, C5, and C7 had OS comparable to pts who achieved a response by those times. Pts with either SD or OR had a longer OS than those with PD at the same time points. Clinical trial information: NCT01311687

Beginning of CPOM + LoDEX
(N = 302)
SDPDOR
C3n1164458
Median OS, mo15.36.317.5
HR vs SD (95% CI)-3.83 (2.39-6.14)0.75 (0.43-1.31)
P value vs SD-< .0001.320
C5N573156
Median OS, mo16.611.018.0
HR vs SD (95% CI)-2.81 (1.38-5.71)0.74 (0.33-1.66)
P value vs SD-.004.462
C7n401847
Median OS, moNot reached16.418.0
HR vs SD (95% CI)-2.66 (0.89-7.94)0.90 (0.3-2.67)
P value vs SD-.080.843

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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lymphoma and Plasma Cell Disorders

Track

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Sub Track

Multiple Myeloma

Clinical Trial Registration Number

NCT01311687

Citation

J Clin Oncol 33, 2015 (suppl; abstr 8593)

DOI

10.1200/jco.2015.33.15_suppl.8593

Abstract #

8593

Poster Bd #

411

Abstract Disclosures