Mount Sinai Medical Center, New York, NY
Sundar Jagannath , Craig C. Hofmeister , Rachid C. Baz , David Samuel DiCapua Siegel , Ravi Vij , Christine Chen , Sagar Lonial , Kenneth Carl Anderson , Min Chen , Mohamed H. Zaki , Paul Gerard Guy Richardson
Background: POM demonstrated clinical efficacy and favorable tolerability in RRMM pts previously treated with lenalidomide (LEN) and bortezomib (BORT), in the randomized, multicenter, open label MM-002 phase II trial. This analysis evaluated whether the efficacy and tolerability of POM+LoDEX treatment is consistent across age subgroups. Methods: Pts with RRMM who had received ≥ 2 prior therapies, including LEN and BORT, and were refractory to their last regimen were randomized to either POM+LoDEX (POM 4 mg/day, days 1–21 of a 28-day cycle; LoDEX 40 mg/week) or POM alone. End points included progression-free survival (PFS), response rate (based on EBMT criteria), response duration, and safety. A post-hoc analysis based on age (≤ 65 vs. > 65 yrs) was conducted. Results: A total of 221 pts with a mean age of 64 yrs (range 34–88) were randomized to POM+LoDEX (n = 113) or POM (n = 108). The efficacy outcomes and the most common treatment emergent grade 3/4 adverse events (AEs) for the age subgroups according to treatment arm are presented in the Table. Conclusions: Regardless of age (≤ 65 vs. > 65 yrs), POM with or without LoDEX was effective and generally well tolerated in heavily pretreated RRMM pts who had already received LEN and BORT. POM with or without LoDEX represents a new clinical option for pts previously treated with numerous lines of therapy. Updated data will be presented at the meeting. Clinical trial information: NCT00833833.
≤ 65 yrs | > 65 yrs | |||
---|---|---|---|---|
Efficacy | POM+LoDEX (n = 62) |
POM (n = 69) |
POM+LoDEX (n = 51) |
POM (n = 39) |
≥ PR (%) | 31 | 13 | 37 | 18 |
≥ MR (%) | 47 | 23 | 43 | 44 |
Median DoR (monthsa) | 10.1 | 8.3 | 7.7 | 10.6 |
Median PFS (months, range) | 4.7 (3.7–6.7) | 1.9 (1.8–2.7) | 3.7 (2.1–5.5) | 3.3 (2.8–5.5) |
Safety | POM+LoDEX (n = 61) |
POM (n = 68) |
POM+LoDEX (n = 51) |
POM (n = 39) |
Hematologic AEs (%) | ||||
Neutropenia | 46 | 40 | 35 | 59 |
Anemia | 26 | 24 | 18 | 26 |
Thrombocytopenia | 18 | 24 | 20 | 21 |
Nonhematologic AEs (%) | ||||
Pneumonia | 16 | 10 | 29 | 21 |
Urinary tract infection | 10 | 3 | 8 | 0 |
a For pts who achieved ≥ PR. DoR, duration of response; MR, minimal response; PR, partial response.
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Abstract Disclosures
2023 ASCO Annual Meeting
First Author: Darrell White
2018 ASCO Annual Meeting
First Author: Paul G. Richardson
2016 ASCO Annual Meeting
First Author: Philippe Moreau
2021 ASCO Annual Meeting
First Author: Xavier Leleu