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In the primary analysis of the CASTOR trial (median follow-up of 7.
4 months), daratimumab plus bortezomib and dexamethasone (D-Vd) significantly prolonged progression-free survival in patients with relapsed or refractory multiple myeloma (RRMM) compared with bortezomib and dexamethasone (Vd) alone
.
The latest analysis of overall survival (OS) from this trial is reported
.
The trial was a multicenter, randomized, open-label, Phase 3 study enrolling patients with relapsed or refractory multiple myeloma who had previously received ≥ 1st line therapy and were randomized to Vd (up to 8 courses) or Vd + daratumumab (D-Vd) (treatment until disease progression).
After a positive initial analysis and a modification of the protocol, patients in the Vd group were given daratumumab monotherapy after disease progression
.
OS and PFS in both groups
After a median follow-up of 72.
6 months, there was a significant overall survival benefit in the D-Vd group (HR 0.
74, p=0.
0075).
The median OS in the D-Vd and Vd groups was 49.
6 months and 38.
5 months
, respectively.
Scheduled subgroup analysis showed that D-Vd had OS advantages over Vd regimens in most subgroups, including subgroup patients aged ≥65 years, prior treatment regimens of 1 or 2 regimens, stage III of the international staging system, genetic abnormalities in high-risk cells, and prior bortezomib therapy
.
Common grade 3/4 adverse reactions
The most common (≥10%) grade 3/4 treatment-related adverse effects were thrombocytopenia (D-Vd vs Vd: 46.
1 versus 32.
9%), anaemia (16.
0 versus 16.
0%), neutropenia (13.
6 versus 4.
6%), lymphopenia (10.
3 versus 2.
5 percent), and pneumonia (10.
7 versus 10.
1 percent).
In summary, daratumumab plus bortezomib and dexamethasone significantly prolonged overall survival in patients with relapsed/refractory multiple myeloma who had previously received ≥-1 line therapy
.
Original source:
Pieter Sonneveld, et al.
Overall Survival With Daratumumab, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma (CASTOR): A Randomized, Open-Label, Phase III Trial.
J Clin Oncol.
November, 2022.
https://ascopubs.
org/doi/full/10.
1200/JCO.
21.
02734
