Ps1425 Results of the Daratumumab Monotherapy Early Access Treatment Protocol (Eap) in Patients From Europe and Russia With Relapsed or Refractory Multiple Myeloma

Abstract

either 0, 1, 2, 3 or 4 CRAB features at initial presentation, with a score of 0 denoting a diagnosis of smouldering myeloma. We then studied the relationship between CRAB score and overall survival using Kaplan Meier curves plotted by the statistics programme SPSS. Results: Our analysis reveals that each additional CRAB feature confers a stepwise statistically significant poorer outcome in terms of overall survival as shown in Figure 1a. This result was regardless of the treatment regimen the patient received and gave 5-year survival percentages of 81%, 58%, 41%, 22% and 0% for patients with CRAB scores 0-4 respectively. We also found CRAB score to have coherence with the current International Staging System (ISS) scoring system, which combines serum albumin as a measure of general patient health with β2-microglobulin as a measure of tumour bulk to estimate risk. Cytogenetic data required for the revised ISS score was not undertaken for the majority of patients, highlighting the lack of feasibility of this system in practice, although we did observe higher CRAB scores for those patients identified with poor risk chromosomal abnormalities. A trend for higher ISS score with higher CRAB score was observed, further validating the CRAB scoring system (figure 1b). Summary/Conclusion: Our study shows that the CRAB score yields accurate prognostic predictions for patients with newly diagnosed multiple myeloma based on simple clinical criteria. It has more prognostic categories than the currently used ISS score (5 versus 3) and superior clinical utility than expensive and time-consuming cytogenetic-based scoring systems that have been recently described. These results indicate that the CRAB score may provide a useful and reliable tool to guide prognostic evaluation in newly diagnosed myeloma patients, requiring only routine laboratory testing to be undertaken, and therefore greater availability to patients in diverse clinical settings.

Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myeloma

“…3 A pooled analysis of these monotherapy studies showed an overall response rate (ORR) of 31.1%, median progression-free survival (PFS) of 4.0 months, median overall survival (OS) of 20.1 months, and a manageable toxicity profile for patients treated with daratumumab at 16 mg/kg. 10 The efficacy and favorable tolerability of daratumumab monotherapy has been consistently reported from recent real-world studies performed in countries such as the United States, Korea, Poland, Spain, Italy, Russia, the United Kingdom, Hungary, and Japan, with the ORR ranging from 23% to 56.3% [11][12][13][14][15][16][17] ( Table 1).…”

“…14 The results from a pooled analysis of 293 heavily pretreated patients with RRMM enrolled in the MMY3010 EAP of daratumumab monotherapy from Spain, Italy, Russia, and the United Kingdom revealed a similar ORR of 33.1% (VGPR in 12.3%, CR or better in 2.7%) after a median follow-up of 6.3 months. 15 In addition, the median PFS was 4.63 months, and the estimated 6month PFS rate was 42.9%. 15 The investigators emphasized that the pooled analysis had confirmed the safety profile and efficacy of DARA monotherapy in patients with heavily pretreated RRMM, without identification of new safety concerns and with maintenance of health-related quality of life during a median of 4.2 months of daratumumab treatment.…”

“…Salomon-Perzy nski et al 13 Cejalvo et al 14 Cook et al 15 Lovas et al 16 Iida et al 17 Present Study (Turkish Cohort)…”

“…Hence, our findings indicate that daratumumab monotherapy is an effective and tolerable treatment option for RRMM in Turkish patients, similar to that consistently reported in recent real-world studies from other countries. [11][12][13][14][15][16][17] The findings from the US cohort of a multicenter, open-label, daratumumab EAP study of patients with RRMM and ! 3 previous therapy lines revealed an ORR of 23% (PR in 18%, VGPR in 5%, stringent CR in 0.6%).…”

“…15 The investigators emphasized that the pooled analysis had confirmed the safety profile and efficacy of DARA monotherapy in patients with heavily pretreated RRMM, without identification of new safety concerns and with maintenance of health-related quality of life during a median of 4.2 months of daratumumab treatment. 15 In another real-world retrospective analysis of 99 patients with RRMM with a median of 3 previous therapy lines from Hungarian centers, the ORR was assessable for 88 patients (CR, 13.6%; VGPR, 11.4%; PR, 38.6%). 16 In the Hungarian cohort, 48 of 99 patients had received monotherapy with dexamethasone only; for the others, either bortezomib or lenalidomide was combined.…”