Ropeginterferon alfa-2b versus anagrelide for the treatment of essential thrombocythemia: Topline results of the phase 3 SURPASS-ET trial.
Bibliographic record
Abstract
6500 Background: BCR::ABL1 -negative myeloproliferative neoplasms (MPNs), including essential thrombocythemia (ET), polycythemia vera (PV) and myelofibrosis (MF). No new treatments have been approved for ET in the US since anagrelide in 1997. Ropeginterferon alfa-2b (ropeg) is an anti-clonal interferon-based therapy approved by the FDA and globally for PV, providing the rationale for evaluation in ET and other MPNs. Methods: SURPASS ET is an open-label, multicenter, Phase III trial comparing ropeg with anagrelide over 12 months in patients with ET who were hydroxyurea-resistant or-intolerant. A total of 174 patients were randomized in a 1:1 ratio to receive ropeg or anagrelide. Ropeg was administered at 250 mcg at Week 0 titrating to 350 mcg at Week 2 and 500 mcg from Week 4 if tolerated. The primary endpoint was the rate of response, as defined by the Modified European LeukemiaNet response criteria, at both Months 9 and 12. Secondary endpoint assessments included JAK2 V617F allele burden, MPN-associated symptoms, thromboembolic events, spleen size, and safety. Results: Baseline patient characteristics were balanced across treatment arms (Table 1). The primary endpoint was achieved in 42.9% of patients in the ropeg arm versus 6.0% in the anagrelide arm (p=0.0001). Ropeg showed response improvements by each parameter: 1) Platelets ≤400x10 9 /L and white blood cells <9.5x10 9 /L: 56.0% vs. 6.0%. 2) Improvement or stabilization of splenomegaly: 87.9% vs. 54.2%. 3) Symptom improvement or stabilization: 71.4% vs. 33.7%. 4) Absence of hemorrhagic/thrombotic events: 84.6% vs. 51.8%. ET-related major thrombotic and cardiovascular events occurred in 1 (1.1%), and 0 patients in the ropeg arm vs. 7 (8.8%) and 6 (7.5%) patients, respectively, in the anagrelide arm. Mean JAK2 V617F allelic burden decreased from 33.7% at baseline to 25.3% at 12 months (ropeg arm) vs. 39.7% to 37.3% (anagrelide arm). Ropeg showed lower rate of adverse event (AE)-related discontinuation (5.5% vs.18.8%) and treatment-related serious AEs (2.2% vs. 10.0%). Conclusions: Ropeg showed superior efficacy and safety compared to anagrelide as second-line therapy for ET. It represents a potential new therapeutic option for ET. Clinical trial information: NCT04285086 . Patient demographics and baseline characteristics. Ropeg (n*=91) Anagrelide (n=83) Total (N=174) Age, y 61 (21-80) 64 (20-83) 63 (20-83) Race, x (%)CaucasianAsian 586 281 7167 Gender, x (%)FemaleMale 47 (52)44 (48) 44 (53)39 (47) 91 (52)83 (48) Total symptom score at baseline (MPN-SAF) 9 (0, 71) 9 (0, 74) 9 (0. 74) Spleen length by ultrasound, cm 13.1 (5.2-16.3) 15.2 (9.2-23.4) 13.9 (5.2-23.4) Leukocytes, x10 9 /L 11.4 (7.2-47.7) 11.6 (7.2-75.9) 11.5 (7.2-75.9) Platelets, x10 9 /L 942 (384-2132) 870 (406-4199) 925 (397-4199) JAK2 V617F, x (%) 72 (79) 70 (84) 142 (82) CALR exon 9, x (%) 11 (12) 10 (12) 21 (12) *n (%) presented for categorical variables. Median (range) for continuous variables.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".