Clinical benefit and predictors of response to momelotinib after ruxolitinib failure: A cooperative real-world study.
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Palandri Francesca, Marchetti Monia, Elli Elena M, Isidori Alessandro, Gianesello Ilaria, Sartor Chiara, Pugliese Novella, Di Perna Maria, Morsia Erika, Gallo Susanna, Itri Federico, Montefusco Vittorio, Crisà Elena, Biagi Annalisa, Beggiato Eloise, Mulas Olga, Benevolo Giulia, Abruzzese Elisabetta, Santoro Marco, Iurlo Alessandra, Calistri Elisabetta, Rossi Marco, Martino Bruno, Tiribelli Mario, Fava Carmen, Dizdari Arbana, Crugnola Monica, Duminuco Andrea, Votto Amedeo, Guerzoni Selene, Caocci Giovanni, Pane Fabrizio, Lanza Francesco, Branzanti Filippo, Dedola Alessandra, Salvatore Flavia, Heidel Florian H, Breccia Massimo, Palumbo Giuseppe A, Kuykendall Andrew T, Lucchesi Alessandro, Galimberti Sara
Аннотация
METHODS: This study retrospectively analyzed 221 patients who received momelotinib after ruxolitinib failure by assessing spleen, symptom, and anemia responses, safety, and survival. Logistic regression analyses identified the responses' predictors.
RESULTS: Before momelotinib initiation, all patients had received ruxolitinib for a median of 31.5 months and discontinued as a result of resistance (29.9%), intolerance (48.0%), or both (22.1%). At baseline, all patients started at full dose; 97.3% presented with cytopenia, 34.8% presented with large splenomegaly, and 43.9% were highly symptomatic. Most patients (74.7%) switched from ruxolitinib stop to momelotinib within 2 months without tapering, whereas 18.1% waited over a year. After a median exposure of 8.2 months, adverse events occurred in 35.7% of patients, which prompted dose reductions or permanent discontinuation in 12.7% and 19.9% of cases, respectively. At 6 months, 30.0% achieved ≥50% spleen length reduction (SR50), with higher responses in those with prior SR50 to ruxolitinib and shorter transition intervals. Symptom and anemia responses occurred in 39.2% and 63.4% of cases, respectively. After a median follow-up of 10.3 months, 11 patients (5.0%) progressed to blast phase, and 37 patients (16.7%) died. Two-year overall and progression-free survival (including death and blast phase transformation) were 60.9% and 59.0%, respectively.
CONCLUSIONS: Momelotinib demonstrated meaningful clinical benefit and acceptable safety in cytopenic patients pretreated with ruxolitinib, which supports its role after ruxolitinib failure.