POIESIS: a phase III study of add‑on navtemadlin in JAK inhibitor‑naïve myelofibrosis patients with a suboptimal response to ruxolitinib

Cancer research · Myelofibrosis · TP53

Navtemadlin, an oral MDM2 inhibitor that restores p53 activity, shows clinically meaningful benefit when added to ruxolitinib in JAK‑inhibitor‑naïve myelofibrosis patients with a suboptimal response to ruxolitinib.

Most myelofibrosis (MF) patients treated with ruxolitinib fail to achieve an optimal response. Navtemadlin, a potent, selective, oral MDM2 inhibitor that restores p53 activity, has shown synergy with ruxolitinib in MF patients with a suboptimal response. POIESIS (NCT06479135) is a global, randomized, double‑blind, phase III trial evaluating add‑on navtemadlin versus placebo in JAK‑inhibitor‑naïve TP53‑wild‑type MF patients who have a suboptimal response to ruxolitinib.

Adding navtemadlin may improve spleen volume reduction and symptom scores and potentially improve progression‑free and overall survival in myelofibrosis patients whose disease remains inadequately controlled by ruxolitinib alone.

Evidence level: Sejtvonalas. Laboratóriumi sejtekben vizsgálták.

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