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Association details:
| Biomarker: | TP53 wild-type |
|---|---|
| Cancer: | Endometrial Cancer |
| Drug: | Xpovio (selinexor) (XPO1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Karyopharm Announces New Preliminary Data in Overall Survival (OS) in Selinexor-Treated Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer as Part of Pre-Specified Exploratory Subgroup Analysis of the SIENDO Study
Published date:
11/06/2023
Excerpt:
Karyopharm Therapeutics Inc...announced the presentation of updated long-term safety and efficacy data from a pre-specified exploratory subgroup analysis of the SIENDO study (NCT03555422) in patients with advanced or recurrent TP53 wild-type endometrial cancer...an exploratory analysis of a pre-specified subgroup of patients with TP53 wild-type endometrial cancer showed a promising efficacy signal.
Trial ID:
Source:
Title:
264 - Long-Term Follow Up Of Selinexor Maintenance For Patients With TP53wt Advanced Or Recurrent Endometrial Cancer: A Pre-Specified Subgroup Analysis From The Phase 3 ENGOT-EN5/GOG-3055/SIENDO Study
Published date:
09/18/2023
Excerpt:
SIENDO (NCT03555422) was a phase 3 double-blind study evaluating selinexor vs placebo as maintenance in patients with advanced/recurrent EC....Long-term follow-up of a pre-specified subgroup analysis showed durable PFS with selinexor maintenance in TP53wt EC, which offers the potential to prolong prior chemotherapy response.
Trial ID:
Source:
Title:
Selinexor Delays Wild-type TP53 Endometrial Cancer Progression
Published date:
09/06/2023
Excerpt:
In a phase III trial, taking the XPO1 inhibitor selinexor as maintenance therapy was associated with a significant and durable progression-free survival benefit for women with advanced or recurrent TP53 wild-type endometrial cancer-regardless of microsatellite stability.
DOI:
10.1158/2159-8290.CD-NB2023-0054
Source:
Title:
Randomized phase III study of maintenance selinexor versus placebo in endometrial cancer (ENGOT-EN5/GOG-3055/SIENDO): Impact of subgroup analysis and molecular classification.
Published date:
05/26/2022
Excerpt:
Subgroup analysis of pts with TP53wt showed a PFS of 13.7 mo with SEL vs. 3.7 mo with PLB (HR 0.375; 95% CI, 0.210-0.670; nominal p =.0003) and pts with MSS/pMMR disease had a PFS of 6.9 mo with SEL vs. 5.4 with PLB (HR 0.593; 95% CI, 0.388-0.905, nominal p =.007). An analysis of patients with NSMP (p53wt, MSS) showed a substantial difference in PFS for SEL vs. PLB: medians NR and 3.71 months, respectively (HR 0.163; 95% CI, 0.060-0.444; nominal p <.0001)....SEL showed improved PFS over PLB in the SIENDO study based on the stratification adjusted analysis. As an indirect p53 activator, preliminary exploratory subgroup analyses of SEL showed improvement over PLB amongst the patients with TP53wt, MSS, and the NSMP EC comprising approximately 50% of patients with advanced/recurrent EC.
DOI:
10.1200/JCO.2022.40.16_suppl.5511
Trial ID:
Source:
Title:
Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Excerpt:
...- TP53 wt assessed by next generation sequencing (NGS), evaluated by a central vendor....
Trial ID:
Source:
Title:
A MULTICENTER TRIAL OF SELINEXOR IN MAINTENANCE THERAPY FOR PATIENTS WITH ENDOMETRIAL CARCINOMA ENSAYO MULTICÉNTRICO DE SELINEXOR COMO TERAPIA DE MANTENIMIENTO PARA PACIENTES CON CÁNCER DE ENDOMETRIO
Excerpt:
...TP53 wt assessed by NGS, evaluated by a central vendor.4. ...
Trial ID:
