Trial results for lurbinectedin monotherapy in participants with advanced or metastatic solid tumors were posted on ClinicalTrials.gov on 2025-02-28. The Phase 2 study reported an objective response rate (ORR) of 2 participants in the Poorly Differentiated Neuroendocrine Carcinomas cohort and 1 participant in the Homologous Recombination Deficient-Positive Malignancies Agnostic cohort.
Background
Lurbinectedin was investigated in patients with various advanced or metastatic solid tumors, including Urothelial Cancer, Poorly Differentiated Neuroendocrine Carcinomas, and Homologous Recombination Deficient-Positive Malignancies Agnostic.
Trial design
The open-label, multicenter, Phase 2 study (NCT05126433) evaluated lurbinectedin monotherapy in 47 enrolled participants with advanced or metastatic solid tumors. The trial included cohorts for Urothelial Cancer (UC), Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC), and Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD). The study was terminated.
Key results
Key efficacy outcomes were assessed by investigators according to RECIST v.1.1:
- Objective Response Rate (ORR):
- Urothelial Cancer (UC) Cohort: 0 Participants
- Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort: 2 Participants
- Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort: 1 Participant
- Progression Free Survival (PFS):
- Urothelial Cancer (UC) Cohort: Median 1.46 months (95% Confidence Interval)
- Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort: Median 2.07 months (95% Confidence Interval)
- Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort: Median 1.38 months (95% Confidence Interval)
- Time-To-Response (TTR):
- Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort: Median 2.76 months (Full Range)
- Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort: Median 1.31 months (Full Range)
- Duration of Response (DOR):
- Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort: Median 5.67 months (Full Range)
- Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort: Median 2.79 months (Full Range)
- Disease Control Rate (DCR):
- Urothelial Cancer (UC) Cohort: 4 Participants
- Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort: 5 Participants
What this means
The results from this Phase 2 trial indicate limited objective responses to lurbinectedin monotherapy across the studied advanced solid tumor cohorts. While some responses were observed in the Poorly Differentiated Neuroendocrine Carcinomas and Homologous Recombination Deficient-Positive Malignancies Agnostic cohorts, the overall objective response rates were low, and median progression-free survival was short, ranging from 1.38 to 2.07 months. The termination of the study further suggests that lurbinectedin monotherapy may not offer substantial clinical benefit in these specific advanced solid tumor populations.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05126433, titled "Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors," were posted on 2025-02-28 on clinicaltrials.gov.