Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study
Federico Longo-Muñoz1, Daniel Castellano2, Jerome Alexandre3
1Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain.
Background:
Patients with neuroendocrine tumours (NETs) need alternative therapies after failure of first-line therapy.
Patients And Methods:
This phase II trial evaluated lurbinectedin, a selective inhibitor of oncogenic transcription, at 3.2 mg/m2 as a 1-h intravenous infusion every 3 weeks in 32 NETs patients treated in the second- or third-line setting. The primary efficacy endpoint was overall response rate (ORR) according to RECIST v1.1 assessed by the investigators. Secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety.
Results:
Two of 31 evaluable patients had confirmed partial responses (ORR = 6.5%; 95%CI, 0.8-21.4%). Median DoR was 4.7 months (95% CI, 4.0-5.4 months), median PFS was 1.4 months (95% CI, 1.2-3.0 months) and median OS was 7.4 months (95% CI, 3.4-16.2 months). Lurbinectedin showed an acceptable, predictable and manageable safety profile. The most common grade 3/4 toxicity was neutropenia (40.6%; grade 4, 12.4%; febrile neutropenia, 3.1%).
Conclusions:
Considering the exploratory aim of this trial that evaluated a heterogeneous population of NETs patients, and the signs of antitumour activity observed (two confirmed partial responses and seven long disease stabilisations), further development of lurbinectedin is warranted in a more selected NETs population.
Trial Registration Number:
Sponsor Study Code: PM1183-B-005-14. EudraCT number: 2014-003773-42.
Clinicaltrials:
gov reference: NCT02454972.
Insights
Lurbinectedin showed antitumor activity in neuroendocrine tumors (NETs) patients, with two partial responses observed. Further research in selected NETs populations is recommended due to manageable safety and signs of efficacy.
Area of Science:
- Oncology
- Medical research
- Pharmacology
Background:
- Neuroendocrine tumors (NETs) often require alternative treatments after initial therapies fail.
- Investigating novel therapeutic agents is crucial for improving NETs patient outcomes.
Purpose of the Study:
- To evaluate the efficacy and safety of lurbinectedin in patients with neuroendocrine tumors (NETs) who have progressed on prior treatments.
- To determine the overall response rate (ORR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS) of lurbinectedin in this patient population.
Main Methods:
- A phase II clinical trial was conducted involving 32 NETs patients receiving second- or third-line therapy.
- Lurbinectedin was administered intravenously at 3.2 mg/m² every 3 weeks.
- Efficacy was assessed by investigator-evaluated ORR per RECIST v1.1, with secondary endpoints including DoR, PFS, OS, and safety.
Main Results:
- The overall response rate (ORR) was 6.5% (2 partial responses in 31 evaluable patients).
- Median progression-free survival (PFS) was 1.4 months, and median overall survival (OS) was 7.4 months.
- The most frequent grade 3/4 toxicity was neutropenia (40.6%), with a manageable safety profile.
Conclusions:
- Lurbinectedin demonstrated signs of antitumor activity in a heterogeneous group of NETs patients.
- The drug exhibited an acceptable safety profile.
- Further investigation of lurbinectedin in a more selected NETs population is warranted.
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