FDA Grants Priority Review to Lurbinectedin for Patients with Small Cell Lung Cancer
The Food and Drug Administration granted a priority review to the new drug application for lurbinectedin to treat patients with small cell lung cancer.
BY Kristie L. Kahl
PUBLISHED February 18, 2020
The Food and Drug Administration (FDA) granted a priority review designation to lurbinectedin to treat patients with small cell lung cancer (SCLC) who have progressed following platinum-containing therapy, according to PharmaMar and Jazz Pharmaceuticals.
The designation is based on findings from a multicenter, single-arm phase 2 basket trial, designed to evaluate the safety and efficacy of lurbinectedin in patients across advanced several solid tumors, including SCLC.
Treatment with lurbinectedin induced a 35.2% overall response rate, which consisted of all partial responses occurring in 37 of 105 patients. An additional 35 patients had stable disease, leading to a disease control rate of 68.6%.
Overall, 65% of patients had a decrease in tumor size and responses occurred in five of eight patients who had failed prior immunotherapy. Twenty-eight patients (26.7%) had progressive disease and five patients were not evaluable.
The median duration of response was 5.3 months. The response rate was higher in patients with platinum-sensitive disease, where the overall response rate was 45% compared with 22.2% in patients with resistant disease.
Overall, the median progression-free survival (the time from treatment to disease progression or worsening) was 3.9 months and the six-month progression-free survival rate was 33.6%. In the chemotherapy-sensitive subgroup, the median progression-free survival was 4.6 months and the six-month progression-free survival rate was 44.6%. In the resistant population, the median progression-free survival was 2.6 months and the six-month progression-free survival rate was 18.8 months.
At a median follow-up of 17.1 months, the median overall survival was 9.3 months and the 12-month overall survival rate was 34.2%. The median overall survival was 11.9 months in sensitive patients versus five months in resistant patients.
The most common grade 1/2 side effects were fatigue (51.4%), nausea (32.4%), decreased appetite (21.0%), vomiting (18.1%), diarrhea (12.4%), constipation (9.5%), and neutropenia (5.7%). Grade 3/4 AEs included neutropenia (22.9%), anemia (6.7%), fatigue (6.7%), thrombocytopenia (4.8%), febrile neutropenia (4.8%), pneumonia (1.9%), increased alanine aminotransferase level (1.9%), skin ulcer (1.0%) and diarrhea (1.0%).
The agency is set to make its decision by Aug. 16, 2020.