The Food and Drug Administration has approved Zepzelca™ (lurbinectedin; Jazz Pharmaceuticals) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
The approval of lurbinectedin, an alkylating drug, was based on data from a single-arm phase 2 study (NCT02454972) involving patients with advanced or metastatic solid tumors. A cohort of patients with SCLC and disease progression on or after platinum-based chemotherapy received lurbinectedin by intravenous infusion every 21 days (n=105). The primary efficacy outcome was overall response rate (ORR).
Results showed an ORR of 35% (95% CI, 26-45) in the overall population, 45% (95% CI, 32-58) in patients with sensitive disease (chemotherapy free interval [CTFI] ≥90 days, defined as recurrence or progression ≥90 days after the last dose of platinum-containing therapy) and 22% (95% CI, 11-37) in patients with resistant disease (CTFI <90 days, defined as recurrence or progression <90 days after the last dose of platinum-containing therapy). Median duration of response was 5.3 months (95% CI, 4.1-6.4) in the overall population; 35% of patients had responses ≥6 months.
With regard to safety, the most common treatment-emergent adverse events observed were leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase (ALT), increased glucose, thrombocytopenia, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase (AST), vomiting, cough, decreased magnesium and diarrhea.
In clinical studies involving 554 patients treated with lurbinectedin, Grade 3 or 4 neutropenia occurred in 41% of patients, with a median time to onset of 15 days and a median duration of 7 days. Additionally, Grade 3 elevations of ALT and AST were observed in 6% and 3% of patients, respectively, and Grade 4 elevations of ALT and AST were observed in 0.4% and 0.5% of patients, respectively.
As Zepzelca was approved under accelerated approval based on ORR and duration of response, continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
Zepzelca is supplied as 4mg of lyophilized powder in single-dose vials. It is expected to be available in early July 2020.
For more information visit jazzpharma.com.