The FDA granted accelerated approval to lurbinectedin (Zepzelca, Pharma Mar/Jazz) to treat adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

“Seeing firsthand the aggressive nature of SCLC and knowing that the large majority of those diagnosed will experience relapse, I am excited to see an effective new treatment demonstrating durable responses,” commented Jeff Petty, an oncologist at Wake Forest Baptist Health, in Winston-Salem, N.C. “For doctors, patients and their families, [lurbinectedin] is an important and much-needed addition to the treatment landscape for relapsing SCLC.”

The approval was based on results from the PM1183-B-005-14 trial, also called Study B-005 (ClinicalTrials.gov Identifier: NCT02454972), a multicenter, open-label, single-arm phase 2 study enrolling 105 patients at 26 hospitals in the United States and six European countries. Patients had metastatic SCLC that had progressed during or after platinum-based chemotherapy. 

In the study, both platinum-sensitive and platinum-resistant patients received 3.2 mg/m² of lurbinectedin in an IV infusion over 60 minutes every 21 days until disease progression or unacceptable toxicity. The main efficacy outcome measures were overall response rate (ORR) determined by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and response duration. 

The data, which were reported in The Lancet Oncology (2020;21[5]:645-654) showed that after a median follow-up of 17 months, response was seen in 37 patients (ORR, 35%; 95% CI, 26%-45%), with a median response duration of 5.3 months (95% CI, 4.1-6.4 months). The ORR, per independent review committee, was 30% (95% CI, 22%-40%), with a median response duration of 5.1 months (95% CI, 4.9-6.4 months).

Adverse events (AEs) occurring in at least 20% of patients included constipation; cough; decreased appetite; diarrhea; dyspnea; fatigue; musculoskeletal pain; myelosuppression; nausea; vomiting; increased levels of alanine aminotransferase, aspartate aminotransferase, creatinine and glucose; and decreased levels of albumin, magnesium and sodium.

Serious treatment-related AEs occurred in 11 patients (10%); neutropenia and febrile neutropenia were the most common, occurring in five patients (5%) each. No treatment-related deaths were reported. 

Lurbinectedin treatment was discontinued in 1.9% of patients and was delayed in 30.5% of patients due to an AE. One-fourth of patients required dose reductions because of an AE.

For more information, view the full prescribing information for lurbinectedin. 

Lurbinectedin will be commercially available in the United States in early July.

—Clinical Oncology News Staff

Based on press releases from the FDA and Jazz, and a report in The Lancet Oncology (2020;21[5]:645-654).