KEY TAKEAWAYS
- The LEAP-008 phase III trial aimed to compare the efficacy and safety of lenvatinib plus pembrolizumab to docetaxel in treating metastatic NSCLC.
- The primary endpoints were OS and PFS.
- The combination failed to improve efficacy over docetaxel in advanced NSCLC after prior anti-PD-(L)1 and platinum therapy, highlighting the need for more effective treatments.
Lenvatinib plus pembrolizumab (len + pembro) has demonstrated effectiveness in advanced melanoma and renal cell carcinoma patients who experienced progression on a PD-(L)1 inhibitor.
For a study, researchers aimed to compare the efficacy and safety of len+ pembro to docetaxel(doce) in treating metastatic non-small cell lung cancer(NSCLC) previously unresponsive to PD-(L)1 inhibitor and platinum chemotherapy.
Patients with stage IV squamous or nonsquamous NSCLC, regardless of PD-L1 status, experiencing progression after prior anti-PD-(L)1 therapy and platinum-containing chemotherapy were randomly assigned to three treatment groups: len+pembro, doce, or len alone.
The primary endpoints were overall survival (OS) and progression-free survival (PFS) for len + pembro versus doce. Secondary endpoints included objective response rate (ORR) for len + pembro versus doce, ORR for len + pembro versus len, and safety assessments. The blinded, independent central review evaluated PFS and ORR based on RECIST 1.1 criteria.
The interim analysis 1 (IA1) assessed the superiority of len + pembro over doce for ORR, IA2 for PFS, and the final analysis (FA) for OS. ORR for len + pembro versus len was evaluated at IA2. All reported P values are one-sided.
Among 422 randomized patients, len + pembro did not significantly improve OS, PFS, or ORR compared to doce. The median study follow-up at the FA was 31.8 months (range, 16.5-48.7).
Treatment-related adverse event (TRAE) rates at FA for len + pembro versus doce versus len were 59.7% versus 48.6% versus 57.4% for grade ≥3 and 3.9% versus 1.1% versus 6.4% for grade 5.
The combination failed to improve efficacy over docetaxel in advanced NSCLC after prior anti-PD-(L)1 and platinum therapy, highlighting the need for more effective treatments.
Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/23
Clinical Trial: https://clinicaltrials.gov/study/NCT03976375
Leighl N. Phase 3 LEAP-008 Study: Lenvatinib plus Pembrolizumab versus Docetaxel for Metastatic Non-Small Cell Lung Cancer Progressed on PD-(L)1 Inhibitor and Platinum-Containing Chemotherapy. Abstract Session-650.
