The Phase 3 SKYSCRAPER-01 trial, evaluating tisotumab vedotin in combination with pembrolizumab and platinum-based chemotherapy for the first-line treatment of advanced non-small cell lung cancer (NSCLC), has failed to meet its primary endpoint of overall survival (OS). The study, which aimed to improve outcomes in this challenging patient population, did not demonstrate a statistically significant improvement in OS with the addition of tisotumab vedotin to the chemotherapy and pembrolizumab regimen.
In addition to the primary endpoint, the trial also assessed progression-free survival (PFS) and objective response rate (ORR) as secondary endpoints. Similar to the OS results, no statistically significant improvements were observed in either PFS or ORR with the addition of tisotumab vedotin. These findings suggest that the addition of tisotumab vedotin to pembrolizumab and platinum chemotherapy did not provide a clinical benefit in this setting.
Tisotumab vedotin is an antibody-drug conjugate (ADC) that targets tissue factor (TF), a protein often overexpressed in various solid tumors. The drug is designed to deliver a cytotoxic payload directly to cancer cells expressing TF, potentially minimizing off-target effects. While the SKYSCRAPER-01 trial did not yield positive results in NSCLC, tisotumab vedotin continues to be investigated in other solid tumors.
Detailed results from the SKYSCRAPER-01 trial will be presented at an upcoming medical meeting. These results will provide further insights into the study's findings, including subgroup analyses and safety data. The data will be crucial for understanding the potential role of tisotumab vedotin in cancer treatment and for guiding future research efforts.
While this trial's outcome is a setback for the specific combination studied, ongoing research continues to explore the potential of tisotumab vedotin in other cancer types. The development of novel therapeutic strategies remains crucial for improving outcomes in patients with advanced malignancies.
