Vibostolimab/Pembrolizumab Fails to Reach Statistical Significance in NSCLC
The combination of vibostolimab and pembrolizumab plus docetaxel did not significantly improve progression-free survival compared with docetaxel monotherapy in patients with previously treated metastatic non–small cell lung cancer.
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Vibostolimab, an anti-TGIT antibody, and pembrolizumab (Keytruda) plus docetaxel improved progression-free survival (PFS) by 2.4 months compared with docetaxel alone in patients with previously treated metastatic non–small cell lung cancer (NSCLC); however, the results were not statistically significant, according to findings presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2023.1,2
Findings from the KeyVibe-002 trial (NCT04725188) showed that vibostolimab with pembrolizumab and docetaxel demonstrated a median PFS of 5.6 months compared with 3.2 months with docetaxel alone (HR, 0.77; 95% CI, 0.53-1.13; P =.0910). Further, the combination of vibostolimab and pembrolizumab alone did not increase median PFS compared with docetaxel alone (2.7 months v 3.2 months [HR, 1.40; 95% CI, 0.96-2.02; P =.9622).
Investigators also presented data from key secondary end points at ESMO IO. Vibostolimab/pembrolizumab and docetaxel improved overall survival (OS) compared with docetaxel alone at 10.2 months (95% CI, 8.6-14.9) vs 8.8 months (95% CI, 6.4-11.1). However, the improvement also did not meet statistical significance (HR, 0.76; 95% CI, 0.50-1.15). Moreover, vibostolimab and pembrolizumab alone did not improve OS compared with docetaxel alone (7.5 months [95% CI, 5.2-13.4] v 8.8 months; HR, 1.05; 95% CI, 0.70-1.58).
Patients given vibostolimab and pembrolizumab plus docetaxel had an overall response rate (ORR) of 29.9% (95% CI, 20.5%-40.6%). The ORR for vibostolimab and pembrolizumab alone was 6.0% (95% CI, 2.0%-13.5%) and 15.3% (95% CI, 8.4%-24.7%) for docetaxel alone. The median duration of response was 6.5 months (range, 2.1-15.4+ months) with vibostolimab, pembrolizumab, and docetaxel, not reached (NR) with vibostolimab and pembrolizumab alone (range, 2.6-6.2+ months), and NR with docetaxel alone (range, 1.6-11.1+ months).
“This study was designed to evaluate a coformulation of vibostolimab and pembrolizumab in a population of patients who are heavily pre-treated and have progressed following treatment with standard of care therapies, often leaving them with limited treatment options and a poor prognosis,” said Scot Ebbinghaus, MD, vice president, global clinical development, Merck Research Laboratories, in a press release.1 “We will leverage our evolving understanding of novel combinations and coformulations to help inform our comprehensive research program evaluating this coformulation across a wide range of tumor types.”
Regarding safety, no new safety signals were identified, and the safety profiles were consistent with the known profiles of the individual agents. Immune-mediate adverse events (AEs) and infusion reactions were observed in 29.4% of patients in the vibostolimab/pembrolizumab plus docetaxel arm, 20.5% in the vibostolimab/pembrolizumab arm, and 12% in the docetaxel arm.
Treatment-related deaths occurred in 4 patients in the vibostolimab/pembrolizumab plus docetaxel arm and 1 patient each in the vibostolimab/pembrolizumab and docetaxel arms. All-grade treatment-related AEs (TRAEs) occurred in 60.2% of the vibostolimab/pembrolizumab only arm, 89.2% of the docetaxel arm, and 96.5% of the vibostolimab/pembrolizumab plus docetaxel arm.
The most common grade 3 or higher TRAEs in the vibostolimab/pembrolizumab plus docetaxel arm were neutropenia (16.5%), anemia (7.1%), and asthenia (4.7%). For the vibostolimab and pembrolizumab arm, the most common grade 3 or higher TRAEs were asthenia (2.4%) and diarrhea (2.4%). Further, neutropenia (14.5%) and anemia (6.0%) were the most common severe TRAEs in the docetaxel arm.1,2
