Phase 3 Motesanib Trial for East Asian Patients With NSCLC Misses Primary Endpoint
For this randomized phase 3 study, patients were assigned to motesanib plus paclitaxel and carboplatin (197 patients) or to placebo plus paclitaxel and carboplatin (204 patients).
Among East Asian patients with non–small cell lung cancer (NSCLC), motesanib does not improve progression-free or overall survival (PFS and OS, respectively) when given with paclitaxel and carboplatin, according to research published in the Journal of Clinical Oncology.1
Motesanib (AMG-706) is a selective vascular endothelial growth factor (VEGF) inhibitor; phase 2 trial data suggested that East Asian patients, and not Caucasian patients, might benefit from the drug added to carboplatin and paclitaxel treatment.
For this randomized phase 3 study, patients were assigned to motesanib plus paclitaxel and carboplatin (197 patients) or to placebo plus paclitaxel and carboplatin (204 patients). In the motesanib and placebo groups, median ages were 65 and 64, respectively, 171 and 194 had initial stage IV disease, and 26 and 10 had recurrent disease. The primary endpoint was PFS.
Median PFS was 6.1 months with motesanib vs 5.6 months for placebo (P = .0820); median OS was not reached for motesanib vs 21.6 months for placebo (P = .5514).
The objective response rate (ORR, includes complete response and partial response) was, however, higher in the motesanib group vs placebo (60.1% vs 41.6%, respectively). The duration of response was 5.3 months with motesanib vs 4.1 months with placebo.
Grade 3 or worse adverse events were observed in 86.7% of patients receiving motesanib vs 67.6% with placebo.
The authors concluded that, while motesanib did not improve PFS or OS among East Asian patients with NSCLC, “treatment with motesanib plus [paclitaxel and carboplatin] shows some hypothesis-generating efficacy signals in terms of ORR and [duration of response] versus placebo.”
- Kubota K, Yoshioka H, Oshita F, et al. Phase III, randomized, placebo-controlled, double-blind trial of motesanib (AMG-706) in combination with paclitaxel and carboplatin in East Asian patients with advanced nonsquamous non–small-cell lung cancer. J Clin Oncol. 2017 Sep 13. doi: 10.1200/JCO.2017.72.7297 [Epub ahead of print]