Phase III CONTACT-01 trial of Cabometyx + Tecentriq fails to meet primary endpoint in metastatic non-small cell lung cancer.- Exelixis
Exelixis announced that the CONTACT-01 study did not meet its primary endpoint of overall survival at the final analysis. CONTACT-01 is a phase III trial evaluating Cabometyx (cabozantinib) in combination with Tecentriq (atezolizumab) versus docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) without actionable mutations who experienced disease progression on or after treatment with an immune checkpoint inhibitor and platinum-containing chemotherapy.
The safety profile of the combination of cabozantinib and atezolizumab observed in the trial was consistent with the known safety profiles for each single agent, and no new safety signals were identified. Detailed findings from CONTACT-01 will be submitted for presentation at a future medical meeting.
CONTACT-01 is a global, multicenter, randomized, phase III, open-label study that enrolled 366 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of docetaxel. The study enrolled patients with both squamous and non-squamous NSCLC who progressed during or following anti-PD-1/PD-L1 therapy administered either concurrently or sequentially with chemotherapy. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, objective response rate and duration of response. Results from cohort 7 of the phase Ib COSMIC-021 trial informed the CONTACT-01 trial design.