Athenex, Inc. announced a clinical trial collaboration and supply agreement with Merck. The agreement applies to the expansion phase of the Phase 1 clinical trial evaluating Athenex's oral paclitaxel in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for certain NSCLC patients. The agreement will support the expansion phase of the trial to further investigate the preliminary encouraging results of the KX-ORAX-011 Phase 1 clinical trial evaluating Oraxol (encequidar plus oral paclitaxel) in combination with pembrolizumab for certain NSCLC patients.

The two companies will form a Joint Development Committee to review the clinical trial results. KX-ORAX-011 is an ongoing Phase 1 trial evaluating Oraxol in combination with pembrolizumab in patients with advanced solid tumors. Following completion of the dose escalation phase, the expansion phase is currently evaluating the combination therapy in patients with NSCLC who progressed on previous anti-PD1/anti-PD-L1 therapy or in combination with chemotherapy.

The NSCLC expansion cohort is actively recruiting and aims to enroll approximately 50 patients.