[{"orgOrder":0,"company":"Athenex","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Athenex Provides an Update on Oral Paclitaxel FDA Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Athenex","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Athenex Announces Acceptance of Oral Paclitaxel Phase II Study in Angiosarcoma Abstract at ASCO20 Virtual Scientific Program","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase 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III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Athenex","sponsor":"Merck & Co","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Athenex Announces Clinical Collaboration with Merck to Evaluate Oraxol Plus KEYTRUDA\u00ae (pembrolizumab) in Patients with Non-Small Cell Lung Cancer (NSCLC)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Athenex","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Athenex Presents Data from Oral Paclitaxel + Pembrolizumab Phase 1 Study at ESMO 2021","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Athenex","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Athenex to Present Subgroup Analysis from Phase 3 Study of Oral Paclitaxel Plus Encequidar (KX-ORAX-001) in Metastatic Breast Cancer at SABCS 2021","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Athenex","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Athenex Announces Publication of Data from Phase 3 Study Comparing Oral 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Find Clinical Drug Pipeline Developments & Deals for Encequidar
Oral paclitaxel, relative to intravenous paclitaxel, was associated with less neuropathy and was not associated with an increase in febrile neutropenia.
The publication of phase 3 data, which show that oral Taxol (paclitaxel) plus encequidar significantly improves tumor response in patients with metastatic breast cancer, compared to IV administration.
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.
Post hoc analysis of this subgroup of patients with hepatic impairment was conducted and showed a median survival rate of 18.9 months in patients treated with Oral Paclitaxel.
The primary objective for dose escalation phase of the study was to determine the maximum tolerated dose (MTD) and identify the recommended Phase 2 dose (RP2D) of Oraxol (Oral Paclitaxel + Encequidar) in combination with pembrolizumab in patients with advanced solid tumors.
In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm.
Data presented at SABCS indicates benefits of oral paclitaxel and encequidar (oral paclitaxel) versus IV paclitaxel (IVP) on Progression-Free Survival (PFS) and on Overall Survival (OS), which supports superiority on the primary endpoint Overall Response Rate (ORR).
Presentations will include data from the pivotal Phase 3 clinical trial of oral paclitaxel in metastatic breast cancer, a spotlight poster on progression-free survival and overall survival, and posters on neuropathy (CIPN), and management of gastrointestinal side effects.
The Oral Paclitaxel NDA submission is supported by data from a single pivotal Phase III study of Oral Paclitaxel for the treatment of metastatic breast cancer.
The Company expects the proceeds from the financing will be used to fund the commercial launch of oral paclitaxel and encequidar (Oral Paclitaxel), ongoing pipeline development, manufacturing infrastructure, and working capital and general corporate purposes.
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