Good to Know > Athenex & Merck to Evaluate Oraxol Plus Pembrolizumab in Non-Small Cell Lung Cancer

Athenex & Merck to Evaluate Oraxol Plus Pembrolizumab in Non-Small Cell Lung Cancer

Athenex announced a collaboration with Merck for a clinical trial to study the efficacy of Oraxol with Keytruda (Pembrolizumab) for the treatment of patients with Non-Small Cell Lung Cancer.


A global pharmaceutical company, Athenex, announced its collaboration with Merck on May 16, 2022, for the evaluation of Oraxol in combination with Keytruda (Pembrolizumab) for the treatment of people diagnosed with non-small cell lung cancer using a clinical trial. Their agreement majorly puts light on the expansion of Phase 1 clinical trial being conducted for the evaluation of the two compositions in NSCLC. It is based on the encouraging outcomes of Phase 1 clinical trial KX-ORAX-011 which studied encequidar plus oral paclitaxel administered to patients with NSCLC in combination with pembrolizumab.


In patients with advanced solid tumors, the KX-ORAX-011 study is assessing Oraxol in conjunction with pembrolizumab. The expansion phase is presently evaluating the combination therapy in patients with NSCLC whose tumors have progressed on previous anti-PD1/ anti-PD-L1 therapy or in combination with chemotherapy after the dose-escalation phase. The NSCLC expansion cohort is currently recruiting patients and hopes to enroll about 50 people.


Adults aged 18 to 99 are eligible to participate in the study. Participants in the dose-escalation phase must have histologically confirmed metastatic or unresectable solid tumors, whereas those in the dose-expansion phase must have a histologically confirmed diagnosis of gastric/gastroesophageal adenocarcinoma, metastatic urothelial carcinoma, or NSCLC. Patients in the dose-expansion group must have stable disease or have tumors progressed on anti-PD-L1 therapy that has previously failed.


Patients must also have tumors progressed through or become intolerant of at least one line of systemic chemotherapy for metastatic or advanced disease, have at least one measurable site of disease as defined by RECIST 1.1 criteria, have an ECOG performance status of 1 or higher, and have adequate hematology, blood chemistry, liver function, and renal function. Participants must also adhere to regular appointments, treatment programs, and laboratory testing, as well as have a 3-month life expectancy.


About Oraxol (paclitaxel/encequidar)

Oraxol is a co-formulation of HM30181 methanesulfonate, an oral tablet, and paclitaxel capsules. HM30181 is a medication that aids in the absorption of paclitaxel for cancer treatment.


About Keytruda (Pembrolizumab)

Keytruda is a formulation of a monoclonal antibody namely Pembrolizumab. It is approved by the US FDA for the treatment of patients diagnosed with metastatic or recurrent cervical cancer. It is also used to treat a type of skin cancer known as melanoma, lung cancer, and head and neck squamous cell tumor.