Study to Investigate Oraxol Plus Pembrolizumab in NSCLC

A collaboration between Merck and Athenex, Inc. has been announced to evaluate oraxol plus pembrolizumab in certain patients with non-small cell lung cancer.

The combination oraxol (paclitaxel plus HM30181A) and pembrolizumab (Keytruda) for certain patients with non-small cell lung cancer (NSCLC) will be investigated in a study as part of a collaboration between Merck and Athenex, Inc, according to an announcement.

The agreement follows encouraging preliminary results from the phase 1 KX-ORAX-011 (NCT03588039) and will support the expansion phase of the trial. A joint development committee to further investigate and review the clinical trial results will also be put in place by the companies.

“We are keen to collaborate with Merck to further investigate the therapeutic potential of Oraxol plus Keytruda in patients with NSCLC patients who progressed on previous anti-PD1/ anti-PD-L1 therapy or in combination with chemotherapy,” stated Rudolf Kwan, MD, chief medical officer of Athenex, Inc., in the press release. “If the preliminary efficacy and safety data can be confirmed, it may lead to a new paradigm in the treatment of certain NSCLC patients.”

The ongoing KX-ORAX-011 trial is an open-label study evaluating oraxol administered in combination with pembrolizumab. The study consists of 2 parts including both a dose-escalation and dose-expansion portion and aims to enroll approximately 50 patients within the trial.

Within the dose-escalation part, subjects with advanced solid tumors will be enrolled in order to determine the maximum tolerated dose and the recommended phase 2 dose of the combination. Following this, the dose-expansion part will enroll subjects with advanced/metastatic urothelial, gastric/gastro-esophageal, or NSCLC into 3 independent arms. Here, the study will further evaluate the activity and safety of the combination of oraxol and pembrolizumab.

Those eligible for enrollment in the trial are patients 18-99 years of age. Those enrolled in the dose-escalation portion of the study must have histologically confirmed metastatic or unresectable solid tumors while those in the dose expansion portion are required to have a histologically confirmed diagnosis of advanced or metastatic urothelial carcinoma, gastric/gastro-esophageal adenocarcinoma or NSCLC. Patients in the dose-expansion portion must have stable disease or have progressed on previously failed anti-PD1 or anti-PD-L1 therapy

Patients are also required to have previously progressed on or become intolerant of at least 1 line of systemic chemotherapy for metastatic or advanced disease, at least 1 measurable site of disease as defined as per RECIST v1.1 criteria, an ECOG performance status of 1 or higher, and adequate hematology, blood chemistry, liver function, and renal function. Further, participants must comply with scheduled visits, treatment plans, and laboratory tests and have a life expectancy of at least 3 months.

Besides curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder, patients must have no concurrent malignancy. Men enrolled must be sterile or agree to use a condom with spermicide and not donate sperm during the study and for at least 30 days following the last dose of oraxol. Women enrolled must be postmenopausal, surgically sterile, or must be using effective contraception and agree to continue use of contraception for 30 days after their last dose of assigned study treatment.

Primary end points of the trial include determining the maximum tolerated dose and tumor response rate with secondary end points consisting of progression-free survival, overall survival, duration of response, and pharmacokinetics of oraxol.

The NSCLC expansion cohort is actively recruiting and has an estimated primary completion date of March 30, 2023.

  1. Athenex announces clinical collaboration with Merck to evaluate oraxol plus keytruda (pembrolizumab) in patients with non-small cell lung cancer (NSCLC). News Release. Athenex, Inc; May 16, 2022. Accessed May 17, 2022.
  2. Study of oraxol and pembrolizumab in subjects with advanced solid tumors. Accessed May 17, 2022.