BeiGene has reported positive data from the Phase III clinical trial of tislelizumab in combination with chemotherapy as a first-line treatment for squamous non-small cell lung cancer (NSCLC).
Interim data showed that the trial met its primary endpoint of progression-free survival (PFS).
Participants with treatment-naïve advanced squamous NSCLC were treated with tislelizumab in combination with two chemotherapy regimens or chemotherapy alone.
The chemotherapy regimens included a tislelizumab combination with paclitaxel and carboplatin, as well as with nanoparticle albumin-bound (nab) paclitaxel (Abraxane) and carboplatin.
According to the study data, both tislelizumab groups passed a pre-specified efficacy margin compared to chemotherapy-only treatment.
Safety analysis revealed a consistent profile in both combinations, with the known risks of individual therapies and no new safety signals.
BeiGene Immuno-Oncology chief medical officer Yong Ben said: “Tislelizumab was recently approved in China for patients with relapsed or refractory classical Hodgkin’s lymphoma, and we have a broad development programme with more than 5,000 patients enrolled in over 25 tislelizumab studies, including 15 potentially registration-enabling trials.
“We look forward to continuing the development programme for tislelizumab in lung cancer, which includes three other Phase III trials, and reporting additional data.”
Tislelizumab is a humanised IgG4 anti–PD-1 monoclonal antibody designed to reduce binding to FcγR present on macrophages. The drug is being developed to treat various solid tumours and hematologic cancers.
This randomised, open-label, multi-centre Phase III trial assessed 200mg tislelizumab given every three weeks in combination with chemotherapy regimens in a total of 360 stage IIIB or IV squamous NSCLC patients across mainland China.
Based on the trial data, the company is planning to submit a supplemental new drug application (sNDA) to the National Medical Products Administration (NMPA)’s Center for Drug Evaluation (CDE) in China.
Tislelizumab is currently featuring in 15 trials worldwide, including 11 Phase III and four Phase II studies. The company started enrolling patients for Phase III gastric cancer and esophageal cancer trials in December 2018.