Positive interim results from phase III trial of tislelizumab in patients with first-line squamous NSCLC.- BeiGene

BeiGene, Ltd. announced that the pivotal Phase III trial evaluating its anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens for the first-line treatment of patients with squamous non-small cell lung cancer (NSCLC), met the primary endpoint of improved progression-free survival (PFS) at the planned interim analysis, as assessed by independent review committee (IRC).

In this study, patients with previously untreated advanced squamous NSCLC were randomized to receive either tislelizumab in combination with paclitaxel and carboplatin, tislelizumab in combination with nanoparticle albumin-bound (nab) paclitaxel (Abraxane) and carboplatin, or paclitaxel and carboplatin alone. Based on the pre-planned interim analysis, both tislelizumab treatment arms crossed the pre-specified efficacy boundary compared to chemotherapy alone. The safety profile of tislelizumab in both combinations in this trial was consistent with the known risks of each study treatment, and no new safety signals were identified.

�Tislelizumab was recently approved in China for patients with relapsed or refractory classical Hodgkin�s lymphoma, and we have a broad development program with more than 5,000 patients enrolled in over 25 tislelizumab studies, including 15 potentially registration-enabling trials,� commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. �We are extremely excited about the compelling results that tislelizumab demonstrated in this Phase III trial and for its potential use as a first-line treatment for patients in China with advanced squamous NSCLC. We look forward to continuing the development program for tislelizumab in lung cancer, which includes three other Phase III trials, and reporting additional data.�

The company plans to discuss its plans for filing a supplemental new drug application (sNDA) for tislelizumab as a first-line treatment for squamous NSCLC with the Center for Drug Evaluation (CDE) at the National Medical Products Administration (NMPA) in China and to present these data at an upcoming medical meeting.