Tislelizumab hits Phase III goals in NSCLC trial

The pivotal Phase III trial evaluating Sino-America biotech firm BeiGene’s (Nasdaq: BGNE) 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), the company announced today.

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 previously partnered with Celgene, but BeiGene regained full rights to the drug in June this year, as the US biotech accepted a $74 billion takeover offer from Bristol-Myers Squibb (NYSE: BMY), which had little interest in the product.