BeiGene’s Checkpoint Inhibitor Hits the Mark in Phase III Lung Cancer Study


A preliminary analysis of late-stage trial data shows that BeiGene’s investigational checkpoint inhibitor tislelizumab is hitting the mark as a potential first-line treatment in patients with non-squamous non-small cell lung cancer (NSCLC).

This morning, BeiGene said tislelizumab in combination with pemetrexed and platinum chemotherapy has met the primary endpoint in a Phase III trial in NSCLC. The treatment has demonstrated a statistically significant improvement in progression-free survival (PFS) compared to pemetrexed and platinum chemotherapy alone at the planned interim analysis. The safety profile of tislelizumab in combination with pemetrexed and platinum chemotherapy has remained consistent and no new safety signals were identified, the company said.

The Phase III trial is assessing the combination therapy in patients with previously untreated stage IIIB or stage IV non-squamous NSCLC and with no EGFR mutations or ALK translocations. The primary endpoint of the trial is progression-free survival, with secondary endpoints including overall survival and safety.

Checkpoint inhibitors have proven to be a valuable tool in combating various cancers, with Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo leading the pack. Tislelizumab (BGB-A317) is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. It is being developed as both a monotherapy and as part of a combination treatment for both solid and hematologic tumors.

Earlier this year, BeiGene announced positive results from a pivotal Phase III trial of its anti-PD-1 antibody tislelizumab in combination with two chemotherapy agents in squamous non-small cell lung cancer (NSCLC). In that study, tislelizumab met the primary endpoint of improved progression-free survival.

Yong Ben, chief medical officer of immuno-oncology at BeiGene said the company was excited about the latest Phase III results in NSCLC following the previous positive trial data in squamous NSCLC.

“These results add to our growing body of evidence demonstrating the efficacy and safety of tislelizumab for the treatment of advanced cancers. We look forward to continuing to evaluate tislelizumab in more than 25 studies, including 15 potentially registration-enabling trials,” Ben said in a statement.

Non-small cell lung cancer is the most common form of lung cancer in China. In 2018, there were approximately 770,000 new cases of lung cancer in China and it is the leading cause of cancer-related death in both men and women, with approximately 690,500 deaths.

Shun Lu, a professor at Shanghai Chest Hospital and lead investigator for the Phase III trial, said approximately 60% of lung cancer diagnoses are made when the disease is in advanced stages and patients need more treatment options.

“The positive outcome at interim analysis for tislelizumab in this study and in other clinical trials, including for first-line squamous NSCLC, demonstrate that it is a promising option for people living with this advanced cancer,” Lu said in a statement.

With the strong data from the interim analysis in hand, BeiGene intends to discuss a potential filing for regulatory approval for tislelizumab as a first-line treatment for non-squamous NSCLC in China.

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