BeiGene reports positive Phase III interim analysis for lung cancer drug

Although it didn’t disclose data for the study, the Beijing-based biotech company said it planned to seek Chinese approval for tislelizumab in first-line, non-squamous non-small-cell lung cancer. The drug is in several Phase III trials, including in the U.S.

Interim results from a Phase III clinical trial have shown that patients receiving a cancer immunotherapy drug for a form of lung cancer on top of chemotherapy were more likely than those receiving chemotherapy alone to survive without their disease worsening, the company developing the drug said Monday.

Beijing-based BeiGene reported an improvement in progression-free survival (PFS) among first-line patients with non-squamous non-small-cell lung cancer (NSCLC) receiving tislelizumab along with platinum chemotherapy and pemetrexed, compared with those receiving chemotherapy and pemetrexed alone. However, it did not disclose the data.

The company said it plans to file for approval of the drug with Chinese drug regulators and present data from the study at upcoming medical conferences. Shares of BeiGene were up around 6% on the Nasdaq in Tuesday afternoon trading, following the after-hours announcement.

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

BeiGene has already filed for approval of the drug in China for relapsed or refractory Hodgkin’s lymphoma, previously treated or metastatic urothelial carcinoma, solid tumors that carry the microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) biomarkers and others. The drug is also in several global Phase III trials.

In the U.S., Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) are approved PD-1 checkpoint inhibitors, while there are also several approved PD-L1 checkpoint inhibitors, which are similar but have a somewhat different mechanism of action. Opdivo and Keytruda are approved for Hodgkin’s lymphoma and various NSCLC indications, while Keytruda is approved for solid tumors with the MSI-H or dMMR biomarker, which in the case of the former biomarker must be unresectable or metastatic.

BeiGene has not yet filed for approval of tislelizumab in the U.S., and the aforementioned NSCLC trial only has sites in China. However, several of its other Phase III trials of the drug include sites in the U.S. It also won Food and Drug Administration approval in November for Brukinsa (zanubrutinib), a BTK inhibitor, for previously treated mantle cell lymphoma.

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