BeiGene beefs up PD-1 data with positive PhIII results for tislelizumab, this time in metastatic NSCLC
BeiGene has been angling to disrupt the PD-1 market for quite some time, and on Tuesday appeared to take one step closer.
The Chinese biotech announced that a Phase III study evaluating its PD-(L)1 checkpoint inhibitor tislelizumab in metastatic non-small cell lung cancer met its primary endpoint of overall survival. BeiGene didn’t provide numbers or p-values with Tuesday’s results, but noted that this was the drug’s third Phase III in NSCLC to go positive at the interim readout.
“As we continue to advance tislelizumab in its broad clinical program,” CMO Yong Ben said in a statement, “we expect to see a growing body of clinical evidence that we believe will help further evaluate this potentially differentiated checkpoint inhibitor and support potential regulatory filings in China and globally.”
This trial enrolled 805 patients and compared tislelizumab to docetaxel in the second- or third-line setting for those who had progressed on platinum-based chemotherapy. Patients were randomized 2 to 1 to the drug arm.
BeiGene said that the primary was overall survival in both the intention-to-treat population — those with locally advanced or metastatic NSCLC — and patients with high PD-L1 expression. Though the biotech was also looking at key secondaries such as objective response rate, duration of response and progression-free survival, they did not divulge any details on these data.
In terms of safety, results proved consistent with the “known risks” of the drug, and no new safety signals were detected.
Tislelizumab was the fourth PD-(L)1 inhibitor to be approved by Chinese regulators in the span of about 12 months when it received the green light just before 2019 ended. The drug is also the first to use a foreign partner in Boehringer Ingelheim to be marketed under a reformed contract manufacturing regulatory system.
The initial indication was third-line relapsed/refractory Hodgkin’s lymphoma and it’s since been OK’d in bladder cancers with high PD-(L)1 expression. In addition to metastatic NSCLC, BeiGene is evaluating the drug in combination with chemo for both advanced squamous and non-squamous NSCLC.
Unlike in the metastatic arena, which is for second- or third-line patients, BeiGene is seeking approval in the first-line setting for squamous and non-squamous NSCLC patients.
Data from those indications have proved promising, as the drug hit similar PFS results in both areas earlier this year when compared to chemo alone. At the time, SVB Leerink analyst Andrew Berens took a look at the big picture, predicting that, with approvals already in two areas and positive outcomes in NSCLC, tislelizumab could end up with the broadest label among all Chinese domestic PD-(L)1 agents.
Given that the drug has yet to be approved outside China, that could give BeiGene an advantage against its non-Chinese competitors, Berens said.