Novartis, BeiGene's PD-(L)1 play takes home another win in late-stage data, adding some heft to its market potential
Continuing its quest to shake up the PD-1 market, BeiGene revealed more data Friday for its checkpoint inhibitor tislelizumab, this time in recurrent or metastatic nasopharyngeal cancer.
Revealing interim topline results from a Phase III study, BeiGene said the drug met its primary endpoint of progression-free survival in the first-line setting, combined with chemotherapy. The drug topped chemotherapy alone at a statistically significant rate, BeiGene said, potentially setting up a Chinese approval in the indication.
“This is our fifth positive Phase III readout for tislelizumab, which we are developing broadly as a potentially differentiated anti-PD-1 antibody,” CMO of I/O Yong Ben said in a statement.
First approved in China in late 2019, tislelizumab has steadily been chalking up more approvals after being first conditionally OK’ed for third-line relapsed/refractory Hodgkin’s lymphoma. The drug has since garnered full approval for first-line advanced squamous NSCLC, as well as conditional approvals in bladder cancers with high PD-L1 expression.
The latest Phase III effort comes from a trial of 263 patients in Asia, who were randomized 1:1 into the drug or placebo plus chemo arms. BeiGene did not release any figures or p-values regarding the results.
Friday’s results are part of BeiGene’s continuing effort to expand the drug’s use in China, and NPC could prove to be a big one. Nearly half of all global NPC cases occur in the country, with higher rates in southern China. Roughly 60,000 Chinese individuals were diagnosed with the disease in 2018, BeiGene said.
But BeiGene is also apparently ready to soon take the drug overseas. Earlier this year, Novartis plunked down $650 million in upfront cash to partner with the biotech, promising up to $1.55 billion in future milestones. For that price, Novartis won commercial and co-development rights to most major markets outside of China.
They haven’t submitted any regulatory filings just yet, but the duo is chasing more than a dozen potential indications. Among the group are NSCLC, hepatocellular carcinoma, esophageal squamous cell carcinoma, gastric cancer and NPC.
The drug is already seeing big uptake in China as well, recording $48.9 million sales in the first quarter — a figure up nearly 140% from the first quarter of 2020. Estimates have only grown for the drug, with Leerink analyst Andrew Berens last year raising peak sales expectations to $768 million, up from $461 million previously.
BeiGene’s NPC data come from a swath of potential registrational trials: The biotech said it has launched or completed 17 different studies for the checkpoint inhibitor.