Ploughing through a crowded PD-(L)1 market, BeiGene loads up on promising lung cancer data
BeiGene’s entry to the PD-1 market — as the fourth domestic drugmaker to score approval in China, lagging months behind multinational players — might have been unremarkable. But the follow-up act is where it plans to shine.
Three months after posting positive top-line progression-free survival results for their pivotal Chinese study with tislelizumab and chemo for frontline squamous non-small cell lung cancer, BeiGene said the PD-1 antibody hit the same mark for non-squamous cases of NSCLC. In both trials, the drug was paired with chemotherapy and the regimen was compared to chemo alone.
Why does it matter? SVB Leerink analyst Andrew Berens summed it up this way:
This positive outcome in non-squamous NSCLC, and prior success in squamous NSCLC, along with approved indications in bladder cancer and classic Hodgkin’s lymphoma, could potentially enable Tisle to have the broadest label among all China domestic PD-1/L1 agents, which could give the company a competitive advantage and broad national reimbursement, which could ultimately challenge the multinational agents.
The company has indicated that it plans to submit an sNDA for first-line squamous NSCLC in China in 2020. Once the overall survival results, which constitute one of the secondary endpoints in these trials, are in, Berens expects BeiGene to leverage the datasets to support potential filing in the US.
Tislelizumab is being studied in more than 25 trials worldwide, added Yong Ben, CMO of immuno-oncology. They include a Phase III pitting the drug against docetaxel in second-line or third-line NSCLC, expected by early 2021, in addition to trials in hepatocellular carcinoma and esophageal cancer.
Berens estimates peak revenues at $460 million in China, with $28 million in 2020 — which he said “could prove to be very conservative if the company is able to capture a significant portion of the rapidly growing PD-1 market.”
CEO John Oyler is going all out. Just days ago BeiGene nabbed its first solid tumor OK in locally advanced or metastatic urothelial carcinoma. China’s National Medical Product Administration, which granted the sNDA priority review pre-pandemic, based its decision on a single-arm pivotal Phase II.
It marked tislelizumab’s second indication after the initial approval for classical Hodgkin’s lymphoma in December 2019.
Like urothelial cancer, patients with Stage IIIB or Stage IV non-squamous NSCLC are also in need of more treatment options, BeiGene said. Its rivals at Innovent and Hengrui evidently agree, lining up their own programs to tackle the market.