As tislelizumab gains traction in China, BeiGene pulls the curtain on NSCLC data supporting the PD-1 drug
In a world now brimming with checkpoint inhibitors, companies often struggle to make a mark given a raft of therapies have already captured a considerable portion of the vast oncology market.
BeiGene’s tislelizumab was the fourth PD(L)-1 inhibitor to secure approval in China — and as it works on expanding its share the company has put out detailed data on the use of the drug in certain patients with lung cancer.
Only last month did BeiGene unveil that tislelizumab in combination with standard chemotherapy fared better than chemo alone as the first line of defense in patients with advanced squamous non-small cell lung cancer (NSCLC). On Friday, as part of the key cancer conference American Society of Clinical Oncology (ASCO), the China-based drugmaker disclosed the numbers.
The 360-patient trial, which tested the checkpoint inhibitor with two different chemo regimens against chemo alone, showed that the median time during which patients did not see disease progression in the tislelizumab combo groups was 7.6 months versus 5.5 months for chemo alone.
Objective response rates were also “meaningfully higher” — between 73% and 75% in the tislelizumab groups, versus 50% in the chemo alone arm. In addition, treatment with the BeiGene drug also roughly doubled the median duration of response compared to chemotherapy alone: 8.2 months and 8.6 months for the two tislelizumab groups, versus 4.2 months for the chemo arm.
Tislelizumab was first approved in China in late 2019 for classical Hodgkin’s lymphoma and then later for metastatic urothelial carcinoma patients. The drug marked a key milestone in the country — the first instance of a foreign partner producing a marketed drug under a reformed contract manufacturing regulatory system. BeiGene’s partner in this case is Germany’s Boehringer Ingelheim, which is supplying the PD-1 antibody for commercial use using a Shanghai facility.
The approval of tislelizumab in late 2019 was roughly a year after the first approval by Junshi for Tuoyi. Innovent’s Tyvyt and Merck’s flagship Keytruda were ushered in after.
Tislelizumab, despite the crowded landscape, has had an encouraging launch. In the first quarter of 2020, the drug generated about $52 million in sales, besting consensus expectations of $47 million, SVB Leerink’s Andrew Berens wrote in a note earlier this month. He lifted his market share expectations for tislelizumab in China, vaulting his in peak sales expectations to $768 million, up from $461 million previously.
Data from the non-squamous NSCLC patient pivotal study have already been disclosed, and the Chinese regulator is currently reviewing an application to market the drug in NSCLC patients. Meanwhile, in 2020 or early 2021, the company expects to reveal topline results from a global late-stage trial comparing tislelizumab versus docetaxel in second and third-line NSCLC patients as well as data from the Phase 3 trial comparing tislelizumab versus chemotherapy in second-line advanced esophageal squamous-cell carcinoma patients.
Meanwhile, akin to pretty much every other checkpoint inhibitor maker, BeiGene is exploring the use of its offering in combination with other treatments. Only days ago, it said it would be testing two of partner Chi-Med’s drug candidates, surufatinib and fruquintinib, in combination with tislelizumab, for the treatment of various solid tumor cancers, in the US, Europe, China and Australia.
Social: Ma Luyao via Wikimedia