- Chinese drugmaker BeiGene on Monday said its cancer immunotherapy tislelizumab, when combined with chemotherapy, kept patients with a type of lung cancer from progressing or dying longer than chemo alone. The company said it will use the data to ask for approval in China.
- If launched, tislelizumab will compete directly with Merck & Co.'s Keytruda, which won approval in the same type of lung cancer in China late last year. Keytruda was on track to record more than $10 billion in global sales in 2019, much of which comes from the U.S. market.
- Tislelizumab won its first Chinese approval in late 2019, for relapsed or treatment-resistant Hodgkin lymphoma in patients who have undergone two previous lines of therapy.
Competition is fierce among drugs that block a protein called PD-1, and it's fiercest in lung cancer.
Keytruda (pembrolizumab) has come out on top thanks to first the Keynote-024 study and then Keynote-189, which showed that Merck's drug plus chemo could shrink tumors and reduce the risk of death in non-squamous non-small cell lung cancer, or NSCLC. These studies set a standard that has been hard to match for rivals like Bristol-Myers Squibb's Opdivo (nivolumab).
That hasn't stopped new entrants from trying, however, and BeiGene is taking on Merck with tislelizumab. In this case, it is squamous-type NSCLC, which represents about 30% of all cases in China. BeiGene didn't disclose details on the study, but said that in combination with carboplatin and paclitaxel, tislelizumab kept patients alive and their disease in check for longer than the chemotherapy agents alone.
The finding was made at an early, interim review of Beigene's trial, rather than the final analysis, so the data should be persuasive when it is revealed. BeiGene said the side effect profile of tislelizumab in this study was consistent with earlier trials.
Keytruda has set a fairly high bar in squamous disease. In the Keynote-407 study, the Keytruda chemo combo proved capable of reducing the risk of death by more than a third, and the risk of progression or death by 44% when compared with chemo alone. A China extension of Keynote-407 showed even better results: a 56% reduction in the risk of death and 68% reduction in the risk of progression.
BeiGene has yet to launch tislelizumab in Hodgkins lymphoma, and has not disclosed pricing. SVB Leerink analyst Andrew Berens said the $1,100-per-month price of Innovent and Lilly's recently approved PD-1 inhibitor Tyvyt (sintilimab) in China provides a benchmark.
Berens said the tislzelizumab squamous NSCLC data, along with that from a non-squamous trial due to deliver results this year, could be used for a submission to the U.S. Food and Drug Administration.
If so, Beigene would be a repeat customer. In November, the FDA approved Beigene's lymphoma drug Brukinsa (zanubrutinib).