With the lack of success of its PD-1/L1 candidate spartalizumab, Novartis last year decided to buy its way into the arena. So it struck a deal with BeiGene of China, paying $650 million up front and committing $1.55 billion in milestone payments to get a piece of its PD-1 antibody tislelizumab.
While Novartis has yet to see tangible gains from the deal, the company's partner continues making waves in China.
On Friday, BeiGene scored an approval in China for tislelizumab as a treatment for second-line patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). The nod is for use in those who are intolerant to first-line chemotherapy or have seen their disease progress after chemo treatments.
Tislelizumab is under review in the same indication in both the United States and Europe. Last September, the FDA accepted Novartis’ biologics license approval for the drug in ESCC, the most common form of esophageal cancer and the sixth-leading cause of cancer deaths worldwide.
In its home country, BeiGene has garnered seven other approvals for tislelizumab, including several for non-small cell lung cancer. The first came in 2019 for third-line Hodgkin lymphoma. That was followed by a nod for previously treated bladder cancer.
The drug, which helps the body’s immune cells detect and fight tumors, has yet to gain an endorsement outside of China.
This green light for tislelizumab is based on results of a phase 3 trial which showed a 30% reduction in the risk of death and that it extended patient survival by 2.3 months compared to the chemotherapy docetaxel.
Even if they are able to crack the ESCC market in the U.S. and Europe, it will be challenging for BeiGene and Novartis to compete against Merck’s entrenched Keytruda and Bristol Myers Squibb’s Opdivo.
Pricing may be the key, however. In seeking approval for the Innovent-partnered PD-1 med Tyvyt, Eli Lilly offered it at a big discount in the U.S. That drug failed to score an FDA nod, but offering discounts is one way for later market entrants to gain share.