AstraZeneca earns another approval in jam-packed Chinese PD-(L)1 market, this time in late-stage lung cancer
One of the first entrants in the PD-(L)1 market in China, British drugmaker AstraZeneca is now looking to cement its advantage there with another approval for checkpoint inhibitor Imfinzi.
Imfinzi was approved by China’s NMPA as a combination with platinum-based chemotherapy for first-line use in “extensive-stage” small cell lung cancer, an advanced form of the disease associated with particularly poor outcomes for patients, the drugmaker said Monday.
The agency based its review on data from the Phase III CASPIAN study, which found Imfinzi plus chemo cut the risk of death by 27% relative to chemo alone, AstraZeneca said. Those topline results released in June 2019 showed a median overall survival of 13 months compared with 10.3 for the chemo solo arm. An estimated 22.2% of patients treated with Imfinzi plus chemo were alive at a two-year follow-up compared with 14.4% for chemo alone, AstraZeneca said.
Most importantly for Chinese regulators, those overall results were consistent for the Chinese cohort of patients.
Back in March 2020, the FDA handed down its own approval in the same patients, setting the stage for a global rollout based on the CASPIAN findings.
AstraZeneca’s Imfinzi first entered the increasingly competitive Chinese PD-(L)1 market back in December 2019, earning an approval in unresectable non-small cell lung cancer and becoming the first drug of its kind approved to treat Chinese patients. Since then, the field has skyrocketed as other global drugmakers and now homegrown Chinese players have looked to capitalize on the boom.
In the US, there are seven approved PD-(L)1s, with Merck’s Keytruda leading the way in terms of sales. But in China, there are as many as 10 of those drugs on the market, with an increasing number coming from native biopharmas working with global partners.
AstraZeneca, for instance, also has a commercialization deal with major player Junshi Biosciences on PD-1 drug toripalimab, which was first approved for Chinese use in second-line melanoma back in December 2018. As part of that unusual deal, AstraZeneca holds rights to market the drug in urothelial cancer across China with an option to pursue other emerging markets. Junshi, meanwhile, also holds an ex-China commercialization deal with Coherus as well for toripalimab, with the collaboration pursuing a filing with the FDA.
As Chinese oncology R&D grows broader, more and more Western pharmas have piled in as collaborators — consider deals like Novartis’ pact with BeiGene on tislelizumab — while those growing Chinese players have looked to crack a US market with less competition and higher barriers to entry. Drugmakers like Junshi, Hutchmed and CStone all have candidates filed for approval in the US, potentially offering a pathway to the sort of price competition that so far hasn’t been a factor in that market.