AstraZeneca joins Merck, Bristol-Myers in China's checkpoint race as regulators OK first PD-L1
AstraZeneca has made a stride toward realizing its ambitions in China as regulators greenlight Imfinzi as a treatment for non-small cell lung cancer.
In particular, the PD-L1 agent is filling a void for immunotherapies in Stage III unresectable case, the company said, where the cancer has not spread to the rest of the body. It is to be used, with curative intent, in patients whose cancer hasn’t progressed following concurrent platinum-based chemotherapy and radiation therapy.
“This approval illustrates our long-standing commitment to improving health outcomes in China, where more than one-third of the world’s lung cancer diagnoses and deaths occur,” said Dave Fredrickson, who heads AstraZeneca’s oncology business unit, in a statement.
Imfinz’s approval also marks the entry of a PD-L1 inhibitor to the country, where PD-1 drugs have been piling up. Bristol-Myers Squibb scored the first-ever Chinese approval for a checkpoint inhibitor in June 2018, with Opdivo indicated for second-line treatment of NSCLC, and Merck has been racking up OKs for different regimens involving Keytruda.
Then there are the domestic rivals, whose drugs are currently limited to lymphoma or melanoma but also have plans for a lucrative lung cancer market. And they are eager to compete on price.
For AstraZeneca, this is just more reason to roll up its sleeves and get to negotiating with payers. Its head of China, Leon Wang, has previously told Bloomberg that he sees new treatments contributing to 60% of all its China revenue within five years. To illustrate that drive, Wang offered the example of its first-gen EGFR-targeting lung cancer Iressa, in which they won the drug supply contract in by slashing the price more than 70%.
Quick approvals for third-gen EGFR TKI Tagrisso (which is now on the National Reimbursement Drug List), as well as the PARP inhibitor Lynparza, helped — and now it’s time for Imfinzi to shine. Notably, Roche’s PD-L1 Tecentriq — which gained FDA approval earlier than Imfinzi — is not yet available in China.
In the Phase III PACIFIC trial, Imfinzi cut the risk of death by 32% and prolonged progression-free survival by 11.2 months versus placebo (median PFS 16.8 vs 5.6 months), when paired with chemo or radiation therapy. At the three-year mark, 57% of patients on the Imfinzi arm are still alive compared to 43.5% on placebo, according to a post hoc analysis presented at ASCO.
Imfinzi sales have gone over the $1 billion mark in the first three quarters of the year, growing 182% compared to the same period last year.