AstraZeneca rounds out stellar China year—and beats Roche to the punch—with Imfinzi lung cancer nod

AstraZeneca’s oncology business has chalked up several wins in China this year. Now, the British drugmaker has another important one to brag about.

China’s National Medical Products Administration approved the company's immuno-oncology med Imfinzi in stage 3 non-small cell lung cancer (NSCLC) that can't be surgically removed. The nod applies to patients who've already been treated with concurrent chemo and radiation, AstraZeneca said Thursday.

It's the first approval for an anti-PD-L1 agent in China, with Roche’s Tecentriq following closely behind. The country already has five marketed PD-1 inhibitors, though, including Bristol-Myers Squibb’s Opdivo and Merck & Co.’s Keytruda, both of which bear lung cancer approvals.

Chinese regulators doled out the new go-ahead based on strong data from the phase 3 Pacific trial, which has helped make Imfinzi the new standard of care in that particular indication and a blockbuster drug with sales collected from more than 50 countries around the world.

In the 713-patient study, Imfinzi cut the risk of death by 32% over placebo and prolonged the time patients lived without tumor progression or death by nearly a year, with a median of 16.8 months of progression-free survival versus 5.6 months for placebo.

According to a recent post hoc analysis, Imfinzi’s benefits also lasted, as 66.3% of treated patients were still alive after three years, while the overall survival rate for placebo patients at that point was only 43.5%.

AstraZeneca has not announced its pricing plan for Imfinzi. But if its fellow checkpoint inhibitor rivals Keytruda and Opdivo can serve as references, a sticker about half the drug’s U.S. price could be expected. “We expect the price of Imfinzi to be comparable to currently available innovative therapies in China as it is in other approved countries and regions,” an AstraZeneca spokesperson told FiercePharma.

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About a third of patients with lung cancer have stage 3 disease, and lung cancer is the largest cancer type in China, accounting for more than a third of the world’s diagnoses and deaths. “As the global standard of care in this curative-intent setting, Imfinzi is an important new option for patients in China,” Dave Fredrickson, AZ’s oncology business head, said in a statement.

Fredrickson’s unit has posted several regulatory wins this year in China. Its targeted therapy Tagrisso won a green light in NSCLC in September to treat newly diagnosed patients with EGFR-mutated disease. Earlier in the year, it had won a spot on the country’s National Reimbursement Drug List (NRDL) in the second-line setting.

And just last week, its Merck & Co.-partnered PARP inhibitor Lynparza nabbed China approval as a first-line maintenance treatment for BRCA-mutated ovarian cancer. The news came shortly after the drug won NRDL coverage to treat recurrent ovarian cancer, effective next year.

Sales from China have fueled growth for both cancer therapies. As the first PARP inhibitor launched in the country, Lynparza’s emerging markets sales more than tripled in the first nine months of 2019, reaching $101 million. During the same period, Tagrisso racked up sales of $553 million in emerging markets, up 120% at constant currencies, “with notable growth in China” after its NRDL listing, the company said in October.

RELATED: Has AstraZeneca finally arrived? Seems so, with oncology and China growth—at least for now

Overall, China now contributes about 20% of AstraZeneca’s total sales, ahead of its haul in the EU. And it’s growing at enviable speed—in the third quarter, AZ’s China sales jumped 40% at unchanged currencies to $1.28 billion.

However, as CEO Pascal Soriot pointed out during a conference call in October, the national rollout of a bulk procurement program aimed at cutting prices of some older medicines will likely slow the company's China growth—to mid-teen percentages in the mid-term. What’s more, its breast cancer drug Faslodex just failed to extend its reimbursement deal with Chinese authorities, meaning it will lose coverage next year.

Outside of China, Imfinzi just won FDA priority review for use in first-line extensive-stage SCLC, teeing up a decision around the first quarter of 2020. If approved, it will go after Tecentriq in that setting. The AZ spokesperson said the company is also eyeing the indication in China based on the phase 3 Caspian trial.

Meanwhile, a pairing of Imfinzi plus AZ's investigational CTLA-4 drug tremelimumab and chemo recently showed it could beat chemo alone in terms of staving off cancer progression in previously untreated NSCLC. However, that would be a much tougher market, given Keytruda’s seemingly unshakeable lead thanks to convincing survival data.