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AstraZeneca rounds off the outstanding China year – and beats Roche with a nod from Imfinzi lung cancer

AstraZeneca’s oncology business has had several successes in China this year. Now the UK drug maker has another important reason to brag about.

China’s National Medical Products Administration approved the company’s immuno-oncology drug Imfinzi for stage 3 non-small cell lung cancer (NSCLC) that cannot be surgically removed. The nod goes to patients who have already been treated with concurrent chemotherapy and radiation, AstraZeneca said on Thursday.

It is the first approval for an anti-PD-L1 compound in China, closely followed by Roche’s Tecentriq. However, the country already has five PD-1 inhibitors in the market, including Opdivo from Bristol-Myers Squibb and Keytruda from Merck & Co., both of which have lung cancer approvals.

Chinese regulators have given the green light, based on solid data from the Phase 3 study in the Pacific, which has helped make Imfinzi the new standard of care in this particular indication and a blockbuster drug with sales in more than 50 countries around the world Making world.

In the study of 713 patients, Imfinzi reduced the risk of death by 32% compared to placebo and increased the time patients lived without tumor progression or death by nearly a year, with a median survival of 16.8 months compared to 5 , 6 months with placebo.

According to a recent post-hoc analysis, the benefits of Imfinzi also continued, with 66.3% of treated patients still alive after three years, while the overall survival rate of placebo patients at that point was only 43.5%.

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

RELATED: China Gives Merck, BMS the cold shoulder on the reimbursement list as the PD-1 battle enters a new phase

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

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

And just last week, the Merck & Co.-affiliated PARP inhibitor Lynparza received approval in China as a first-line maintenance treatment for BRCA-mutated ovarian cancer. The news came shortly after the drug received NRDL coverage for treating relapsed ovarian cancer with effect for the next year.

Sales from China spurred the growth of both cancer therapies. As the first PARP inhibitor to be launched in the country, Lynparza sales in emerging markets more than tripled in the first nine months of 2019, reaching $ 101 million. During the same period, Tagrisso posted sales of $ 553 million in emerging markets, up 120% in constant currencies, “with remarkable growth in China” following its NRDL listing, the company said in October.

RELATED: Has AstraZeneca Finally Arrived? Seems to be so, with the growth of oncology and China – at least for now

Overall, China now contributes around 20% of AstraZeneca’s total sales, even before moving into the EU. And it’s growing at an enviable rate – in the third quarter, AZ sales in China rose 40% on unchanged currencies to $ 1.28 billion.

However, as CEO Pascal Soriot pointed out during a conference call in October, the national roll-out of a mass procurement program aimed at lowering the prices of some older drugs is likely to slow the company’s growth in China – to a mid-range ten percent in the medium term. In addition, breast cancer drug Faslodex just failed to renew its reimbursement agreement with Chinese authorities, which means it will lose coverage next year.

Outside of China, Imfinzi has just won the FDA’s priority review for use in the first-line SCLC at the extensive stage and made a decision in the first quarter of 2020. If approved, it will go to Tecentriq in this environment. The AZ spokesman said the company is also looking at the indication in China based on the Phase 3 study of Caspian.

Meanwhile, a combination of Imfinzi plus AZ’s investigational drug CTLA-4 tremelimumab and chemotherapy recently showed that it could beat chemotherapy alone in preventing cancer progression in previously untreated NSCLC. However, given Keytruda’s seemingly unwavering lead thanks to compelling survival data, this would be a much tougher market.

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