AstraZeneca Lung Cancer Treatment Approved in China

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The National Medical Products Administration (NMPA) in China has approved Tagrisso (osimertinib), a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) developed by AstraZeneca, in combination with pemetrexed and platinum-based chemotherapy, for first-line treatment of adult patients with locally advanced, or metastatic, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) with tumors with exon 19 deletions or exon 21 (L858R) mutations (1). AstraZeneca announced the approval in a press release on June 26, 2024.

While Tagrisso is approved as monotherapy in more than 100 countries including China, the United States, Japan, and across the European Union, according to AstraZeneca, its use as specifically stated in the new decision from the NMPA—that is, in conjunction with chemotherapy for first-line treatment of patients with EGFRm NSCLC—is less widely approved, although the US is also one of those such countries (1).

The approval in China comes after results of a Phase III trial (FLAURA2) were published in The New England Journal of Medicine in addition to results from an exploratory subgroup of Chinese patients, which were presented at the European Society for Medical Oncology Asia Congress 2023 (1,2).

“The approval of osimertinib with the addition of chemotherapy in China is critical for the treatment of the largest population of patients with EGFR-mutated lung cancer worldwide,” said Ying Cheng, MD, director of Jilin Lung Cancer Diagnosis and Treatment Centre, and principal investigator in the Phase III trial in China, in the AstraZeneca press release. “These patients will now have a choice of two highly effective osimertinib-based options for first-line treatment, allowing physicians to tailor their approach to their patients. This is especially important for those with a poorer prognosis, such as cancer that has spread to the brain or those who have L858R mutations.”

Also commenting on the latest approval was Dave Fredrickson, executive vice-president of AstraZeneca’s oncology business unit, who stated in the press release: “Tagrisso with the addition of chemotherapy in FLAURA2 has not only shown unprecedented progression-free survival in the overall trial population, but also among Chinese patients, reducing the risk of disease progression by nearly half.”

“This approval reinforces Tagrisso as a backbone therapy in EGFR-mutated lung cancer and acknowledges its important role, as monotherapy or with chemotherapy, in addressing the high prevalence of this disease in Asian countries and China, specifically,” Fredrickson added.

More than 1 million people in China are diagnosed with lung cancer annually, according to AstraZeneca, accounting for more than one-third of lung cancer patients worldwide (1). Of those with NSCLC, which is the disease’s most common form, about 40% of Chinese patients have tumors with an EGFR mutation—and the majority are diagnosed with advanced disease.

However, Fredrickson pointed out in the release, in the China cohort of the Phase III trial, Tagrisso in combination with chemotherapy reduced the risk of disease progression or death by 44% compared to Tagrisso monotherapy, and extended the median progression-free survival from 22.3 to 27.4 months (1).

References

1. AstraZeneca. Tagrisso with the Addition of Chemotherapy Approved in China as 1st-Line Treatment for Patients with EGFR-Mutated Advanced Lung Cancer. Press Release. June 26, 2024.
2. Planchard, D.; Jänne, P.A.; Cheng, Y.; et al. Osimertinib With or Without Chemotherapy in EGFR-Mutated Advanced NSCLC. N. Engl. J. Med. 2023, 389 (21) 1935–1948. DOI: 10.1056/NEJMoa2306434