China Approves AstraZeneca’s Non-Small Cell Lung Cancer Drug

April 16, 2021 - AstraZeneca recently announced that China approved its prescription drug, Tagrisso, for the treatment of patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). 

The treatment was approved by China’s National Medical Products Administration (NMPA) for use after tumor resection, with or without adjuvant chemotherapy as recommended by the patient’s physician, an AstraZeneca spokesperson explained.  

The approval was based on positive results from a Phase 3 trial called ADAURA, in which Tagrisso demonstrated a statistically significant improvement in disease-free survival (DFS) in the primary analysis of patients with Stage II and IIIA EGFRm NSCLC. 

The drug also showed clinically meaningful improvement in DFS in the overall trial population of patients with Stage IB-IIA disease, which was a key secondary endpoint in the trial.

“The expedited approval of Tagrisso in China as part of a curative-intent regimen for early-stage EGFR-mutated lung cancer underscores the high unmet need in this setting and our commitment to improving outcomes in a country with one of the highest rates of EGFR mutations in the world,” Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca said in the announcement. 

“This approval reinforces the importance of EGFR testing across all stages of lung cancer, prior to treatment decisions, to ensure as many patients as possible can benefit from targeted therapies like Tagrisso and live cancer-free longer,” Fredrickson continued. 

In the ADAURA trial, adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83 percent in patients with Stage II and IIIA disease and by 80 percent in the overall trial population of patients with Stage IB-IIIA disease.

Notably, consistent DFS results were elicited regardless of prior chemotherapy use and across all prescribed subgroups. 

The safety and tolerability of Tagrisso was consistent with previous trials. 

About 30 percent of all patients with NDCLC may be diagnosed early enough to have surgery with curative intent, an AstraZeneca spokesperson said, but recurrence is still common. 

About half of patients diagnosed with Stage IB and over three-quarters of patients diagnosed with Stage IIA have seen recurrence within five years. Additionally, over one-third of the world’s lung cancer patients are in China and about 40 percent of patients with NSCLC have tumors with an EGFR mutation.

Currently, Tagrisso is approved to treat early-stage lung cancer in over 12 countries, including the US. 

The drug is also approved for the first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in China, the US, Japan, the EU, and many other countries.

Additional global regulatory reviews are ongoing as well, AstraZeneca said. 

NMPA’s approval follows a priority review designation by the Center for Drug Evaluation and marks the third approved indication for Tagrisso in China following previous approvals in second-line T790M and first-line EGFRm NSCLC.

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. Lung cancer is split into NSCLC and small cell lung cancer, with 80-85 percent classified as NSCLC.

At the end of May 2020, FDA approved Roche’s first-line treatment, Tecentriq, for adult patients with metastatic non-small cell lung cancer.

Atezolizumab is the fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall in the US.

The approval was based on results from Roche’s clinical trial, IMpower110. It was a multicenter, international trial for patients with stage IV non-small cell lung cancer whose tumors expressed PD-L1 and who had received no prior chemotherapy for metastatic disease.

Researchers found that atezolizumab improved overall patient survival by 7.1 months compared with chemotherapy.