China’s National Medical Products Administration (NMPA) has recently approved Zorifer (zorifertinib), an oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) specifically for the treatment of non-small cell lung cancer (NSCLC) with CNS metastases. Developed by Alpha Biopharma in collaboration with AstraZeneca, this new treatment option is expected to benefit EGFR-mutated NSCLC patients with different levels of CNS metastases, says GlobalData, a leading data and analytics company.

Zorifer Phase III trial demonstrated consistent benefits in patients with intracranial symptoms, EGFR L858R mutations, and multiple lesions, potentially prolonging overall survival with the sequential use of zorifertinib and third-generation EGFR-TKIs.

In December 2016, Alpha Biopharma received exclusive rights from AstraZeneca for the global development and commercialization of zorifertinib, a drug developed exclusively for NSCLC globally.

According to GlobalData’s Pharmaceutical Intelligence Center, the diagnosed prevalent cases of NSCLC in China are expected to increase at an annual growth rate (AGR) of 5.4% from 729,575 in 2023 to 1,068,716 in 2032.

Manoj Lingala, Pharma Analyst at GlobalData, comments: “Treatment for NSCLC with brain metastases (BM) typically involves surgery, radiotherapy, and chemotherapy. Third-generation EGFR-TKIs are the preferred first-line treatment for EGFR-mutated NSCLC, but these are not available for patients with BM. Third generation Zorifer by Alpha Biopharma provides treatment options for lung cancer with BM in China.”

Third-generation EGFR-TKIs, such as osimertinib, aumolertinib, and furmonertinib, have received approval for first-line therapy in NSCLC patients. However, their use in patients with BM is restricted due to the lack of direct comparative studies and limited subgroup data. In contrast, the EVEREST trial involving zorifertinib showed notable advantages, such as a 37% reduction in the risk of intracranial progression and a progression-free survival period of 17.9 months compared to first-generation EGFR-TKIs.

For Alpha Biopharma, Zorifer’s approval marks a significant achievement and its first market launch. The company is also on the verge of completion of Phase III trials in South Korea, Singapore, and Taiwan and plans to launch the drug in these regions.

According to GlobalData’s Pharmaceutical Intelligence Center, as of 26 December 2024, there are 87 drugs in clinical development (Phase I to marketed), targeting EGFR for NSCLC in China. Out of all late-stage assets, only one drug in pre-registration (ASK120067), and two in Phase III trials (TY-9591 and zipalertinib) include NSCLC with BM. TY-9591 is a promising therapy for NSCLC, targeting brain tumors and leptomeningeal disease by penetrating the blood-brain barrier, positioning it as a potential competitor to Zorifer.

Lingala concludes: “Zorifer is expected to dominate the market for NSCLC in China, establishing itself as a leading first-line treatment for patients with CNS metastases. With few assets in late clinical development for these hard-to-treat patients, the company’s lead product Zorifer meets an unmet medical need.”