Fosun Pharma announced that the National Medical Products Administration (NMPA) has officially accepted the marketing authorization application for Foritinib Succinate Capsules (SAF-189), the company’s independently developed, next-generation ALK/ROS1 inhibitor. This milestone brings the innovative treatment closer to patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Foritinib is a highly potent, CNS-penetrant ALK/ROS1 inhibitor designed to address critical unmet needs in lung cancer treatment. The Phase III REMARK study has demonstrated that foritinib significantly improves disease control, particularly in managing central nervous system (CNS) metastases, with a favorable safety profile. The drug has also successfully completed Phase II clinical trials in ROS1-positive NSCLC in China.

Strong Clinical Evidence Supporting Foritinib

Fosun Pharma presented interim results from the Phase III REMARK trial at the 2024 World Conference on Lung Cancer (WCLC), highlighting the drug’s superior efficacy and safety profile:

• Progression-Free Survival (PFS): Foritinib reduced the risk of disease progression or death by 77% compared to crizotinib (HR 0.23, 95% CI 0.14-0.38).
• CNS Progression-Free Survival: The median time to CNS progression (CNS-TTP) was significantly extended in the foritinib group (HR 0.04, 95% CI 0.01-0.14).
• Overall Response Rate (ORR): The ORR reached 92.8%, a 12% increase over crizotinib (P=0.0035). Among patients with baseline brain metastases, the intracranial ORR was 100% in the foritinib group, compared to 50% in the crizotinib group.
• Overall Survival (OS) Trend: Foritinib showed a trend toward improved overall survival (HR 0.60, 95% CI 0.30-1.20), indicating potential long-term benefits.

Study Design

The Phase III REMARK trial is an open-label, randomized study enrolling 275 untreated ALK-positive advanced NSCLC patients. Participants were randomized 1:1 to receive either foritinib (160 mg once daily) or crizotinib (250 mg twice daily). Primary and secondary endpoints included PFS, ORR, time to response (TTR), duration of response (DOR), intracranial efficacy, and overall survival.

Safety and Tolerability

Foritinib exhibited a well-tolerated safety profile:

• Grade 3/4 treatment-related adverse events (TRAEs) were lower in the foritinib group (37.7%) compared to crizotinib (55.6%).
• The most common TRAEs included hyperglycemia, hypertension, and QT interval prolongation.
• No cases of interstitial lung disease or visual impairment were reported in the foritinib group.
• No fatal TRAEs occurred in either treatment group.

A New Era in ALK+ NSCLC Treatment

“The acceptance of foritinib’s marketing application by NMPA is a significant step forward in delivering an innovative, highly effective therapy for lung cancer patients,” said Dr. [Executive Name], Chief Medical Officer at Fosun Pharma. “With remarkable efficacy in controlling CNS metastases and an improved safety profile, foritinib is positioned to become a new standard of care for ALK-positive NSCLC.”

As lung cancer remains one of the leading causes of cancer-related deaths worldwide, foritinib’s advancement underscores Fosun Pharma’s commitment to innovation and global oncology leadership.