#Hong Kong #Akeso #Cadonilimab #NSCLC

Akeso's Cadonilimab: A New Hope for NSCLC Patients

Akeso, Inc. has recently made headlines with the promising results of its cadonilimab (PD-1/CTLA-4 bispecific antibody) combination therapy for patients with advanced or metastatic non-small cell lung cancer (NSCLC). This groundbreaking therapy was presented by Professor Han Baohui from Shanghai Chest Hospital at the 2024 Asian Conference on Lung Cancer (ACLC), giving hope to patients who are resistant to PD-(L)1 inhibitors.

Study Overview

The results stem from a phase Ib/II clinical study, designated AK104-IIT-018, that focuses on individuals with unresectable, incurable locally advanced or metastatic NSCLC who have already experienced disease progression following PD-1/L1 inhibitor treatment combined with chemotherapy. The unique aspect of this study is its prospective, open-label, single-arm design across multiple centers in China, initiated back in February 2023.

Gathering data as of May 31, 2024, a total of 46 patients were enrolled in the trial, with a diverse demographic representation of squamous and non-squamous NSCLC cases. A significant finding revealed that nearly 11% of the patients had brain metastasis, while others presented with liver or bone metastasis, resembling real-world patient conditions.

Efficacy Results

Among the key findings:

• - Six-month Progression-Free Survival (PFS): 56.9%, significantly higher than the 30% observed with docetaxel monotherapy.
• - Median PFS: 6.5 months, enhancing the standard of care metrics that show PFS to be around 4.0-5.4 months for other treatments.
• - Overall Objective Response Rate (ORR): An impressive 30.3%, with 10 patients achieving partial responses, a stark contrast to the 14% ORR recorded in docetaxel studies alone.
• - Disease Control Rate (DCR): A formidable 94.0%, indicating almost all patients benefitted from the treatment.
• - Duration of Response (DoR): Among responders, the median DoR was 5.0 months, showcasing stability in tumor control.

The study's primary endpoint, the six-month PFS rate, was achieved successfully, demonstrating cadonilimab's potential as a leading second-line treatment for immune-resistant NSCLC.

Safety Profile

One of the standout elements of the cadonilimab therapy is its tolerable safety profile. The combination treatment of cadonilimab, anlotinib, and docetaxel was well-received, with manageable adverse events. This favorable safety observation paves the way for broader applications in a patient population that desperately needs effective post-first-line therapies.

Conclusion

The introduction of cadonilimab as a therapeutic option represents a significant advancement in the landscape of NSCLC treatments, particularly for patients facing limited options after first-line therapies. As Akeso continues to refine its clinical approach, the data presented at the ACLC indicates a bright future for innovative treatments in oncology. The results reinforce Akeso's commitment to pioneering breakthroughs in biopharmaceuticals aimed at delivering first-in-class therapies to improve patient outcomes worldwide.

For further updates and information about Akeso's innovations, visit Akeso's official website.