#None #Akeso #Cadonilimab #Cervical Cancer

Overview of Cadonilimab's Subgroup Analysis

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Akeso, Inc. unveiled crucial findings from the Phase III COMPASSION-16 trial, focusing on cadonilimab, a novel PD-1/CTLA-4 bispecific antibody. This groundbreaking study investigates cadonilimab as a first-line therapy for patients grappling with advanced, recurrent, or metastatic cervical cancer.

Significance of the Findings

Cadonilimab's subgroup analysis was showcased through an oral presentation, emphasizing its substantial improvements in both progression-free survival (PFS) and overall survival (OS) among various patient subgroups. Key variables included PD-L1 expression levels, previous treatments involving concurrent chemoradiotherapy (CCRT), and patient age (≥65 and <65). These insights shed light on cadonilimab's potential to alter treatment paradigms and enhance the overall landscape of women's health.

Key Outcomes from the COMPASSION-16 Study

Prior publications in The Lancet and presentations at the 2024 International Gynecologic Cancer Society Global Meeting highlighted cadonilimab's effectiveness, demonstrating marked survival benefits for both PD-L1-positive and negative patient populations. Recent revelations at ASCO underscore this drug's extensive effectiveness:

Mortality Risk Reduction

1. CPS<1:
- mPFS: 12 months (cadonilimab) versus 8.2 months (control); HR=0.65.
- OS: Not reached (cadonilimab) versus 25.3 months (control); HR=0.77.
2. CPS≥1:
- mPFS: 14.7 months (cadonilimab) versus 8.3 months (control); HR=0.62.
- OS: Not reached (cadonilimab) versus 22.7 months (control); HR=0.69.
3. CPS≥10:
- mPFS: 17.1 months (cadonilimab) versus 8.1 months (control); HR=0.54.
- OS: Not reached (cadonilimab) versus 29 months (control); HR=0.68.

Clinical Benefits in Relation to Prior Treatments

• - In patients previously treated with CCRT, mPFS was 16.1 months (cadonilimab) compared to 7.9 months (control); HR=0.55. The mOS was not reached for the cadonilimab arm versus 22.8 months in the control arm.
• - In patients considered unsuitable for bevacizumab, cadonilimab still exhibited improvements, with mPFS at 11.7 months (cadonilimab) versus 6.7 months (control); HR=0.44. OS also improved significantly, reaching 28.2 months versus 15.1 months for control.

Age-Related Effectiveness

The data also indicated positive clinical outcomes across different age subgroups. For patients under 65 years, cadonilimab showed a mPFS of 13.5 months compared to 9.5 months (control); and for those 65 years and older, mPFS was 12 months versus 7.4 months (control), with a significant HR of 0.39 for the older group.

Cadonilimab Combined with Platinum Chemotherapy

Cadonilimab's combination with platinum chemotherapy also yielded promising results:

• - In patients receiving cisplatin, mPFS was recorded at 14.7 months (cadonilimab) versus 8.1 months (control); with OS not being reached compared to 23.9 months for the control group.
• - In the carboplatin cohort, mPFS was 12 months versus 8.2 months, while OS was 27.8 months (cadonilimab) against 22.8 months (control).

Conclusion and Future Perspectives

In 2022, the China National Medical Products Administration approved cadonilimab for recurrent or metastatic cervical cancer after prior platinum chemotherapy failure. It now features prominently in national treatment guidelines. Additionally, ongoing studies and clinical trials estimate cadonilimab's broader potential across various cancers, reaffirming its promise to advance treatment standards and enhance survival rates.

As Akeso, Inc. advances its research measures, these findings could redefine therapeutic options for countless patients facing advanced cervical cancer, underscoring the necessity for continued exploration in immunotherapy and related fields. Stakeholders are eagerly monitoring upcoming results from the ongoing Phase III clinical trials.

Disclaimer

The statements presented here reflect Akeso, Inc.'s forward-looking stance regarding cadonilimab's future and therapeutic potential. Stakeholders are encouraged to remain vigilant of evolving data as the landscape for treating advanced cervical cancer continues to progress.