Akeso's Cadonilimab: A Promising New Hope for PD-(L)1 Resistant NSCLC

Akeso, Inc., a leading biopharmaceutical company specializing in cancer immunotherapy, has presented promising data on its bispecific antibody, Cadonilimab, at the 2024 Asian Conference on Lung Cancer (ACLC). Cadonilimab, a PD-1/CTLA-4 bispecific antibody, has shown remarkable potential in treating PD-(L)1-resistant non-small cell lung cancer (NSCLC), a challenging disease with limited treatment options.

The Phase I/II trial, NCT04646330, evaluated the safety and efficacy of cadonilimab in combination with anlotinib, a multi-kinase inhibitor, as a first-line treatment for advanced NSCLC without sensitizing EGFR/ALK/ROS1 mutations. The trial enrolled 69 treatment-naïve patients, who received cadonilimab at doses of 10 or 15 mg/kg every three weeks (Q3W) in combination with anlotinib at doses of 10 or 12 mg once daily for two weeks on a one-week-off schedule.

The results of the trial were encouraging, with manageable safety and promising efficacy. Treatment-related adverse events (TRAEs) were reported in 98.0% and 95.0% of patients in the cadonilimab 15 mg/kg Q3W and 10 mg/kg Q3W dosing groups, respectively. However, grade ≥3 TRAEs occurred in only 59.2% and 25.0% of patients, indicating that the combination therapy was well-tolerated. Notably, cadonilimab discontinuation due to TRAEs was relatively low, at 16.3% and 5.0% in the respective dosing groups.

The confirmed objective response rates (ORRs) were 51.0% and 60.0% in the cadonilimab 15 mg/kg Q3W and 10 mg/kg Q3W dosing groups, respectively. These impressive results highlight the potential of cadonilimab in overcoming PD-(L)1 resistance in NSCLC, a significant challenge in current cancer treatments.

Cadonilimab's dual-targeting mechanism, which simultaneously blocks PD-1 and CTLA-4, enables it to enhance T cell activation, proliferation, and tumor infiltration. This approach addresses the intricacies of the tumor microenvironment and boosts the anti-tumor immune response, offering a more effective treatment option for patients with PD-(L)1-resistant NSCLC.

The presentation of Akeso's Cadonilimab combination therapy at the 2024 ACLC underscores the potential of bispecific antibodies in overcoming PD-(L)1 resistance in NSCLC. This development has significant implications for the broader landscape of cancer immunotherapy and encourages further investment in research and development of novel bispecific antibodies for cancer treatment.

As the biopharmaceutical industry continues to innovate and adapt to the evolving needs of cancer patients, Akeso's Cadonilimab serves as a promising new hope for those with PD-(L)1-resistant NSCLC. The data presented at the ACLC highlights the potential of this bispecific antibody in improving patient outcomes and addressing the critical challenge of immune checkpoint inhibition resistance.