Akeso's Phase 3 Study of Cadonilimab Shows Positive PFS and OS in Cervical Cancer

HONG KONG, Oct. 16, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) ("Akeso", the "Company") announced favorable outcomes in progression-free survival (PFS) and overall survival (OS) from its Phase 3 clinical trial, COMPASSION-16/AK104-303. The trial assessed the effectiveness of the company's PD-1/CTLA-4 bispecific antibody, 开坦尼® (cadonilimab), both with and without platinum-based chemotherapy and bevacizumab, against a placebo combined with platinum-based chemotherapy and bevacizumab for the first-line treatment of persistent, recurrent, or metastatic cervical cancer. These findings were disclosed during an oral presentation at the 2024 International Gynecologic Cancer Society (IGCS) annual global meeting.

The principal study investigator, Professor Wu Xiaohua from Fudan University-affiliated Cancer Hospital, presented the results, highlighting them to an audience of global gynecological oncology specialists. The findings were also published in The Lancet, emphasizing the study's significant contribution to international clinical cancer research and its potential impact on cervical cancer treatment options.

The COMPASSION-16 study revealed that the cadonilimab regimen, with or without bevacizumab, showed promising results in addressing persistent, recurrent, or metastatic cervical cancer, particularly for patients without access to bevacizumab. Cadonilimab provided substantial benefits to all patients, regardless of PD-L1 expression status. This study underscores the clinical importance and commercialization potential of cadonilimab in enhancing standard treatments for advanced cervical cancer.

The main endpoints of the COMPASSION-16 study were progression-free survival (PFS) and overall survival (OS), assessed by independent central imaging review (BICR) based on RECIST v1.1 criteria. The study enrolled 445 patients, with 27.9% of those in the cadonilimab plus chemotherapy ± bevacizumab group having a CPS < 1, compared to 24.2% in the control group.

Results indicated that the cadonilimab regimen significantly improved survival in the overall population, notably reducing the risk of disease progression and death. Within the intention-to-treat (ITT) population, the median overall survival (OS) for the cadonilimab regimen had not yet been reached, whereas the control group showed a median OS of 22.8 months (HR 0.64, P=0.0011). The 12-month OS rates were 83.1% for the cadonilimab group versus 73.7% for the control group, and the 24-month OS rates were 62.6% and 48.4%, respectively.

For the ITT population, the median progression-free survival (PFS) for the cadonilimab regimen was 12.7 months, compared to 8.1 months for the control group (HR 0.62, P<0.0001). The 12-month PFS rates were 51.1% and 35%, respectively. As of April 30, 2024, the benefits of the cadonilimab regimen became more noticeable, with updated median PFS rates of 13.3 months and 8.2 months (HR 0.62).

Cadonilimab, regardless of bevacizumab combination, exhibited significant improvements in overall survival (OS). Without bevacizumab, the cadonilimab regimen reduced the risk of death by 50% compared to the control group (OS HR 0.5), effectively meeting the clinical needs of patients ineligible for bevacizumab.

Across all PD-L1 expression levels, the cadonilimab regimen substantially lowered the risk for the entire patient population. In the CPS < 1 cohort, the regimen resulted in a 23% reduction in death risk (OS HR 0.77). For the CPS ≥ 1 cohort, there was a 31% reduction (OS HR 0.69), and in the CPS ≥ 10 cohort, a 32% reduction was observed (OS HR 0.68).

The cadonilimab regimen showed a high and enduring antitumor response. The objective response rate (ORR) for the cadonilimab group was 82.9%, compared to 68.6% in the control group. Complete response (CR) rates were 35.6% and 22.9%, respectively. The median duration of response (DOR) was 13.2 months in the cadonilimab group, compared to 8.2 months in the control group.

Combining cadonilimab with chemotherapy ± bevacizumab demonstrated a manageable safety profile, with no new safety signals identified.