AK104 with concurrent radiotherapy shows efficacy in locally advanced cervical cancer
Key takeaways:
- Results showed an objective response rate of 100% and a 12-month PFS of 74.9%.
- AK104 with concurrent chemoradiotherapy had a manageable safety profile, according to researchers.
The addition of AK104 to concurrent chemoradiotherapy improved survival outcomes for patients with locally advanced cervical cancer, according to data presented at Society of Gynecologic Oncology Annual Meeting on Women’s Cancer.
Concurrent radiotherapy is standard of care for women with locally advanced cervical cancer, according to researchers.
However, 30% to 40% of patients experience recurrence or progression within 5 years, prompting the need for additional treatment options.
Fang Jiang, MD, of Peking Union Medical College Hospital, and colleagues conducted the randomized phase 3 AK104-305 study to evaluate the safety and efficacy of AK104 (Akeso Biopharma) — a PD-1/CTLA-4 bispecific antibody — in combination with concurrent chemoradiotherapy for treatment of locally advanced cervical cancer.
The safety run-in stage of the double-blind, placebo-controlled study included 34 patients (median age, 50.8 years; range, 27-72) with previously untreated locally advanced cervical cancer at four centers in China. More than three-quarters of patients (82.4%) had squamous pathology and 52.9% had an ECOG score of 1.
Patients received 10 mg/kg AK104 once every 3 weeks along with concurrent chemoradiotherapy. Chemoradiotherapy consisted of five cycles of cisplatin and external beam radiation therapy, followed by brachytherapy.
PFS served as the primary endpoint. Secondary endpoints included 3-year PFS, objective response rate, disease control rate, OS and safety.
At median follow-up of 19.5 months (range, 0-25), 38.2% of patients had completed five cycles of cisplatin, while 58.8% completed fewer than five.
Less than half of patients (41%) completed radiotherapy within 56 days and 55.9% exceeded 56 days.
Of 33 patients with tumor response evaluation data, 28 patients (84.8%) achieved complete response and five (15.2%) achieved a partial response.
Researchers reported an ORR of 100% and a 12-month PFS rate of 74.9% (95% CI, 56%-86.6%).
Median duration of response (95% CI, 13.7-not evaluable) and median PFS (95% CI, 16.53-not evaluable) had not been reached.
Grade 3 or higher treatment-related adverse events occurred in 91.2% of patients, with 58.8% related to AK104, according to investigators. Grade 3 or higher immune-related adverse events occurred in 23.5% of patients, with no treatment-related deaths occurring during the study.
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Jiang F, et al. AK104 combined with concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer: Safety run-in results from the phase III AK104-305 study. Presented at: SGO Annual Meeting on Women’s Cancer; March 14-17, 2025; Seattle.
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