Akeso and Sino Biopharm's Anniko gains FDA approval for head and neck cancer PD-1 market entry

Akeso has reached a significant milestone with the FDA's approval of its PD-1 inhibitor, Anniko. This development marks Akeso's first innovative drug to achieve FDA approval, a considerable triumph for the company. Anniko, co-developed with Chia Tai-Tianqing Pharmaceutical under Sino Biopharmaceutical, is approved for use alongside chemotherapy for the first-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. Additionally, it can be used as a single agent for patients who have previously undergone platinum-based chemotherapy and at least one other treatment line.

Historically, Anniko had already been approved in China for treating nasopharyngeal carcinoma, a rare form of cancer located in the upper throat behind the nose. A parallel application to use Anniko in combination with Sino Biopharm’s VEGFR2 inhibitor, anlotinib, for first-line liver cancer treatment is under review by Chinese regulators.

Akeso's entry into the U.S. market places it in competition with Coherus BioSciences and Junshi Biosciences’ PD-1 therapy, Loqtorzi, which was the first FDA-approved option for nasopharyngeal carcinoma. Approximately ten PD-1/L1 inhibitors had already entered the U.S. market before Anniko.

The FDA's approval of Anniko was based on results from two key studies: the international phase 3 AK105-304 trial and the pivotal AK105-202 study. In the phase 3 trial, the combination of Anniko and chemotherapy demonstrated a 55% reduction in the risk of disease progression or death compared to chemotherapy alone. Patients treated with Anniko experienced a median progression-free survival of 9.6 months, surpassing the control arm's 7 months. While overall survival data was not conclusive at the time, the FDA indicated no adverse effects on patients' longevity. Detailed findings from the AK105-304 trial are scheduled for presentation at the American Association for Cancer Research meeting in 2025.

In contrast, Loqtorzi received its first-line treatment approval after proving a 37% reduction in death risk with its chemo combination in a similar phase 3 trial. Meanwhile, the single-arm AK105-202 study conducted in China showed that Anniko produced a 28% objective response rate in patients who had previously undergone treatment, although the median response duration was not determined at the time.

Nasopharyngeal carcinoma does not present a large commercial opportunity, with reports indicating approximately 133,000 new cases diagnosed annually worldwide, most of which are in advanced stages. In the U.S., the incidence is less than one case per 100,000 people each year, though rates are higher in regions like South Asia. Coherus recorded $19.1 million in Loqtorzi sales following its U.S. market launch in early 2024.

Despite the limited market size, Anniko's approval emphasizes Akeso's innovative capabilities and dedication to providing difficult-to-treat cancer solutions worldwide, according to Akeso CEO Michelle Xia. However, the spotlight for investors remains on Akeso's PD-1xVEGF bispecific antibody, ivonescimab, a potential rival to Merck & Co.'s Keytruda in the realm of non-small cell lung cancer (NSCLC) immunotherapy.

Recently, Akeso announced positive outcomes from the phase 3 HARMONi-6 trial in China, where ivonescimab combined with chemotherapy outperformed BeiGene’s PD-1 inhibitor Tevimbra with chemotherapy in progression-free survival for first-line treatment of squamous NSCLC. This builds on previous success, where ivonescimab surpassed Keytruda in NSCLC monotherapy trials, a promising sign for its future market performance, as noted by Citi analyst Yigal Nochomovitz.