Anniko Wins FDA Approval for Nasopharyngeal Cancer, Enters Packed PD-1 Space

The FDA has approved Akeso and Sino Biopharm’s Anniko (penpulimab-kcqx), another PD-1 offering in a growing US checkpoint inhibitor market.

Anniko’s approval encompasses two indications:​ first-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma in combination with chemo (platinum-based like cisplatin or carboplatin and gemcitabine). And second, as a monotherapy for patients who have previously received platinum-based chemotherapy and at least one other prior therapy.​

In the announcement of the approval, Akeso said Anniko marks the company’s first innovative medicine to receive FDA approval.

And it’s around the tenth PD-1/L1 inhibitor to hit the US market.

With the FDA approval, Anniko will compete directly with Coherus BioSciences and Junshi Biosciences’ Loqtorzi (toripalimab-tpzi). In 2023, Loqtorzi became the first China-developed PD-1 therapy approved by the FDA for NPC.

Akeso co-developed Anniko with Sino Biopharmaceutical’s Chia Tai-Tianqing Pharmaceutical.

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The Significance of Anniko’s FDA Approval

Recurrent or metastatic NPC has a poor prognosis and limited survival. Akeso says “penpulimab-kcqx’s FDA approval will expand the number of NPC patients that can benefit from its treatment.”

“We are very excited by penpulimab-kcqx’s approval by the US FDA for first-line and later-line NPC. Beyond reaching our first international regulatory milestone, this approval also provides an important immunotherapy treatment option for patients with NPC in the United States,” said Dr. Yu Xia, founder, chairwoman, president and CEO of Akeso.

In the announcement, Akeso cited that according to the WHO 2020 Global Cancer Statistics, over 133,000 new NPC cases are diagnosed annually worldwide. Of these cases, more than 70% of patients have locally advanced disease.

According to the American Cancer Society, there is less than one case of NPC for every 100,000 individuals each year in the US. However, incidence rates are higher in some regions, particularly in countries in South Asia.

Industry watchers note recurrent or metastatic NPC to not be a significant business opportunity. Despite this, Dr. Xia said penpulimab-kcqx’s approval “highlights the quality of our innovation” and “underscores Akeso’s focus on delivering treatments for difficult-to-treat cancers for patients around the world.”

Related: Pfizer’s Sasanlimab in Combo with Standard of Care Improves Event-Free Survival in High-Risk Bladder Cancer

Trial Wins for Anniko

The treatment’s approval was based on results from two clinical trials.

The multi-center Phase III AK105-304 study involved 291 patients with recurrent or metastatic NPC who had not received prior systemic chemotherapy.

In the trial, the Anniko-chemo combo reduced the risk of progression or death by 55% versus chemotherapy alone.

The combination achieved a median progression-free survival (PFS) of 9.6 months compared to 7.0 months in the placebo group.​

In the open-label, single-arm AK105-202 trial with 125 patients who had disease progression after platinum-based chemotherapy and at least one other therapy, the objective response rate (ORR) was 28%.

The median duration of response and overall survival weren’t reached at the time of analysis.​

Penpulimab-kcqx had previously received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA.​

Successes and Setbacks

While Anniko marks a major international milestone for Akeso, investor attention has remained fixated on ivonescimab. The PD-1xVEGF bispecific antibody has been touted to be a strong challenger to Merck & Co.’s Keytruda in non-small cell lung cancer (NSCLC).

Akeso recently shared positive trial results for ivonescimab and won approval in China. However, the survival data released on Friday did not measure up to Keytruda in a head-to-head trial.

Results from the HARMONi-2 trial showed that ivonescimab reduced the risk of death by 22.3%. However, this did not meet the stringent statistical significance threshold set for the interim analysis. This led to investor disappointment and Summit’s stock falling almost 37%.

​Despite the recent market reaction, analysts view the overall survival data as promising. They note that the high statistical bar may have contributed to the lack of significance at this interim stage.

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