Breakthrough NK cell therapy with ANKTIVA shows promise in early cancer trials

A new cancer treatment combining NK cell therapy with ANKTIVA has shown promising results in early trials. The Phase I QUILT-3.076 study confirmed its safety in patients with recurrent or drug-resistant tumours. Meanwhile, ANKTIVA has now secured conditional approvals in 33 countries, including the US, UK, EU, and Saudi Arabia.

The trial involved ten cancer patients who received processed NK cells after enrichment. Across 23 doses, no serious side effects were reported. Researchers also found that NK cells taken from cancer patients worked as effectively as those from healthy donors, even against treatment-resistant tumour types.

The therapy platform can produce up to five billion NK cells from a single blood processing procedure. This yield is enough for eight to ten doses in about twelve days. When combined with ANKTIVA, these M-ceNK cells significantly shrank tumours in two models of small-cell lung cancer.

Neuroendocrine tumours, which make up 62 percent of cases, often lack MHC class I expression. This makes them resistant to T cell therapies but vulnerable to NK cell-based treatments. ImmunityBio has also submitted a supplemental application to the US FDA for ANKTIVA's use with BCG in bladder cancer patients who do not respond to standard treatment.

ANKTIVA's commercial success grew rapidly in 2025, with net revenues reaching $113 million—a nearly 700 percent increase from the previous year. China's SFDA granted the first global conditional approval for its use in metastatic non-small cell lung cancer.

The trial results support the safety and potential of NK cell therapy combined with ANKTIVA. With conditional approvals now spanning multiple regions, the treatment is moving closer to wider clinical use. ImmunityBio's scalable production method could further expand access to this emerging therapy.