ImmunityBio's ANKTIVA shows breakthrough potential in cancer cell therapy trials

ImmunityBio has made significant progress in developing NK cell therapies for cancer treatment. Recent trials and preclinical studies show promising results for ANKTIVA, both as a standalone and combination therapy. The company has also expanded its global approvals and revenue growth for the drug.

A Phase I trial, QUILT-3.076, tested M-ceNK cells combined with ANKTIVA in ten patients with recurrent or refractory tumours, including breast, colon, pancreatic, and kidney cancers. No serious side effects were reported across 23 administered doses, confirming the treatment's safety. Additionally, NK cells taken from cancer patients proved as effective as those from healthy donors, even against tumour types usually resistant to NK cell attacks.

Preclinical research by the National Cancer Institute (NCI) demonstrated that M-ceNK cells plus ANKTIVA significantly shrank tumours in two small-cell lung cancer xenograft models. These findings were presented at the AACR IO conference in 2026. Meanwhile, ImmunityBio has scaled up production, generating up to five billion NK cells from a single leukapheresis procedure—enough for eight to ten doses in about twelve days. Regulatory milestones include ANKTIVA's first global conditional approval from China's SFDA for metastatic non-small cell lung cancer. The drug is now approved in 33 countries across four regions. In 2025, ANKTIVA's net revenue reached $113 million, a nearly 700 percent increase from the previous year. The company also submitted a supplemental Biologics License Application (BLA) to the FDA for ANKTIVA combined with BCG in BCG-unresponsive non-muscle-invasive bladder cancer.

The results highlight ANKTIVA's potential in treating cancers resistant to T cell therapies, particularly neuroendocrine tumours, which often lack MHC class I expression. With expanded approvals, strong revenue growth, and validated production methods, ImmunityBio continues to advance its NK cell-based treatments for broader clinical use.