“ImmunityBio's drug N-803 (anktiva) is being investigated or has demonstrated efficacy in treating, curing, or preventing cancer types beyond bladder cancer.”

Phase 1/2 trial investigating N-803 in combination with gemcitabine/nab-paclitaxel for metastatic pancreatic cancer; primary endpoints focus on safety and objective response rate; recruitment ongoing as of 2026, no final efficacy results demonstrating cure or prevention.

Phase 2/3 trial (S1900G) evaluating N-803 (Anktiva) + pembrolizumab vs. standard chemotherapy in NSCLC without targetable mutations. Sponsored by SWOG Cancer Research Network, NCI-supported. Recruiting status as of 2026.

Completed phase 1/2 basket trial of N-803 (Anktiva) + PD1 inhibitors in advanced solid tumors including NSCLC, TNBC, pancreatic, head/neck cancers post-checkpoint failure. Reported improved survival; multiple tumor types enrolled.

NCI-supported Lung-MAP substudy testing N-803 (Anktiva) + pembrolizumab vs. chemotherapy in second-line NSCLC without targetable alterations. Demonstrated lower adverse events than chemo in prior data; ongoing evaluation of efficacy.

The Lung Cancer Master Protocol (Lung-MAP) public-private partnership, including the National Cancer Institute (NCI), will study ImmunityBio’s IL-15 receptor superagonist complex, N-803 (Anktiva), in combination with Merck’s pembrolizumab (Keytruda) for non-small cell lung cancer (NSCLC) patients who have failed previous treatments and whose tumors lack targetable mutations. The trial is open at more than 700 U.S. sites and will enroll 478 patients in a randomization against standard-of-care chemotherapy.

This study investigates N-803 and PD-L1 t-haNK combined with Bevacizumab for recurrent or progressive glioblastoma. Histologically-confirmed glioblastoma in accordance with the 2021 WHO Classification of Tumors of the CNS (WHO CNS5) that has progressed after initial therapy or therapies is included.

Preclinical and early-phase studies show N-803 enhances NK and T-cell activity in models of pancreatic, breast, and lung cancers, but clinical efficacy beyond bladder cancer remains investigational with no Phase 3 data demonstrating treatment, cure, or prevention in other types as of 2025 publications.

The combination of N803 with the immune checkpoint inhibitor nivolumab demonstrated encouraging clinical responses in nivolumab-naïve and nivolumab-refractory patients with non-small cell lung cancer. Currently, N803 is being evaluated preclinically and clinically in combination with various agents, including chemotherapeutics, immune checkpoint inhibitors, vaccines, and other immuno-oncology agents for the treatment of solid malignancies (Table 1).

On April 25, 2024, ImmunityBio announced positive overall survival results in the QUILT 3.055 study of 2nd- and 3rd-line NSCLC patients who progressed after checkpoint inhibitor therapy. The results reinforced ImmunityBio's belief in the unique mechanism of action of ANKTIVA (N-803) and its potential efficacy as a next-generation immunotherapy across multiple solid and liquid tumor types.

QUILT 3.055 trial shows median overall survival almost double that of standard chemotherapy in 2nd- and 3rd-line NSCLC patients refractory to checkpoint inhibitors. Positive results in both PD-L1 negative and positive participants, with ANKTIVA rescuing checkpoint therapy efficacy and prolonging survival. Company plans FDA meeting to discuss registration path.

ImmunityBio and BeiGene agree to Phase III trial of tislelizumab plus Anktiva in advanced/metastatic NSCLC, building on prior data showing Anktiva restores T-cell function and improves overall survival in PD-1 checkpoint inhibitor-resistant patients.

In February 2026, ImmunityBio announced the Saudi Food and Drug Authority (SFDA) granted conditional accelerated approval for ANKTIVA in combination with checkpoint inhibitors for the treatment of metastatic non-small cell lung cancer (NSCLC), marking the first authorization of ANKTIVA beyond bladder cancer. The company is pursuing accelerated approvals in multiple additional jurisdictions and engaging with the U.S. FDA on a regulatory pathway for this indication, with label expansion plans underway across multiple tumor types and for the treatment of lymphopenia. ImmunityBio also noted growing enrollment in ongoing and planned key clinical trials in glioblastoma, sepsis, Non-Hodgkin lymphoma, and treatment of lymphopenia.

In phase 2 QUILT-3.055 trial for post-checkpoint inhibitor NSCLC patients, 77% receiving Anktiva plus PD-(L)1 were responders by absolute lymphocyte count (ALC), with responders showing higher overall survival versus non-responders. Anktiva activates natural killer cells and CD8+ T cells to restore immune competence.

QUILT 3.055 basket trial across multiple tumor types showed positive overall survival with Anktiva plus checkpoint inhibitors in NSCLC patients where checkpoints failed, reinforcing Anktiva's potential efficacy across multiple solid and liquid tumor types.

FDA expanded access authorization for the use of ImmunityBio's Cancer BioShield platform anchored by ANKTIVA to treat lymphopenia in adult patients with refractory or relapsed solid tumors independent of tumor type who have progressed after first line standard of care. We demonstrated in phase two that we can extend survival in these types of patients... something that activates NK cells is absolutely going to work... phase three trial intended uses in Europe.

On March 17, 2026, the National Comprehensive Cancer Network (NCCN) updated its 2026 Clinical Practice Guidelines in Oncology for bladder cancer to include Anktiva plus Bacillus Calmette-Guérin (BCG) as a Category 2A recommendation for patients with BCG-unresponsive papillary-only non-muscle invasive bladder cancer (NMIBC). This expands Anktiva's use beyond carcinoma in situ (CIS), for which it received initial FDA approval in April 2024. ImmunityBio has an active supplemental Biologics License Application (sBLA) under FDA review to formally expand Anktiva's label to include BCG-unresponsive papillary tumors.

Anktiva is already approved in the U.S. and several international markets for BCG-unresponsive NMIBC with carcinoma in situ. On Friday, the company said enrollment exceeded internal expectations in its randomized registrational trial in BCG-naïve non-muscle-invasive bladder cancer (NMIBC), QUILT-2.005.

This is a phase II/III clinical trial for patients with BCG-unresponsive bladder cancer whereby patients get an IL-15 superagonist, which is N-803, and it’s combined with BCG. The data seems to be extremely exciting... complete response rate was 71% and median durability for patients with carcinoma in situ plus/minus papillary disease was 26.2 months.

As previously disclosed, the Company has been exploring partnering with a large biopharmaceutical company for commercialization of N-803 for intravesical administration.

ImmunityBio's Anktiva (N-803) is enrolled in multiple clinical trials beyond bladder cancer, including Phase 1/2 trials for pancreatic cancer (NCT05098148), colorectal cancer (NCT03485974), and HIV-related cancers, investigating efficacy in combination therapies; some trials report preliminary immune activation but no mature efficacy data for curing or preventing these cancers as of 2025.

Prof Sam Chang speaks to ecancer about the positive efficacy and safety phase 3 results in both CIS and papillary cohorts BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) after IL-15RαFc superagonist N-803 (Anktiva) and BCG infusion.

Anktiva shows statistically significant increased absolute lymphocyte count (ALC) and tripled median overall survival in randomized lung cancer trial versus checkpoint inhibitor alone. Similar universal survival increases seen in triple negative breast cancer, pancreatic cancer, head and neck cancer, and Hodgkin's lymphoma.