ImmunityBio (NASDAQ:IBRX) announced positive results Tuesday from its ANKTIVA® clinical program, signaling a potential paradigm shift in the treatment of advanced non-small cell lung cancer (NSCLC) for patients who have exhausted standard-of-care options.
The data, derived from the QUILT-2.023 and QUILT-3.055 studies, demonstrated that ANKTIVA (nogapendekin alfa inbakicept)—an IL-15 superagonist—can effectively "rescue" the immune system in patients whose cancer has progressed on checkpoint inhibitors like Keytruda® or Opdivo®.
Across 151 patients, the therapy showed a statistically significant association between the restoration of lymphocyte levels and extended survival.
While historical standard-of-care chemotherapy, such as docetaxel, typically yields a median overall survival (mOS) of roughly seven to nine months in this setting, ImmunityBio’s results far exceeded those benchmarks.
In the QUILT-3.055 study, patients who achieved a high level of immune competence, saw their median overall survival reach 21.1 months.
The company is currently conducting a confirmatory Phase 3 trial, ResQ201A, which directly compares the ANKTIVA-checkpoint inhibitor combination against docetaxel in second-line NSCLC.
ANKTIVA is already FDA-approved for the treatment of non-muscle invasive bladder cancer (NMIBC), and the company plans to use this latest data as the foundation for a supplemental Biologics License Application (sBLA) in lung cancer.