ImmunityBio Reports Positive Long-Term Survival Data and Phase 3 Trials for Lung Cancer at Conference

ImmunityBio, Inc., a leader in immunotherapy, has announced promising results from its QUILT 3.055 clinical trial. This trial has demonstrated extended survival rates ranging from 14 months up to five years for patients with advanced non-small cell lung cancer (NSCLC) who are being treated with checkpoint inhibitors (CPI). The results were presented by Dr. John Wrangle from the Medical University of South Carolina at the World Congress on Lung Cancer in San Diego.

The Phase 2b QUILT-3.055 study focused on the combination of ANKTIVA (nogapendekin alfa inbakicept-pmln) with checkpoint inhibitors KEYTRUDA or OPDIVO in patients with various tumor types, including NSCLC, who had previously failed CPI-based treatments. The trial found that the combination therapy resulted in a long-term overall survival rate of 57% at 12 months and 34% at 18 months. These outcomes surpass the current standard of care.

Dr. Wrangle highlighted that most NSCLC patients face disease progression after CPI treatment, with average survival typically under one year. The QUILT-3.055 study enrolled patients who had relapsed after CPI or CPI combined with chemotherapy, indicating that the addition of ANKTIVA could potentially enhance checkpoint inhibitor activity. This enhancement is likely achieved through the activation of NK cells, CD4+, CD8+, and memory T cells. The survival rates observed in patients undergoing their second or third line of cancer therapy were notably higher than expected from existing treatments.

The study included 86 patients with second or third-line NSCLC who had previously failed CPI alone or in combination with chemotherapy, with no intervening therapies. ANKTIVA was administered subcutaneously every three weeks, alongside the checkpoint inhibitor the patient had previously received. The median overall survival for the 86 patients was 14.1 months, with some patients surviving up to 58 months. The survival rate for patients with positive PD-L1 expression was 13.8 months, while those with negative PD-L1 expression had a survival rate of 15.8 months. The combination therapy's adverse event profile was consistent with that of CPI alone, with no cytokine release syndrome observed and only 10% of participants experiencing grade 3 or higher ANKTIVA-related adverse events.

ANKTIVA plus CPI therapy demonstrated long-term median overall survival regardless of PD-L1 status and previous lines of therapy in patients with acquired resistance to CPI. The findings indicate that ANKTIVA can rescue checkpoint inhibitor activity through the activation of NK and T cells, leading to prolonged memory and improved survival rates. Based on these results and other trials involving ANKTIVA and checkpoint inhibitors, ImmunityBio is launching Phase 3 trials combining ANKTIVA with KEYTRUDA or OPDIVO in first and second-line NSCLC treatments.

The study protocol included a 24-month duration for ANKTIVA plus CPI therapy, after which no additional ANKTIVA doses were given. Despite this, 27% of participants survived beyond the two-year therapy period, suggesting that ANKTIVA may activate memory T cells, providing lasting therapeutic benefits even after the treatment period. Dr. Patrick Soon-Shiong, ImmunityBio's Executive Chairman, expressed excitement at the potential of ANKTIVA to convert cold tumors to hot tumors, thereby advancing the field of immunotherapy.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex that activates NK cells and CD8+ killer T cells, essential for targeting and destroying cancer cells. By enhancing the immune system's natural response, ANKTIVA aims to achieve prolonged and durable responses in cancer treatment. The drug has been approved by the FDA for use in BCG-unresponsive non-muscle invasive bladder cancer and is currently being explored for its potential in various tumor types.

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