Positive overall survival results of Anktiva combined with checkpoint inhibitors in non-small cell lung cancer; meeting scheduled with FDA to discuss registration path for Anktiva in lung cancer

The results continue to reinforce ImmunityBio’s belief in the unique mechanism of action of Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) and its potential efficacy as a next-generation immunotherapy across multiple solid and liquid tumor types.

In NSCLC patients who relapsed or were refractory to checkpoint inhibitors, Anktiva was administered together with the same checkpoint inhibitor. The addition of Anktiva resulted in the rescue of the checkpoint therapy efficacy, with significant prolongation of overall survival. These positive results were noted regardless of the patient’s PD-L1 status, consistent with the mechanism of action of Anktiva in activating and proliferating natural killer cells, and stimulating CD8+ Killer Memory T cells. This prolongation of survival in NSCLC following checkpoint failure is consistent with ImmunityBio’s findings of durable complete responses following BCG failure in NMIBC (non-muscle invasive bladder cancer).

A meeting with the FDA has been scheduled for June to discuss the company’s overall survival results in PD-L1 negative and positive patients and registration plans for 2nd-line and 3rd-line NSCLC patients whose cancer did not respond or continue to respond to checkpoint therapy and for whom few alternative therapies are available.

“The results we noted with the completion of the QUILT 3.055 basket trial across multiple tumor types in patients with late-stage cancers for whom standard of care plus checkpoints failed, validates our hypothesis that orchestration of NK cells with killer T cells and memory T cells could result in meaningful clinical improvements to current standards of care. We hypothesized that activation and proliferation of natural killer cells through IL-15 stimulation could rescue T cells after checkpoint failure, regardless of tumor type or of tumor location. As with non-muscle invasive bladder cancer, we believe that Anktiva enhanced the NK and T cell activity critical for targeting and killing cancer cells which have entered the phase of tumor evasion and resistance, ”said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “QUILT 3.055 was the initial and seminal study of our Cancer Moonshot program launched in January 2016 . The findings of a significant extension of overall survival in 2nd- and 3rd-line lung cancer affirms that combination therapy, with the orchestration of the innate and adaptive immune system, could potentially lead to the evolution of immunotherapy beyond T cells for all cancer patients. We are excited that these results continue to demonstrate the broad potential for Anktiva across multiple tumor types and its role as the next-generation immunotherapy. We are committed to pursuing additional indications for ANKTIVA in our pipeline with a mission to deliver new hope to patients with serious, advanced cancers where standard therapies have failed.”

Anktiva (N-803) serves as the backbone to the immunotherapy vaccine across multiple tumor types at late-stage with exploratory evidence of complete remissions. According to the American Cancer Society, lung cancer is the second most common cancer in the U.S. In 2023, it is estimated that 238,340 new cases of lung cancer will be diagnosed in the U.S. and 127,070 deaths will be attributed to the disease. NSCLC accounts for about 80% to 85% of all lung cancers diagnoses and there are very few successful treatment options for these patients once the cancer spreads beyond the lungs.

The development of checkpoint inhibitors in NSCLC has been revolutionary, doubling the median overall survival in some settings; however, patient response may be short lived, due to late response and/or progression after achieving an initial response. Historical and real-world experience (RWE) data show that the median overall survival rates in these patients range from 7 to 9 months.