Anktiva Combined With Checkpoint Inhibitors Produced Positive Overall Survival Results in Non-Small Cell Lung Cancer

ImmunityBio, Inc. today announced positive overall survival results in the QUILT 3.055 study of 2nd- and 3rd-line Non-small cell lung cancer (NSCLC) patients who progressed after checkpoint inhibitor therapy and standard-of-care chemotherapy.

The clinical study's results continue to reinforce 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.

The positive overall survival data of patients enrolled in QUILT 3.055, a basket trial across multiple tumor types in which checkpoint inhibitors failed, will be discussed, along with the status of launch readiness for ANKTIVA for its recently approved indication in Non-Muscle-Invasive Bladder Cancer. (NMIBC) on an investor conference call on April 26 at 8 am PDT.

"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 the 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 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, in a press release on April 25, 2024.

"The findings of a significant extension of overall survival in 2nd—and 3rd-line lung cancer affirm 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 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."

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.

A meeting with the U.S. FDA has been scheduled for June 2024 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.