ImmunityBio, Inc. announced positive overall survival results in the QUILT 3.055 study of 2nd- and 3rd-line NSCLC patients who progressed after checkpoint inhibitor therapy (pembrolizumab, nivolumab, or atezolizumab) and standard-of-care chemotherapy to be discussed during the upcoming conference call. 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.

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 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 NMIBC on an investor conference call, April 26 at 8 am PDT/11 am EDT. The QUILT trials initiated since the launch of the Cancer Moonshot program across multiple tumor types can be found on ImmunityBio.com and are summarized in the figure accompanying this announcement.

As can be seen, ANKTIVA (N-803) serves as the backbone to the immunotherapy vaccine across multiple tumor types at late-stage with exploratory evidence of complete remissions. Updates to this figure denoting the QUILT trials at the time of publication in 2021 will be forthcoming. 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.

In addition, the company will provide information about the status of launch readiness of ANKTIVA for NMIBC. Presentations by the company on ANKTIVA data in NMIBC are scheduled at the upcoming American Urological Association (AUA) conference in San Antonio, Texas from May 3-6, 2024. It is anticipated the first vials of ANKTIVA will be available for shipment the week of May 6, 2024.

Further details regarding ANKTIVA as the backbone of ImmunityBio?s late-stage clinical pipeline across multiple solid and liquid tumor types will be discussed during the conference call, along with commercial launch readiness details, and the corporate financial position to support launch of ANKTIVA for the U.S. market.