Study Results:

Preliminary data from 135 patients (60% NSCLC) with treatment with checkpoint and N-803 following progression on the same checkpoint show CR 0%, PR 8%, Stable Disease 51%, Progression 29%, response unevaluable 12% to date. A PR or SD was seen in all subgroups. Median PFS 3.9 months (95% CI: 2.6,5.0). Median OS 13.8 months (95% CI: 11.8, 16.3) N-803 is well tolerated with grade 1-2 common N-803 treatment-related adverse events (TRAE) were injection site reaction (68%), chills (32%) fatigue (26%), pyrexia (26%), flu-like illness (14%), nausea (12%) and no other individual AE > 10%. Grade 3 N-803 TRAEs were 12%, but no individual grade 3 AEs were greater than 5%.

Study Conclusions:

N803 demonstrates low toxicity in patients previously treated with CPI, promising efficacy of cessation of progression and induction of response, and durable stable disease in patients who had previously progressed on a CPI containing regimen in multiple tumor types and different CPIs.