ImmunityBio Inc. (NASDAQ:IBRX) stock has surged more than 100% year to date after the upbeat fourth-quarter preliminary results and trial data.
Anktiva Trial Update
The company on Friday said enrollment exceeded internal expectations in its randomized registrational trial in BCG-naïve non-muscle-invasive bladder cancer (NMIBC), QUILT-2.005.
Enrollment is now over 85% complete, with full enrollment of the planned study population anticipated by the second quarter of 2026.
Based on the current enrollment trajectory, ImmunityBio anticipates submitting a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) by the end of 2026.
In 2023, the FDA requested that an interim analysis of this randomized controlled trial be performed to assess Anktiva’s (nogapendekin alfa inbakicept) complete response rate and duration of complete response in subjects treated with Anktiva plus BCG compared with BCG alone.
The interim analysis demonstrated that Anktiva significantly prolonged the duration of complete response when combined with BCG compared to BCG alone in the BCG-naïve NMIBC setting.
At six months, 85% of patients receiving Anktiva plus BCG maintained a complete response, compared with 57% of patients receiving BCG alone.
At nine months, 84% of subjects in the experimental arm maintained a complete response, while subjects receiving BCG alone demonstrated a complete response rate of 52%.
Despite the limited sample size of this interim analysis, the difference in duration of complete response at nine months reached statistical significance (p=0.0455).
QUILT-106 Study Update
On Friday, ImmunityBio shared updated efficacy and safety results from the ongoing QUILT-106 study of an off-the-shelf allogeneic CD19 chimeric antigen receptor natural killer cell therapy (CAR-NK) in combination with rituximab for Waldenström Non-Hodgkins lymphoma, a rare B-cell malignancy.
Updated follow-up demonstrated sustained complete responses with durations now extending to 15 months and ongoing, with 100% disease control observed to date.
To date, four patients with Waldenstrom Non-Hodgkin Lymphoma have been enrolled, and all remain in clinical disease control.
Two patients are evaluable for long-term follow-up and continue to demonstrate durable complete remission at seven and 15 months and ongoing, respectively, despite receiving no additional treatment after the initial eight doses of immunotherapy.
In two patients evaluable for long-term follow-up who presented with extensive disease at baseline, one with multiple lymphomatous bone lesions and one with approximately 95% bone marrow infiltration by tumor cells, complete responses were observed after only four doses of CAR-NK + rituximab.
The patient with significant bone marrow involvement had complete bone morphological remission.
In this patient, in which 95% of the bone marrow was overtaken and replaced by tumor cells, the CR after four doses has been maintained now for 15 months and is ongoing as of this date with no further treatment after a total of eight doses.
IBRX Price Action: IBRX stock is up 34.81% at $5.33 at publication on Friday.
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