ImmunityBio Inc. (NASDAQ: IBRX) has seen its share price more than double this year following the release of encouraging preliminary fourth-quarter trial results and positive clinical data updates. The uptick reflects a growing investor confidence anchored in the company’s advancements in cancer immunotherapy development.
On Friday, ImmunityBio provided an update on its ongoing clinical studies, particularly highlighting accelerated enrollment and noteworthy efficacy outcomes from its lead candidates for non-muscle-invasive bladder cancer (NMIBC) and Waldenström Non-Hodgkin lymphoma.
Progress in NMIBC Trial Enrollment and FDA Timeline
The firm reported that enrollment in its QUILT-2.005 study, a randomized registrational trial evaluating Anktiva (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) treatment in BCG-naïve NMIBC patients, has outpaced initial internal forecasts. With over 85% of the targeted patient population enrolled, full recruitment is expected to be completed by the second quarter of 2026.
This accelerated pace supports ImmunityBio’s current projection of submitting a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) before the close of 2026.
In 2023, the FDA mandated an interim analysis of the QUILT-2.005 trial to evaluate the complete response rate and duration of response in patients receiving Anktiva plus BCG versus BCG alone. Results from this analysis demonstrated a statistically significant extension in response duration for patients treated with the Anktiva combination.
Detailed Interim Efficacy Findings
- At the six-month mark, 85% of patients in the combination arm maintained a complete response compared to 57% in the BCG-only group.
- At nine months, 84% of patients receiving Anktiva plus BCG retained complete response status versus 52% in the control group.
Despite the modest sample size of the interim cohort, the improvement in duration of complete response at nine months achieved statistical significance with a p-value of 0.0455.
QUILT-106 Trial Update in Waldenström Non-Hodgkin Lymphoma
Separately, ImmunityBio provided updated clinical and safety results from the ongoing QUILT-106 study, investigating an off-the-shelf allogeneic CD19 chimeric antigen receptor natural killer cell (CAR-NK) therapy combined with rituximab in patients with Waldenström Non-Hodgkin lymphoma, a rare form of B-cell malignancy.
Longer-term follow-up data have shown sustained complete responses extending up to 15 months and still ongoing. To date, all four enrolled patients remain in disease control with no progression.
Two of these patients have undergone long-term follow-up evaluations, revealing durable complete remissions at seven months and 15 months respectively, without any additional treatments following the initial administration of eight immunotherapy doses.
Notable Patient Outcomes
- One patient presenting with multiple lymphomatous bone lesions achieved a complete response after only four doses of CAR-NK plus rituximab.
- Another patient with approximately 95% bone marrow infiltration by tumor cells attained a complete bone morphological remission maintained for 15 months and ongoing, despite no further therapeutic intervention after the initial treatment course.
Market Reaction
ImmunityBio’s shares reflected these clinical advances positively, trading up 34.81% to $5.33 as of Friday's market close. The noteworthy stock performance illustrates the market’s responsiveness to the company’s progress towards potential regulatory milestones and treatment breakthroughs for difficult-to-treat hematologic and uro-oncologic conditions.