ImmunityBio Inc. (IBRX) is having quite the year. The biotech's stock has more than doubled in 2025, and Friday's news sent shares up another 34.81% to $5.33. What's driving the enthusiasm? A pair of trial updates that suggest the company's cancer therapies might actually work as well as hoped.
ImmunityBio Shares Jump on Promising Cancer Trial Data and FDA Filing Plans
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Bladder Cancer Progress Exceeds Expectations
The company announced Friday that enrollment in its pivotal bladder cancer trial is progressing faster than anticipated. The QUILT-2.005 study, testing Anktiva in BCG-naïve non-muscle-invasive bladder cancer patients, has now enrolled over 85% of its planned participants. Full enrollment should wrap up by the second quarter of 2026, with a biologics license application heading to the FDA by the end of that year.
Here's where it gets interesting. Back in 2023, the FDA asked ImmunityBio to conduct an interim analysis comparing how long patients maintained complete responses when treated with Anktiva (nogapendekin alfa inbakicept) plus BCG versus BCG alone. The results look encouraging.
At the six-month mark, 85% of patients receiving the Anktiva combination still had complete responses, compared to 57% getting BCG by itself. By nine months, those numbers were 84% versus 52%. Despite the limited sample size in this interim peek at the data, that nine-month difference hit statistical significance with a p-value of 0.0455.
In plain English: combining Anktiva with the standard BCG treatment appears to help patients stay cancer-free longer than BCG alone. That's exactly what you want to see in a trial designed to support regulatory approval.
Lymphoma Trial Shows Lasting Responses
The other piece of Friday's news involved QUILT-106, a study testing an off-the-shelf CAR-NK cell therapy combined with rituximab in Waldenström Non-Hodgkin lymphoma, a rare type of B-cell cancer. The updated data showed complete responses lasting up to 15 months and counting, with 100% disease control maintained across all enrolled patients so far.
Four patients with this rare lymphoma have been enrolled, and all remain in clinical disease control. Two patients available for long-term follow-up continue showing durable complete remission at seven and 15 months respectively, even though they received no additional treatment after the initial eight doses of immunotherapy.
The cases are particularly striking. Two patients who started with extensive disease saw complete responses after just four doses of the CAR-NK plus rituximab combination. One patient had multiple lymphomatous bone lesions, while another had roughly 95% of their bone marrow infiltrated by tumor cells. The patient with massive bone marrow involvement achieved complete remission that has now lasted 15 months without any further treatment beyond the initial eight doses.
Now, it's worth noting these are small patient numbers in a rare disease. But sustained remissions without ongoing treatment in patients who started with significant disease burden? That tends to get attention in the oncology world.
The combination of faster-than-expected enrollment, statistically significant interim results in bladder cancer, and durable responses in lymphoma helps explain why investors are bidding up ImmunityBio shares. The company now has clearer timelines for potential FDA approvals and early signals that its immunotherapy approach might deliver meaningful clinical benefits.
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