ImmunityBio gets lung cancer boost

ImmunityBio’s market cap isn’t what it once was, but the group is still worth a remarkable $2.8bn, and on Tuesday a topline release from two non-small cell lung cancer studies of Anktiva sent its stock up 9%.

However, details were lacking, including on progression-free survival data from a first-line study that began in 2018. And there are more questions around ImmunityBio’s NSCLC plans; notably, the company previously said it hoped to file Anktiva with the FDA in post-checkpoint inhibitor patients last year, but this doesn’t appear to have happened.

Quilt questions

Tuesday’s announcement came from two studies: the phase 3 Quilt-2.023, and the phase 2 Quilt-3.055. Data from the latter have previously been presented at various venues.

Quilt-2.023, in first-line disease, compares Anktiva plus a checkpoint inhibitor, versus a checkpoint inhibitor alone. The primary endpoints are PFS and change in absolute lymphocyte count (ALC), a measure of immune response.

ImmunityBio said that patients receiving Anktiva plus a PD-(L)1 blocker had a “significant and sustained increase” in ALC versus those receiving PD-(L)1 monotherapy, with a p value of 0.0065.

However, the company didn’t provide any more information, and notably didn’t disclose anything about PFS. Data are being “prepared for peer-review publication and future scientific presentations”, ImmunityBio said.

The next steps here are unclear, with ImmunityBio not mentioning any filing plans, and also noting that enrolment in Quilt-2.023 was closed early “following changes in the first-line NSCLC treatment landscape”.

The trial began in 2018, and since then checkpoint inhibitors and targeted therapies have come to the fore. Still, Quilt-2.023 included a PD-(L)1 control arm, so it doesn’t seem to be particularly outdated.

Second line

Meanwhile, the phase 2 Quilt-3.055 focused on post-checkpoint inhibitor patients. Here, ImmunityBio said 77% of patients receiving Antiva plus PD-(L)1 were responders by ALC, and that responders had higher overall survival versus non-responders.

That trial's co-primary endpoint is described on clinicaltrials.gov as prolongation of OS by ALC response. The company contends that Anktiva could restore immune competence through activation of natural killer cells and CD8+ T cells.

However, Quilt-3.055 was uncontrolled, and findings will need to be confirmed in the phase 3 ResQ201A trial. But there are questions about that study’s design, too. It’s comparing Anktiva plus Tevimbra plus docetaxel versus only docetaxel; for a precise indication of Anktiva's contribution the control arm should also include a checkpoint inhibitor.

Last year ImmunityBio said it was planning a US filing for Anktiva in post-PD-(L)1 NSCLC, based on Quilt-3.055, presumably using ResQ201A as the confirmatory trial. But there’s been no news yet on this submission.

At the time of publication, ImmunityBio hadn’t responded to questions from ApexOnco about this plan, or its next steps in first-line disease.

Anktiva, an IL-15 agonist, ended its run of bad luck when it secured approval in April 2024 for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. But the need for combination with BCG could make this a niche use; ImmunityBio reported product sales of $31.8m in the third quarter. A filing in papillary NMIBC was knocked backed last year, with the FDA requesting a randomised trial.

ImmunityBio-sponsored Anktiva trials in NSCLC

Notes: *ALC ≥1,000 cells/µl; **previously planned to combine Anktiva with Opdivo; ALC=absolute lymphocyte count; CPI=checkpoint inhibitor. Source: OncologyPipeline & clinicaltrials.gov.