What Patrick Soon-Shiong's ImmunityBio Has Actually Proven in Cancer Treatment — and What's Still Unproven

Claim: ImmunityBio has proven oncology has been "done wrong"

A reel from the account @twc.health opens with a line: "Dr. Patrick Soon-Shiong, physician and founder of ImmunityBio, has spent decades building a case that oncology has been..." The sentence is cut off by Instagram's login wall. So we don't know how it ends. But the setup follows a familiar pattern in health content. First it introduces a credentialed founder. Then it hints at a sweeping attack on mainstream cancer treatment. Then it lets the algorithm do the rest. Soon-Shiong is a real doctor and businessman. ImmunityBio is a real, publicly traded biotech company (Nasdaq: IBRX). The real question is narrower than the reel implies. What has this company actually proven? Look at its FDA approvals and published trial data. Then look at what is still just a sales pitch.

For a related, more recent claim — including an FDA warning letter directly addressing similar statements made about ANKTIVA — see Patrick Soon-Shiong's ANKTIVA Claims Are Spreading Fast on Social Media.

What's verified: one FDA-approved drug, one specific indication

ImmunityBio's main product is ANKTIVA (nogapendekin alfa inbakicept-pmln). It is a type of immunotherapy called an IL-15 receptor agonist. The FDA approved ANKTIVA on April 22, 2024. It is approved for use with BCG (bacillus Calmette-Guérin). It treats adults with a specific bladder cancer: BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. This is a narrow group. Their cancer has stopped responding to standard BCG therapy.

The approval was based on the QUILT-3.032 trial. That trial enrolled 77 patients in this BCG-unresponsive group. The FDA summary reports the results. The complete response rate was 62%. Of those who responded, 58% were still in remission at 12 months. And 40% were still in remission at 24 months. Common side effects hit 15% of patients or more. These included increased creatinine, painful urination, blood in the urine, and urinary frequency and urgency. They also included urinary tract infection, increased potassium, muscle and bone pain, chills, and fever. The National Cancer Institute's drug dictionary confirms the same approved use.

This is a real, meaningful result. It helps a specific group of patients. Before this, they had few options short of bladder removal (cystectomy). But it does not prove that "oncology has been done wrong" more broadly. And it does not make ANKTIVA a treatment for other cancers.

What's promotional or still unproven

ImmunityBio's own marketing calls ANKTIVA "the first FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer cells, T cells, and memory T cells for a long-duration response." That describes its approved use. It is not a broader breakthrough for all cancers. The company is testing other N-803 combinations for other cancers. But those uses are still in clinical trials. They are not FDA-approved. You should not mix them up with the bladder cancer approval.

The reel's framing blurs this line. It says he "spent decades building a case that oncology has been [wrong/failing/missing something]." That kind of story presents one narrow, real approval as proof of a much bigger shift. We could not read the reel's full caption. Instagram's login wall cuts it off for viewers who are not logged in. So we can't fact-check the exact claim. But here is what we can say. No large, independent evidence supports a sweeping rewrite of cancer treatment from ImmunityBio's work so far. There is only the specific, FDA-reviewed bladder cancer result described above.

Why this distinction matters for patients

Say you or someone you love has BCG-unresponsive NMIBC with carcinoma in situ. Then ANKTIVA plus BCG is a real, FDA-approved option. It is worth discussing with a urologic oncologist. The trial data behind it are public and can be reviewed. But watch out for a different kind of claim. Some claims suggest one company's immunotherapy is about to "fix" cancer as a whole. That is a sales pitch that runs ahead of the evidence. Approved drugs work for their approved uses, in the groups that were studied. Stretching that into bigger promises is exactly the gap that good reporting should flag.

The bigger picture

Biotech founders with strong personal brands often do this. They take one narrow, hard-won trial result. Then they turn it into a much bigger story about changing medicine. ImmunityBio's ANKTIVA approval is real and specific. It is one drug. It is one combination regimen. It treats one bladder cancer group. It is backed by a 77-patient trial with lasting response data reviewed by the FDA. That is worth taking seriously on its own. But it is not proof that "oncology has been done wrong." When you meet claims like this, look for the specific approved use. And look for the trial data behind any bigger claim.

Sources

• FDA — Approval of nogapendekin alfa inbakicept-pmln (ANKTIVA) for BCG-unresponsive non-muscle invasive bladder cancer
• National Cancer Institute — Nogapendekin Alfa Inbakicept-pmln (Anktiva)
• Drugs.com — Anktiva FDA Approval History
• ImmunityBio — ANKTIVA product information
• Instagram (@twc.health) — original reel

How this article was prepared

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

Cancer Explained is published by the National Cancer Information Foundation. It is not medical advice and does not suggest a test or treatment.

See an error, old source, or unclear wording? Tell us.