HIS SPEW...
For
@alc2022
and all the other folks naively buying into the exaggerated medical claims that
@DrPatSoonShiong
is making about $IBRX Anktiva Piercing the hype around Dr. Patrick Soon-Shiong's 'Bioshield' cancer treatment Published 9.11.25 Clinical trial results presented earlier this week do not support the claim made by billionaire physician Patrick Soon-Shiong that a drug sold by his company, ImmunityBio, prolonged the lives of patients with advanced lung cancer. The drug, Anktiva, is marketed as a treatment for a type of bladder cancer. Commercial sales are modest, and a competing, potentially superior drug from Johnson & Johnson was approved this week. Anktiva might one day prove beneficial to lung cancer patients, a much larger and more lucrative commercial market, but only if a recently started, randomized Phase 3 clinical trial reads out positively. That’s going to take a few years, as are randomized studies in other tumor types. To claim now that the drug “extends overall survival” — as Soon-Shiong and ImmunityBio stated this week — is an overreach based on questionable data from an uncontrolled study. It also undersells future risks. I’ll get to the red flags in the lung cancer study in a moment, but first, you need some background on Anktiva and how it plays into Soon-Shiong’s vision for a cancer “Bioshield.” ImmunityBio declined my interview requests and did not respond to a list of submitted questions. God, lymphocytes, and the ‘Bioshield’ Soon-Shiong’s theory is that the established practice of cancer care — using drugs and radiation to kill tumors — can be effective in the short term but detrimental to long-term survival. While standard treatments wipe out cancer cells, they also destroy certain types of immune cells, called lymphocytes, that are needed to find and destroy residual cancer cells remaining in the body. When these lymphocytes are depleted, a condition called lymphopenia, cancer cells can escape, regrow into tumors, and shorten a patient’s life. The solution to preventing cancer recurrence, and even curing it altogether, Soon-Shiong believes, is reversing lymphopenia. If one boosts a patient’s lymphocyte count, the strengthened immune system will work on its own to monitor, find, and destroy cancer cells. It just so happens that Soon-Shiong’s biotech company, ImmunityBio, has a drug to achieve this ambitious goal, he has said. Anktiva targets a molecule called IL-15 to stimulate the production of the same type of lymphocytes that he claims are needed to cure cancer. And not just bladder cancer where Anktiva is currently approved, but all types. It’s a potentially transformative idea but also one in which the catchy buzz phrase Soon-Shiong has created — the Bioshield — isn’t yet supported by convincing clinical evidence, including the lung cancer study results presented this week. That hasn’t stopped Soon-Shiong from making exaggerated claims about Anktiva curing cancer during guest appearances on podcasts hosted by the likes of Tucker Carlson, Megyn Kelly, and others. Soon-Shiong describes himself as a selfless scientist who has spent decades and millions of dollars of his own money in the search for a cancer cure to share with the world. Lymphocytes were invented by God 400 million years ago, he told Kelly on a recent episode of her podcast. “This cell exists so that it prevents us from having cancer, it prevents us from dying from infection, from Covid, from sepsis, from bacteria. How to activate this cell with a single jab? That’s what we’ve discovered.” Conveniently left out of the discussion is the fact that Soon-Shiong owns 70% of publicly traded ImmunityBio and the “jab,” Anktiva, is its sole commercial product. The podcast marketing push is also spiked with conspiracy theories claiming interference from Big Pharma and deep state FDA officials — unsubstantiated talk that MAGA audiences lap up. A look at the data This week, ImmunityBio reported data from a Phase 2 study called QUILT 3.055 that enrolled 86 participants with non-small cell lung cancer relapsed after initial treatment with a PD-1/PD-L1 checkpoint inhibitor. All of the study participants received injections of Anktiva and continued treatment with their same checkpoint inhibitor. In a group of patients with lymphocyte counts in a normal or high range, the median overall survival was nearly 16 months compared to 11.5 months for patients with low or reduced lymphocyte counts. Statistically, a higher lymphocyte count was associated with a 58% reduction in the risk of death, the company reported. “These results present the clinical evidence that a low lymphocyte count, as measured by ALC [absolute lymphocyte count] levels, is an actionable, accessible biomarker to identify and treat therapy-induced lymphopenia in cancer patients with Anktiva and prolong overall survival,” said Soon-Shiong, in a statement. The Anktiva data was presented at the World Conference on Lung Cancer, held this week in Barcelona. Some red flags to consider: -- The study was not randomized and didn’t include a true comparator arm. ImmunityBio presented survival from two groups of patients who received the exact same treatment — Anktiva plus a checkpoint inhibitor. -- The study was not prospectively designed to measure lymphocyte counts, or correlate change in lymphocyte counts with overall survival. The analysis was conducted after the study was completed. -- ImmunityBio also retrospectively defined the level at which lymphocyte counts were considered high/normal or low/reduced. The number in this study was 1,200 cells, but in other studies, the company has set the threshold at 1,000 cells. Unless prospectively defined, the finding is biased. ImmunityBio could simply set the cutoff at whatever level made the survival outcome look best. -- How frequently did patients need to have lymphocyte counts above 1,200 to be included in the better-surviving group, since lymphocyte counts can rise and fall frequently? The study, as presented, doesn’t clarify how lymphocyte counts were measured, or how frequently. ImmunityBio also reported a median overall survival of 14 months for all 86 patients who participated in the study. The standard treatment for lung cancer patients like this is typically a chemotherapy called docetaxel, which has been shown to prolong survival by seven to nine months, according to previously conducted studies cited by the company. That cross-trial comparison puts Anktiva’s survival benefit in a favorable light. However, larger and more current randomized studies have pegged docetaxel’s median overall survival at 11 months — making Anktiva’s result less impressive. None of the Anktiva data are conclusive. Last January, ImmunityBio told investors that it would be seeking FDA approval to expand the use of Anktiva to treat lung cancer patients based on the QUILT 3.055 study results. More recently, the company pulled the guidance for reasons it hasn’t disclosed. The FDA’s refusal to consider non-randomized data sufficient for approval is a good bet. I wouldn’t rule out the possibility that Anktiva, by raising lymphocyte counts, prolongs cancer survival. Maybe it’s the cure that Soon-Shiong promises. But instead of just talking about it, let’s see the clinical data that prove it.
10:07 PM · Oct 25, 2025
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