Does ANKTIVA's New Trial Data Add Up? — Let’s Look Closely!

We analyze ImmunityBio’s (ANKTIVA) new trial data to see whether the results actually support the claims.

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Episode Description: 

Every January, biotech companies flood the news cycle with bold claims, exciting headlines, and promises of cancer treatment breakthroughs. And at first glance, some of them sound incredible.  But when you look closely at the actual data, the story can change — sometimes dramatically.  In our newest blog post, Dr. Jay Chaplin breaks down the latest ImmunityBio updates, including for Anktiva, and explains why these clinical trial results deserve a much closer look. Not because the science lacks potential — quite the opposite — but because how a drug is tested and reported matters just as much as what it’s designed to do. 
This post walks through:
    • Why small trial sizes distort cancer immunotherapy results
    • How missing control groups make it impossible to know what’s really working
    • Why immune cell expansion doesn’t automatically mean tumor control
    • How hype-driven reporting can delay real progress for cancer patients
If you or someone you love is navigating cancer treatment, understanding how to separate solid science from marketing language is essential. This isn’t about tearing down innovation — it’s about protecting patients from confusion, false hope, and wasted time.

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Inquiries: 

info@elevatingcancertreatment.com

https://elevatingcancertreatment.com

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Disclaimer:
The information provided in this podcast is for educational and informational purposes only, and does not constitute medical advice. It is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have heard or read in this podcast or on this channel.
Reliance on any information provided by Dr. Jay Chaplin or Elevating Cancer Treatment is solely at your own risk. Dr. Jay Chaplin is a scientist and drug developer, not a medical doctor providing patient care. The content presented here reflects general scientific understanding and research, and may not be applicable to your individual health circumstances. Individual medical conditions and treatments vary, and no two situations are exactly alike.
Always consult with your personal healthcare provider before making any decisions about your health or treatment plan.

Transcript

SPEAKER_00 0:00

So today we're talking about Anctiva again and Immunity Bio in general, the company that makes it. And you'll want to stick around because this is the most bizarre set of clinical updates I've seen in my entire career, more than 30 years. To be clear, right up front, I think these drugs have real potential, and that's what makes it so incredibly frustrating. Because what we're looking at today is a masterclass in how to not try and develop a drug. Hello, and welcome to Elevating Cancer Treatment, where we explain the science and debunk myths to help you navigate your health journey. My background is a little different. Beyond educating about cancer, I'm actually designing new drugs that are defining the future of oncology. This direct hands-on experience offers me a very different perspective of how these cancer treatments work on the body, interact with the cancer cells, and cause side effects. And these are insights that I'm excited to share with you. If that sounds interesting, make sure to like this video, subscribe to the channel, and hit that notification bell so you never miss an update. And please share it if you find it useful. I'm Dr. Jay Chaplin. An important reminder, I'm a PhD, not an MD. The information in this video is education and it's not medical advice. Every cancer is unique and no general information applies to everyone. Please remember that. Always consult with your healthcare provider for guidance on your specific situation. And two quick things. First, as a thank you for being here, I've created a free resource, 10 things to elevate your chemo journey, which you can download from the link below. And second, by signing up, you'll also get updates on that innovative cancer treatment I'm working on. I'm confident it represents a significant advancement in immunotherapy. So please take a moment, download your free guide, and join us in shaping the future of cancer treatment. So every January, the biotech companies flood the news cycle ahead of the JP Morgan Healthcare Conference. That's normal. That's totally standard. This is where companies want to look their absolute best. They're trying to find investors, they're trying to find companies to acquire, they're trying to look good. Immunity Bio is no different. Immunity Bio released four press statements in rapid succession. One about approvals in Saudi Arabia, fine, we'll touch on that later. And three press releases with data. And this is where things get totally bizarre. Because while the headlines sound fantastic, the details tell a very different story. And today we're going to separate hype from reality. Now, again, an important disclaimer because a lot of people get confused about this. Let me be crystal clear before we go any further. I believe Anctiva has significant potential. I believe that their car NK cell therapy has significant potential. I want these drugs to succeed. I share about this in the first two videos that I've done about Anctiva, and I put a link in the description below. A lot of the same issues are coming up. Now, I read tons of clinical trials. I read tons of research papers. I've read thousands and thousands of them. I dive into the details and pick them apart, try to figure out what's done well and what's not done well. So potential only matters for drugs if they're developed correctly, and that matters to you because you want to look for studies that are solid. You want to know that a drug works for most people instead of something that has very little benefit. You want to invest your time, energy, and resources in drugs that will work, not ones that might work. And right now these therapies are being marketed as a standalone alternative to everything else, to chemotherapy, radiation, to targeted therapy, all the other immunotherapies. In other words, according to Patrick Sun Xiang, this works by itself and for every cancer. And that's a massive claim. So together, let's dig into what the data actually shows here and see what we think. First press release: the lung cancer checkpoint inhibitor and combo. First data set involves lung cancer, and it is in theory comparing immune checkpoint inhibitors, which we know work alright, against immune checkpoint inhibitors and anctiva. This should be a really straightforward comparison. Does this work better than this? That's not what we're given. Problem number one is the sample size. This analysis pulls from two separate clinical trials with a total of 151 patients. Let me pause there. In oncology, a good phase three trial has a minimum of 300 patients per group. The industry average is slightly higher than 700 per group. This analysis has three treatment groups and 151 total patients. 151. They should have been a minimum of 900. Ideally, more than 2,100 patients. So, right away, what we're dealing with here are numbers so small that outliers can totally dominate the results. And we have no idea how well patients were randomized or if these were blinded treatments. Now, you might be saying to yourself, so what? That's something that only statisticians care about. But these numbers are really small. They're small enough, and human beings are varied enough in their genetics in the way that they eat in their environments that with a sample size this small you don't get a good representation, and a decent drug could, by just bad luck alone, look like a total failure, and that would be a shame for you. Or the exact opposite can easily occur, and by blind luck, something dangerous and completely ineffective might seem like it gave a good response. That's why a big group size is essential. Now, that alone doesn't kill the data, but it means we have to be extremely cautious. Were they? No. Instead of focusing on the cancer outcomes, the thing that we really want to know about, the press release emphasizes immune restoration, specifically white blood cell counts. Yes, EVA increases white blood cell counts. That's literally what it's designed to do. It primarily expands natural killer cells. Those may or may not do anything to the tumor. NK cells themselves can't work on all tumors. They'll work great on some and not at all on others. And we don't even know if those are healthy and functional NK cells. That part is completely missing. We have no data on the cell function. The numbers go up, but we don't know if they work. We have no data showing tumor killing. We have no data showing these cells actually help cancer patients. This is a classic cytokine therapy problem. More immune cells do not necessarily mean better outcomes. It's been seen regularly with other cytokine therapies similar to this, like interleukin 2 or interleukin 7. It happens all the time. Now, they could have easily measured NK cell function. It's trivial. First year grad students do it all the time. But they didn't. And that's kind of curious. Problem number three, the comparison that never happens. So here's where this one goes completely off the rails. So we have a checkpoint inhibitor only group. Let's say this is the New England Patriots. Okay. Have a checkpoint plus Anctiva group. Let's say this is the Seattle Seahawks. You're going to play them against each other. Which one is better? Does adding Anctiva improve outcomes? Do the Seahawks do better than the Patriots? Just compare them. They never answer that. They do that analysis. So imagine your announcer is doing this. We're going to completely ignore the Patriots. Goodbye. We're going to take the combination group, we're going to separate them into the ones who are responders. They did really well, they scored a lot. And the non-responders, the ones who didn't, and we're going to compare these against each other. We're going to ignore this one and compare these against each other. Top scorers in the Seahawks, the people who benefited against the bottom scorers in the Seahawks, the people who didn't, despite them receiving the exact same treatment being on the same team. This tells us nothing about whether Anctiva adds benefit. Nothing. What we actually need to know is how big was this, how big was this, what percentage responded in the combo group, and what percentage responded over here. Is the percentage of responders higher in the combo than in checkpoint inhibitors alone? And that data's nowhere. It's conspicuously absent. And believe me, if it were positive, you can be sure it would be up front and center. That would be top line news. Now, I hope that worked because I'm not a sports fan, I'm a total nerd. But I hope that you can see that this is completely insane. If a ref did that kind of analysis, what would you think about them? Would you think that they've lost their mind? I do. The second press release looks better at first. This is a phase three trial in non-muscle invasive bladder cancer, and it's got two groups. Okay, simpler, cleaner, two groups, BCG alone and BCG plus Anctiva. The thing that's different about this trial from the one that they already finished and got approval for in the first place is the first one was for folks who had already failed on BCG alone, and this is to start with BCG plus Anctiva right off the bat. Now, good parts, they're shooting for 596 patients total, and they're 85% of the way done recruiting that population. So kudos for finally getting close to the minimum group size for this kind of trial. That's solid. Credit where credit is due. Now, the headline results. At six months, 85% of the people in the combination group had a good response. Anctiva plus BCG 85%, 57% with BCG alone. And over at nine months, 84% in the combo group still responded, and 52 in the BCG only. So that's a 28% gap, 28% improvement, and that sounds great. But when you look closer, there's something hidden here. The response rates don't improve over time, they stay flat. That gap is 28% in all the time points. Now you might wonder what I'm seeing in that. If the BCG wasn't very helpful, it would drop off and that gap would get bigger, but it doesn't. So what that's telling me is the Anctiva isn't really contributing to durability. It helps you get a response in the first place, but it's not keeping anything going. The heavy lifting for durability is all in the BCG. And that's something that showed up in their earlier data as well, something we've talked about multiple times, and those are linked down below. That separation, that 28% gap, does not get bigger over time. So the durability is not with the Anctiva. So here's the part that you won't find in any press release, and you have to dig to find it. And so far no one else seems to be talking about it. This is a bigger problem. Standard BCG dosing is 120 milligrams, and this trial uses 50. 50 milligrams is considered low dose maintenance therapy, not induction therapy. In other words, they started patients on a dose of BCG that wouldn't really do the job. Then they added Anctiva on top of it. That makes Anctiva look better than it probably is. Once again, Antiva has never been tested alone. There's no evidence that it does anything by itself. It's being put out there as a standalone, but it's never once been tested by itself, and here they're cranking down the BCG to make the Anctiva look better. This is really odd at best. And this kind of thing is why so many of my clients are totally turned around and confused on what to trust. Because it's hard to tell what's real and what's hype. Your clinical trial press release should not sound like clickbait. It should not be bait and switch with the data. And this is the kind of thing I help clients cut through so they can figure out with their limited time, energy, and resources what's going to work versus what might work, what's of the best value to them. So please reach out if you need help with analyzing these types of things. The third press release got me really, really excited. I love cell therapies. That headline reads durable, complete response of 15 months with chemotherapy free, car NK cell therapy. That sounds incredible. What do you think? 15 months, 100%? Sounds like a slam dunk. The reality? The actual data there? Total patients treated 4. Not 400, 4. Only half of them. Two. Had data. Two. Did you hear that? Two. Reminder, standard trial is between 300 and 700 per group. Here, they're combining two drugs, the new one, car NK cells, and an old one, Rituximab, which is a drug that already has a 30% cure rate in this disease. And then when I think it can't get any worse, again, there it is. No rituximab only control group. The drug that they are combining it with already works and there's no control group. There's no way to know what the CAR NK cells actually contributed to this. I am exhausted by the lack of controls in immunity biostudies. So out of our huge sample group of two whole patients, two! One has a seven-month response, and the other patient has a 15-month response. That's it. And they put it out there as if it's all a 15-month response. That's why there's two time points, one for a seven-month and one for a 15-month patient, and no controls for Rituximab. The laughable group size isn't the only odd claim here. It gets even a little stranger. They make a big deal out of claiming that this is a lympho-depletion-free process. So if you're going to use CAR T cells, a different kind of cell therapy, you have to eliminate some of the normal immune cells first to make room before you infuse in the cell therapy. They don't do that here, and they claim that it's beneficial because you haven't had to eliminate part of your immune system. That's a fair claim. Completely believe that. But rituximab kills antibody-producing B cells. That's what it was designed for, and it's what it does well. That is lymphodepletion. You can't say no lymphodepletion while administering a drug that causes lymphodepletion. That's nonsensical. That's like saying you won't get wet while you're shoving them into a pool. So, for those of you who are commenting, aren't you embarrassed now that Patrick Sun Xiang is showing such great data? No, I'm not. If this were good data, I would happily say that I'm wrong. I've done it before. This is not good data. This is confusing, it's selectively reported, and it's designed to sound impressive without proving anything. Especially the lung cancer trial. This screams post hoc analysis. Now, for those of you who aren't familiar with it, post hoc, Latin, it means basically you play the game, then you decide how to score it so that you will always win. It's like scoring basketball by how many passes rather than how many baskets. It's not good science, and the FDA won't accept this. This is not a way to make things move faster and smoother for patients. This is a guarantee that things will get held up at the FDA. And it really doesn't have to be this way. So it's very sad to see it happen again and again. Immunity Bio is designing trials and reporting on them in a way that will cause maximum trouble for them in the future. Seriously, there are consultants, there are groups for this, they should get help with this. Or watch these episodes because they need help designing these trials and reporting them so they can get these drugs to market to the people who need them. This is like blaming the referee when you're playing tennis in the middle of a football game. That's what they're doing. They're blaming the FDA when they're playing the wrong game. It's not smart. So these are powerful technologies being developed in a way that will slow them down. It does not help them reach patients. And that's the tragedy here. Folks, if you want drugs to succeed in development, you have to test them rigorously the first time. You have to be honest about the data instead of clickbait press releases, and you have to let the results speak for themselves without doing complicated gymnastics to try and justify them. Hype doesn't get drugs approved. Good science does. Thank you and stay curious. We really have to stay curious when it comes to these kinds of things and people's lives. We really do. Thank you. Beyond these videos, if you need more personalized guidance or a deeper dive into specific treatments to have your treatment be as effective as possible, I offer one on one sessions and medical advocacy. You can find information on our website, which is linked down below. Again, if you found this video informative, please give it a thumbs up, click the notification bell, and subscribe to our channel for more science based cancer insights.