Chemo?, Science

Immunotherapy Drugs: New Hope or More Hype?

“Cancer cure: Miracle drugs are the biggest breakthrough since chemotherapy” -Irish Mirror
“Immunotherapy the big new hope for cancer treatment” -The Guardian
“Cure for terminal cancer found in game changing drugs” -Telegraph
Researchers have made what looks like a “once in a generation” breakthrough in fighting cancer, advancing a technique that could become one of the “pillars of oncology,” next to surgery and chemotherapy. The technique enables the immune system, which ordinarily treats malignant cancer cells as if they were healthy, normal cells, to identify and attack tumors.

The big “cancer breakthrough” announced last week at ASCO 2015 was a melanoma study funded by Bristol-Myers Squibb which found that their immunotherapy drug Opdivo (nivolumab) produced longer progression-free survival than the current first-line immunotherapy drug Yervoy (ipilimumab), which Bristol Myers-Squibb also owns. And when the two drugs were combined they had the best results, sort of.

Here’s what everyone’s making a big deal about:

Progression free survival was twice as long with Opdivo compared to Yervoy, and nearly four times as long with the combination.

After a follow-up period of at least 9 months, median progression-free survival was 2.9 months for patients taking Yervoy, 6.9 months for patients taking Opdivo, and 11.5 months for patients taking both. The combo benefit occurred largely in the patients with PD-L1-negative tumors. Patients who were PD-L1 positive had a median progression-free survival of 14 months with the combo, and with Opdivo alone.

Keep in mind, the median is not an average. It is the exact middle point. So in the case of the latter group of patients, half of them had progression free-survival less than 14 months, and half had progression-free survival longer than 14 months.

Yervoy is given intravenously every three months. Opdivo is given every two weeks until it stops working.

Toxicity
These two drugs together are much more toxic than either one alone, and treatment-related “adverse events” were much more common in patients treated with the combination. Over half (55%) of the patients taking both drugs had adverse events of grade 3 and 4 compared with only 16% of the Opdivo group and 27.3% of the Yervoy group. About 1/3 (36%) of patients had to discontinue treatment because of adverse events. There were no drug related deaths reported for the combo therapy group.

The median follow up was right around 1 year for all three groups. As of February 27, 2015 (the study database lock date), only 260 patients of the original 937 patients were still taking Yervoy, Opdivo, or both. (see here)

425 patients stopped taking the drugs because they had disease progression.

194 patients stopped because the drugs were too toxic.

285 patients died during the study.

Combo Therapy Recap
-Almost 2/3 of patients taking the two drugs had their tumors shrink by a third or more.
-Only 11.5% had complete remission. We don’t know how many of them stayed that way.
-The median time that tumors shrank or did not grow was 11.5 months.
-60% of the patients stopped the therapy because of disease progression or toxicity.
-It’s too early to tell how many long-term survivors this therapy will produce.

The Cost
In his presentation at ASCO, Dr Leonard Saltz broke down the cost:
Opdivo costs $28 per mg of drug, whereas Yervoy costs $157 per mg.
Yervoy costs 4000 times more than gold!

In the latest trial, the cost of using Yervoy alone was $158,282 to get an extra 3 months.
The cost of Opdivo alone was $103,220 for an extra 7 months.
The cost of the combination was $295,566 for an extra 11.5 months

Patients on Medicare, and those whose insurance requires a 20% co-pay, will have to pay $60,000 out of their own pocket for 1 year of this treatment.

Opdivo for lung cancer
Opdivo was approved in March to treat squamous non-small cell lung cancer. Researchers at ASCO 2015 presented results of a study using it on non-squamous non-small-cell lung cancer.

The late-stage study showed that patients receiving Opdivo had a median overall survival of 12.2 months, versus 9.4 months for patients taking chemo drug docetaxel. Adverse effects were also less severe.
Again, we’re talking about the median, so half the patients lived over 12 months, half of them did not. Comparing the two median patients, one got an extra 3 months of life from a $100k therapy.

Current clinical trials on Keytruda
There’s another immunotherapy drug approved for melanoma last year called Pembrolizumab. The brand name is Keytruda and it currently costs around $14,500 per month.

Right now it’s being studied on 20 different types of cancer, and has shown anti-tumor activity in 13 tumor types like small cell lung cancer, esophageal cancer, and ovarian cancer.

But the latest clinical trials are using a dose that is 5 times higher than what was approved for melanoma, and costs about $83,000 per month. Yes, per month.

For a 165lb (75 kg) patient, Keytruda at the higher dose (26 doses per year at $51.79 per mg) will cost over 1 million dollars per patient per year.

According to Dr. Saltz, “This is unsustainable.” By definition, “Not able to be maintained or supported in the future, especially without causing damage or depletion of resource.”

Listen to Dr. Leonard Saltz discuss this in on NPR

Let me conclude with this statement:
I am for any therapy that restores health to the body and cures cancer.
I’m not against immunotherapy.
What I am against is the hype and false hope that the cancer industry has been selling since the 1950s.

If you are taking immunotherapy, I sincerely hope you become one of the success stories.
In the meantime, I’ve interviewed several people who have healed melanoma.
Learn how they did it here

Sources

(((c)))

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  • Roland Giesler

    For that price one could buy a farm, convert it to carrot production, buy high quality juicers and treat everyone that can be found and still have a lot of money left over!

    It’s not a hard choice to make, unless you’re complete duped by the modern alchemists of medicine!

    • Chris Wark

      Well said Roland!

  • A couple things readers should understand when breaking down cancer research numbers and their interpretations. Stats are very easy to misconstrue, and can be twisted to support conflicting options, be they from pharma, media, or bloggers like Chris and I. Take the cost part out for a moment and let’s focus on the effectiveness of the drugs referenced above.

    The measure of Progression Free Survival (PFS) isn’t the best one; it is simply a surrogate for Overall Survival (OS) because doctors cannot ethically wait until a patient dies to determine the drug’s response. PFS is the most effective measure of *time* that a clinical study has in determining a comparative analysis of Treatment A vs. Treatment B. OS is the *best* measure of effectiveness but often cannot be determined via scientific method; i.e. you cannot tell someone they are only able to take one drug, ever, to determine their overall survival duration (so as not to mess up the data pool).

    In the cited studies, it is important to note a couple of things that were seemingly downplayed in the video. The combination offers PFS of nearly 12 months on the combo, or almost 9 more months than Ipi alone. This doesn’t mean the patients all drop dead after those 11.5 months; their cancer began growing again 11.5 months after treatment, some after having a response (see below). It also means that, as a median, half of all responses were above 11.5. Remember – median isn’t mean/average, it simply states that 11.5 was the middle number of the sequence (in this study of 314 people, listed by PFS lowest to highest, the guy at #157 had 11.5 months before his melanoma got worse). This is used so outliers, both on the survival and death side, don’t skew the numbers to make a drug appear better or worse than it is. Which brings us to…

    The second set of stats are the response stats – Complete Response (CR) and Partial Response (PR). CR is pretty self-explanatory; medically it’s termed No Evidence of Disease (NED), even though we all know there’s *always* cancer cells in our body. This just says “hey, we cannot find any evidence” and is casually known as remission. A PR is disease reduction but still measureable tumor. To note – some partial responses can actually be CRs but because there is still “something” showing on scans, they are only considered a PR. And a PR can evolve into a CR after the study goes to publication. Here is a quick and good read on trial “endpoints” as these stats are called: http://cancerguide.org/endpoints.html

    For the combo melanoma study, the CRs are low, but the ORR (which is CR+PR) is high – 57% for the combo and 43% for PD-1 alone. The study is only 24 months old, and you could expect a significant number of those PR’s to become CR’s and/or have a pretty long Overall Survival when all is said and done. Whether it means their cancer was “cured” or just that their life was extended significantly, I would imagine most/all are thrilled with the response they got. Jim Allison, the pioneer of ipi and this wave of immunotherapy, has often stated that patients who survive 24+ months on Ipi generally don’t die of cancer (side note: Ipi isn’t a constant infusion – it’s 4 doses over 3 months and then you are done). So once many hit the 24-30 month range on the Kaplan Meier curve, they tend to be a part of a survival group that plateaus, for ipi, at just under 25%, for years. Studies for both PD-1 and the combos are not far enough along to give conclusive data (you’ll see it as “median OS has not yet been reached” in trial reports), but from the anecdotal evidence, they will shatter the 20-something percent success rate.

    Finally, the Adverse Events – side effects. “Grade 3/4″ is a wide variety of things
    that can be pretty awful and consistent (colitis is the big one for Ipi), to relatively tolerable or isolated. I had shingles, which would be a Grade 3/4, but I can assure you the 5 days in the hospital were a drop in the bucket compared to the response I have had. So the stats can be misleading, especially considering how low they are for the PD-1 arm.

    The bottom line from the ASCO presentations (again, excluding cost, a Pandora’s box) is that PD-1 is performing way better than Yervoy, and the combination is exceeding both but with a fairly tough toll on the body. While 50 testimonials on Chris’ site is great for promoting complementary treatments or lifestyle changes, some of the nastiest and most difficult to treat Stage IV cancers are being put into
    stable or No evidence of disease in hundreds of metastatic melanoma/lung cancer
    patients. If you’re in one of those groups, certainly consider these as an option.
    I just turned 40, 31 months after a Stage IV melanoma diagnosis, and I’ve never been healthier, thanks to my PD-1 treatments enabling my immune system to beat this cancer.

    • Cynnergy

      Thanks, Chris and TJ Sharpe for the well researched info. My question is: how do the Grade 3/4 side effects compare to those of chemotherapy and radiation? Are there long term effects as there are in rad. and chemo? If money were no issue, would it make sense to take the immunology drugs as a measure to curb growth while implementing a holistic change in lifestyle? Is the pricing just due to the initial availability of these drugs (assuming doctors are prescribing them already) and perhaps, over time, the pricing will decrease as competitive forces take hold? Certainly, it might take up your life savings, but that won’t matter if you’re dead otherwise! Might as well live three more months!

      • They are mostly different than chemo/radiation, but different doesn’t necessarily mean less or better. Yervoy has colitis/diarrhea, and that gets serious in a significant number of patients (I got lucky and didn’t have any 3/4 Yervoy side effects). Rash is the other big one for Yervoy; typically the “lesser” side effects like nausea, fatigue, and skin irritation come and go. the PD-1 drugs have a much better profile; fatigue is by far the most common, shingles, edema (leg swelling) and rash/itchy skin are common but usually not 3/4.

        I’ve written a few times about why these drugs are going to change the way cancer is treated, although the paradigm shift in the oncology world is a little different (or differently worded/marketed) than how I view it. At the base, these drugs and targeted therapies aim at shutting down very specific functions that enable cancer cells to evade detection – PD-1 is named after the receptor on a t-cell literally called “Programmed Death” – which is the function the t-cell is trying (and failing, in the case of tumors) to perform in these abnormal cells. There are other “checkpoint inhibitors” that are under investigation as well. What *should* happen is that oncologists discover the many ways cancer fools our bodies and develops immunity; these strides come as the medical community realizes the benefits of nutrition and supplementation (among other things), and we get closer and closer to personalized medicine – while at the same time realizing how to best fight (and prevent) this disease with the tools God already gave us.

  • Chris Wark

    Dr. Coley was brilliant. Northern Baja Healing Center uses Coley’s therapy in combo with Gerson :)

    • Prudence15

      Just interviewed Dr. Barry Sears Ph.D about this. Here’s what he had to say. Diet is everything. If you decide to take these drugs still with an anti-inflammatory diet as well.
      What advances have they made with the new immunotherapy today?They are on the right track (as was Coley and his toxin therapy in the 19th century). Rather than unleashing it, it is best to modulate it by increasing the resolution of systemic inflammation. That approach is best done by the diet than drugs.
      Why is there so much hype in the media right now about these immunotherapy drugs? Because current therapy is so pathetic. It’s hard to win the war against cancer if you are still primarily using drugs developed more than 40 years ago and they weren’t very effective then.

      How do these drugs differ from interleukin-2?These new drugs remove the brakes on the immune system that could possibly kill us as in the case of sepsis. Interleukin-2 tries to gently stimulate the immune system (with still a lot of side effects). These new drugs put the immune system on steroids. It is like driving a truck down a steep mountain pass. You can use the gear box or simply never use the brakes to get more speed. However, sometimes speed kills.

  • Scarlett Johnson

    What were the side effects

    • James Peters

      I’ve added some info on the side-effects of Yervoy (Ipilimumab) and will add some soon on Opdivo (Nivolumab) and Keytruda (Pembrolizumab)

  • John

    Well done Candice. Never argue with a stupid person.They will only bring you down to their level . Then beat you with experience.

  • Dzndef

    Thank you, Chris for posting this video. I am following these immunotherapy drugs closely as I have Stage IV melanoma. I have not yet had any medical intervention (apart from surgical removal of a lung tumor in 2012 and then a lung needle biopsy in March 2014 to confirm recurrence). I radically changed my diet and reduced stress and my 3 lung mets remained unchanged for 9 months. At that point, however, they began growing and a new met appeared in January. I started Dr. Gonzalez’ protocol in March 2015. I am uncertain if it is working for me. I certainly hope so, but if not, I am at a loss as to what to try next apart from these immunotherapy drugs.

    So far the only success stories for natural treatment of melanoma I have seen were for earlier stages than me or their tumors had been surgically resected or they had no tumors in organs. I would love to read a natural survivor story of someone who had unresected melanoma in an organ if anyone could point one out.

    • danny

      have you tried high doses of curcumin?

      • Dzndef

        Thank you for replying, danny. Yes, I was on high doses of curcumin during the 9 month period when my mets were unchanged. But then they started growing. Dr. Gonzalez does not have me taking curcumin but he does have me taking lots of other things. I believe the key to healing is to find just the right mix of things that I personally need (which may be different for someone else). I have every confidence in Dr. Gonzalez’ protocol in general but even he will tell you that it doesn’t work 100% of the time. I certainly prefer natural treatments to the drugs, but if I am one of the unlucky ones, I might have to try the drugs.

  • MyGuess

    I hate toxic side effects.

  • Jennifer Schuman

    I just came across your site – I have never written to anybody before but felt compelled to write to you. How dare you decide a few months of some ones life isn’t worth the cost. My husband age 48 has stage 4 melanoma. He never felt unwell until a month before being diagnosed with brain tumors. There was never a spot as it started internally. We also have a 13 year old son.

    That diagnose came on 2/13/15. We were told that it had spread from head to toe. He is still alive today thanks to the drugs. By listening to your video you feel that the money that it costs to keep him alive is not worth it.

    Now I know nothing about you other than your story on your site. I did watch your interview with Prudence who also had stage 4 melanoma. You both said your programs and natural approach to fighting cancer would take at least 2-4 years. My husband without the drugs would not have made it a month. Prudence did not have brain tumors but my husband did.

    I just want you to know that I would and will pay any amount of money I can to keep him alive longer. I guarantee that if your holier than thou approach fails and all you had to depend on was drugs to save your life you would take them. You would choose to watch your kids grow up for as long as you can.

    • Chris Wark

      Hi Jennifer. This post is directed at the cancer industry’s obscene unconscionable drug prices, and exaggerated drug effectiveness claims. I’m defend and advocate for cancer patients, I don’t attack them, not sure why you took this personally… Glad your husband is still with you and I hope they cure him.

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