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.
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.
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.”
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
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