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Personalized Cancer Vaccines Safely Fight, Kill Tumors In Early Human Trials (arstechnica.com)
Emily Mullin reports via MIT Technology Review: Now two personalized cancer vaccine approaches appear to have safely prevented cancer relapse in a dozen patients with late-stage skin cancer. In recent years, scientists have realized that each patient's tumor harbors a unique set of genetic characteristics, or mutations. So for cancer vaccines to be effective, they'll probably also have to be unique. Two clinical trials, detailed today in separate papers in Nature, are among the first to show that this might be possible. In one trial, eight of 13 melanoma patients who got a personalized cancer vaccine were tumor-free nearly two years after being treated. In a smaller study, four of the six patients who received a vaccine had no detectable cancer for more than two years after treatment. All patients had their tumors surgically removed before getting the vaccine. The customized vaccines are an emerging class of therapies that take advantage of neoantigens, proteins that appear on tumors and seem to be specific to each cancer patient. To make the vaccines, researchers first sequenced DNA and RNA extracted from each patient's tumor. They then used computer algorithms to analyze the mutations on each tumor and predict the best targets that code for neoantigens. Based on that data, they created a personalized vaccine containing up to 20 of these neoantigens. Each patient received several injections of the vaccine over a few months.
This all sounds promising, but the problem with personalized treatment is the cost.
From the article:
"The customized vaccines are an emerging class of therapies that take advantage of neoantigens, proteins that appear on tumors and seem to be specific to each cancer patient. To make the vaccines, researchers first sequenced DNA and RNA extracted from each patient’s tumor. They then used computer algorithms to analyze the mutations on each tumor and predict the best targets that code for neoantigens. Based on that data, they created a personalized vaccine containing up to 20 of these neoantigens. Each patient received several injections of the vaccine over a few months."
Protein discovery is really hard to do. This is a good approach, by sequencing the DNA and using that to feed into a computer model to determine what proteins are expressed by the mutations. This modeling though is extremely complex and rarely accurate, as there are too many variables that are hard to determine without extensive lab analysis to support it. This could cost around $100,000 or more, if you're lucky it could cost less, but still in the $50k to $75k range.
Then once you have your target, you need to develop something to neutralize it. Most cancer immunotherapy are monoclonal antibodies, of which the methodology to develop them is well known in industry, but can still be expensive. There's never been a synthetic, computer modeled antibody that's as good as a mouse or rabbit monoclonal antibody, and to get one good antibody you're likely going through about 1,000 mice at around $200 to $400 a pop, so this is most likely around $200k to $400k.
And there's no way to scale this with volume, because it's discovery not production. Every person would need a new discovery every time, so you're looking at $500,000 per patient roughly speaking. So while promising science, no healthcare system can afford this without bankrupting itself.
Herein is the problem with cancer immunotherapy. The latest one on the market is Keytruda by Merck. One year's dosage can cost around $150,000, so while it's quite effective as a drug, it can bankrupt patients and payer systems very quickly. Somehow the cost aspects of these drugs need to be addressed, because there's simply no way they be effective on the broader market without some ability to lower the cost.
He thought he was dead for sure - stage IV melanoma. He's cancer free. Amazing stuff
-- 73 de KG2V For the Children - RKBA! "You are what you do when it counts" - the Masso
Early stage (Phase I) trials usually don't have control groups because the goal is to test for toxicity of the therapy. Later stage (Phase II, III) look to compare efficacy against the "standard of care." In this study, no one was admitted to the study but did not receive the therapy - that will happen in the next study.
Phase I trials are traditionally done in health volunteers, but these days, cancer trials are frequently performed in late stage cancer patients because they are desperate and have no other (Western medical) options. These patients had exceedingly little chance of spontaneous recovery, so you can assume the "control" group would have close to 0% survival.
The fact that they got such a huge response is amazing and highly promising.