News reports emanating from family of Jimmy Carter reveal that the former president, who in August was diagnosed with a life-threatening melanoma, is now free of detectable cancer after several rounds of chemotherapy with new, expensive agents.
A mass in his liver was removed, and it was found to be a metastatic melanoma, a deadly cancer originating most often in the skin. At the same time, imaging surveys seeking evidence of melanoma elsewhere detected four small lesions in his brain. He subsequently received three courses of a new immuno-oncology drug, given every two weeks.
The drug he received is Merck's pembrolizumab (brand name is Keytruda), which was approved for use in melanoma by the Food and Drug Administration only last year. It is one of the first immunotherapy drugs which work against cancer by boosting the patient's own immune system, rather than by killing cancer cells. It is, in fact, a monoclonal antibody which targets a protein called PD-1 that is expressed by immune cells. The protein interferes with (or inhibits) the patient's own immune system, keeping its T cells from recognizing and attacking cancer cells, which, if left unchecked, keep its immune-activating T cells from recognizing and attacking cancer cells.
In the largest Phase I study in the history of oncology, the trials were conducted at UCLA and 11 other sites in the United States, Europe and Australia. Keytruda was found to be somewhat more effective than ipilimumab the first breakthrough immunotherapy drug and it also had fewer side effects. The drug was tested on more than 600 patients who had metastatic melanoma. Because so many of the patients in the early trial showed significant long-lasting responses, the FDA granted the drug breakthrough therapy status, allowing it to be fast-tracked for approval.
Survival rates among patients with advanced melanoma who were given pembrolizumab were excellent: three-quarters of those patients given the drug bi-weekly were still alive one year later. Similar results were obtained in an even larger trial that was published a few months ago.
Oftimes, older patients are thought to be poor candidates for intense chemotherapy due to sluggish immune systems and reduced tolerance to side effects. However, in this instance, older age may be beneficial. In fact, scientists were so optimistic age would not be an issue that patients in one clinical trial of the drug were as old as 94.
Although Carter s immune system, boosted by Keytruda, is likely the main reason he is cancer-free, he undoubtedly benefited as well from the high-precision, high-intensity radiation therapy to his brain. Carter said in August that he had four spots of melanoma in his brain, and received so-called stereotactic radiation therapy.
It is known that such stereotactic, or targeted, radiation therapy may have synergistic effects with the immuno-oncology drugs. And indeed, the four small brain lesions have apparently been radiated away for at least the time being. "Cure" is far from assured, however, as latent cancerous cells may well crop up in the medium-term future.
Interestingly, thus far, not one politician has expressed any thoughts about the cost of Carter's treatment. Given their recent focus on the "exorbitant" cost of drugs, not even Democratic presidential candidate Bernie Sanders who's suggested that the Veteran's Administration break Gilead's Sovaldi so that veterans who are infected with Hepatitis C will have mor access has seen fit to take note of Keytruda's costs.
While Senator Sanders and Carter are both well-covered by generous federal government insurance, leaving the ex-president with little or no out-of-pocket costs for his approximately $150,000 annual drug costs (not including the price of specialized radiation and other drugs he may be taking), if any one of us common folks required similar treatments, bankruptcy is a possible outcome regardless of health status.
My colleagues and I at the American Council wish only the best for Jimmy Carter and his family, and continued remission. But at what cost? Is this not a worthy subject for discussion on the campaign trail?