As always, the more new treatments become available in melanoma, the more new challenges arise. With eight new drugs approved for melanoma in the last five years, oncologists may sometimes face the difficult choice of what drugs to choose for a patient’s first-line treatment. Immune checkpoint drugs sometimes cause serious side effects, but progress is being made on how to treat these and also how to treat patients with pre-existing autoimmune conditions. New approaches are needed in efforts to prevent recurrence of melanomas diagnosed at earlier stages of disease progression. These and other challenges are discussed below. Continue reading…
“Modern cancer drugs supercharge immune systems, target specific gene mutations and pack modified viruses into vaccines. Amid the increasing sophistication, one investigational treatment stands out for its simplicity.
“Rose Bengal, a cheap industrial chemical that turns yarn and food bright red, has been used as a diagnostic staining agent for some time. Now, some scientists are looking at its potential to fight various forms of cancer.
“At the forefront is Provectus Biopharmaceuticals Inc, which is testing a reformulated version of the industrial dye on melanoma, the deadliest form of skin cancer. The Knoxville, Tennessee, company reported promising results in a small melanoma study.”
In the past 3 years, the treatment landscape for metastatic melanoma has changed dramatically. We saw the advent of drugs that inhibit mutant BRAF and activate MEK proteins (vemurafenib, dabrafenib, and trametinib) and drugs known as immune checkpoint inhibitors (ipilimumab, Keytruda, Opdivo, and others). These treatments are ‘systemic’; that is, they are taken by mouth or injected directly into the bloodstream and spread throughout the body. However, as I reported earlier this year, drugs that are injected directly into tumors—’intralesional drugs’—have recently gained some attention. Two of them were featured at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting. New data, and doubts, on these drugs have since emerged. Continue reading…
The gist: Earlier this month we posted about promising results from a clinical trial testing a new treatment called PV-10. Now, an oncologist who was not involved in the research has told a Forbes reporter that the results may not be as promising as they sound.
“A new cancer drug benefited 51% of stage III and IV melanoma patients during a phase II trial, achieving complete response (total cancer disappearance) in 26% during the treatment period. That was all in just 16 weeks of treatment, and would seem to suggest this drug, being developed by a small company ignored by Wall Street, has potential for treating certain cancers in the future.
“But an independent oncologist not associated with the trial says that the results may not be so impressive after all, based on the data from the published study.
“John Glaspy, an oncology professor at UCLA, says that ‘it’s not clear’ whether the result are important. If they are talking about lesions that were not directly injected with the drug, the results would be meaningful. ‘If they are talking about the injected lesion, not so much,’ Glaspy says.
“When asked about it, he repeated: ‘Like I said, these SQ melanomas are an indolent disease, and it is not a big deal if you inject them and they regress. I don’t think you have any evidence that anybody is cured.’ “
The gist: A new treatment has shown early promise for treating people with cutaneous melanoma that worsened after previous treatment. The new treatment involves injecting a substance called rose bengal disodium into melanoma lesions. It was tested in volunteer patients in a recent clinical trial. The treatment proved safe, and 51% of the patients experienced a good response.
“Intralesional injection of rose bengal disodium was well-tolerated in patients with refractory cutaneous melanoma, with just over half of patients meeting the primary study endpoint, according to a poster presented at the European Society of Medical Oncology Annual Congress.
“Researchers included 80 patients with 6.3-cm median sum lesion diameter in biopsy-confirmed melanoma that was refractory to a median of six previous interventions in the study. The patients received intralesional injections of rose bengal disodium (PV-10) in up to 20 cutaneous and subcutaneous lesions up to four times during a 16-week period. Follow-up was 52 weeks.
“The researchers assessed best overall response rate (BORR) in up to 10 injected target lesions, and secondary endpoints included the assessment of response duration, BORR of untreated bystander lesions, overall survival and adverse events.
“PV-10 was found to be well-tolerated, and 41 patients achieved the study’s primary endpoint of an objective response for an overall response rate of 51%.”
“Half of patients with locally advanced cutaneous melanoma who had all their lesions injected with the investigational agent PV-10 achieved a complete response in a phase 2 study, according to a presentation at the 50th American Society of Clinical Oncology meeting, held in Chicago, IL, May 30th to June 2nd.”
Editor’s note: PV-10 is a new drug that can be injected directly into a cutaneous melanoma tumor. In a recent clinical trial testing the drug on volunteers, half of all patients who had all of their tumors injected experienced complete disappearance of their tumors.