In spring of 2014, Peter Fortenbaugh noticed what appeared to be a tick that had bitten his lower calf. “It turned out not to be a tick, but it didn’t really go away,” he says.
The spot began to grow and bulge, and in October, Peter showed it to his primary care doctor, who referred him to a dermatologist to remove it. At the time, Peter recalls, it did not occur to him that the growth could be serious.
“I was actually very concerned about skin cancer because I spent a lot of time out in the sun sailing,” Peter says. “I put on a tremendous amount of sunscreen and protection, but never on my legs…I never connected the dots.”
However, a biopsy of the growth came back positive for melanoma. Peter, who lives in Palo Alto, California, with his wife and three children, immediately reached out to several doctors in the San Francisco Bay Area, and all had the same advice: “Take it out, take a biopsy.” Continue reading…
“Bristol-Myers Squibb (BMS) and AstraZeneca have each announced separate delays in the development of PD-1 and CTLA-4 inhibitor combinations as first-line therapies for patients with advanced or metastatic non–small cell lung cancer (NSCLC), according to statements from each of the companies.
“In its statement, BMS noted that it would not be pursuing an accelerated approval for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) as a frontline therapy for NSCLC. Instead, the company plans to delay the submission of data to the FDA until findings from a phase III study are available, most likely from the phase III CheckMate-227 trial.”
“Bristol-Myers Squibb Co on Thursday said it has decided not to seek accelerated U.S. approval for a combination of its two immunotherapy drugs as an initial treatment for lung cancer.
“Shares of Bristol, which closed at $55.49 on the New York Stock Exchange, were down 6.2 percent at $52.08 after hours.
“The pharmaceutical company cited ‘a review of data available at this time’ for the decision to hold off on filing for Food and Drug Administration approval of the combination of its cancer drugs Opdivo and Yervoy.”
“Results of an initial study of tumors from patients with lung cancer or head and neck cancer suggest that the widespread acquired resistance to immunotherapy drugs known as checkpoint inhibitors may be due to the elimination of certain genetic mutations needed to enable the immune system to recognize and attack malignant cells. The study, conducted by researchers on the cells of five of their patients treated at the Johns Hopkins Kimmel Cancer Center, is described online Dec. 28 in Cancer Discovery.”
“Patients with stage III melanoma who were considered to be at high risk for recurrence derived an overall survival benefit from adjuvant treatment with ipilimumab (Yervoy), although it came at the price of considerable toxicity, according to updated survival results from the phase III European Organisation for Research and Treatment (EORTC) 18071 trial. The results were presented at the 2016 European Society for Medical Oncology (ESMO) Congress by Alexander Eggermont, MD, Director General of the Institut Gustave Roussy in Villejuif, France, and simultaneously published in TheNew England Journal of Medicine.”
“Combined ipilimumab and nivolumab administered pre- and post-surgery reduced the tumor burden in patients with Stage III B/C melanoma, according to first results from the OpACIN trial reported at the ESMO 2016 Annual Congress.
“Tumor load was reduced after 6 weeks of ipilimumab plus nivolumab immunotherapy in 8 of 10 patients. Pathologic complete response (pCR) was achieved by 3 patients; and 5 patients showed minimal remaining micro metastases, including one partial response (PR) with remaining metastasis of 0.5 mm. One patient showed stable disease and 1 patient experienced progressive disease.”
“Patients with completely resected stage 3 melanoma who received adjuvant treatment with ipilimumab (Yervoy, Bristol-Myers Squibb) lived longer than those who received placebo, show the latest results from the CA184-029 (EORTC 18071) study.
“This is the first time such a clear survival benefit has been seen with adjuvant therapy in the patient population, commented lead researcher Alexander M.M. Eggermont, MD, PhD, director general, Cancer Institute Gustave Roussy in Villejuif, France, noting that previous trials with adjuvant interferon have suggested a survival benefit, but only in some subgroups of patients.”
“Melanoma research is rapidly advancing, particularly with immunotherapy, explains Jedd D. Wolchok, MD, PhD.
“ ‘With immunotherapy, we have come an extremely long way in the treatment of melanoma,’ says Wolchok, the Lloyd J. Old/Virginia and Daniel K. Ludwig Chair in Clinical Investigation, chief, Melanoma and Immunotherapeutics Service, associate director, Ludwig Center for Cancer Immunotherapy, Memorial Sloan Kettering Cancer Center.
“Combination trials with immunotherapies offer great promise, he says. Recently, the combination of talimogene laherparepvec (T-VEC; Imlygic) and ipilimumab (Yervoy) in patients with advanced melanoma demonstrated an objective response rate of 50% in a single-arm phase Ib trial after a median follow-up time of 20 months. Forty-four percent of patients had a durable response lasting more than 6 months; after 18 months, progression-free survival (PFS) was 50% and overall survival was 67%.”
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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…