Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) and Opdivo Monotherapy Significantly Improved Overall Survival Versus Yervoy Alone in Patients with Previously Untreated Advanced Melanoma

Excerpt:

Bristol-Myers Squibb Company (NYSE:BMY) today announced the first overall survival (OS) data from the Phase 3 CheckMate -067 clinical trial. With a minimum follow-up of 28 months, the median OS had not yet been reached in either of the two Opdivo treatment groups and was 20 months for the Yervoy monotherapy group (95% CI: 17.1-24.6). Opdivo in combination with Yervoy and as a monotherapy reduced the risk of death 45% [hazard ratio (HR) 0.55; 95% CI: 0.42-0.72; P<0.0001] and 37% (HR 0.63; 95% CI: 0.48-0.81; P<0.0001), respectively, compared with Yervoy alone. The two-year OS rates were 64% for the Opdivo plus Yervoy combination, 59% for Opdivo alone and 45% for Yervoy alone. Results will be presented today in the press program and an oral presentation during the Update, Novel Indication, and New Immuno-oncology Clinical Trials session from 3:35 to 3:50 p.m. ET (Late-Breaking Abstract CT075) at the American Association for Cancer Research Meeting 2017 in Washington, D.C.”

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Expert Discusses State of Immunotherapy in Prostate Cancer

Excerpt:

“Advancements in immunotherapy in the field of prostate cancer have been slow ever since the FDA approval of sipuleucel-T (Provenge) several years ago.

” ‘It’s an exceptionally challenging area. After the success of sipuleucel-T, there have been combinatorial approaches using radiopharmaceuticals, such as radium-223, the checkpoint inhibitor ipilimumab (Yervoy), as well as some chemotherapy regimens,’ says Susan F. Slovin, MD, PhD.

“In an interview with OncLive at the 2017 Interdisciplinary Prostate Cancer Congress, Slovin, a medical oncologist at Memorial Sloan Kettering Cancer Center, offered her expert insight on the current state of immunotherapy in prostate cancer.”

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Clinical Trials Test Treatments for High-Grade Brain Tumors


With a few exceptions, glioblastoma (GBM) remains largely incurable, and the U.S. Food and Drug Administration (FDA) has approved few treatments for the disease. Surgery (when feasible), radiation, and temozolomide are used in most patients. But even if a newly diagnosed tumor can be surgically excised, recurrences are too common.

In this blog post, I simply list some of the new treatments available in clinical trials for GBM and other high-grade brain tumors. Only drugs that have at least some preliminary results of activity are included, and the list is not meant to be fully comprehensive. The interested reader can judge for herself what might be of interest, keeping in mind that no single treatment is suitable or will work for all GBM patients. Continue reading…


Super Patient: Peter Fortenbaugh Faces the Uncertainty of Pioneering Melanoma Treatment


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…


Frontline Immunotherapy Combo Setbacks Strike NSCLC

Excerpt:

“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.”

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Bristol Won’t Seek Faster Opdivo/Yervoy Lung Cancer Approval

Excerpt:

“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.”

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Cancers Evade Immunotherapy by ‘Discarding the Evidence’ of Tumor-Specific Mutations

Excerpt:

“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.”

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Adjuvant Ipilimumab Improves Survival in High-Risk Melanoma

Excerpt:

“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 The New England Journal of Medicine.

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High Response Rates Observed with Ipilimumab Plus Nivolumab in Advanced Melanoma

Excerpt:

“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.”

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