Cancer Drugs Yervoy, Xtandi Get NICE Thumbs Up

“Cost regulators for the National Health Service in England and Wales have this morning issued guidance recommending the use of Bristol-Myers Squibb’s Yervoy (ipilimumab) for skin cancer and Astellas’ Xtandi (enzalutamide) for prostate cancer.

“First-line use of Yervoy will be funded in patients with advanced malignant melanoma when the full tumour cannot be removed or the cancer has spread to other parts of the body.

“The drug costs £3,750 per 10-ml vial or £15,000 per 40-ml vial, but B-MS has also agreed a patient access scheme with the Department of Health, in which it will be sold to the NHS at a discounted price.

“NICE analysis concluded that the most plausible cost per Quality Adjusted Life Year (QALY) was £47,900 for Yervoy compared with the chemotherapy dacarbazine and £28,600 per QALY compared with Roche’s Zelboraf (vemuraf [sic]).”


UPDATE 1-Bristol Immunotherapy Prolongs Survival in Melanoma Trial

“A late-stage trial testing Bristol-Myers Squibb Co’s cancer immunotherapy nivolumab in advanced melanoma patients was halted early after it was determined that the drug was likely to prolong survival, the company said on Tuesday…”

“The 418-patient Phase III study, called CheckMate -066, was testing nivolumab as an initial, or first line, therapy for patients with advanced melanoma, the deadliest form of skin cancer.”

Editor’s note: In a clinical trial with volunteer patients, researchers have been testing a new drug called nivolumab to see if it is a good first treatment for people with advanced melanoma. Nivolumab is an immunotherapy, meaning that it boosts a patient’s own immune system to fight cancer. In the clinical trial, some of the patients were being treated with nivolumab, and some with a standard chemotherapy drug called dacarbazine. Nivolumab showed so much better results than dacarbazine that the trial was ended early, and the patients who had been taking dacarbazine were switched to nivolumab.


Dabrafenib Improved Quality of Life in Patients with Metastatic Melanoma

“Patients with metastatic melanoma treated with dabrafenib demonstrated improved quality of life compared with those who received dacarbazine, according to phase 3 study results.

“Initial analyses of the BREAK-3 trial indicated dabrafenib (Tafinlar; GlaxoSmithKline) prolonged median PFS compared with dacarbazine (DTIC) in patients with BRAFV600E-mutant metastatic melanoma (5.1 months vs. 2.7 months; HR=0.30; 95% CI, 0.18-0.53).”


Ipilimumab in Advanced Melanoma: Added Benefit for Non-Pretreated Patients Not Proven

“The German Institute for Quality and Efficiency in Health Care (IQWiG) already assessed the added benefit of ipilimumab in advanced melanoma in 2012. A considerable added benefit was found for patients who had already received previous treatment. In the new dossier compiled by the drug manufacturer, the drug was now compared with the appropriate comparator therapy dacarbazine specified by the Federal Joint Committee (G-BA) also for non-pretreated patients.”

Editor’s Note: This story is a little confusing, so here is a summary to clarify: It was already known that ipilimumab can be beneficial for people who have received previous treatment for melanoma. A new study aimed to find out if ipilimumab also improves survival for patients who have not received prior treatment. However, for a variety of reasons, the study did not show that ipilimumab performs any better than dacarbazine in patients who have not received prior treatment.


Extended Follow-up in BRIM-3 Shows Prolonged Survival With Vemurafenib in BRAF V600E/K Mutation–Positive Melanoma

In the BRIM-3 trial, vemurafenib (Zelboraf) was associated with improved progression-free and overall survival vs dacarbazine in patients with advanced BRAF V600 mutation–positive melanoma. In an extended follow-up reported in The Lancet Oncology, McArthur et al found that superior survival outcomes were maintained and were present in both theBRAF V600E and BRAF V600K mutation subgroups.”

Editor’s note: Read more about vemurafenib here: http://www.nlm.nih.gov/medlineplus/druginfo/meds/a612009.html


Combo Chemotherapy Bests Single Drug Against Melanoma

Two chemotherapy drugs may be better than one against melanoma, according to results from an ongoing clinical trial that were presented at the 2013 meeting of the  International Society for Melanoma Research. The drugs were dacarbazine, which is U.S. Food and Drug Administration (FDA)-approved for melanoma, and paclitaxel, which is FDA-approved for breast, lung, and pancreatic cancers. In a phase III trial of 529 melanoma patients, the drug combination kept tumors from growing two times longer than dacarbazine alone (4.8 vs 2.5 months, respectively). The subgroups that did best included men and people with melanomas that had spread to the liver or brain. This is particularly encouraging for the latter group because they have the worst prognosis.


Tumor Genetic Analyses of Patients with Metastatic Melanoma Treated with the BRAF Inhibitor Dabrafenib (GSK2118436)

“Dabrafenib is a selective inhibitor of V600-mutant BRAF kinase, which recently demonstrated improved progression free survival (PFS) as compared with dacarbazine, in metastatic melanoma patients. The current study examined potential genetic markers associated with response and PFS in the phase I study of dabrafenib.”


Selumetinib Plus Dacarbazine Versus Placebo Plus Dacarbazine as First-Line Treatment for BRAF-Mutant Metastatic Melanoma: A Phase 2 Double-Blind Randomised Study

“Patients with metastatic melanoma, 50% of whose tumours harbour a BRAF mutation, have a poor prognosis. Selumetinib, a MEK1/2 inhibitor, has shown antitumour activity in patients with BRAF-mutant melanoma and in preclinical models when combined with chemotherapy. This study was designed to look for a signal of improved efficacy by comparing the combination of selumetinib and dacarbazine with dacarbazine alone.”


Dabrafenib Bests Chemotherapy and May be Safer than Vemurafenib

A clinical trial found that dabrafenib, a BRAF inhibitor, was far more effective in treating melanomas that have BRAF mutations than the chemotherapy drug dacarbazine, according to a report at an American Society of Clinical Oncology meeting. Patients treated with this drug lived without getting worse for 70% longer than those treated with dacarbazine (5.1 vs. 2.7 months, respectively). Moreover, compared to those treated with vemurafenib in other studies, dabrafenib-treated patients had less risk of another kind of skin cancer called squamous cell carcinoma. This suggests that dabrafenib, which is experimental, could be safer than vemurafenib, which is FDA approved.