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Combination Dabrafenib/Trametinib Increased PFS in BRAF-Positive Melanoma

Combination Dabrafenib/Trametinib Increased PFS in BRAF-Positive Melanoma | Melanoma Dispatch | Scoop.it

"Data from a phase 3 trial demonstrate combination dabrafenib and trametinib was superior to dabrafenib plus placebo for improved PFS in patients with BRAFV600-positive metastatic melanoma, according to data presented here at the ASCO Annual Meeting.


“ 'This is the first melanoma trial, phase 3, to have an active control arm,' researcher Georgina V. Long, BSc, PhD, MBBS, FRCP, oncologist at Melanoma Institute Australia at the University of Sydney, said of the COMBI-D trial."


Editor's note: This story describes the results of a clinical trial, in which volunteer patients are help test a new treatment. The treatment consists of a combination of the targeted therapy drugs dabrafenib and trametinib. Patients treated with the combination lived longer without progression of their cancer than patients who received dabrafenib plus a non-active placebo. Importantly, these results are specific to patients whose tumors have "BRAF V600E" mutations, which doctors can detect via molecular testing.

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Healio  |  Jun 2, 2014

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Dabrafenib Improved Quality of Life in Patients with Metastatic Melanoma

Dabrafenib Improved Quality of Life in Patients with Metastatic Melanoma | Melanoma Dispatch | Scoop.it

"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)."

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Healio  |  May 2, 2014

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New Treatments for Advanced Melanoma Presented at AAD

New Treatments for Advanced Melanoma Presented at AAD | Melanoma Dispatch | Scoop.it

"In recent years, the FDA has approved new drugs for the treatment of advanced melanoma, which has presented new ways to treat the disease, according to a presentation at the American Academy of Dermatology annual meeting.


“ 'In the last four years there have been four new drugs that have been FDA-approved for melanoma and what’s even more exciting is that they really speak to two new ways to treating melanoma,' Allan C. Halpern, MD, MSc, chief of dermatology service at Memorial Sloan-Kettering Cancer Center, told Healio.com.


"The most recent FDA approval, in January, was the combination of a BRAF inhibitor and a MEK inhibitor for treating advanced melanoma."

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Healio  |  Mar 23, 2014

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Blocking Autophagy with Malaria Drug May Help Overcome Resistance to Melanoma BRAF Drugs

Blocking Autophagy with Malaria Drug May Help Overcome Resistance to Melanoma BRAF Drugs | Melanoma Dispatch | Scoop.it

"Half of melanoma patients with the BRAF mutation have a positive response to treatment with BRAF inhibitors, but nearly all of those patients develop resistance to the drugs and experience disease progression.


"Now, a new preclinical study published online ahead of print in the Journal of Clinical Investigation from Penn Medicine researchers found that in many cases the root of the resistance may lie in a never-before-seen autophagy mechanism induced by the BRAF inhibitors vermurafenib and dabrafenib. Autophagy is a process by which cancer cells recycle essential building blocks to fuel further growth. Block this pathway with the antimalarial drug hydroxycholoroquine [sic] (HCQ), the authors found, and the BRAF inhibitors will be able to do their job better...


"Based on these promising preclinical results, Dr. Amaravadi and his team have already launched a clinical trial for patients with advanced BRAF mutant melanoma to see how well-tolerated HCQ is with the BRAF inhibitor vemurafenib. 'So far,' he said, 'we are seeing a benefit to patients and low toxicity.' "

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Medical Xpress  |  Feb 24, 2014

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US FDA OKs Combo Treatment for Melanomas with BRAF Mutations

US FDA OKs Combo Treatment for Melanomas with BRAF Mutations | Melanoma Dispatch | Scoop.it

Good news for people with melanomas that have BRAF mutations — the US Food and Drug administration just greenlighted using two targeted treatments at the same time. The two targeted treatments are the BRAF inhibitor Tafinlar (dabrafenib) and the MEK inhibitor Mekinist (trametinib), and both were previously FDA-approved for separate use. Melanomas often become resistant to BRAF inhibitors, and adding the MEK inhibitor could prevent or stave off this resistance.

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Reuters  |  Jan 9, 2014

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Combination Treatment Extends Life in People with Melanoma

Combination Treatment Extends Life in People with Melanoma | Melanoma Dispatch | Scoop.it

Two targeted treatments that are U.S. Food and Drug Administration (FDA)-approved for melanoma may be even more effective together. The drugs are dabrafenib, a BRAF inhibitor, and trametinib, a MEK inhibitor. In a phase II clinical trial with 160 people, the median survival was nearly 2 years with the combination treatment compared to 20 months with dabrafenib alone. These findings were presented at the 10th International Congress of the Society for Melanoma Research in Philadelphia, Pennsylvania. Now, the dabrafenib/trametinib combo has advanced to phase III trials.

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Cancer Network│Nov 20, 2013

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How to Predict Who Will Benefit from BRAF Inhibitors

A new study suggests there may be a way to predict how well a targeted treatment will work against melanomas with BRAF mutations. This finding is from a phase II clinical trial that included 76 people with BRAF V600E mutated melanomas who were treated with dabrafenib, a BRAF inhibitor. Besides confirming the efficacy of dabrafenib, the study showed that the higher the initial level of tumor DNA in the blood, the better dabrafenib worked. That said, the researchers caution that this correlation must be confirmed in a larger study.

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CancerNetwork│Aug 18, 2013

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FDA Greenlights Two New Targeted Treatments for Melanoma

FDA Greenlights Two New Targeted Treatments for Melanoma | Melanoma Dispatch | Scoop.it

Good news for people with melanomas that have spread—the U.S. Food and Drug Administration just approved two new drugs that target tumors with common mutations. The drugs are dabrafenib (Tafinlar), a BRAF inhibitor, and trametinib (Mekinist), an MEK inhibitor. Developed by the pharmaceutical firm GlaxoSmithKline, both drugs target BRAF V600E mutations, which occur in about half of melanoma tumors. In addition, trametinib also targets V600K mutations, which are the next most common BRAF abnormalities. While these drugs have been tested in combination, using them together is not yet approved. The FDA also okayed a new test for the BRAF V600E mutation that is made by diagnostics firm bioMerieux.

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MedPage Today | May 29, 2013

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New Phase III Study to Test Combining Dabrafenib and Trametinib

New Phase III Study to Test Combining Dabrafenib and Trametinib | Melanoma Dispatch | Scoop.it

Pharmaceutical firm GlaxoSmithKline has started a phase III study to see if a drug combination can prevent or delay the recurrence of melanomas with BRAF V600 mutations. Both drugs—dabrafenib, a BRAF inhibitor, and trametinib, a MEK inhibitor—are experimental and the study will assess the efficacy and safety of the combination. The researchers plan to enroll about 850 people from more than 200 sites worldwide in the study. Another pharmaceutical firm, Roche, is also doing late-stage trials of a different BRAF inhibitor/MEK inhibitor combination.

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GlaxoSmithKline Press Release | Feb 1, 2013

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Combining Dabrafenib and Trametinib Increases Melanoma Patient Survival

People with melanoma lived longer when treated with a combination of dabrafenib (a BRAF inhibitor) and trametinib (a MEK inhibitor) than with dabrafenib alone, according to research in The New England Journal of Medicine. The study included 247 people with melanomas that had BRAF V600E mutations. Treatment with both drugs increased survival to 9.4 months, compared to 5.8 months with dabrafenib alone. In addition, tumors were not evident or shrank considerably in 76% of people treated with both drugs, compared to 54% of those treated with dabrafenib alone.


Primary source: http://www.nejm.org/doi/full/10.1056/NEJMoa1210093

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The ASCO Post | Nov 1, 2012

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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.

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MedPage Today | Jun 4, 2012

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10 Issues to Consider During National Skin Cancer Awareness Month

10 Issues to Consider During National Skin Cancer Awareness Month | Melanoma Dispatch | Scoop.it

"Accounting for approximately half of all cancers in the United States, skin cancer is widely recognized as the most common cause of cancer nationwide. More than 3.5 million cases of skin cancer are diagnosed each year, and according to the Skin Cancer Foundation, incidences of skin cancer outnumber all combined cases of breast, colon, lung and prostate cancers.


"With the month of May designated as National Skin Cancer Awareness Month, HemOnc Today highlights 10 issues for oncologists and dermatologists to consider for their patients, as well as the new guideline revisions and research regarding the identification, treatment and management of patients with melanoma and skin cancer."

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Healio  |  May 15, 2014

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Conference Abstract - MAP Kinase Pathway Alterations in BRAF-Mutant Melanoma Patients With Acquired Resistance to Combined RAF/MEK Inhibition

Conference Abstract - MAP Kinase Pathway Alterations in BRAF-Mutant Melanoma Patients With Acquired Resistance to Combined RAF/MEK Inhibition | Melanoma Dispatch | Scoop.it

"Treatment of BRAF-mutant melanoma with combined dabrafenib and trametinib, which target RAF and the downstream MAP–ERK kinase (MEK)1 and MEK2 kinases, respectively, improves progression-free survival and response rates compared with dabrafenib monotherapy. Mechanisms of clinical resistance to combined RAF/MEK inhibition are unknown. This study represents an initial clinical genomic study of acquired resistance to combined RAF/MEK inhibition in BRAF-mutant melanoma, using WES and RNA-seq. The presence of diverse resistance mechanisms suggests that serial biopsies and genomic/molecular profiling at the time of resistance may ultimately improve the care of patients with resistant BRAF-mutant melanoma by specifying tailored targeted combinations to overcome specific resistance mechanisms."


Editor's note: We previously covered the benefits of a dabrafenib/trametinib combo for advanced-stage melanoma. However, some patients' tumors become resistant to this drug combination and new treatment routes need to be considered. This study is exploring how molecular testing of specific genetic mutations in patients' tumors might be used to help guide treatment decisions after they become resistant to the dabrafenib/trametinib combo.

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MDLinx  |  Apr 8, 2014

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Immunotherapy, BRAF Inhibitor Sequence Affected Outcomes in Metastatic Melanoma

Immunotherapy, BRAF Inhibitor Sequence Affected Outcomes in Metastatic Melanoma | Melanoma Dispatch | Scoop.it

"Prior treatment with immunotherapy did not limit response to BRAF inhibitors among patients with metastatic melanoma, according to results of a retrospective study.


"However, patients who underwent initial treatment with BRAF inhibitors and subsequently received immunotherapy with ipilimumab (Yervoy, Bristol-Myers Squibb) demonstrated poorer outcomes, results showed.


"Patients with BRAF-positive metastatic melanoma have several treatment options, including BRAF inhibitors vemurafenib (Zelboraf, Hoffmann-La Roche) and dabrafenib  (Taflinar, GlaxoSmithKline), the MEK inhibitor trametinib (Mekinist, GlaxoSmithKline), and the immunotherapy agents ipilimumab and interleukin-2. Yet, there are limited data with regard to optimal sequencing, according to researchers."

Cancer Commons's insight:

Healio  |  Mar 14, 2014

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Krishan Maggon 's curator insight, March 15, 2014 4:19 AM

Prior treatment with BRAF inhibitors reduced subsequent response to immunotherapy. Prior treatment with ipilimumab had no effect on response to BRAF inhibitors.

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Trial Supports Recent US FDA Approval of New Melanoma Combo Treatment

Trial Supports Recent US FDA Approval of New Melanoma Combo Treatment | Melanoma Dispatch | Scoop.it

The US Food and Drug Administration just granted accelerated approval for a treatment that combines two drugs that target melanomas with BRAF mutations — but this was contingent results of an ongoing phase III clinical trial. The drugs are the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist). Now the latest results of the trial are in and they look good. This combination treatment is not approved elsewhere in the world, and the trial included 423 people from Australia, Europe, and North and South America. Final results are expected later this year and will be presented at a scientific meeting. In addition, another trial is comparing this combination treatment to the BRAF inhibitor vemurafenib (Zelboraf), which is also FDA-approved.

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GlaxoSmithKline │ Jan 24, 2014

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Overcoming Resistance to BRAF Inhibitors May Take Two More Drugs

Overcoming Resistance to BRAF Inhibitors May Take Two More Drugs | Melanoma Dispatch | Scoop.it

We already knew that melanomas can resist BRAF inhibitor drugs by activating a particular cancer pathway (a group of proteins in a cell that work together to control cell multiplication, which can lead to tumor growth)—but new research shows that this resistance can also be caused by activating a second cancer pathway. The first pathway is called MAPK and the second is called PI3K-PTEN-AKT. The researchers studied 100 melanomas that resisted the BRAF inhibitors vemurafenib or dabrafenib, and found that 70% had mutations in the first pathway, while 22% had mutations in the second pathway. Moreover, mutations in both pathways could occur in the same tumor, suggesting that thwarting resistance to BRAF inhibitors may require targeting both pathways with a combination treatment.

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Cancer Discovery│Nov 21, 2013

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Speedy Review for Melanoma Combo Treatment

The U.S. Food and Drug Administration (FDA) has granted a priority review of whether two melanoma drugs work better together. The drugs are a BRAF inhibitor called Tafinlar (dabrafenib) and a MEK inhibitor called Mekinist (trametinib); both are already FDA-approved for use separately. Tumors, however, often become resistant to BRAF inhibitors, growing back after an initial period of shrinking. The hope is that adding a MEK inhibitor will prevent this resistance. The FDA's ruling on this combination targeted treatment is expected in January 2014.

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Reuters│Sep 16, 2013

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FDA Asked to Approve New Combination Treatment for Melanoma

FDA Asked to Approve New Combination Treatment for Melanoma | Melanoma Dispatch | Scoop.it

Two new drugs that target melanomas were just approved by the U.S. Food and Drug Administration (FDA) in May, and the drug developer has already filed for approval to use them in combination. The drugs are dabrafenib (Tafinlar), a BRAF inhibitor, and trametinib (Mekinist), a MEK inhibitor, and both are made by GlaxoSmithKline. The combination treatment request is based on promising results of a phase I/II trial, which showed that the two drugs work better together than dabrafenib does alone. Results of a phase III trial of the combination therapy are expected later this year.

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PharmaTimes│Jul 9, 2013

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Europe Accelerates Trametinib Review

Europe Accelerates Trametinib Review | Melanoma Dispatch | Scoop.it

The European Medicines Agency has granted a speedy review of trametinib, an experimental MEK inhibitor made by pharmaceutical company GlaxoSmithKline. The firm’s application for a European license includes findings from two studies of melanomas that have BRAF V600 mutations: a phase III trial comparing trametinib to two standard chemotherapy drugs (dacarbazine and paclitaxel) and a phase I/II trial comparing trametinib alone and in combination with the experimental BRAF inhibitor dabrafenib. If approved, trametinib could be available to people with melanoma within 6 months.

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GlaxoSmithKline Press Release │ Feb 7, 2013

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Researchers Write New Guide to Optimal Treatments for Melanomas with BRAF Mutations

Based on current data, researchers have developed a new treatment guide for melanomas with the most common mutations (BRAF V600). While these melanomas can be targeted with vemurafenib and dabrafenib, challenges remain. Not all tumors respond, some become resistant, and side effects can include another type of skin cancer called squamous cell carcinoma. Other treatment options include trametinib, which targets a protein called MEK, as well as immunotherapies such as high-dose interleukin 2 and ipilimumab, both of which can control tumors completely.

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Lancet Oncology | Feb 1, 2013

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Dabrafenib May Shrink Melanomas in the Brain

An early stage clinical trial suggests that dabrafenib, a BRAF inhibitor, could treat melanomas that have spread to the brain. The study, reported in The Lancet, included 10 people with brain metastases of melanomas that had BRAF mutations. Tumors shrank in 9 patients and were not evident in 4 patients. This is a surprise because the drug had not been expected to cross the blood-brain barrier effectively. Indeed, melanoma patients with brain metastases have been routinely excluded from previous trials of vemurafenib (Zelboraf) and other BRAF inhibitors.

 

Primary source: http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2812%2970269-3/abstract

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MedPage Today | May 18, 2012

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