Array BioPharma Announces Positive Top-Line Results from Part 2 of the Phase 3 COLUMBUS Study of Binimetinib and Encorafenib for BRAF-Mutant Melanoma

Excerpt:

“Array BioPharma (Nasdaq: ARRY) today announced top-line results from Part 2 of the Phase 3 COLUMBUS study evaluating binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The primary analysis of Part 2 compared progression free survival (PFS) in patients treated with binimetinib 45mg twice daily plus encorafenib 300mg daily (COMBO300) to patients treated with encorafenib 300mg daily as a single agent. The median PFS for patients treated with COMBO300 was 12.9 months compared to 9.2 months for patients treated with single agent encorafenib, with HR of 0.77 [95% CI 0.61-0.97, p=0.029]. COMBO300 was generally well-tolerated and reported dose intensity and adverse events were consistent with COMBO450 results in COLUMBUS Part 1. Part 2 was designed specifically to assess the contribution of binimetinib to the combination of binimetinib and encorafenib by reducing the dose of encorafenib to 300mg in the combination arm to allow for a comparison of equal doses across arms. Further results from Part 2 will be presented at a medical meeting during the second half of 2017.”

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FDA Takes Action against 14 Companies for Selling Illegal Cancer Treatments

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“The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.

” ‘Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,’ said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs. ‘We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.’ ”

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Which Patients Will Be Helped By Immune Cancer Drugs? This Test May Tell

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“You’ve probably heard about powerful new cancer medicines like Keytruda and Opdivo. As advertised on TV, these drugs release brakes on the immune system to make tumors disappear and extend survival in deadly diseases like lung cancer and melanoma. But these agents, called checkpoint inhibitors, work in only a fraction of patients. Scientists are searching for diagnostic tests to predict who will be helped, and who won’t.

“A promising solution comes from Foundation Medicine, a molecular diagnostics company headquartered in Cambridge, Mass. Foundation offers a cancer genome profiling test that evaluates mutations in DNA. With results from its standard FoundationOne panel, Foundation calculates a Tumor Mutation Burden (TMB) score. This quantitative readout―based on the number and type of DNA changes per megabase, a length of DNA―may prove helpful to patients considering immune treatment for many advanced forms of cancer.”

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Surgery May Be Best for Advanced Melanoma

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“Surgery to remove melanoma—the deadliest form of skin cancer—can extend the lives of patients whose disease has spread to the abdomen area, new research suggests.

“Patients who get and to remove their cancer live twice as long—18 months on average—as those who only get medication, researchers found.

” ‘Now that there are better options systemically, the decision-making about treatment has become more complex. Having this data available could potentially impact discussions about treatment and benefit long-term,’ said study leader Dr. Gary Deutsch, a cancer surgeon at Northwell Health in Great Neck, N.Y.”

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Immunotherapy Combination Promising in Advanced Melanoma

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“Combination treatment with an intratumoral injection of Coxsackievirus A21 (CVA21) and the cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) inhibitor ipilimumab has demonstrated durable response with minimal toxicity among patients with advanced melanoma, according to data (abstract CT114) presented at the American Association for Cancer Research (AACR) Annual Meeting 2017, held April 1–5 in Washington, DC.

“Response to the combination occurred even among several patients whose melanoma had progressed despite prior treatment with an immune checkpoint inhibitor.”

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Metastatic Melanoma: Not Quite Curable…But Getting There


By 2050, the number of deaths due to malignant melanoma in the U.S. could be three times lower than peak levels reached before 1960. Researchers presented the data behind this prediction at the 2017 European Cancer Congress in January.

It is unclear how much of this anticipated decline in deaths can be attributed to the availability of new, effective treatments. However, it is obvious that much-increased awareness of sunlight exposure as the single factor most responsible for the development of skin melanoma has contributed to lower incidence of the disease.

In any case, the armament of treatments available for metastatic melanoma is currently such that this diagnosis has transformed from being almost universally fatal (even just a few years ago) into a being largely treatable. Since 2011, the U.S. Food and Drug Administration (FDA) has approved eight new drugs for melanoma. Continue reading…


New Study Finds That Most Cancer Mutations Are Due to Random DNA Copying ‘Mistakes’

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“Johns Hopkins Kimmel Cancer Center scientists report data from a new study providing evidence that random, unpredictable DNA copying ‘mistakes’ account for nearly two-thirds of the mutations that cause cancer. Their research is grounded on a novel mathematical model based on DNA sequencing and epidemiologic data from around the world.

” ‘It is well-known that we must avoid environmental factors such as smoking to decrease our risk of getting . But it is not as well-known that each time a normal cell divides and copies its DNA to produce two new cells, it makes multiple mistakes,’ says Cristian Tomasetti, Ph.D., assistant professor of biostatistics at the Johns Hopkins Kimmel Cancer Center and the Johns Hopkins Bloomberg School of Public Health. ‘These copying mistakes are a potent source of cancer that historically have been scientifically undervalued, and this new work provides the first estimate of the fraction of mutations caused by these mistakes.’ ”

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Innovative Immunotherapy Combo Tests IDO Inhibitor in Melanoma Trial

Excerpt:

“Investigators are looking into a novel immunotherapy combination that pairs the first-in-class IDO1 inhibitor epacadostat (INCB024360) with the checkpoint blockade agent pembrolizumab (Keytruda) in patients with unresectable or metastatic melanoma.

“The phase III KEYNOTE-252/ECHO-301 trial, which is enrolling at more than 120 locations, will randomize 600 patients in a 1:1 ratio to either epacadostat combined with pembrolizumab or pembrolizumab plus placebo (NCT02752074).”

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Array Walks Back Its FDA Pitch on Binimetinib, Derailing Plans for Commercial Launch

Excerpt:

“Array BioPharma has some explaining to do. Fifteen months after the Boulder, CO-based biotech said that it had the data needed for its first approval of binimetinib for NRAS-positive melanoma, execs are walking back the application and its plans for a launch.

“In a statement out Sunday evening, Array $ARRY said that after getting feedback from the FDA, execs ‘concluded that the clinical benefit demonstrated in the Phase 3 NEMO clinical trial would not be found sufficient to support approval of the NRAS-mutant melanoma NDA.’ ”

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