GSK lands one-two punch in melanoma trial

Posted under ASCO, Blog, BRAF inhibitor, Companies, dabrafenib, Diagnostics, Funding, GlaxoSmithKline, Medical Devices, Medical Supply, Melanoma, personalized medicine, Pharmaceuticals, R&D, Roche, skin cancer, Startups, targeted therapies, trametinib, Universities, Videos, Zelboraf by rmcbride

GlaxoSmithKline ($GSK) is rushing to start a late-stage trial of an experimental cocktail therapy against deadly skin cancer after a mid-stage study produced impressive results. And data from the small trial provide early evidence that GSK's two-drug combo could have an edge over Roche's ($RHHBY) approved melanoma drug Zelboraf.

In the 77-patient study, those who took the combo of GSK's BRAF inhibitor dabrafenib and MEK-targeting agent trametinib lived for 7.4 months without their melanoma getting worse. Also, there were data to support that the combo could reduce a patient's risk of developing a separate cancer known as squamous-cell carcinoma while taking BRAF blockers, which are linked to growth of the tumors, Bloomberg reported.

Roche's Zelboraf is the first BRAF inhibitor approved for treating melanoma. GSK aims to stymie mutated forms of BRAF with dabrafenib, and pack the added punch of the MET-blocking trametinib to close an escape route that melanomas travel to skirt attacks from BRAF inhibitors. And despite the advance in care that Zelboraf has provided, about a third of patients on the drug develop cutaneous squamous-cell carcinoma and most patients' tumors eventually build up resistance to the targeted drug, Reuters reported.   

"We know that cancers are smart," said ASCO president-elect Dr. Sandra Swain, as quoted by Reuters. "They find work-around pathways. We are seeing a very innovative approach that ostensibly blocks off some of this pathway."

The results of GSK's study were revealed Wednesday as part of an avalanche of cancer trial news tied to next month's ASCO meeting, where the London-based drug giant will present the study and feed a frenzy in the oncology world for targeted treatments that are tailored for cancer patients based on the specific molecular drivers of their tumors.

Not surprisingly, GSK's combo is already drawing comparisons to Zelboraf. And Bloomberg noted that, while the London-based giant's study showed that its two-drug combo provided longer profession-free survival than Roche's BRAF inhibitor in similar studies, Roche pointed out to the news service that such comparisons are premature.

- check out Bloomberg's article
- see Reuters' report

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Big trouble seen for targeted cancer drugs

Posted under Blog, Cancer Drugs, Companies, companion diagnostics, Diagnostics, DNA test, Funding, Medical Devices, Medical Supply, Novartis, personalized medicine, Pfizer, Pharmaceuticals, Roche, Startups, targeted therapies, Universities, Videos by Ryan McBride

Researchers have discovered that the genetic complexities of cancer could thwart current methods of matching a patient's tumor with targeted drugs. The study by U.K. researchers could mean that more extensive digging into the genetics of cancer will be required before dispatching targeted treatments to attack tumors, a change that could drive up the already high cost of cancer care.

With an arsenal of targeted cancer drugs at their disposal now, doctors use DNA tests, typically of a single tumor specimen from their patients, to determine which meds are the best fit to take out their tumors. Alas, U.K. researchers conducted DNA tests from multiple areas of kidney tumors and found that only one third of all the key genetic mutations were present in all tumor samples, The Wall Street Journal reported.

The study is unlikely to unhinge enthusiasm about targeted cancer meds, but the findings could prompt doctors to take extra caution before using the drugs. What's more, the results could explain how cancers eventually bounce back after gene-targeted drug treatments, Bloomberg reported. And, rather than forming to overcome the effects of targeted drugs, the mutations that drive a cancer's comeback could already be present before treatment with the meds.

The targeted cancer drug phenomenon has pushed many of the top drugmakers into action, with Pfizer ($PFE), Roche ($RHBBY), and Novartis ($NVS) among the leading developers of such meds. It's probably too early to tell how the results of the U.K. study impact those companies' fortunes, but it's worth watching how the study impacts enthusiasm in the field.

"It's a sobering finding," Andrew Futreal, a co-author of the study and former director of cancer genetics and genomics at Wellcome Trust Sanger Institute in London, said, as quoted by the WSJ. He added that, with just one biopsy, "you might miss the connection between the mutation and whatever outcome you are looking at."

- read Bloomberg's article
- check out the WSJ piece

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Genomics revolution ignites new M&A talk, showstoppers

Posted under Blog, Companies, Diagnostics, Dna Sequencing, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Roche, Startups, targeted therapies, Universities, Videos by Ryan McBride

Roche's $5.7 billion hostile bid to scoop up DNA sequencing machine maker Illumina ($ILMN) has triggered talk of further merger targets in the promising genomics arena. And the race to invent faster and cheaper ways of decoding the genome has pushed small companies to the cutting edge of the field, giving industry leaders such as Illumina and Life Technologies ($LIFE) a run for their money.

While Swiss drug giant Roche continues its advance to gobble up a resistant Illumina, analysts have noted that rival Life Technologies could generate interest from other companies wanting a foothold in the blossoming market for DNA sequencers, Bloomberg reports. Genomics touches drug development, diagnostics and basic research. Other potential targets could be cancer test maker Genomic Health and Affymetrics, a maker of gene-analysis products, JMP Securities said, as quoted by Bloomberg.

"Roche's hostile bid for Illumina sparked a lot of interest in the genetic sequencing space," Alex Morozov, a Morningstar analyst, told the news service. Buyers could "look to supplement their internal R&D with external candidates, especially if they see something that could potentially be promising."

Both Life Technologies and Illumina announced last month their latest sequencers promise to push the cost of decoding a whole genome to the prized price tag of $1,000, making the technology more practical for screening patients' DNA for genetic clues about the best treatments. Drugmakers have seized the fruits of the technology as sequencers uncover new genetic targets for personalized drugs against cancer and genetic diseases.

Roche, which is also a leading diagnostics company, has stood alone among the Big Pharma groups making bids for sequencing companies. Sanofi CEO Chris Viehbacher has already said his company would prefer to stick to partnerships to access such platform technologies. Rather, the large potential buyers include companies with diversified healthcare businesses such as General Electric ($GE) and Siemens, Bloomberg reported. Experts have pointed out the speed at which the genomics field is changing, potentially making the standout products of today obsolete in a short period of time.

The field was reminded of this rapid change last week at a genomics meeting in Florida, during which Oxford Nanopore Technologies technology chief Clive Brown unveiled a sequencer that will cost just $900 and fit neatly in a device that is the size of a computer thumb drive, Xconomy reported.

- check out Bloomberg's article

- see Xconomy's report

Related Article:
Roche looks to snatch up Illumina for $5.7B