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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GSK will cut 3 R&D units, add 4 as DPU review triggers shakeup

Posted under Andrew Witty, Blog, Companies, Diagnostics, Funding, GlaxoSmithKline, Hepatitis C, Medical Devices, Medical Supply, Melanoma, Moncef Slaoui, Pharmaceuticals, Promacta, Relovair, Startups, Theravance, Universities, Videos by John Carroll

Following a three-year review of its new approach to R&D, GlaxoSmithKline ($GSK) today revealed that it has decided to ax three of its 38 tightly-focused research units and add four more in a shakeup. The final tally, which doesn't specify exactly who wins or loses, also included plans to beef up the budgets for 6 of their Discovery Performance Units while slicing funding on 5 others. And CEO Andrew Witty (photo) pronounced himself quite satisfied with the DPUs' overall performance, with the new annual numbers reflecting a boost in productivity as GSK moves ahead with plans to file for approvals on four new drugs and vaccines--including an MEK inhibitor for melanoma, trametinib, which scored paydirt data in Phase III, according to today's release.

Alone among the Big Pharma companies, GlaxoSmithKline has been tracking the rate of return on the money it spends on its late-stage pipeline work. In 2010, the return rate was 11%. Last year, that figure swelled to 12% as Witty vows to make it to the 14% mark. GSK says it will keep its R&D budget, a bellwether in the industry, flat at 3.7 billion euros.

In one of the most closely watched R&D restructurings in the industry, GSK launched its DPU approach to drug development back in 2008, promising to cut groups that underperform and back those making headway after winning three-year budgets for their work. The idea, advanced by Witty and R&D chief Moncef Slaoui, was that scientists would stay more closely focused if they knew their teams' funding relied on tangible progress--a daily reality for most biotech companies.

"These units comprise 5-70 scientists, with each group focusing on one particular disease or pathway," noted Witty in GSK's annual report. "Over the last three years, I have visited many of the DPUs and am very pleased with the energy, approach and productivity we are seeing from our scientists in these units." There's no word of any layoffs or departures in R&D today. GSK has made it clear that even if some teams didn't make the cut, it would transfer employees to other DPUs.

Now that the three-year review is over, GSK says the next three years will see 30 programs move into late-stage development.

Those DPUs are now wrapping six late-stage programs, Witty says. The four slated to be filed for approval this year include Relovair, its COPD treatment partnered with Theravance ($THRX), Promacta for hepatitis C and the MEK inhibitor for melanoma. The melanoma drug is GSK'212, or trametinib, which went into Phase III about a year ago.

- here's the release from GSK (.pdf)

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Roche gets key nod for targeted skin cancer drug en route to EU approval

Posted under Blog, Cancer Drugs, Companies, companion diagnostics, Diagnostics, Funding, Medical Devices, Medical Supply, Melanoma, Pharmaceuticals, Roche, Startups, Universities, Videos, Zelboraf by Ryan McBride

A standout drug for "personalized" skin cancer treatment has gained a key endorsement from European regulators. Roche ($RHHBY) said that the European Medicines Agency backed the targeted melanoma drug for approval. The Swiss drug giant hopes to secure from the European Commission in February.

The drug--developed by Daiichi Sankyo-owned biotech Plexxikon in Berkeley, CA--is intended to treat the aggressive forms of melanoma in which BRAF gene mutations are found, and Daiichi Sankyo's partner Roche is providing a companion diagnostic that screens patients for the mutation prior to treatment. The FDA approved the drug in August, after giving the market green light to Bristol-Myers Squibb's ($BMY) Yervoy for melanoma. Analysts expect sales of Zelboraf--which costs $56,000 for a six-month course of treatment--to reach nearly $1 billion in sales in 5 years, Reuters reported.

Zelboraf combats the deadliest form of skin cancer, and, unfortunately, one that has been on the rise. Globally, there were 200,000 new cases of melanoma in 2008, up from 160,000 cases in 2002, and the cancer kills about 40,000 people per year, according to figures cited by Roche. With fewer than one in four patients with the cancer expected to live beyond a year, Roche impressed clinicians last year with data that the drug, known generically as vemurafenib, reduced patients risk of dying by 63% during treatment compared to those on standard chemo treatments.

"The (Committee for Medicinal Products for Human Use) recommendation to approve Zelboraf represents an important milestone for people with metastatic melanoma who until recently had limited treatment options," Dr. Hal Barron, Roche's chief medical officer and head, global product development, said in a statement. "We are working closely with health authorities worldwide to bring Zelboraf to people with this deadly disease as soon as possible."

- here's the release
- read Reuters' coverage

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