Wednesday, December 18, 2013

Lambrolizumab To Be Studied (Phase I/II), In A Combo With Glaxo's Votrient® (Pazopanib) -- In Treatment-Naive Advanced Renal Cell Carcinoma

Merck has partnered with GlaxoSmithKline to begin Phase I/II studies with Glaxo's Votrient® (pazopanib), delivered to treatment-naive advanced renal cell carcinoma patients, along with MK-3475 -- Merck's melanoma candidate that recently won breakthrough status at FDA. This will take a year or two to sort out, but could be an important additional indication/market for the MK-3475 Lambrolizumab candidate, should it pan out.

That said, Lambrolizumab is more likely to first reach market in the United States as a skin cancer drug -- as I say, for melanoma treatment -- then later be prescribed "off-label" directly by oncologists, if/when the newly-announced Phase II study shows good efficacy without increased toxicity -- in advanced carcinomas. [To be clear, Merck/GSK cannot market it off-label directly, under applicable US FDA regulations, but clinicians can always use it, investigationally, if they are willing to eat the potential malpractice risk. A good study outcome here will largely blunt that risk, for the US oncologists. That's how actual, practical pharma/medical practice works.]

And once again, this is smart and aggressive preparation, clearly underway at Whitehouse Station -- to allow MK-3475 the widest possible berth it can reasonably garner, when it does reach US markets, some time next year.

Per the Rock Hill Herald Online, then -- a bit -- do go read it all:

. . . .“Collaborations like this are central to Merck’s strategy to evaluate the potential of MK-3475 for the treatment of cancer,” said Iain Dukes, senior vice president, Licensing and External Scientific Affairs, Merck Research Laboratories. “We look forward to initiating further collaborations to investigate MK-3475 in combination with other anti-cancer agents across a range of tumor types.”

Merck and GlaxoSmithKline entered a collaboration to study MK-3475 with Vortrient® (pazopanib) and other agents in the GlaxoSmithKline portfolio in the future. This Phase I/II clinical trial is designed to evaluate the safety and efficacy of a combination of MK-3475 and pazopanib in treatment naïve patients with advanced renal cell carcinoma. Further details of the collaboration were not disclosed. . . .

We will -- as ever -- keep you up to date. This sort of pre-market pump priming, with expensive studies (something north of $100 million per Phase I/II study -- and presumably shared revenue streams, with other drug companies) suggests that Merck believes whole-heartedly in MK-3475. This will pay off handsomely -- if Mr. Frazier is right -- but will look like lots of money down a rabbit hole, should MK-3475 hit a last minute snag. So, taking bigger risks, and making bigger, earlier bets -- may well yield much bigger returns. Yep -- I like his style. [Ed. Note: Graphics up soon. "Let Christmas not be a time looked back upon, only later, with regrets." Words to live by. Maybe, just maybe. . . if only I had listened to him, a little more actively. . .]

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