Sunday, June 2, 2013

Merck's Lambrolizumab Melanoma Candidate Makes Pretty Big Splash At ASCO in Chicago Today

UPDATE: Merck says it will shortly (Q3 2013) launch a Phase III study in lung cancer patients, as well -- by far the largest US market. If that study shows similar results as are now appearing for melanoma patients -- Merck could easily have a $5 billion to $7 billion drug in the bag, by 2016. Wow.

Of course, if this perhaps $1 billion bet on a fast track large Phase III trial for a lung cancer indication on Lambrolizumab pays off for Merck, Dr. Roger Perlmutter will get the lion's share of the credit -- as he should. Afterall, he was a chief proponent of this class of drugs while at Amgen -- and now, as MRL's new chief, he is clearly betting a significant portion of the MRL budget on this possibility. Even if Lambrolizumab shows only moderate efficacy in lung cancer, at least here in the US, doctors will probably still use it off label, once it is approved for melanoma.

I should also mention that a fairly large portion of the US patient base suffering from lung cancer does have "Cadillac" insurance, as a result of unionized working careers, over the last 30 years. They tend to be blue collar, and yet quite well-insured. So, this would be especially good news for Merck -- if the trial shows strong efficacy in lung cancer -- because it would make a high price per dose pretty feasible, as these insurers would pick up the tab readily, for the prospect of avoiding near term, and expensive, end of life care scenarios in lung cancer patients. If the patient lives on for several years, the insurer has saved money. Not to seem crass, but this is the way insurers look at the equasion. [End, updated portion.]

While BMS has a candidate (nivolumab) that is deeper into Phase III testing, and Merck's Lambrolizumab PD-1 cell-death candidate is likely either second, or third in line, to reach market (depending on who you ask) -- the data in the New England Journal of Medicine (editorial here, on the nivolumab study result) is quite impressive. Almost all of this -- including the 38 per cent response rate was previously known -- but I think the 10 per cent cure rate, in the highest dose group, may in fact be new information.

Since all the MSM seems to be covering it -- I'll likely not live blog the webcast at 1 PM CDT today, and opt for a bike ride -- and workout, instead.

This is pretty darn exciting news for Merck, just the same -- here's a bit from Reuters, on it:

. . . .Overall, lambrolizumab resulted in 38 percent of patients having confirmed improvement of their cancer across all dose levels given after 12 weeks of treatment. But there was a wide range among doses, with only a 25 percent rate among patients who got the lowest dose and 52 percent among those who got the highest dose. In the highest dose group, 10 percent had a complete response, meaning their tumors could not be detected on scans.

Side effects were generally mild and included fatigue, fevers, skin rash, loss of skin color and muscle weakness. More severe side effects were seen in 13 percent of patients, including inflammation of the lung or kidney and thyroid problems.

"This study is showing the highest rate of durable melanoma responses of any drug we have tested thus far in this cancer, and it is doing it without serious side effects in the great majority of patients," Ribas said. . . .

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