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January 13, 2014 at 6:54 pm #21742Catherine PooleKeymaster
i’m trying to get the details! Thanks to Eric for sending my wayJanuary 13, 2014 at 7:21 pm #63341MathewRParticipant
Thanks for posting. Not clear, but the wording of the article suggests that the initial approval might only apply to patients treated previously with ipi?January 13, 2014 at 10:21 pm #63342Catherine PooleKeymaster Here’s what I heard from a source at Merck: Short-term there’s no immediate change to patients. We continue to enroll to our studies. In the bigger picture, initiating a submission brings us all that much closer to learning whether MK-3475 will be approved in melanoma.
And I bet it will be approved soon!January 14, 2014 at 1:17 am #63343Celeste MorrisParticipant
I hope rapid approval is what that means….but with Fierce Biotech…I’m not sure. They are all about talking to investors not patients. If interested you can check my blog (just Google “Chaotically Precise”) November 9, 2013 post for the Fierce Biotech low down on Merck’s 3475, BMS’s Nivolumab, and Roche’s PDl 1 product.
Hang in there ratties!!! Best, CelesteJanuary 14, 2014 at 5:37 pm #63344MathewRParticipant
More on the same topic. Again, the wording suggests that the initial approval may require patients to have been previously treated with ipi. Note also that BMS appears to be favoring lung cancer over mel in its initial approval.
Jan 13 (Reuters) – Shares of Merck & Co Inc rose as much as 6.5 percent Monday after it filed the first part of an application to market its experimental drug, MK-3475, for advanced melanoma, putting the treatment on track to become the first in a new class of promising cancer drugs to reach the market.
The application was filed earlier than investors had expected and ups the ante in a race between Merck and Bristol-Myers Squibb Co for dominance of a class of drugs known as anti-PD-1 inhibitors that are expected to generate billions of dollars in peak sales.
Merck’s drug is designed to treat patients with advanced melanoma who have previously been treated with Bristol-Myers’ melanoma drug Yervoy. The company is also testing the drug in other cancers, including lung and renal cancer.
Bristol is testing its own PD-1 drug nivolumab in a variety of cancers, with lung cancer likely to be one of the first to move forward.
“This is probably one of the most important classes of new drug,” said Damien Conover, an analyst at Morningstar, who forecasts peak sales for Merck’s drug, including multiple cancer indications, of $3 billion. He forecasts peak sales for Bristol’s drug of $6 billion.
The drugs are designed to restore the natural ability of the immune system to recognize and target cancer cells.
While Bristol has more clinical trials and data to show for nivolumab, Merck’s move in filing for MK-3475 early “is a way to fight Bristol by getting out ahead of them,” Conover said.
Merck said it expects to complete its application in the first half of this year. Under a rolling application, completed portions of the package may be submitted and reviewed by the Food and Drug Administration on an ongoing basis.
Jeffrey Holford, an analyst at Jefferies, said in a research note that the future of PD-1 development could focus on combination regimens. He said it is too early to decide on a winner in the PD-1 space, though he said Merck’s drug “does appear to have the best overall profile as a monotherapy.”January 15, 2014 at 12:42 pm #63345
I talked to Dr Infante about this yesterday and he said he doesn’t think a rolling application to the FDA necessarily means an accelerated approval date, but gives the FDA the opportunity to see, if the early results continue to look convincing, that an earlier completion date would merit early acceptance. Since Merck’s drug is supposed to be hitting around a 40% response rate to date, that might do it if that continues. But it certainly won’t be approved early this year! Maybe expanded use might kick in before 2015, one can hope.
Clearly this is being driven by 2 things – the drug is the most promising to come along for a wide variety of cancers in a looonng time, and because of competition with BMS – bring it on!!1
JonathanJanuary 15, 2014 at 4:01 pm #63346jamesaParticipant
I was so happy to see you post. I often think about you and how you are doing.
Please give us an update on your situation. I pray that everything is going well for you.
Stay well my friend,
JamesJanuary 15, 2014 at 8:37 pm #63347
Thanks, I’m pretty stable, is the word. No new tumors, and minimal growth in one of the larger tumors, but Infante isn’t worried at this point – says they go up and down a little on these ADC drugs. The anemia is still there, but not serious enough to warrant an infusion, at least at this point – haven’t had one of those for 6 months.
I’m very happily off the Lyrica – didn’t like the side effects at all – blurry vision, dizzy walking, and some short term memory probs (NOT MY AGE!!!), among other things. Apparently I’m not the only one – very common probs – oversold drug?
Hope all is well with you, too. I would love to try the anti-PD1 if/when things don’t do so well.
JonathanJanuary 15, 2014 at 9:28 pm #63348EricW1Participant
If i remember right you had PD-1 that did not work. There is a trial with PD-1 and LAG-3 that allows prior PD-1 treatment. Just an FYI….January 16, 2014 at 7:00 pm #63349zephyr66Participant
i’ve read this thread but don’t understand what any of it means. i know nobody has a crystal ball but hope you can decipher something from the article, catherine!January 16, 2014 at 9:09 pm #63350 Hi EricW,
Thanks very much for that alert on the phase I anti-PD1/LAG-3 combo trial with prior anti-PD1 progression, that’s just opened in Chicago – very interesting. I did immediately call the number on the trial, and unfortunately, prior IPI is an exclusion, and the guy said they were trying to convince BMS to change that (since who’re they gonna get??), but thusfar, no success. Worth keeping track of, for sure.
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