› Forums › Cutaneous Melanoma Community › Article re: Merck PD1 Phase I trial (unable to post link)
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rbruce.
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- July 12, 2013 at 6:22 pm
hi, hope this isn't old…the date is today, but the data refers only to phase I test. Also, it shows differences in response between 10 mg. and 2 mg. doses…last I read response rate was the same. SO confusing! Best–Karen. (interesting that they see it as a drawback that PhaseI trial has no chemo, and to us it's a huge plus!)
Published: July 11, 2013 Updated: 12:44 p.m.
Melanoma drug holding up well after further testing
hi, hope this isn't old…the date is today, but the data refers only to phase I test. Also, it shows differences in response between 10 mg. and 2 mg. doses…last I read response rate was the same. SO confusing! Best–Karen. (interesting that they see it as a drawback that PhaseI trial has no chemo, and to us it's a huge plus!)
Published: July 11, 2013 Updated: 12:44 p.m.
Melanoma drug holding up well after further testing
By LANDON HALL/ ORANGE COUNTY REGISTER
Merck's late-stage melanoma drug, lambrolizumab, continues to show great promise in shrinking the deadly tumors, particularly when taken at the highest dosage offered in trials, according to a study published today in the New England Journal of Medicine.
At the end of 12 weeks, the intravenous drug had shrunk tumors in 52 percent of patients when administered every two weeks, at a dosage of 10 milligrams per kilogram of body weight. Even when a lower dosage, and more time in between dosages, were taken into account, the overall tumor-response rate was 38 percent.
In most patients who showed a positive response, the results lasted beyond one year. And a dozen patients showed a "complete response," meaning their cancer was gone altogether.
Considering that melanoma is the deadliest of the skin cancers, killing some 9,000 people each year, discussing survival in terms of years and not months has cancer specialists using words they had rarely ventured to use during the previous three decades of research into the disease.
"This is monumental," said Dr. Jack Jacoub, medical oncologist at the MemorialCare Cancer Institute at Orange Coast Memorial Medical Center in Fountain Valley, who was not involved in the research. "Things look much more optimistic for this disease."
In recent years, much of scientists' energy, and research funding, has been focused on using the body's immune system to fight invading cancer cells. An FDA-approved drug called ipilimumab (brand name Yervoy) acts like a brake on a protein called CTLA-4, allowing the body's own T cells to battle cancerous melanoma tumors. Alone, it has a response rate of 10.9 percent in trials, but when maker Bristol-Myers Squibb combined it with another drug, nivolumab, the response rate jumped to 41 percent, according to data released in May.
Lambrolizumab, which used to be called MK-3475, puts the brakes on a different protein, PD-1, the same one nivolumab works on.
"Most patients think their immune system is weak and wonder why cancer is growing," said Dr. Bartosz Chmielowski, an oncologist at Ronald Reagan UCLA Medical Center who was a co-investigator for the study. "They say, 'I just want to boost my immune system.' Usually, it's not true. It's not that the immune system is weak; the cancer has found a way around the immune system.
"These results are extremely exciting and encouraging."
A subgroup in the study had taken Yervoy previously, with no improvement; in this study, they enjoyed the same response as other patients.
The most common side effects of the drug were fatigue, rash and diarrhea, but they were low-grade. One drawback of the study, which was funded by Merck, is that it was not randomized: There was no alternative therapy to compare the drug with, and no placebo.
Researchers are still seeking patients for a larger study, Chmielowski said, with a goal of enrolling 500.
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- July 12, 2013 at 8:53 pm
Karen, this is fairly recent data – the article was published NEJM online June 2 during ASCO.http://www.nejm.org/doi/full/10.1056/NEJMoa1305133#t=articleTop
The charts are particularly encouraging. How are you feeling Karen??
Amy
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- July 12, 2013 at 8:53 pm
Karen, this is fairly recent data – the article was published NEJM online June 2 during ASCO.http://www.nejm.org/doi/full/10.1056/NEJMoa1305133#t=articleTop
The charts are particularly encouraging. How are you feeling Karen??
Amy
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- July 12, 2013 at 8:53 pm
Karen, this is fairly recent data – the article was published NEJM online June 2 during ASCO.http://www.nejm.org/doi/full/10.1056/NEJMoa1305133#t=articleTop
The charts are particularly encouraging. How are you feeling Karen??
Amy
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- July 12, 2013 at 9:54 pm
Hi Amy,
I hope that you are doing well on Merck PD1.
Last post that I read you were concerned about a "new" brain met? Hoping you next MRI show it to be stable. If the brain met grows, does that mean you could get kicked off the Merck pd1 trial??
Do you know if you are a responder yet? When are your next MRI & CT scans?
Wishing you the Best!
Suzanne
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- July 12, 2013 at 11:39 pm
No new brain mets since starting the trial – just finished dose 4. Sometimes things aren’t black and white but shades of gray -I have to live for today!! -
- July 14, 2013 at 1:07 pm
Hang in there Karen. Yes the waiting is so so hard, ESP when you know it’s already in your brain. Not too proud to admit that’s when they put me on a very low dose of Paxil, when told I had to wait 4 weeks, I was coming apart at the seams.I continue to pray for you. I have had some amazing things happen in the past couple of weeks and I feel so good, I did almost all our laundry yesterday (5 of us). I Will share more when I can, the time just isnt right.
I have been off Z since April 9. Believe in the impossible!!
Amy
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- July 22, 2013 at 12:41 am
You may be confusing BMS version of Anti PD1 and Mercks. BMS showed a similar response for the low and high dose versions of around 38% whereas Merck has shown 38% on the 2mg per kg versus 52% on the 10 mg per kg. I have been on the 10 mg dose every 2 weeks at UCSF since March of 2012. I started with lots of lung mets, a couple of rib bone lesions and a tumor in my axillary lymph node that biochemo and then PI3k trial did not help. since Anti PD1, tumors shrank continuously and now lung tumors and bone mets show 0 uptake on PET and tiny uptake in my axillary lymph node. that tumor used to be the size of a walnut that we cant even feel anymore. The continuing news for Anti PD1 and immunotherapy is miraculous and changing the treatment of ALL cancers, not just melanoma.
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- July 22, 2013 at 12:41 am
You may be confusing BMS version of Anti PD1 and Mercks. BMS showed a similar response for the low and high dose versions of around 38% whereas Merck has shown 38% on the 2mg per kg versus 52% on the 10 mg per kg. I have been on the 10 mg dose every 2 weeks at UCSF since March of 2012. I started with lots of lung mets, a couple of rib bone lesions and a tumor in my axillary lymph node that biochemo and then PI3k trial did not help. since Anti PD1, tumors shrank continuously and now lung tumors and bone mets show 0 uptake on PET and tiny uptake in my axillary lymph node. that tumor used to be the size of a walnut that we cant even feel anymore. The continuing news for Anti PD1 and immunotherapy is miraculous and changing the treatment of ALL cancers, not just melanoma.
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- July 22, 2013 at 12:41 am
You may be confusing BMS version of Anti PD1 and Mercks. BMS showed a similar response for the low and high dose versions of around 38% whereas Merck has shown 38% on the 2mg per kg versus 52% on the 10 mg per kg. I have been on the 10 mg dose every 2 weeks at UCSF since March of 2012. I started with lots of lung mets, a couple of rib bone lesions and a tumor in my axillary lymph node that biochemo and then PI3k trial did not help. since Anti PD1, tumors shrank continuously and now lung tumors and bone mets show 0 uptake on PET and tiny uptake in my axillary lymph node. that tumor used to be the size of a walnut that we cant even feel anymore. The continuing news for Anti PD1 and immunotherapy is miraculous and changing the treatment of ALL cancers, not just melanoma.
-
- July 12, 2013 at 9:54 pm
Hi Amy,
I hope that you are doing well on Merck PD1.
Last post that I read you were concerned about a "new" brain met? Hoping you next MRI show it to be stable. If the brain met grows, does that mean you could get kicked off the Merck pd1 trial??
Do you know if you are a responder yet? When are your next MRI & CT scans?
Wishing you the Best!
Suzanne
-
- July 12, 2013 at 9:54 pm
Hi Amy,
I hope that you are doing well on Merck PD1.
Last post that I read you were concerned about a "new" brain met? Hoping you next MRI show it to be stable. If the brain met grows, does that mean you could get kicked off the Merck pd1 trial??
Do you know if you are a responder yet? When are your next MRI & CT scans?
Wishing you the Best!
Suzanne
-
- July 12, 2013 at 11:39 pm
No new brain mets since starting the trial – just finished dose 4. Sometimes things aren’t black and white but shades of gray -I have to live for today!! -
- July 12, 2013 at 11:39 pm
No new brain mets since starting the trial – just finished dose 4. Sometimes things aren’t black and white but shades of gray -I have to live for today!! -
- July 14, 2013 at 1:07 pm
Hang in there Karen. Yes the waiting is so so hard, ESP when you know it’s already in your brain. Not too proud to admit that’s when they put me on a very low dose of Paxil, when told I had to wait 4 weeks, I was coming apart at the seams.I continue to pray for you. I have had some amazing things happen in the past couple of weeks and I feel so good, I did almost all our laundry yesterday (5 of us). I Will share more when I can, the time just isnt right.
I have been off Z since April 9. Believe in the impossible!!
Amy
-
- July 14, 2013 at 1:07 pm
Hang in there Karen. Yes the waiting is so so hard, ESP when you know it’s already in your brain. Not too proud to admit that’s when they put me on a very low dose of Paxil, when told I had to wait 4 weeks, I was coming apart at the seams.I continue to pray for you. I have had some amazing things happen in the past couple of weeks and I feel so good, I did almost all our laundry yesterday (5 of us). I Will share more when I can, the time just isnt right.
I have been off Z since April 9. Believe in the impossible!!
Amy
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