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Epacadostat(INCB024360) powder video
Indoleamine 2,3-dioxygenase 1 (IDO1) is a key immunosuppressive enzyme that modulates the anti-tumor immune response by promoting regulatory T cell generation and blocking effector T cell activation, thereby facilitating tumor growth by allowing cancer cells to avoid immune surveillance. Epacadostat powder is an investigational, highly potent and selective oral inhibitor of the IDO1 enzyme that regulates the tumor immune microenvironment, thereby restoring effective anti-tumor immune responses. In single-arm studies, the combination of Epacadostat powder and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma. In these studies, Epacadostat powder combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitor KEYTRUDA improved response rates compared with studies of the immune checkpoint inhibitors alone.
|Product Name||Epacadostat(INCB024360) Powder|
|Melt Point||151–153 °C|
|Storage Temp||-20°C Freezer|
|Color||White to off-white powder|
Epacadostat powder was supposed to further immunotherapy. The body contains an enzyme called IDO, which stops T cells from doing their job. Epacadostat powder is an IDO inhibitor, meaning it stops IDO from suppressing T cells.
Incyte hoped Epacadostat powder, in conjunction with Keytruda, would fight cancer more effectively than Keytruda alone. But Epacadostat powder failed to stop the progression of cancer, and it hasn’t helped overall survival. The disappointing trial caused Incyte stock to drop more than 19 percent on Friday; Merck shares were down near 3 percent, though that merely matched the selloff in the stock market.
“We are disappointed that this study did not confirm the efficacy of Epacadostat powder in combination with KEYTRUDA in patients with unresectable or metastatic melanoma,” said Dr. Steven Stein, chief medical officer of Incyte, in a release. “We remain dedicated to transforming the treatment of cancer and will continue to explore how IDO1 inhibition and other novel mechanisms can potentially improve outcomes for patients in need.”
After halting the melanoma study, Incyte wants to test Epacadostat powder with other types of cancer. Dr. Jason Luke, an oncologist at the University of Chicago, believes the Incyte study examined a patient sample that was too broad. Only patients with T cell-inflamed tumors react to immunotherapy at all. Patients without T cell-inflamed tumors don’t have a natural immune response against cancer. IDO inhibitors won’t make any difference.
“This is why we need to select those patient that have an immune response,” said Luke. For patients that have the natural immune response, Epacadostat powder still might be effective. Unfortunately, this is the minority of cancer patients.
Doctors can use RNA-based sequencing to test if a patient would be a prime candidate for immunotherapy. Although the Incyte and Merck press release mentions lung cancer, Luke said IDO inhibitors might help this minority of patients with any type of cancer.
Dr. Roy Herbst, a Yale University oncologist, believes there is no one-size-fits-all cancer solution. “You have to personalize immunotherapy,” he said. “You need to know who will benefit from drug A and who will benefit from drug B.”
The more research that goes into immunotherapy, the more doctors will understand how best to treat patients. Combining different medications, like Merck and Incyte were trying to do, could improve treatment in the future.
Even with the trial failure, “That’s all the interest right now,” Herbst said.
It says that giving them ipilimumab/nivolumab is a good idea because they will get as much benefit from the ipilimumab/nivolumab with disease in the brain as they would as if the disease were extracranial. It will have some impact on how people practice. It suggests that having brain metastases is not a death sentence.
If you go way back to the original MDX010-020 study, which was the study that led to the registration of ipilimumab in 2011. A good proportion of those patients had prior brain metastases that were generally radiated, and their survival was no worse than those who had no brain metastases. The suggestion being that having brain metastases in the year of checkpoint inhibition is not a death sentence, and some of those patients will go on to long-term survival.
We all understand that often brain metastases are associated with other poor outcomes indicators like high lactate dehydrogenase (LDH), multiple sites of disease, and poor performance status, but if you are a low LDH, low tumor burden patient who happens to have brain metastases, you may do very well with ipilimumab plus nivolumab. That is the message.
INCB024360 Powderhas been in many combinations, [but] relatively few of them have matured. The most interesting ones to me and to most of my colleagues are the phase III studies of Epacadostat(INCB024360) Powder with T-VEC or without and INCB024360 Powderwith the IDO inhibitor INCB024360 Powder without.
Since progression-free survival (PFS) is the endpoint, at least of the INCB024360 Powder trial, we will probably hear something within the year. It could be as early as the 2017 ESMO Congress, but perhaps it will be at the 2018 ASCO Annual Meeting. If that’s a positive study, that would be very impressive.
This then brings up the issue of what if you fail—and half or more of the patients will fail in the first couple of year—what do you do then? Do you just give single-agent ipilimumab? Do you give ipilimumab/nivolumab? It suggests that we should be paying attention to ipilimumab combinations. Ipilimumab was always the bad guy. It was useful with nivolumab or INCB024360 Powderbut, other than that, single-agent ipilimumab was not that popular.
If INCB024360 Powder becomes a frontline treatment of choice, then we have to start thinking about what you would combine with ipilimumab. Ipiliumumab and T-VEC? Ipilimumab and T-VEC—in the randomized phase II study of 198 patients presented at the 2017 ASCO Annual Meeting—had greater than 30% response rate. That’s pretty good.
We don’t know the long-term outcome; it’s too early. However, that would be a potential second-line choice if INCB024360 Powderbecome the first-line choice. Then, what do you do if the flipped dose of ipilimumab/nivolumab is a lot less toxic but is just as effective at 1 and 2 years?
Then, the pendulum will swing back and now people will use ipilimumab/nivolumab in the frontline setting and then can use INCB024360 Powderin the second-line setting. You’ll have a lot of choices and that’s good for patients.
It will create some controversy with physicians as to what they use first. It will be a wealth of resources to be able to treat patients, which will be great. You will get more shots on goal—meaning you will get more chances to push someone into a long-term remission and maybe cure them.
♣ Niki：Hello everyone! I am curious if anybody out there has been in this clinical trial? I am a Stage 4 patient who completed 4 doses of Ipi ( October 2015 – December 2015) and was not a responder. I did 2 follow up Pet Scans after treatment on Dec 17th and January 28 which showed my main tumor (chest wall) was still growing..and now I have several subcutaneous tumors around my upper torso, but mainly seeming to favor my left side of my body. I have a great melanoma specialist who has been working with my husband and I but is now recommending I move forward with a clinical trial. I shouldn’t be surprised at how invasive the pre-testing for a clinical trial is but sometimes it feels overwhelming. I handled the Ipi really, really well with very little side effects besides some minor itching but I always get nervous when it comes to new drugs. This trial includes taking the pills (Epacadostat powder) every day and the infusion of nivolumab every two weeks. Has anyone been through this? Side effects? Reponses to the treatment? We’ve been going through this for almost a year and I feel like we’re starting to grasp at treatments because we keep getting let down every time I have a scan update. Very frustrating but I’m also very determined to WIN! any input would awesome! Many thanks and love!
♣ Emily: Started in this trial on 4/12. Had to suspend drugs for one week due to bad rash (not sure stage of the rash), but it was an adverse reaction to the drugs. Now the rash seems to have gone away and i’m back on the drugs again.
only other side effect is i’m easily fatiqued and tend to sleep more than usual. Even the rash was fairly tolerable even at its worst(about 4/25). So, thus far, it’s been rather easily taken and the side effects are minimal.
Don’t know if it’s doing any good so far, as my first scan isn’t until 6/3. I take 6 pills orally evey day plus infusions one ever other two weeks which take place at the hospital. I’m optimistic that this combo will produce some positive results where the previous stuff has done little good.
♣ Christal: Hi,My husband was diagnosed in April of this year with mucosal melanoma in his gastrointestinal track. He started this trial in May. At his last scan his primary tumor was no longer detectable, and although he still has the swollen lymph nodes in his groin they believe there is no more melanoma in them. It appears to be fluid and necrotic tissue which makes sense to me, because that is where the “dead” cancer would drain from his primary site.
His only side effects are fatigue and dry mouth. He had a very mild rash early in the trial. He says he is fatigeud but still rides his bike to work on nice days, and goes to crossfit 5 days a week. He’s a beast. The dry mouth is very noticable. Sometimes he’s hard to understand, but he’s crushing this cancer so it feels like a small price to pay. Especially because we have a 6 year old son.
My dad died of cutaneous melanoma in 2011 and I am a hospice RN. It is very exciting (and so very personal) to see the progress in melanoma treatment. My dad did 5 clinical trials in the 9 years after he was diagnosed. I miss him so much, but I am so grateful that he contributed to the science that is keeping my husband/ my sons dad here.
I wish you all the best. I believe we are making history.
“If the history of medicine is told through the stories of doctors, it is becaue their contributions stand in place of the more sustantive heroism of their patients.” -Siddhatha Mukherjee
♣ Tom: I know this topic is a bit old now, but the trial is current and so I wanted to post that I am also in this trial. I’ve had 3 infusions (every 2 weeks). So far the side effects have been itching (without rash) and minor fatigue. I notice that I sleep longer and occasionally take a nap which is rare for me. Daily functions aren’t affected too much, but I realize the limitations of the drug when trying to complete Crossfit workouts as I cannot perform like I used too.
I had melanoma 2C on my right sideburn in 2012 and no lymph node involvement. It came back in 2015 just above my right ear as another atypical mole. This time it’s 3C as the two sentinal nodes removed showed microscopic melanoma cells. They did a wide local excision and skin graft to cover it up. I tried ippy but only tollerated 3 infusions (10mg/kg dose) before stage 1 collitus set in. Then a few months went by and I noticed what I thought was scar tissue on my right sideburn that was bothersome. It turned out to be a lymph node full of melanoma.
I have a follow-up PET CT in 4 weeks, and I’m going to MD Anderson in Houston next week for a second opinion. I’ll try to keep the post updated as this site has been a huge resource for me during this struggle and I hope that my info will be helpful to someone else. I’m currently a patient at UCSF.
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