Posts Tagged ‘ipilimumab’

More Hope for Melanoma Patients in a Year of Milestones

Wednesday, August 24th, 2011

Treatment options for melanoma have advanced in the past year with heartening results.  As we wrote in March 2011, the drug Yervoy (ipilimumab or “ipi”) appears to be successful for a small group of patients with inoperable, metastatic melanoma in extending survival.  In fact, WebMD says that “Yervoy … is the first drug ever shown to help late-stage melanoma patients live longer.”

Now, there’s more news to be hopeful about on the pharma front with potentially greater results: The FDA has also given the go-ahead to a drug called ZELBORAF (vemurafenib, pronounced vem-yoo-RAF-en-ib).   A comprehensive overview by ABC News offers a clear explanation of how Zelboraf attacks a genetic mutation (known as BRAF V600E) which is found in about half of melanoma patients, inhibiting the disease’s ability to spread.

We now have the capability to analyze a patient’s melanoma tumor for the genetic mutation BRAF and use the targeted treatment Zelboraf to attack the tumor, shrink it and stop the progression of this deadly disease,” said Dr. Anna Pavlick, director of the NYU Melanoma Program at the NYU Cancer Institute, who has been involved in clinical trials for Zelboraf. …Zelboraf shuts down the abnormal signals of the tumor cells that are caused by the genetic mutation and stops the cells from dividing, without affecting healthy cells.

At the same time, the FDA approved a genetic test to determine if patients carry the mutation since only those with the abnormal “BRAF” gene can take Zelboraf.  Interestingly, since the same genetic mutation is found in those with other forms of cancer, there may be future help from this drug beyond skin cancer and is now, for example, being tested on thyroid cancer patients.

This is the fastest the FDA has ever approved a drug to come to market – in just five years.  And even better: Zelboraf, which is a first-in-class drug, is anticipated to be available in the next two weeks.

There are differences between Yervoy and Zelboraf.   As described in the coverage by the SF Chronicle,

Yervoy was found to extend patients’ lives, an improvement over many current treatments. However, the drug works for less than 20 percent of patients, and doctors say they can’t predict which patients will find it most effective.

Zelboraf was clinically effective in 50 percent of patients [with the] specific genetic mutation … Most of the therapies for melanoma work for less than 20 percent of patients, and some fall into single digits.

Neither Zelboraf nor Yervoy cure melanoma.  And as a patient who had great success in a clinical trial for the new drug said, “there’s nothing that says this medication will help you forever.”  But these drugs bring hope for a longer life, and as new therapies come along the melanoma pipeline, there is reason to be optimistic.

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Green Light for Yervoy May Slow Melanoma in Its Tracks

Monday, March 28th, 2011

As we wrote about back in June, the most promising drug in the war on Melanoma, ipilimumab, was fast-tracked and finally approved as “Yervoy” for Bristol-Myers Squibb by the FDA last week.

Ipi is an immune therapy drug: it tries to activate or stimulate the immune system to clear cancer cells. While ipi’s funny name has not improved much with a brand name like Yervoy, it is anything but laughable.  We have been challenged to make ANY progress with drug therapy and this new therapy is a welcome advance. With the usual current immuno-therapy treatments, such as interleukin, we haven’t been able to significantly extend the immune response to melanoma cells.  As described on WebMD:

Yervoy appears to extend survival when used as a first-line treatment for inoperable stage III or stage IV melanoma, Bristol-Myers announced earlier this week. Details of the study will be reported at the June meeting of the American Society of Clinical Oncology.

Yervoy is a biologic therapy. It’s a kind of man-made antibody (a monoclonal antibody) that blocks a crucial switch on immune cells called CTLA-4. Cancers use this switch to turn off the body’s anticancer immune responses.

Most drugs like this come with possibly severe side effects, and Yervoy is no exception. The drug can provoke powerful autoimmune reactions in which the immune system attacks normal cells in the body. In clinical trials, nearly 13% of patients taking Yervoy had severe or fatal autoimmune reactions.

Even with those caveats this does seem to be some light at the end of the tunnel:

FDA approved the drug based on a Bristol Myers study of 676 people with advanced, inoperable melanoma who had already failed two other treatments, giving them a very short life expectancy. They were given one of three treatments: ipilimumab by itself, ipilimumab combined with another immune-stimulating treatment, or the immune-stimulating treatment alone.

Average survival was 10 months with ipilimumab versus just more than six months for the others. But a very small group of patients survived longer than six years, suggesting that with more study the drug could be targeted to those who will respond the most.

About 85 percent of patients had little response to the drug. Researchers say the response rate should improve as the drug is used earlier in the disease cycle.

“I think the direction this is headed is toward intervening earlier, when patients’ immune systems are still intact, rather than waiting until they are so sick,” said Dr. Anna Pavlick, director of the New York University’s melanoma program. Pavlick, a spokeswoman for the Skin Cancer Foundation, helped conduct several early-stage trials of ipilimumab.

Bristol-Myers Squibb expects to begin shipping YERVOY within weeks.

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Deciphering Treatment News for Melanoma

Tuesday, September 14th, 2010

The past couple of months, some compelling new stories have circulated about promising Melanoma treatments. In June, you read about “ipi” – in the news and here on Melanoma Updates. And, this past month, more news touted early clinical trials with another targeted therapy drug, PLX4032. As always, we are cautiously optimistic, but to shed some light on two exciting, but still emerging options, I thought a basic overview might be helpful.

So, what do these drugs do? Quite simply, one attacks a gene mutation found in about 50% of all melanoma patients. And one works to modulate the immune system.

Ipi for Immunity

Ipi is an immune therapy drug: it tries to activate or stimulate the immune system to clear cancer cells. With the usual current immuno-therapy treatments, such as interleukin, we haven’t been able to significantly extend the immune response to melanoma cells. But Ipi has been shown to extend that immune protection for longer and longer time spans, for the first time ever, leading to 2-year survival rates in around 56% of a certain group of patients (again, with advanced melanoma survival rates typically not extending past 10 months.) Ipi has been in advanced trials for years, and the very promising Phase III results spurred the recent media frenzy. As such, it is on the fast track for priority approval – perhaps as soon as the end of this year – and may become the first new melanoma drug approved in decades.

Gene Mutation Therapy

First, it’s important to know that about half of patients with metastatic melanoma have a mutation in a gene called BRAF. This is a gene that seems to program the “runaway cell division that is a hallmark of cancer.” When the impact of the BRAF gene mutation was established, scientists set to work to find a way to switch it off or slow down the programming to cells, and one of those ways may be an exciting new gene therapy drug, PLX4032 (no catchy name as of yet.) A remarkable 81% of cases showed marked and in many cases immediate improvement and reduction in tumor size and growth. Granted, the news came after just a small Phase I clinical trial, but there was such excitement about the results that in a rare move, the drug has skipped Phase II and is now being tested in longer term and wider scope Phase III trials.

As reported in USA Today:

No other drug has ever helped that high a percentage of patients with melanoma or any other solid tumor, says Paul Chapman, co-author of the study in today’s New England Journal of Medicine. The results are especially striking, he says, considering that only 10% to 20% of patients respond to standard treatments for melanoma, which don’t improve overall survival.

USA Today also has a sidebar Q&A piece that does a nice job of summarizing the caution and optomisim surrounding PLX4032. They include a phone number for more information about it as well: 888-662-6728.

A One-Two Punch?

Since the back to back encouraging news broke for ipi and PLX4032, some are combining the two in other drug therapy trials. Here is a quote from the National Cancer Institute Bulletin this past week:

In June, researchers announced that ipilimumab, a treatment that targets the immune system, helped patients with advanced melanoma live longer. Together, ipilimumab and PLX4032 have changed the landscape of melanoma research and raised the prospect that the new agents could be tested in combination or sequentially, said Dr. Claudio Dansky Ullmann, who oversees melanoma trials for the NCI Cancer Therapy Evaluation Program.

"These studies have opened the doors to a lot of possibilities for treating metastatic melanoma,” said Dr. Dansky Ullmann. "We can now test many treatments that were not available or proven until recently. This area of research is taking off.”

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Melanoma News and Reviews – Ipi and “The Big C”

Friday, August 20th, 2010

Just watched the premiere of Showtime’s new hit, “The Big C,” in which Laura Linney plays a woman newly diagnosed with Stage Four Melanoma. The plot revolves around her decision to “carpe diem” and forgo traditional therapies to live out her anticipated remaining year joyfully and sometimes frivolously. As the show’s writer says,

“in many ways, this series is not about cancer per se. It’s about living the life we want to live and not wasting our precious time!”

“Seizing the day” can be a good prescription for any human being, and I encourage it wholeheartedly (though not as foolhardily, perhaps, as she does, when she knocks down her porch and shade tree to spontaneously add a swimming pool to her small front yard!) However, I would remind viewers that while the most serious and often most aggressive form of skin cancers, melanoma can be treatable and when caught early especially with proper screenings does not have to be a death sentence.

Aside from that, it is good to see the disease brought to light. While there is not much apparent sidebar content or instructive information about melanoma on Showtime’s site, there is an alliance with the American Cancer Society that promises donations in exchange for viewing a clip of the show…a good approach to raise awareness of the show, for sure, but also for our passion: raising awareness about melanoma.

View Big C trailer to have $1 Donated, thanks to Showtime and American Cancer Society

View Big C trailer to have $1 Donated, thanks to Showtime and American Cancer Society

And here’s a link to the Big C Facebook page in case you want to participate there (to be sent right to that page be sure you’re logged in on Facebook) and weigh in. Oddly, though, neither that Facebook page or the Showtime page for the show itself seem to provide any links to the More Birthdays Facebook page which they are supporting. That is a lost opportunity to drive more donations and align themselves deeper with the cause. Clearly, this is a “comedy that plays with dark and light tones.” And entertainment sells, but there is always more room for responsible education, even if via links from their site.

In terms of Cathy’s life expectancy, as depicted on the show, it is, unfortunately fairly accurate: The typical survival rate for patients with metastatic melanoma is six to nine months. However, the new drug you may have read about here in June and elsewhere is continuing to show some promise in extended life expectancy, if slowly:

Metastatic melanoma patients who took the drug demonstrated a median survival rate of 10 months, a 3.6 month improvement over those who did not take the medication.

No one is laughing about the seriousness of melanoma. But we all must just keep trying to find the joy, if even through television escapes.

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Melanoma News and Reviews – Ipi and "The Big C"

Friday, August 20th, 2010

Just watched the premiere of Showtime’s new hit, “The Big C,” in which Laura Linney plays a woman newly diagnosed with Stage Four Melanoma. The plot revolves around her decision to “carpe diem” and forgo traditional therapies to live out her anticipated remaining year joyfully and sometimes frivolously. As the show’s writer says,

“in many ways, this series is not about cancer per se.  It’s about living the life we want to live and not wasting our precious time!”

“Seizing the day” can be a good prescription for any human being, and I encourage it wholeheartedly (though not as foolhardily, perhaps, as she does, when she knocks down her porch and shade tree to spontaneously add a swimming pool to her small front yard!)  However, I would remind viewers that while the most serious and often most aggressive form of skin cancers, melanoma can be treatable and when caught early especially with proper screenings does not have to be a death sentence.

Aside from that, it is good to see the disease brought to light.  While there is not much apparent sidebar content or instructive information about melanoma on Showtime’s site, there is an alliance with the American Cancer Society that promises donations in exchange for viewing a clip of the show…a good approach to raise awareness of the show, for sure, but also for our passion: raising awareness about melanoma.

View Big C trailer to have $1 Donated, thanks to Showtime and American Cancer Society

View Big C trailer to have $1 Donated, thanks to Showtime and American Cancer Society

And here’s a link to the Big C Facebook page in case you want to participate there (to be sent right to that page be sure you’re logged in on Facebook) and weigh in.  Oddly, though, neither that Facebook page or the Showtime page for the show itself seem to provide any links to the More Birthdays Facebook page which they are supporting.  That is a lost opportunity to drive more donations and align themselves deeper with the cause.  Clearly, this is a “comedy that plays with dark and light tones.”  And entertainment sells, but there is always more room for responsible education, even if via links from their site.

In terms of Cathy’s life expectancy, as depicted on the show, it is, unfortunately fairly accurate:  The typical survival rate for patients with metastatic melanoma is six to nine months.  However, the new drug you may have read about here in June and elsewhere is continuing to show some promise in extended life expectancy, if slowly:

Metastatic melanoma patients who took the drug demonstrated a median survival rate of 10 months, a 3.6 month improvement over those who did not take the medication.

No one is laughing about the seriousness of melanoma.  But we all must just keep trying to find the joy, if even through television escapes.

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