8th Annual Scientific Retreat Recap

The end of February was a momentous one for the MRA team and all the folks in the melanoma community. We hosted our 8th Annual Scientific Retreat in Washington, DC, and they truly just seem to get better and better.

The Retreat serves two main roles for those invited participants. First, is the centerpiece of scientific knowledge sharing, as evidenced by the more than 20 MRA-funded investigators who presented at the meeting as well as several supplementary events and sessions aimed to provide a holistic look at the state of melanoma research and treatment. Secondly, the Retreat provides an opportunity for participants from all sectors to network. We consistently hear about the new collaborations to fight melanoma that arise from networking at this meeting.

Our Melanoma Forum opened the Retreat with a session about the continuing evolution of patient participation in the research process. It was attended by 50 patients, advocates, and supporters who shared their personal experiences to help advance our work by articulating the unmet needs and burden of the disease from those who understand it personally. Special thanks to Raj Kulkarni, an MRA Young Investigator at UCLA, and Kim McCleary of FasterCures for helping to build out this event.

MRARetreat_Selects-16Our lunchtime panel discussion (left), moderated by Mike Milken, featured four amazing thought leaders in melanoma. Drs. Boris Bastian of UCSF, Levi Garraway of Dana-Farber Cancer Institute, Lynn Schuchter of U Pennsylvania and Suzanne Topalian of Johns Hopkins University wo provided a look forward for the future of melanoma research.

In addition, we convened the growing group of MRA-funded Young Investigators to explore several key issues in clinical translation, while our Industry Roundtable meeting brought together representatives from the NCI, FDA, academia and industry to thoughtfully address challenges and opportunities for future collaboration on behalf of patients.

MRARetreat_Selects-19A highlight of the meeting was welcoming newly appointed FDA Commissioner Robert Califf (left), who came straight from his confirmation at the White House to deliver remarks to the MRA community.

It was truly a convergence of the brightest stars in the field and a community dedicated to achieving MRA’s mission of defeating melanoma. You can read more about in blog posts from Dr. Len, of the American Cancer Society, and T.J. Sharpe, a melanoma survivor who blogs for Philly.com.

We thank everyone who came to participate in the meeting, as well as our sponsors, who all helped make our 8th Annual Scientific Retreat a success!

 

 

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Expanded Access Programs: A Time of Amazement in Melanoma

Immunotherapy Science Mag CoverFor those of you keeping a close eye on the field of melanoma treatments, you know that we find ourselves living in a simply amazing period of opportunity and innovation—even though there is still a long way to go.

The creation of new cancer drugs is pharmaceutical alchemy, transmuting a base idea into a life-prolonging new treatment that is both safe and effective.  While not magic, drug development is an expensive, incredibly complex and time-consuming process.  And when it works well—when there are exceptionally promising treatments near at hand—the wait for full availability to those agents can be frustrating beyond measure.

Such is the case right now with certain immunotherapy drugs that stimulate the patient’s immune system to recognize and attack cancer.  The data with these immunotherapies targeting the PD-1/PD-L1 axis (anti-PD-1 drugs) is so encouraging that three have earned U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation* which aims to speed FDA approval of the most promising drugs.

This is fantastic, but how are promising drugs made available to patients in the pre-approval period?

To accelerate the accessibility of new drugs to patients, drug developers may open so-called Expanded Access Programs (EAP).  EAPs are compassionate use programs whereby drugs are made available to patients before they are fully approved for sale by the FDA.  EAPs consume resources from treatment centers and drug companies alike, but EAPs endeavor to do the right thing to help patients before drug approval and sale. MRA is proud to have been part of the conversation with companies, clinicians and the FDA that encouraged and facilitated the opening of the anti-PD-1 drug EAPs.

So, why talk about EAPs and anti-PD-1 drugs right now?

Because melanoma is once again a case study for the cutting edge. Presently, three EAPs for melanoma are open with similarly targeted agents (the anti-PD-1 antibodies). Merck’s pembrolizumab was the first EAP to open for melanoma in March 2014, followed by BMS’ nivolumab EAP in May.  Most recently, in July, BMS launched an EAP for the combination of nivolumab with its anti-CTLA4 drug, ipilimumab.  This may not sound like much, but to have three EAPs at the same time for the same cancer is unprecedented.  To have this happen with the same type of drug is nothing short of amazing!

While anti-PD-1 treatments don’t work for everyone and do have certain side-effects, MRA and others are funding research to overcome these limitations.  Nevertheless, the demonstrated progress against melanoma fuels the hope that we’ll look back to 2014 and say, “That was the year everything changed.”

About the Author

Louise Perkins HeadshotLouise M. Perkins, Ph.D., joined the Melanoma Research Alliance (MRA) as Chief Science Officer in 2013 where she is responsible for the development and implementation of MRA’s scientific strategy.  Her interests center on translational research with specific concentration on genomics, drug discovery and the advancement of novel therapeutic approaches. Prior to joining MRA, she was Chief Scientific Officer at the Multiple Myeloma Research Foundation (MMRF) for five years following a research career of 16 years at two major pharmaceutical companies.

*Note: Merck’s anti-PD-1 pembrolizumab received Breakthrough Therapy designation for melanoma in May 2013; BMS’ anti-PD-1 nivolumab received Breakthrough Therapy designation for Hodgkin Lymphoma in May 2014; Genentech/Roche’s anti-PD-L1 MPDL-3280A received Breakthrough Therapy designation for bladder cancer in June 2014.

Melanoma News Round-Up, July 12

Hello everyone! We’re back to bring you the news highlights for all things melanoma and MRA.

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In celebration of UV Safety Month this July, J.Crew will donate $1 to MRA for every Instagram upload showing how you cover up and have fun in the sun.  Just tag it #JCrewSmartSun and help win donations for MRA.  Thanks to the generosity of our founders, 100% of funds raised will go directly toward melanoma research.  Stay sunsafe and help fund cutting-edge research – it’s a win-win!

This week marked game-changing progress for melanoma treatment as regulators in Japan granted the world’s 1st approval of the anti-PD-1 drug, nivolumab.  News also broke that Bristol-Myers Squibb will be seeking FDA approval of nivolumab, making this breakthrough immunotherapy available in the United States months ahead of schedule.

MRA also hailed the launch of an Expanded Access Program for advanced melanoma patients to receive a combination therapy of ipilimumab and nivolumab.  This method of combination therapy has shown promising results for late-stage melanoma patients.

On the prevention front, MRA is delighted to report Hawaii became the 10th state to ban indoor tanning for minors under 18 years of age.  There is much more work to be done to reduce everyone’s risk for skin cancer and melanoma, but the passage of this bill is a step in the right direction.

You don’t want to miss this great interview on the dangers of sun exposure and skin cancer with dermatologist, Dr. Mitchell Kline, by legendary PIX11 broadcaster, Marvin Scott.

GENlogoCMYK_092313Finally, we’re proud to share that MRA was ranked the #1 Grant-Giving Disease Foundation by Genetic Engineering & Biotechnology News (GEN).  As always, we are dedicated to finding a cure for melanoma and working toward a day when no one will suffer or die from this disease.

 

Melanoma News Round-Up, May 31

Today is the last day of Melanoma Awareness Month and what a ride it’s been!  Thank you to all of our allies and everyone who dedicated their efforts to raising awareness of melanoma and offering support to fund melanoma research.

MRA is delighted to share our brand new video featuring our world-class research program. We’re incredibly proud of our impact on melanoma research, providing $120 million through grants and leveraged funding to accelerate scientific discovery and its translation. Watch the video and learn how we do it!

[youtube https://www.youtube.com/watch?v=9X9Q-uNWnQI]

 

From May 30 to June 3, MRA is attending the American Society of Clinical Oncology‘s (ASCO) 50th annual meeting in Chicago and ASCO is all abuzz about immunotherapies and melanoma treatment.  To learn more about immunotherapy treatments, check out these articles:

New drugs aid in the fight against melanoma, the deadliest skin cancer via Miami Herald

Immune Therapy’s Cancer Promise Creates Research Rush via Bloomberg

Advances in Melanoma Treatment Prolonging Lives via Boston Globe

This Thursday, the FDA announced it will now require warning labels on tanning beds.  This black-box warning will state that sunlamps in tanning salons should not be used by persons under 18.  This marks another incredible advancement in melanoma prevention policy, in addition to Minnesota and Louisiana announcing legislation banning minors from tanning bed use.

Nine states total have instituted under-18 bans for indoor tanning to address the alarming incidence of melanoma in young people.  Melanoma is the second most common form of cancer people aged 15-29.  A recent study shows that indoor tanning increases your risk of melanoma, even if you don’t burn, because “tanning is a biological response to damage to the DNA […] and you’re going to get that [ultraviolet light] damage in a tanning booth whether or not you burn.”

To address this health risk to young people, the Jeff Dulude Melanoma Foundation and Edgemakers are inviting teenagers to help create a PSA to warn their peers about the dangers of melanoma and how to prevent it.  Learn more about the contest here.

Finally, we would like to share this story about a melanoma survivor who has dedicated himself to supporting other melanoma patients.

 

 

Melanoma News Round-Up, May 10

Week two of Melanoma Awareness Month is coming to a close–catch up on all the news with MRA!

MRA Board Members and funded researchers spoke on a panel about the promise of cancer immunotherapies at the Milken Institute’s 2014 Global Conference in Beverly Hills, Calif.  The panel video also features an animated explanation of cancer immunotherapies, as well as powerful patient testimonials.

 

This week, we shared a new survivor story on our website: Caitlyn was pregnant when her husband noticed a mole that did not look right…

T.J. Sharpe talks about the FDA’s priority review of Merck’s MK-3475 via Philly.com

MRA-supported researcher Dr. Stephen Hodi tells us five things we really ought to know about melanoma via Dana-Farber Insight

Jim Allison’s pioneering spirit is pure Texan—and his cancer drug is a global breakthrough via Alcade

8 Things You Didn’t Know About Melanoma…but Really, Really Should via Glamour

Finally, if you can support MRA and pledge to stay sun safe in one easy action:  Sign the Ipreo-DebtDomain Skin Check Pledge today!

Melanoma News Round-Up, March 28

Take a look at this week’s melanoma news, which features new hope for patients through incredible research advances and compelling progress toward reducing the risk of melanoma through new sunscreens and stronger regulations on indoor tanning. 

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FDA review of new sunscreen ingredients has languished for years, frustrating advocates via Washington Post

Sunscreen delay: Stronger products need OK from FDA via FIOS1 News

New Hope for Melanoma Patients via ABC News

Drug Firms Focus on Advanced Melanoma via Wall Street Journal

Boy With Melanoma Raises Thousands Making Bracelets To Battle Cancer via CBS News

Clinicians emphasize risk of skin cancer in patients with skin of color via Dermatology Times

The Burning Truth campaign via the CDC

Melanoma survivor talks about bill that would ban teens from using tanning beds via WPXI

Inslee signs bill banning tanning beds for youth via King 5

Innovation Coming to America

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Though many people may not have realized it until reading today’s front page Washington Post article, sunscreen products sold in the US are not reflective of the latest innovations and science in understanding how best to protect people against harmful UV rays from the sun.  But it is true – the last time a new sunscreen product was approved for use in the US was in the 1990’s, not because scientists and companies haven’t been innovating, but because applications for approval of new products have been collecting dust on the shelf at the Food and Drug Administration (FDA).

Hopefully, things are about to change for the better.  Last Thursday, a bipartisan, bicameral group of Members of Congress introduced the Sunscreen Innovation Act to jumpstart the sunscreen ingredient review process at the FDA so the American public can have access to the most innovative, effective sunscreen products.  If the bill moves forward and becomes law, Americans may finally be able to purchase sunscreen products which have been on store shelves for years in Europe, Asia, Central and South America.

For the past two decades, the FDA process for reviewing new sunscreen ingredients has stalled due to needlessly complex regulations.  The resulting backlog has ground the review process to a halt.

Shockingly, the most recent sunscreen ingredient to receive FDA approval dates back to the age of the dial-up modem.

The Melanoma Research Alliance (MRA) is committed to reducing the toll of melanoma, the deadliest of all skin cancers.  We routinely urge people to know their risks and take steps to reduce those risks, including avoiding exposure to UV radiation and the damage it causes to the skin.  We have worked to improve the safety and efficacy review of new sunscreen innovations that offer essential protection from hazardous ultraviolet (UV) rays.  As a leading member of the Public Access to Sunscreens (PASS) Coalition, MRA has engaged with Congress and the FDA to address the current standstill in a process that is clearly broken.

The need for the most advanced and effective sunscreen products is clear, especially during a time when the deadliest skin cancer, melanoma, is increasing in prevalence.  Each year more than 9,800 Americans die of melanoma – that’s one person every hour.  Skin cancer is the most common form of cancer in the United States with more than 2 million Americans diagnosed every year.  Exposure to UV rays is a leading cause of melanoma and other skin cancers.

Protecting your skin from harmful UV rays offers incredible benefits, preventing sunburns, skin aging, and reducing your risk of skin cancer.  Experts recommend you protect your skin with the regular usage of sunscreen that is:

1) Broad Spectrum

2) Water Resistant

3) SPF 30 or higher

You can dramatically reduce your risk of skin cancer with the proper use of sunscreen, and hopefully you’ll soon be able to purchase the most cutting-edge sunscreen technologies as Congress, the FDA, the PASS Coalition, and MRA work to enact this bill into law.  Be sure to follow MRA for updates as we track this bill’s progress.