News From the Foundation Working To End Melanoma | 01.2022

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Happy 2022! I hope this year is joyful and healthy for you and your family. I want to call your attention to three important research developments that were announced recently. The first is detailed in our latest In Plain English article by Dr. Kim Margolin. A study called DreamSeq has provided extremely valuable information on the treatment of advanced melanoma that is BRAF positive. Dr. Margolin clearly explains what the study found, why it’s important, and what questions remain. The second announcement was that the U.S. Food and Drug Administration (FDA) approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection. The approval is based upon the results of a Phase 3 clinical trial involving 976 newly diagnosed patients in which Keytruda showed a statistically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 35% compared to placebo alone. Observation was previously the standard of care for Stage IIB and Stage IIC patients, even though the risk of recurrence for these patients is nearly as high as for patients with Stage IIIA and IIIB disease for whom treatment is recommended.

PRESIDENTS LETTER

You can read more about the Keytruda approval in this issue. You can also watch the video of the webinar we recently presented on What is the Standard of Care for Stage II Melanoma Patients in 2022? with Jason J. Luke, MD, FACP, director, Cancer Immunotherapeutics Center, UPMC Hillman Cancer Center, associate professor of medicine, Division of Hematology/Oncology, University of Pittsburgh School of Medicine. The third and most recent announcement is the approval by the FDA of Kimmtrak (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma. Kimmtrak is the first and only FDA-approved therapy for the treatment of unresectable or metastatic uveal melanoma (mUM). mUM is a devastating diagnosis: The median overall survival after diagnosis is just one year. The approval is based on a study of 378 previously untreated patients randomly assigned to the Kimmtrak (tebentafusp) group or the control group who received one of three single agent treatments. Overall survival (OS) at one year was 73% in the tebentafusp group and 59% in the control group. In this issue, you can read more about the Kimmtrak approval. Please read the latest in our “How Can I Help?” series. Since so many of you ask this question (and we’re grateful you do), we describe different ways you can help in each newsletter. The goal is to assist you in finding the way to get involved that is best for you. We also have three stories to share. Tamara is from Australia and part of AIM’s MIPAC group. Ann Marie lives in California and is a member of our Peer Connect group. And Rhonda is part of the KDB Walk family that has raised so much money for AIM and so much awareness of melanoma in the state of Michigan. Thank you to Tamara, Ann Marie, and Rhonda for sharing your stories with the AIM community. Finally, on behalf of our whole organization, I want to express my thanks for your support of our mission throughout 2021 — please watch the video, Check out the second video, too, which wraps up our celebration of gratitude. In November, we asked our community to share what they are grateful for, and we posted many of these submissions online and on social media. Our staff also shared what they are grateful for, and we created a video to share their submissions with you. Enjoy! Sam Guild President AIM at Melanoma Foundation

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