Skin Cancer Roundup: The Year so Far

Medicus Pharma Submits Phase 2 IND Clinical Protocol to FDA to Non-Invasively Treat BCC

Medicus Pharma announced its submission to the FDA of a phase 2 investigational new drug (IND) clinical protocol, SKNJCT-003, for the non-invasive treatment of basal cell carcinoma (BCC) using micro-array needles containing doxorubicin (D-MNA), developed by its wholly-owned portfolio company, SkinJect.¹

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DermTech’s 2-GEP Assay Succeeds at Guiding Biopsy Decision-Making for Ambiguous Skin Lesions of All Skin Phototypes

A poster from the 2024 Winter Clinical Hawaii Dermatology Conference in Honolulu, Hawaii, held January 12th through the 17th, analyzed the ability of DermTech’s 2-gene expression profiling (GEP) assay to detect the expression of LINC00518 and PRAME as a non-invasive assessment of clinically atypical, pigmented skin lesions to rule out melanoma with a negative predictive value (NPV) of 99%.²

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SkinCure Oncology Receives Patent for New Image-Guided Superficial Radiation Therapy

SkinCure Oncology announced that it has received a patent from the US Patent and Trademark Office for a new image-guided technology that will be the fourth generation of superficial radiation therapy (SRT) for the treatment of nonmelanoma skin cancer. SkinCure Oncology has not yet submitted its data to the FDA for marketing clearance, however once cleared, the new devices will use hybrid laser-generated confocal and photoacoustic imaging in a single fused volumetric image. SkinCure Oncology expects the new devices to help clinicians to better image nonmelanoma skin cancer and provide accurate treatments.³

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Lifileucel Receives FDA Accelerated Approval for Advanced Melanoma

Iovance Biotherapeutics announced that the FDA approved lifileucel (Amtagvi) suspension for intravenous infusion for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. Lifileucel’s indication is FDA- approved under an accelerated approval based on overall response rate and duration of response. Iovance is also conducting TILVANCE-301, a phase 3 trial to confirm the clinical benefit of lifileucel.⁴

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Facial Skin Cancer Surgery Yields Low and Improved Scores For Perceived Stigmatization, Body Image Concerns, and Psychosocial Distress

Non-melanoma skin cancers (NMSCs) are on the rise, with basal cell carcinomas and squamous cell carcinomas being the most common types. Surgery remains the primary treatment for these cancers, with conventional excision and Mohs micrographic surgery being the standard approaches.

While both methods are effective, Mohs surgery is capable of examining 100% of tissue margins during surgery, potentially leading to lower recurrence rates. However, facial surgery for NMSCs can have significant psychological implications due to changes in appearance.⁵

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What does Skin Cancer Awareness Month mean to you as a clinician? Email us at DTEditor@mmhgroup.com for an opportunity to be featured.

References

1. Medicus Pharma Ltd. submits to the FDA phase 2 IND clinical protocol to non-invasively treat basal cell carcinoma of the skin. News release. Medicus Pharma. January 3, 2024. Accessed May 10, 2024. https://medicuspharma.com/medicus-pharma-ltd-submits-to-the-fda-phase-2-ind-clinical-protocol-to-non-invasively-treat-basal-cell-carcinoma-of-the-skin/
2. Skelsey M, Lofitis B, Kaufmann M, et al. Non-invasive gene expression analysis rules out melanoma with high negative predictive value regardless of skin phototype. Poster presented at: 2024 Winter Clinical Hawaii Dermatology Conference; January 12-17, 2024; Honolulu, HI.
3. SkinCure Oncology awarded patent for next-generation image-guided superficial radiation therapy. News release. PR Newswire. February 14, 2024. Accessed May 10, 2024. https://www.prnewswire.com/news-releases/skincure-oncology-awarded-patent-for-next-generation-image-guided-superficial-radiation-therapy-302061378.html
4. Iovance’s AMTAGVI (lifileucel) receives US FDA accelerated approval for advanced melanoma. News release. Iovance Biotherapeutics. February 16, 2024. Accessed May 10, 2024. https://ir.iovance.com/news-releases/news-release-details/iovances-amtagvitm-lifileucel-receives-us-fda-accelerated
5. Subramaniam P, Olsen CM, Thompson BS, Whiteman DC, Neale RE. Anatomical distributions of basal cell carcinoma and squamous cell carcinoma in a population-based study in Queensland, Australia. JAMA Dermatol. 2017. Accessed May 10, 2024.