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Marie Bosslett is the assistant editor of 

 and joined the MJH Life Sciences team in October 2024. She attended Loyola University in Baltimore, Maryland, and earned a Bachelor of Arts in Communication with minors in marketing and writing. When she’s not writing, Marie enjoys going to concerts, reading on the beach, and spending time with friends and family.

Articles

A post hoc analysis of OLYMPIA 1 and 2 trial data found significant improvement in the first 14 days of treatment.

Nemolizumab Delivers Rapid Itch Response in Patients with PN

and joined the MJH Life Sciences team in February 2023. She attended Kent State University and earned a Bachelor of Science degree in journalism with minors in public relations and creative writing. She enjoys making and listening to music, reading, and spending time with her cats, Astrid and Marceline.

The target action review date has been pushed to March 12, 2025.

PDUFA Date for Tapinarof 1% Cream in Atopic Dermatitis Pushed to 2025

4 case histories highlight the physical and psychosocial burden of generalized pustular psoriasis.

Quality of Life Severely Affected for Patients with GPP

Kaitlyn Bader is the assistant managing editor of 

 and joined the MJH Life Sciences team in June 2022. She attended Otterbein University in Westerville, Ohio, and earned a Bachelor of Arts degree in literary studies with minors in creative writing and film studies. Prior to health care news, Kaitlyn worked in industrial marketing. She enjoys cooking, reading, and tending to her house plants.

As news of benzene contamination in benzoyl peroxide products continues to raise safety discussions, Steve Xu, MD, MSc, advocates for stricter regulations, increased research, and the consideration of safer acne treatment alternatives. 

Benzene Concerns in Benzoyl Peroxide Spark Calls for Safer Acne Treatment Standards 

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Panelists discuss how advanced basal cell carcinoma (BCC) presents unique treatment challenges and examine recent developments that show promise for improving outcomes in patients with this aggressive form of skin cancer.

Overview of Advanced BCC and Highlights From Panel Discussion

Final Thoughts: The Importance of Comparative Studies in AD

Panelists offer concluding insights and emphasize the critical role of comparative studies in advancing atopic dermatitis treatment strategies.

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All 3 drugs listed in this poll have recently made appearances in the news for various reasons.

Moderna and Merck recently announced follow-up data

 from the phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with pembrolizumab (Keytruda), Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection.

V940 plus pembrolizumab also continued to demonstrate a meaningful improvement in distant metastasis-free survival, compared with pembrolizumab alone, reducing the risk of developing distant metastasis or death by 62%.

AiViva Biopharma recently announced positive and promising data

 from its phase 1/2 clinical trial of AIV001 (Axitinib), a novel intradermal treatment, in patients with basal cell carcinoma.

“It is exciting and important to have AiViva Biopharma develop a drug, with a new mechanism of action, that has the potential to treat BCC that avoids surgery,” said Brian Berman, MD, PhD, in a press release. Berman is Professor Emeritus of Dermatology and Dermatologic Surgery at The University of Miami Miller School of Medicine.

Checkpoint Therapeutics, Inc. faces a delay

 in the approval process for its cosibelimab biologic license application (BLA) following the issuance of a complete response letter (CRL) by the US Food and Drug Administration (FDA). 

The CRL specifically points to issues uncovered during an FDA inspection of Checkpoint's third-party contract manufacturing organization.

Notably, no concerns were raised regarding clinical data, safety, or labeling. 

James Oliviero, President and CEO of Checkpoint, remains optimistic, stating that the company aims to address the deficiencies in a resubmission, anticipating marketing approval for cosibelimab in 2024. 

U.S. Food and Drug Administration Issues Complete Response Letter for COSIBELIMAB solely due to inspection findings at third-party manufacturer. Checkpoint Therapeutics, Inc. December 18, 2023. Accessed December 19, 2023. 

https://ir.checkpointtx.com/news-events/press-releases/detail/111/u-s-food-and-drug-administration-issues-complete-response

Moderna and Merck's phase 2b study of mRNA-4157 (V940) with pembrolizumab shows significant improvement in distant metastasis-free survival for high-risk melanoma patients. AiViva Biopharma's phase 1/2 trial of AIV001 (Axitinib) presents promising results for basal cell carcinoma treatment, potentially offering a non-surgical option. Checkpoint Therapeutics faces a delay in cosibelimab's approval due to manufacturing issues, not clinical data concerns. The company plans to address these deficiencies and anticipates approval in 2024.

Click here to answer this week's poll about a recent FDA Complete Response Letter.

Polls 

POLL: Which Skin Cancer Drug Recently Received a Complete Response Letter From the FDA?

Cabtreo (Ortho Dermatologics; formerly known as IDP-126) was approved by the US Food and Drug Administration

 (FDA) in October 2023 for the treatment of patients aged 12 years and older with acne vulgaris. Cabtreo is the first FDA-approved fixed-dose triple-combination gel (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) for patients with acne. Cabtreo is expected to be available in Q1 of 2024.

, more than half (52.5%) of patients treated with Cabtreo achieved treatment success as measured by a 2-point or greater reduction from baseline in Evaluator’s Global Severity Score and clear or almost clear skin. In the first of the phase 3 trials, the proportion of patients treated with Cabtreo achieving clear or almost clear skin (49.6%) was significantly greater than patients being treated with a vehicle gel (24.9%). The second phase 3 trial demonstrated consistent significant rates of treatment success among Cabtreo- treated patients (50.5%) versus patients in the vehicle gel group (20.5%).

What are your thoughts about Cabtreo as the newest acne topical? Email us at 

Cabtreo, a fixed-dose triple-combination gel, received FDA approval in October 2023 for treating acne vulgaris in patients aged 12 and older. It combines clindamycin, adapalene, and benzoyl peroxide, marking the first such approved formulation. Clinical trials demonstrated its efficacy, with over half of the patients achieving significant improvement in acne severity. Phase 3 trials showed Cabtreo's superiority over a vehicle gel, with nearly 50% of patients achieving clear or almost clear skin. Cabtreo is anticipated to be available in the first quarter of 2024.

Click here to answer this week's acne poll.

POLL: Have Your Patients Asked About Cabtreo for Acne?

SkylineDx, an oncology biotechnology company, announced new data from the MERLIN__001 trial, confirming the validity and efficacy of the Merlin test in identifying sentinel lymph node biopsy (SLNB) status in patients with melanoma.

The prospective US multi-center trial is the largest ever conducted to assess the performance of a genomic test for melanoma.

The first results from the study were presented at the 2024 Society for Melanoma Research Congress from October 10 to 13 in New Orleans, Louisiana.

The trial was performed at 9 academic sites in the US. It included 1686 patients with melanoma (T1-T3) who underwent SLNB. Patients were classified as “High Risk” or “Low Risk.” Overall, 37% of participants were in the low-risk category. Among these, only 7.1% had a positive SLN. This resulted in a negative predictive value of 92.9%. Conversely, 23.8% of patients deemed “High Risk” patients had positive SLNs.

The study also took a closer look at T1a, with the goal of avoiding overtreatment for early-stage melanoma. Patients with low-risk T1 melanoma (88%) had a post-test SLN positivity rate of only 1.5%. In contrast, 12% of patients were classified as high-risk with a higher SLN positivity rate of 15.8%.

Several patients with adverse features were also tested, including patients under age 40, those with lymph vascular invasion, and those with a high mitotic rate. These 37 patients were categorized in the low-risk group, with a post-test SLN positivity rate of 0%. Additionally, 7 patients without any adverse features were identified as high-risk (SLN positivity rate of 14.3%).

"The intent is to help prevent undertreatment in seemingly low-risk early-stage melanoma patients who are actually at risk for nodal metastasis,” Alexander Meves, MD, MBA, dermatologist at Mayo Clinic and principal inventor of the CP-GEP model, shared in a statement. “By accurately identifying these at-risk individuals, we ensure that they receive the necessary interventions, even in the absence of traditional clinical risk factors."

The CP-GEP (clinical pathologic and gene expression profiling) Merlin model was developed by Mayo Clinic and SkylineDx BV and has already been launched in the US and Europe. Validated with an overall sentinel lymph node positivity rate of over 17%, CP-GEP is an accurate, non-invasive procedure that categorizes patients with melanoma as being at high or low risk for metastasis. The results can guide clinicians in choosing the most appropriate actions for prevention, screening, and SLNB treatment.

SLNB is a common procedure often recommended for patients with a predicted metastasis risk of >10%. However, because more than 80% of these procedures reveal no metastasis, patients experience increased risk of complications and costs, without realizing therapeutic benefit. The Merlin test allows surgeons to explore less aggressive treatment plans and improve overall patient care.

Vernon Sondak, MD, chair of the Department of Cutaneous Oncology at Moffitt Cancer Center and 1 of 3 principal investigators for this study, noted the results were significant for patient care.

"This landmark trial will allow us to have more informed conversations with our patients about their surgical treatment options,” Sondak said in a press statement. “These results provide critical insights for clinicians, allowing us to move toward more precise and individualized care."

Editor's note courtesy of Aaron Farberg, MD, as of 10/30/24

: The CP-GEP Merlin Test test was designed to predict patients with less than a 5% risk of a positive sentinel lymph node. That 5% is the current standard of care by NCCN guidelines. The study was designed with the hypothesis that the test could predict patients with less than 5% positivity. Their outcome was that the test predicts patients with 7% risk, which makes it inadequate compared to our current standard of care.]

1. Hieken TJ, Egger ME, Angeles CV, et al. MERLIN_001: A prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of patients with sn-negative melanoma. 

 2022;40(16_suppl). doi:10.1200/jco.2022.40.16_suppl.tps9606

2. SkylineDx Announces Data from Largest Prospective Multi-Center Melanoma Gene Expression Profiling Trial at 21st International Congress of the Society for Melanoma Research. SkylineDx. Published October 13, 2024. 

https://www.prnewswire.com/news-releases/skylinedx-announces-data-from-largest-prospective-multi-center-melanoma-gene-expression-profiling-trial-at-21st-international-congress-of-the-society-for-melanoma-research-302274550.html

3. SkylineDx Announces Presentation of New Data Highlighting the Predictive Power of the CP-GEP Merlin Test for T1a Cutaneous Melanoma Patients at the 21st International Congress of the Society for Melanoma Research. SkylineDx. Published October 11, 2024. 

https://www.prnewswire.com/news-releases/skylinedx-announces-presentation-of-new-data-highlighting-the-predictive-power-of-the-cp-gep-merlin-test-for-t1a-cutaneous-melanoma-patients-at-the-21st-international-congress-of-the-society-for-melanoma-research-302273871.html

SkylineDx's MERLIN__001 trial validates the Merlin test's efficacy in predicting sentinel lymph node biopsy (SLNB) status in melanoma patients. Conducted across nine US academic sites, the trial involved 1686 patients, classifying them as "High Risk" or "Low Risk" for SLN positivity. The CP-GEP Merlin model, developed by Mayo Clinic and SkylineDx, offers a non-invasive method to identify patients at risk for metastasis, potentially reducing unnecessary SLNB procedures. This approach aims to enhance patient care by enabling more precise and individualized treatment strategies.

Results from Society for Melanoma Research Congress demonstrated excellent predictive power of noninvasive CP-GEP Merlin test.

SkylineDx Data Confirms Accuracy of the Merlin Test for Low- and High-Risk Melanoma 

Moderna and Merck recently announced new results

 from a planned analysis from the phase 2b randomized KEYNOTE-942 clinical trial (

) evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with pembrolizumab (Keytruda), Merck’s anti-PD-1 therapy, in patients with resected high-risk stage III/IV melanoma following complete resection (n=157). After a median follow-up of 3 years (34.9 months), adjuvant treatment with mRNA-4157 in combination with pembrolizumab continued to show a clinically meaningful and durable improvement in the primary end point of recurrence-free survival (RFS), reducing the risk of recurrence or death by 49% (HR [95%CI], 0.510 [0.288–0.906]), compared with pembrolizumab as monotherapy.

The combination of mRNA-4157 and pembrolizumab also demonstrated a meaningful improvement in one of the key secondary end points of distant metastasis-free survival (DMFS), compared to pembrolizumab as monotherapy, therefore reducing the risk of developing distant metastasis or death by 62% (HR [95% CI], 0.384 [0.172–0.858]).

The new 3-year data on mRNA-4157 and pembrolizumab was presented at the 2024 American Society of Clinical Oncology Annual Meeting. According to the news announcement, an additional year of follow-up is planned, adding to the earlier analyses of the primary and secondary end points.

Based on continued positive data, Merck and Moderna have initiated a phase 3 randomized clinical trial evaluating mRNA-4157 combined with pembrolizumab as an adjuvant treatment in patients with resected high-risk (stage IIB-IV) melanoma (INTerpath-001, 

), which is actively enrolling participants.

“We are encouraged by the latest results from the KEYNOTE-942/mRNA-4157-P201 study. These data highlight the sustained benefit in RFS and DMFS of mRNA-4157 (V940) as adjuvant treatment in combination with KEYTRUDA in people with resected high-risk melanoma. Importantly, this benefit was observed across various patient exploratory subgroups, reflecting the potential of mRNA-4157 (V940) for a broad range of these patients,” said Kyle Holen, MD, senior vice president and head of development of therapeutics and oncology at Moderna, in the news release. “These findings reinforce our commitment to advancing this innovative treatment in collaboration with Merck, and we are dedicated to harnessing mRNA technology to potentially transform cancer therapy and improve patient outcomes.”

The previous 2.5-year RFS rate of mRNA-4157 plus pembrolizumab was 74.8%, as compared to 55.6% for pembrolizumab as monotherapy, with the benefit observed across exploratory subgroups.

“The sustained improvements in recurrence-free survival and distant metastasis-free survival observed at approximately three years in the KEYNOTE-942/mRNA-4157-P201 study provide further support of the potential of mRNA-4157 (V940) in combination with KEYTRUDA to help patients with resected high-risk melanoma,” said Marjorie Green, MD, senior vice president and head of oncology and global clinical development at Merck Research Laboratories, in the news release. “We look forward to building on our legacy of turning breakthrough science into medicines that may have a meaningful impact on patients’ lives as we continue advancing our broad clinical development program evaluating this novel approach with Moderna.”

Additional data from an exploratory subgroup analysis of KEYNOTE-942 in patients with resected high-risk stage III/IV melanoma following complete resection showed that improvement in RFS was seen with mRNA-4157 plus pembrolizumab compared to pembrolizumab as monotherapy regardless of tumor mutational burden (TMB) or programmed death-ligand 1 (PD-L1) status.

The RFS benefit of mRNA-4157 plus pembrolizumab compared to pembrolizumab as monotherapy was maintained across both TMB high (HR [95% CI], 0.564 [0.253–1.258]), TMB non-high (0.571 [0.245–1.331]), PD-L1 positive (0.471 [0.226–0.979]), PD-L1 negative (0.147 [0.034–0.630]), and circulating tumor DNA (ctDNA) negative (0.207 [0.091–0.470]) subpopulations. Additionally, data could not be collected on ctDNA-positive HR due to the small sample size. There were no significant associations between individual human leukocyte antigen alleles and RFS observed for mRNA-4157 plus pembrolizumab.

The exploratory end point of overall survival (OS) favored mRNA-4157 plus pembrolizumab compared to pembrolizumab as monotherapy, with a 2.5-year OSrate of 96.0% vs. 90.2%, respectively (HR [95% CI], 0.425 [0.114–1.584]). The most common adverse events attributed to mRNA-4157 plus pembrolizumab were fatigue (60.6%), injection site pain (56.7%), and chills (49.0%).

1. Moderna & Merck announce 3-year data for mRNA-4157 (v940) in combination with KEYTRUDA (pembrolizumab) demonstrated sustained improvement in recurrence-free survival & distant metastasis-free survival versus KEYTRUDA in patients with high-risk stage III/IV melanoma following complete resection. News release. Merck. June 3, 2024. Accessed June 3, 2024. 

https://www.merck.com/news/moderna-merck-announce-3-year-data-for-mrna-4157-v940-in-combination-with-keytruda-pembrolizumab-demonstrated-sustained-improvement-in-recurrence-free-survival-distant-metastasis-free-su/

Moderna and Merck's phase 2b KEYNOTE-942 trial results reveal that mRNA-4157 combined with pembrolizumab significantly improves recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in high-risk stage III/IV melanoma patients post-resection. The combination therapy reduced recurrence or death risk by 49% and distant metastasis or death risk by 62% compared to pembrolizumab alone. These benefits were consistent across various subgroups, regardless of tumor mutational burden or PD-L1 status. A phase 3 trial is underway to further evaluate this promising adjuvant treatment.

Phase 3 trials have been initiated in patients with high-risk melanoma. 

Moderna and Merck Announce New 3-Year Data for mRNA-4157 Combined With Pembrolizumab for High-Risk Stage III/IV Melanoma 

Photodynamic Pearls and Best Practices

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Monica Boen, MD, discusses how implementing proven photodynamic therapy techniques and adhering to best practices can significantly improve treatment outcomes and patient satisfaction.

Vatche Tchekmedyian, MD

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