Moderna and Merck & Co – known as MSD outside the US and Canada – have shared positive follow-up results from a phase 2b study of their investigational individualised neoantigen therapy in high-risk melanoma.

The incidence of melanoma has been rising over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020.

The randomised KEYNOTE-942/mRNA- 4157-P201 trial has been evaluating the candidate, mRNA-4157 (V940), in combination with Merck’s Keytruda (pembrolizumab) compared to the anti-PD-1 therapy alone in patients with resected high-risk, stage 2b to 4 melanoma following complete resection.

The combination has already been shown in the primary analysis of the study to cut the risk of recurrence of melanoma or death by 44% and the risk of distant metastasis or death by 65%, compared to Keytruda alone, at a median planned follow-up of approximately two years.

According to the latest results shared by the companies, at a median follow-up of around three years, the combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% compared to Keytruda alone.

The combination has been given breakthrough therapy designation in the US as an additional treatment for high-risk melanoma patients.

Bristol Myers Squibb’s (BMS) Opdualag (nivolumab-relatlimab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line treatment for advanced melanoma in patients aged 12 years and older.

Around 10% of melanoma patients are diagnosed at stages 3 or 4, and despite usually being curable when caught early, the disease becomes more difficult to treat as it progresses.

The active ingredients in Opdualag are designed to harness the body’s own immune system to help restore its antitumour immune response, BMS explained.

NICE’s recommendation came less than one month after the Medicines and Healthcare products Regulatory Agency (MHRA) approved the therapy for the same patient population through Project Orbis, a global partnership between regulatory bodies to review and approve promising cancer drugs, to help patients access treatments more quickly.

Both decisions were supported by results from the phase 2/3 RELATIVITY-047 trial of 714 patients with previously untreated metastatic or unresectable stage 3 or 4 melanoma who were randomised to receive a combination of nivolumab and relatlimab or nivolumab alone.

The combination was shown to have more than doubled median progression-free survival compared to nivolumab alone at a median follow-up of 19.3 months.

Bristol Myers Squibb (BMS) and Elekta have entered into a pilot collaboration aimed at developing a digital solution for patients with melanoma.

Around 16,700 new cases of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, are diagnosed in the UK every year.

Although financial details of the partnership have not been disclosed, Elekta outlined that the collaboration will leverage its digital health interventions platform, Kaiku Health, to “facilitate communication between healthcare professionals and their patients on symptom management”.

It is hoped that the digital solution will give patients an accessible and user-friendly way to share relevant information on their well-being with their care team, and to receive personalised support and guidance during treatment.

Through the use of machine learning algorithms, the platform will allow for real-time evaluation of patient-reported data, giving healthcare providers personalised insights that could improve care pathways and experiences.

Anish Patankar, senior vice president and head of business line software, Elekta, said: “We are thrilled to collaborate with BMS to potentially advance the use of digital health interventions, such as in the treatment of melanoma.

“By providing patients with the tools and support they need, we aim to empower them to actively participate in their treatment journey.”

Dermavant Sciences has announced positive new results from a phase 3 trial of its Vtama (tapinarof) cream, 1% in adult and paediatric patients as young as two years with moderate-to-severe atopic dermatitis (AD).

Previous results from the ADORING 1 and ADORING 2 trials showed that the efficacy of the Vtama cream continued to improve beyond the eight-week double blind treatment period across multiple endpoints, with a Validated Investigator Global Assessment for Atopic Dermatitis (vIGAAD) score of zero (clear) or one (almost clear) and a two-grade improvement from baseline in 73% of patients.

The ongoing ADORING 3 trial consisting of 728 patients is a long-term extension study to evaluate the safety and efficacy of Vtama cream, 1% in patients with AD for up to 48 weeks of total treatment.

The interim analysis safety data of ADORING 3 demonstrated that Vtama cream, 1% was well tolerated across all treatment areas, including sensitive skin and intertriginous locations, with over 51% of patients achieving complete disease clearance with a vIGA-AD score of zero.

The analysed data will be included in the company’s Supplemental New Drug Application submission to the US Food and Drug Administration in the first quarter of this year.

LEO Pharma has announced positive results from a head-to-head study of its investigational JAK-inhibitor cream, delgocitinib, in adults with severe chronic hand eczema (CHE).

Hand eczema is the most common skin disorder of the hands and one of the most common types of eczema.

CHE, which affects a substantial number of patients, is defined as hand eczema that lasts for more than three months or relapses twice or more within a year.

Alitretinoin is currently the only treatment specifically approved to treat severe CHE in patients who do not respond to topical corticosteroids.

The late-stage DELTA FORCE study has been comparing the efficacy and safety of twice-daily delgocitinib cream with oncedaily alitretinoin capsules.

The primary endpoint of the trial was met, with delgocitinib cream demonstrating a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to week 12 compared to alitretinoin.

The candidate also demonstrated superiority to alitretinoin capsules in all key secondary outcome measures, including Investigator’s Global Assessment-CHE treatment success, a reduction in HECSI score from baseline to week 24, and a significant improvement in health-related quality of life.

Additionally, patients receiving delgocitinib cream experienced a lower number of treatment-emergent adverse events compared to those receiving alitretinoin capsules.