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The Benefits Of Advanced Clinical Practitioners In Skin Cancer Services

Skin cancer advanced clinical practitioners ensure continuity of care for oncology patients with malignant melanoma and other advanced skin cancers

Abstract

Melanoma, the most serious type of skin cancer, has a high propensity to metastasise. However, while incidence rates have increased, mortality has declined with the advent of immunotherapy and targeted therapy, meaning patients with metastatic melanoma now have the potential for long-term survival. Skin cancer advanced clinical practitioners play a vital role in providing high-quality, patient-centred care for patients with malignant melanoma and other advanced skin cancers. This article describes advances in the treatment and care of patients with skin cancer and how advanced clinical practitioners improve the patient experience, as well as service efficacy and capacity.

Citation: Sherman C (2025) The benefits of advanced clinical practitioners in skin cancer services. Nursing Times [online]; 121: 4.

Author: Carol Sherman is skin cancer advanced clinical practitioner, University Hospitals Dorset NHS Foundation Trust.

This article has been double-blind peer reviewed

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Introduction

Skin cancer is a major global public health concern. It is more commonly diagnosed than all other malignancies combined (Skcin, no date). In the UK, one in four men and one in five women will develop a form of skin cancer at least once in their lifetime (Skcin, no date). The incidence of skin cancer in the UK is rising faster than any other cancer, with figures doubling every 10-20 years (Skcin, no date).

Melanoma, often referred to as 'malignant melanoma', is a type of cancer that usually starts in the skin. There are four main types of skin melanoma:

Superficial spreading;

Nodular;

Lentigo maligna;

Acral lentiginous (Macmillan Cancer Support, 2022a).

These four types are known as cutaneous melanoma.

Although it is rare, melanoma can occur in other parts of the body, such as the eye (ocular melanoma) and the mucosal membranes in the head, neck and genital areas (mucosal melanoma) (Macmillan Cancer Support, 2022a). This article will focus on patients who have cutaneous melanoma of the skin.

Melanoma is the fifth most common cancer in the UK, accounting for ~4% of all new cancer diagnoses each year. Every year, there are 17,537 new melanoma diagnoses and 2,341 deaths (Cancer Research UK, no date), with new cases predicted to rise to 20,000 by 2025 (Skcin, no date).

"Having five or more episodes of sunburn in a person's life more than doubles a person's chances of developing melanoma later in life"

Causes and detection

Cutaneous melanoma develops when there is an uncontrolled growth of melanocytes (pigment cells) in the skin, which is mostly caused by overexposure to UV radiation from sun exposure or sunbed use. Having five or more episodes of sunburn in a person's life, or just one serious sunburn in childhood or adolescence, more than doubles a person's chances of developing melanoma later in life (Skin Cancer Foundation, 2023).

Melanoma skin cancer arises from:

Otherwise normal-appearing skin;

From within a pre-existing mole or freckle that changes appearance in shape, colour or size (Seebacher, 2022).

Accurate history taking and examination of the lesion's clinical features are an essential part of assessment.

Early detection and treatment with primary surgery are key to improving patient outcomes and survival rates (Garrison et al, 2023). If caught early, the majority (~90%) of stage 0, I or II melanomas can potentially be cured with surgery alone (Seebacher, 2022). More-advanced melanomas (stages III and IV) require a combination of treatments, including surgery, drug therapy and targeted radiotherapy (Melanoma Focus, no date a). Fig 1 illustrates the different stages of melanoma.

Advances in treatment

Melanoma is considered an aggressive and highly metastatic cancer. Historically, patients with metastatic melanoma had a poor prognosis with an average survival rate of 6-8 months (Chan and Corrie, 2024).

The introduction of immunotherapy and targeted therapy anti-cancer drugs have completely transformed the treatment landscape for patients with stage II – IV melanoma. Whereas cutaneous melanoma was previously considered one of the cancer types that was resistant to drug treatment, patients' survival can now be measured in years, rather than months (Larkin et al, 2019).

Drug therapy for melanoma is rapidly evolving, with the frequent availability of new and effective treatment regimes offered in both palliative and adjuvant settings. Adjuvant treatment is offered to patients with completely resected stage II-III disease for one year, to potentially reduce the risk of disease recurrence (Melanoma Focus, no date b). After a detailed discussion in clinic, single-agent intravenous immunotherapy (pembrolizumab or nivolumab) or targeted therapy (dabrafenib and trametinib tablets) may be offered, depending on the stage of disease, the patient's performance status, volume of disease, other comorbidities and genetic BRAF status (National Institute for Health and Care Excellence (NICE), 2022).

Around half (40-50%) of people with melanoma have a genetic change in their melanoma cells called a BRAF V600e gene mutation (Macmillan Cancer Support, 2022b). A mutation in the BRAF gene causes melanoma cells to make a protein that encourages the cells to divide and grow uncontrollably (Macmillan Cancer Support, 2022b). To confirm a patient's BRAF status, genetic tests are performed on the melanoma cells removed during surgery. If the BRAF mutation is detected, melanoma is described as 'BRAF positive' or 'BRAF mutated'; if the mutation is not detected, melanoma is described as 'BRAF negative' or 'wild type'. The BRAF mutation is not inherited so cannot be passed to children (Melanoma Focus, no date c).

Treatment according to disease stage

Patients with stage II melanoma may be offered adjuvant immunotherapy only. Pembrolizumab is currently the only drug approved for stage II disease so it is not dependent on the patient's BRAF status (Melanoma Focus, no date c).

Individuals with stage III melanoma may be offered adjuvant immunotherapy if they are BRAF wild type, or targeted therapy (dabrafenib and trametinib) if they have the BRAF mutant gene (Melanoma Focus, no date c).

Stage IV melanoma is advanced or unresectable disease and is known as 'metastatic melanoma'. Patients with stage IV melanoma may be offered palliative treatment, dependent on performance status, burden of disease, other comorbidities and genetic BRAF status. Complex, skilled conversations are needed with patients and their families to explain the various treatment options and their associated unique side-effect profile.

Palliative systemic anti-cancer treatment (SACT) options are as follows:

Recommended first-line therapy – dual agent immunotherapy (ipilimumab and nivolumab) for two years for BRAF wild type and patients with a BRAF mutation who are deemed fit enough to tolerate dual therapy (Cancer Research UK 2023a; Keilholz et al, 2020);

Single-agent pembrolizumab or nivolumab for two years for patients with BRAF wild type (Cancer Research UK, 2023b; Cancer Research UK, 2023c; Keilholz et al, 2020);

Targeted lifelong therapy tablets (dabrafenib and trametinib or encorafenib and binimetinib) for patients with a BRAF mutation (Cancer Research UK, 2023d; Cancer Research UK, 2025e; Keilholz et al, 2020);

Patients remain on treatment for as long as the drugs are tolerated with manageable side-effects and no relapse of disease (Cancer Research UK, 2023d; Keilholz et al, 2020).

Specialist nurse and advanced practice roles

The UK currently employs an array of specialist and advanced practice nurses in skin cancer services, but there is considerable variation in their role titles, scope of practice, job descriptions and educational backgrounds (Machin, 2020). Role titles such as clinical nurse specialist (CNS), nurse practitioner and advanced clinical practitioner (ACP) are often used interchangeably but, although these roles can have significant overlap, there are some distinguishing factors.

Health Education England's (no date) Aspirant Cancer Career and Education Development capability framework outlines the distinction between specialist and advanced practice in the cancer care workforce and refers to different levels of practice, rather than job roles. The levels of practice are distinguished as: supportive, assistive, pre-registration, registration, enhanced, advanced and consultant.

Specialist and enhanced clinical practitioners are considered experts in their chosen clinical area. They work predominantly in one of the four clinical pillars of nursing (clinical practice, education, research and leadership) and attain a depth of knowledge specific to their area (NHS Employers, 2023). CNSs do not necessarily have to have a post-graduate degree, although it is deemed preferable; however, enhanced clinical practitioners (ECPs) are educated to postgraduate level. In contrast, nurses who are ACPs demonstrate a depth and breadth of knowledge that extends across all four pillars of nursing and are educated to master's level (NHS Employers, 2023; NHS, 2017).

The specialist skin cancer nursing team across University Hospitals Dorset NHS Foundation Trust consists of an ACP, an ECP and four CNSs. Despite many commonalities in our roles, we have different levels of responsibility and expertise that are commensurate with our knowledge, skills and scope of clinical practice. To meet patient and service delivery needs, it is essential to develop a responsive, flexible workforce with multiprofessional advanced practice credentials. Having a mix of capabilities and skills at different levels is recognised as advantageous, as service needs are more likely to be met and optimum care delivered to patients (NHS Employers, 2023).

The ACP role

The ACP role is characterised by a high degree of:

Autonomy and complex decision making;

Analysis and synthesis of complex problems;

The ability to independently complete whole episodes of care (NHS, 2017).

The development of advanced practice in skin cancer services varies enormously across the UK and depends on whether the ACP's expertise lies in surgical, dermatology or oncology services. For example, some skin cancer ACPs take on the role as nurse surgeons, who are predominately involved in the surgical sampling and removal of skin malignancies (Machin, 2020). In dermatology, the literature mainly discusses CNS-led clinics rather than those that are ACP-led, but these commonly include skin cancer surveillance, fast-track two-week wait clinics, health education and melanoma follow-up.

Similarly, skin cancer nurses with a background in oncology have established metastatic skin cancer clinics to manage the unique and complex needs of patients who are undergoing immunotherapy and targeted therapy. Again, due to lack of academic evidence, it is not possible to ascertain whether these clinics were established by CNSs or ACPs – or, indeed, whether they were effective. What is evident, however, is that advanced practice is prolific in skin cancer services, where nurses have reshaped service provision by developing advanced practice roles across different specialities (Rammanohar et al, 2023). Box 1 gives the background as to why and how ACP roles have developed.

Box 1. Development of advanced clinical practice roles

National NHS policies are committed to models of care that cross traditional sectors and professional boundaries as part of the transformation of healthcare delivery; examples of such policies include NHS (2020), NHS (2019) and NHS England (2016). As well as policy directives, influencing factors include rising healthcare demand and costs, increased patient expectations, a global shortage of doctors and, more recently, the Covid-19 pandemic (Evans et al, 2021). This has led to the establishment of non-medical advanced clinical practice roles; these are defined as needing an advanced level of practice applicable across professions, rather than being role specific (NHS, 2017).

The development of the ACP role involves nurses and other clinicians embracing some of the tasks and responsibilities that were traditionally done by doctors. This is expanding and extending the traditional scope of nursing. Traditional role boundaries have been challenged and new ways of working have been actively encouraged, enabling nurses to create successful ACP nurse-led services (Mann et al, 2023).

ACP = advanced clinical practitioner

In my role as the lead skin cancer ACP for oncology, I exercise autonomous practice and professional judgement across all aspects of my work, not just in my oncology clinic. My depth and breadth of knowledge across all four pillars of nursing, together with my oncology and palliative care nursing background, allows me to provide continuity of care throughout the whole of the skin cancer pathway. This involves applying advanced critical reasoning and decision-making skills to every aspect of the care pathway, from diagnosis to referring patients for end-of-life care. Patient satisfaction audits show that the ACP role, by consistently delivering continuity of care, has improved patient experience, as well as service efficacy and capacity (Mann et al, 2023; Hooks and Walker, 2020).

One requirement of my role is to critically reflect on my clinical competence and where my level of practice lies on the advanced practice continuum. As an established ACP, my level of practice is considered over and above that of junior doctors. This is in keeping with case study findings by Hooks and Walker (2020), who reported that ACPs in advanced and highly discipline-specific roles across various professions demonstrate skillsets that are often at consultant level, due to their extensive clinical experience in their speciality.

"Patient satisfaction audits show that the ACP role has improved patient experience, as well as service efficacy and capacity"

ACP-led skin cancer clinics in oncology

The past decade has seen a rapid increase in the number and range of nurse-led clinics in primary and secondary care, but little is documented about their effectiveness in oncology services. In 2017, Farrell et al noted that most of the evidence available at that time applied to CNS follow-up clinics after surgery and nurse-led clinics offering clinical assessment and symptom management for patients who were having chemotherapy. In May 2023, I conducted a literature review of nurse-led initiatives in oncology (unpublished), focusing particularly on ACPs prescribing anti-cancer drug treatments for melanoma patients. This revealed a dearth of published evidence in this area.

Autonomous practice in ACP-led clinics empowers ACPs to make informed and complex decisions within their scope of clinical competence. Studies show that nurse-led consultations in the context of expanded nursing practice associated with complex decision making and new responsibilities contribute to increased patient satisfaction, as well as greater job satisfaction and professional identity among practitioners (Gyldenvang et al, 2022). In my ACP-led skin cancer clinics, I use advanced clinical reasoning and complex decision-making skills to assess patients with stage II-IV melanoma and other metastatic skin cancers before prescribing SACT. Box 2 outlines my clinic protocol and scope of clinical practice.

Box 2. Protocol for advanced clinical practice oncology skin cancer clinic

At University Hospitals Dorset NHS Foundation Trust, the protocol for the advanced clinical practice oncology skin cancer clinic is as follows:

Assess new patients and gain their consent for systemic anti-cancer treatment (SACT) under the supervision of the consultant oncologist

Assess and prescribe SACT for patients with stage II, III and IV malignant melanoma who are receiving adjuvant and palliative immunotherapy and targeted therapy

Assess and prescribe immunotherapy for patients with metastatic squamous cell skin cancer and Merkel cell skin cancer

Review bloods, recent scans and any relevant investigations prior to prescribing SACT and inform the patient of results

Refer to other specialists as needed

Request investigations, such as blood tests and radiological imaging

Advise patients of scan results if the scan is stable or confirms responding disease (otherwise patients see the consultant – see below)

Provide emotional and psychosocial support to patients and their caregivers

Develop and implement management plans in the event of immune-related adverse events (irAEs) and refer to the consultant oncologist as needed

In the event of increasing or persistent irAEs or complex symptoms, patients are reviewed by the consultant oncologist

If patients switch or stop treatment, have disease progression or deteriorate in health, they are reviewed by the consultant oncologist

The clinic runs in parallel with the consultant oncologist clinics

If consultants are on leave, the clinic is cancelled

All patients remain under a named consultant

At the end of each consultation, the advanced clinical practitioner documents directly into the electronic patient record; this will generate a letter to the patient and their GP, which will be typed and sent by the oncologist's secretary

The wider literature reports that ACP nurse-led consultations are highly acceptable to patients and their families because patients feel valued and listened to (Htay and Whitehead, 2021). This high patient satisfaction may be attributed to the importance nurses place on holistic assessment and prioritising a patient-centred approach. Taking the time to understand patient's unique needs and concerns fosters trust and open communication, which Htay and Whitehead (2021) stated were key elements to establishing successful ACP-led consultations.

Patient satisfaction survey

To evaluate the effectiveness of my clinical practice, I created a short satisfaction questionnaire for patients who had attended my clinic in person or who I had assessed over the telephone. All patients were receiving SACT at the time or had received it over the previous 18 months.

Thirty-six patients completed the questionnaire – a response rate of 100%. All 'agreed' or 'strongly agreed' that they:

Were given the opportunity to talk;

Felt listened to;

Were included in decision making about their care.

Patients also said they had confidence in my ability as a practitioner to:

Assess and prescribe their treatment;

Answer their questions;

Provide them with a clear treatment plan.

Fig 2 shows the results of the survey. Although this was done on a small scale, it suggests high patient satisfaction with the skin cancer ACP consultation. This confirms Htay and Whitehead's (2021) findings which showed that ACPs give consistent improvements in patient experience.

Conclusion

Melanoma is a serious and potentially life-threatening cancer that needs to be detected and treated early. Skin cancer ACPs play a vital role in providing high-quality, patient-centred care for patients with malignant melanoma and other advanced skin cancers.

Advances in clinical practice and professional development have enabled skin cancer nurses to reshape service provision by developing advanced practice roles across various specialities, including oncology. However, although existing evidence supports the benefit and efficacy of nurse-led clinics in oncology, more research is needed to support the widespread adoption of ACP-led clinics and advanced practice roles in skin cancer services.

Key points

One in four men and one in five women in the UK will develop a skin cancer at least once in their lifetime

Melanoma skin cancer is the fifth most common cancer in the UK, accounting for ~4% of all new cancer diagnoses each year

Immunotherapy and targeted therapy are effective drug treatments for patients who have metastatic melanoma, and give the potential for long-term survival

Advanced clinical practitioners have resulted in positive outcomes in terms of patient satisfaction levels, as well as service efficacy and capacity

More research is needed on the benefits of advanced clinical practitioner-led clinics in skin cancer services

References

Cancer Research UK (no date) Melanoma skin cancer statistics. Cancerresearchuk.Org (accessed 4 March 2025).

Cancer Research UK (2023a) Ipiliumab and nivolumab. Cancerresearchuk.Org, 10 May (accessed 4 March 2025).

Cancer Research UK (2023b) Pembrolizumab (Keytruda). Cancerreasearchuk.Org, 28 September (accessed 4 March 2025).

Cancer Research UK (2023c) Nivolumab (Opdivo). Cancerreasearchuk.Org, 9 May (accessed 4 March 2025).

Cancer Research UK (2023d) Dabrafenib and trametinib. Cancerresearchuk.Org, 26 April (accessed 4 March 2025).

Cancer Research UK (2023e) Encorafenib and binimetinib. Cancerresearchuk.Org, 26 April (accessed 4 March 2025).

Chan PY, Corrie PG (2024) Curing stage IV melanoma: where have we been and where are we? American Society of Clinical Oncology Educational Book; 44: 3, e438654.

Evans C et al (2021) Characterising the outcomes, impacts and implementation challenges of advanced clinical practice roles in the UK: a scoping review. BMJ Open; 11: e048171.

Farrell C et al (2017) Are nurse led chemotherapy clinics really nurse led? An ethnographic study. International Journal of Nursing Studies; 69: 1-8.

Garrison ZR et al (2023) Advances in early detection of melanoma and the future of at-home testing. Life; 13: 4, 974.

Gyldenvang HH et al (2022) Experiences and perspectives of patients and clinicians in nurse led clinics in an oncological setting: a sequential multi-methods study. European Journal of Oncology Nursing; 61: 102203.

Health Education England (no date) Career Pathway, Core Cancer Capabilities and Education Framework for the Supportive, Assistive and Registered Nursing and Allied Health Professions Workforce. HEE.

Hooks C, Walker S (2020) An exploration of the role of advanced clinical practitioners in the East of England. British Journal of Nursing; 29: 15, 864-869.

Htay M, Whitehead D (2021) The effectiveness of the role of advanced nurse practitioners compared to physician-led or usual care: a systematic review. International Journal of Nursing Studies Advances; 3: 100034.

Keilholz U et al (2020) ESMO consensus conference recommendations on the management of metastatic melanoma: under the auspices of the ESMO Guidelines Committee. Annals of Oncology: 31: 11, 1435–1448.

Larkin J et al (2019) Five-year survival with combined nivolumab and ipilimumab in advanced melanoma. The New England Journal of Medicine; 381: 16, 1535-1546.

Machin C (2020) The evolution of advanced practice for nurses working in skin cancer care. British Journal of Nursing; 29: 3, 140-141.

Macmillan Cancer Support (2022a) Melanoma. Macmillan.Org.Uk, 1 October (accessed 11 March 2025).

Macmillan Cancer Support (2022b) BRAF gene mutation test for melanoma. Macmillan.Org.Uk, 1 October (accessed 11 March 2025).

Mann C et al (2023) Exploring the role of advanced clinical practitioners (ACPs) and their contribution to health services in England: a qualitative exploratory study. Nurse Education in Practice; 67: 103546.

Melanoma Focus (no date a) Advanced melanoma. Melanomafocus.Org (accessed 11 March 2025).

Melanoma Focus (no date b) Melanoma Information by Stage, melanomafocus.Org (accessed 18 March 2025)

Melanoma Focus (no date c) Adjuvant therapy for melanoma. Melanomafocus.Org (accessed 12 February 2025).

NHS (2020) We are the NHS: People Plan 2020/21: Action for Us All. NHS.

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NHS Employers (2023) Advanced practice. Nhsemployers.Org, 23 November (accessed 11 March 2025).

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Rammanohar J et al (2023) A first census of skin cancer specialist nurses across UK secondary care trusts. BMC Nursing; 22: 216.

Seebacher NA (2022) Melanoma. Dermnetnz.Org, October (accessed 11 March 2025).

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Should I Consider A Clinical Trial For Metastatic Melanoma?

It's natural to want the very latest treatments when you have a serious health condition like metastatic melanoma. One way to get those cutting-edge drugs is to sign up for a clinical trial.

Before you enroll, you'll want to learn all you can about the study, what's being tested, and the risks and benefits. Work with your doctor to get that information and make sure the trial is a good fit for you. But first, get to know what's involved.

Scientists look for new ways to treat metastatic melanoma in these studies. Some trials test new drugs, surgeries, and other methods to see if they're safe and if they work. Others look for ways to help people deal with pain, nausea, eating problems, depression, and other effects of cancer.

Through clinical trials, researchers test the effects of new medications on a group of volunteers with melanoma/skin cancer. Following a strict protocol and using carefully controlled conditions, researchers evaluate the investigational drugs under development and measure the ability of the new drug to treat the cancer, the safety of the new drug, and any possible side effects.

To take part in a clinical trial, you can visit a:

Hospital

Doctor's office

Cancer center

University medical center

Veterans' or military hospital

A "principal investigator," usually a medical doctor, will lead the clinical trial. The research team might also include other doctors, nurses, social workers, scientists, and other health workers.

You'll want to know what phase the study is in.

Phase 1 trials help doctors learn what dose of the treatment is safe and how it affects the body.

Phase 2 trials see if the treatment works to kill melanoma cells.

Phase 3 trials compare the new treatment with the current treatment for metastatic melanoma.

Phase 4 trials look at how well the new treatment works over a long period of time and monitor side effects.

A clinical trial can give you early access to a new drug or other treatment. By taking part in a study, you also help doctors discover new treatments or cures that could one day help other people with metastatic melanoma.

Many clinical trials will pay for your:

Tests

Treatments

Medical care that is part of the study

You might also get money to pay for travel and hotel costs if the trial is far from your home.

Some patients with melanoma/skin cancer are reluctant to take part in clinical trials for fear of getting no treatment at all. This is simply not true. Patients with melanoma/skin cancer who participate in cancer clinical trials receive the most effective therapy available -- or they may receive treatments that are being evaluated for future use. These melanoma/skin cancer drugs may be even more effective than the current treatment.

There are also risks when you try an experimental treatment, including:

It might not work as well as the current treatment for metastatic melanoma.

The results might be better for some people than for you.

You may need to have extra tests as part of the study.

There might be side effects.

The trial might not pay for all of your treatment costs, and your health insurance may not cover the rest.

If you'd like to take part in a study, ask your doctor to help you find one that would be good for you.

You can also visit one of these websites to search for trials in your area:

TrialCheck. This website, developed by the nonprofit Coalition of Cancer Cooperative Groups, is an unbiased cancer clinical trial matching and navigation service enabling patients to search for cancer trials based on disease and location.

National Cancer Institute. This website lists more than 6,000 cancer clinical trials and explains what to do when you find one that you think is right for you.

ClinicalTrials.Gov. This website offers up-to-date information for locating federally and privately supported clinical trials for cancer.

CenterWatch. This website lists industry-sponsored clinical trials that are actively recruiting patients.

www.Nih.Gov/health/clinicaltrials

www.Clinicaltrials.Gov

www.Nhlbi.Nih.Gov/studies/index.Htm

A doctor or nurse will tell you all about the clinical trial and what tests and treatments you can expect. This is called informed consent.

Joining a study is your choice. You have the right to leave the trial at any time and for any reason.

Researchers who do clinical trials must follow strict standards to keep patients safe. If they learn the treatment is not safe, they'll stop the trial or take you out of it.

Before you can join, the researchers will make sure you're a good match for the study. They'll look at:

The stage of your cancer

Your age

What treatments you've had in the past

Your health and medical history

Make sure you understand what is involved in the study. Ask your doctor:

What is the purpose of this trial?

What kinds of tests, medicines, surgery, or other treatments will I get?

How might this treatment help my cancer?

Which doctors or other staff will care for me?

Which tests will I have?

What side effects or risks could the treatment cause?

Who will look out for problems and make sure I'm safe?

How long will the trial last?

Who will pay for my tests and treatments?

Will my insurance pay for any costs the study doesn't cover?

What will happen after the clinical trial?

You'll be assigned to a group so the researchers can compare one treatment with another. You may not be told which treatment you're getting. This is called "blinding."

Most studies will not give a fake treatment (placebo) to people with cancer. You'll likely get either a new treatment or the best standard treatment for your metastatic melanoma.

ASCO: Moderna, Merck Melanoma Vaccine Set For Phase 3

Moderna's move into personalised cancer therapy continues to proceed at a rapid pace, with Merck & Co-partnered melanoma vaccine mRNA-4157 heading for a pivotal phase 3 programme after a phase 2b data drop at ASCO.

In the study, mRNA-4157 (V940) – which targets dozens of unique tumour-associated antigens or neoantigens that are expressed by a patient's cancer cells – was combined with Merck's PD-1 inhibitor Keytruda and compared to Keytruda alone in patients with high-risk stage 3 or 4 melanoma who were given the therapy as an adjuvant treatment after surgery.

There was a 65% reduction in the risk of distant metastasis or death for the combination compared to Keytruda alone, a key secondary endpoint in the 157-subject KEYNOTE-942 study. At 18 months, distant recurrence or death was seen in 8.4% and 24% of patients, respectively.

In April, the partners reported the first efficacy results from the study, including a 44% improvement in recurrence-free survival (RFS), the study's primary endpoint, which came in at nearly 79% for the combination and 62% for Keytruda alone at the 18-month timepoint.

Moderna and Merck will start a phase 3 trial of the combination in adjuvant melanoma therapy later this year, and the proof-of-concept for this personalised neoantigen vaccine approach means that studies will follow in other cancers, focusing on those where immunotherapy with drugs like Keytruda is known to have an effect.

The results reinforce the view that after decades of stuttering development, mRNA-based vaccines spanning many neoantigens that can be developed within weeks could usher in a new era of cancer vaccines, supported by checkpoint inhibitors that boost immune responses.

KEYNOTE-942 has already earned the combination a breakthrough designation from the FDA and PRIME status from the EMA, both of which could accelerate the vaccine's progress through the review process.

Also announced at ASCO was some intriguing new data on circulating tumour DNA (ctDNA) – fragments of genetic material from cancer cells – that can indicate the presence of minimal residual disease (MRD), i.E. The lingering presence of some tumour material.

A subgroup of 125 patients from KEYNOTE-942 had ctDNA measured using NeoGenomics' RaDaR sequencing assay, and found that most patients (88%) had no ctDNA present at the start of the study. In that group, RFS was higher than for the overall study population, reduced by 78%.

A similar trend was seen in the ctDNA-negative group, although the number of patients here was too low to generate a statistically reliable result. Moderna and Merck said the association between MRD patterns and the effect of mRNA-4157 therapy will be explored in future studies.

Merck took up an option to partner with Moderna on mRNA-4157 last October, its first under a 2016 alliance aimed at finding individually tailored cancer vaccines for patients across a spectrum of cancers. Merck paid $200 million to activate the programme, and another $250 million to license the melanoma vaccine.

Fuelled with the windfall cash from its massively successful COVID-19 shot, Moderna has been accelerating development of its R&D pipeline, focusing on vaccines for other respiratory diseases, including flu, respiratory syncytial virus (RSV), and cytomegalovirus (CMV), as well as therapeutics for cancer, rare disease, and cardiovascular indications.

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