Cancer Vaccine Breakthrough Highlights the Tragedy of Fatal Delayed Cancer Diagnosis

A personalised cancer treatment has achieved significant results in a large phase 3 melanoma trial, offering fresh hope that more patients could remain free from cancer following surgery.

For bereaved families, however, developments of this kind may raise a deeply painful question: could an earlier diagnosis have given their loved one access to potentially life-saving surgery and treatment?

The experimental treatment, known as intismeran autogene, was developed by Merck and Moderna. It is a personalised mRNA therapy manufactured using the unique genetic characteristics of an individual patient’s melanoma.

In the INTerpath-001 trial, the vaccine was administered with pembrolizumab, the immunotherapy medicine marketed as Keytruda, after the patient’s melanoma had been completely removed by surgery.

According to the primary phase 3 trial announcement from Merck and Moderna, the combination significantly improved recurrence-free survival when compared with Keytruda alone.

It also significantly improved distant metastasis-free survival, meaning patients went longer without the melanoma spreading to a distant part of the body or the patient dying.

The findings are potentially transformative. They also emphasise an enduring reality: even the most advanced cancer treatment may offer limited help if cancer is negligently missed until surgery is no longer possible or the disease has already spread.

What did the personalised melanoma vaccine trial establish?

INTerpath-001 was an international, randomised phase 3 trial involving approximately 1,089 patients with high-risk stage IIB, stage IIC, stage III or stage IV melanoma.

Importantly, the participants’ melanomas had been completely removed before they entered the trial. The vaccine was an adjuvant treatment, meaning it was given following surgery to reduce the risk of residual cancer cells causing recurrence.

The trial compared:

• intismeran autogene combined with Keytruda; and
• Keytruda combined with a placebo.

The study met its primary endpoint of recurrence-free survival and an important secondary endpoint of distant metastasis-free survival. The trial can be independently checked through the registered INTerpath-001 clinical study record.

However, Merck and Moderna have not yet published the detailed numerical results from the phase 3 trial. It would therefore be premature to state by precisely what percentage the new treatment reduced the risk of recurrence, metastasis or death.

The treatment also remains investigational. It has not yet been approved for routine use as a personalised melanoma treatment in the UK.

Does the cancer vaccine stop melanoma returning?

The present evidence does not establish that the vaccine prevents every recurrence.

The phase 3 announcement confirms that the combination significantly improved the period during which patients remained free from recurrence and distant metastasis. That is different from guaranteeing that cancer will never return.

Intismeran is also not a conventional vaccine given to healthy people to prevent melanoma. It is an individualised treatment for a patient who has already developed cancer.

Scientists analyse tissue taken from the patient’s tumour and identify mutations unique to its cancer cells. Selected targets are encoded into messenger RNA, producing a bespoke treatment intended to train the immune system to recognise and attack any cancer cells remaining after surgery.

Keytruda helps the immune system attack cancer by blocking the PD-1 pathway, which cancer cells can exploit to avoid detection. Researchers hope that the two treatments will work together: the vaccine identifies the targets, while Keytruda helps the immune system respond to them.

Earlier trial results should not be confused with the new phase 3 findings

An earlier phase 2b study involving 157 patients produced encouraging numerical findings.

At five years, intismeran combined with Keytruda was associated with:

• a 49% reduction in the risk of recurrence or death; and
• a 59% reduction in the risk of distant metastasis or death.

Those figures were reported in the manufacturers’ five-year phase 2b melanoma study results.

They are not the numerical results of the new phase 3 trial. Detailed phase 3 data are expected to be presented at a medical conference and submitted for peer-reviewed publication.

This distinction matters. The latest announcement represents an important scientific milestone, but the size of the benefit, possible side-effects, effect on overall survival and long-term durability of the treatment still require full examination.

Cancer advances make timely diagnosis even more important

The personalised vaccine trial depended upon the patient’s melanoma being diagnosed and completely removed.

The treatment was then used to target cancer cells that might have remained undetected after surgery. It was not a substitute for identifying and removing the original tumour.

This is why a delayed diagnosis can be so devastating. Depending upon the type of cancer, an avoidable delay may allow a tumour to:

• grow in size;
• invade nearby tissue;
• spread to lymph nodes;
• metastasise to distant organs;
• become unsuitable for curative surgery;
• require more aggressive treatment; or
• progress from potentially curable to incurable disease.

Cancer Research UK explains that melanoma survival is affected by its stage at diagnosis, the treatment received and the patient’s general health.

Modern immunotherapies and personalised treatments may improve outcomes. Nevertheless, they do not remove the need for healthcare professionals to recognise warning signs, make appropriate referrals, report test results accurately and begin treatment without an unreasonable delay.

How can a delayed cancer diagnosis lead to death?

Cancer delays can arise at several points in a patient’s care.

A patient may attend their GP repeatedly with concerning symptoms but not receive an appropriate examination or urgent referral. An abnormal scan may be misreported. A biopsy result may be interpreted incorrectly, overlooked or not communicated. An urgent referral can be lost, downgraded or left unactioned.

There may then be a further delay between diagnosis and the start of treatment.

Examples of potential failures include:

• failing to recognise recognised cancer symptoms;
• failing to conduct an adequate examination;
• incorrectly attributing symptoms to a harmless condition;
• failing to refer the patient under an urgent suspected cancer pathway;
• failing to order appropriate blood tests, imaging or a biopsy;
• misinterpreting a scan, tissue sample or pathology result;
• failing to inform the patient about an abnormal finding;
• failing to recall the patient for further investigation;
• losing a referral or test result;
• failing to arrange appropriate follow-up; or
• causing an avoidable delay in surgery, chemotherapy, radiotherapy or immunotherapy.

Not every delay amounts to negligence. Nor does every negligent error cause a patient’s death. These are separate legal questions requiring careful investigation.

When can a family claim after a death caused by delayed cancer diagnosis?

A family may have a fatal delayed cancer diagnosis claim where medical evidence establishes that:

1. the care provided fell below the standard reasonably expected of the healthcare professional;
2. the failure caused an avoidable delay in diagnosing or treating the cancer; and
3. on the balance of probabilities, earlier competent care would have prevented the death, extended the patient’s life or otherwise produced a materially better outcome for which damages are recoverable.

It is not enough to show that cancer was diagnosed late or that a healthcare professional made a mistake. The evidence must connect the negligent delay with the outcome.

Independent experts may need to consider:

• when the cancer should reasonably have been diagnosed;
• the cancer’s probable type and stage at that earlier date;
• whether it had already spread;
• what treatment would probably have been offered;
• whether curative surgery would have been possible;
• the patient’s likely response to treatment;
• whether death would probably have been avoided; and
• if death could not have been avoided, whether the negligence shortened the patient’s life.

Our specialist guide to fatal medical negligence claims explains how claims against NHS and private healthcare providers are investigated.

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What if the cancer was already terminal?

A claim is not necessarily excluded because the patient’s cancer would ultimately have proved fatal.

There can be a legally significant difference between a patient dying when they did and living for a further period with appropriate treatment.

For example, independent medical evidence might establish that earlier treatment would probably have given the patient additional months or years of life. That period might have allowed the person to spend more time with their family, continue working, provide care and services, or arrange their personal and financial affairs.

A claim may also arise where negligence did not cause the underlying cancer but led to:

• avoidable pain and suffering;
• a shorter life expectancy;
• the loss of an opportunity for effective treatment where the legal causation test is satisfied;
• more aggressive or distressing treatment;
• loss of earnings before death; or
• additional care and medical expenses.

The precise medical and legal test is highly fact-sensitive. Specialist expert evidence is essential.

Who can bring a fatal cancer negligence claim?

Different claims may arise following a death, and the person entitled to pursue them will depend upon the legal basis of the claim.

The personal representatives may bring a claim on behalf of the deceased’s estate. If no grant of probate or letters of administration has yet been obtained, advice may be required about who has authority to act.

A claim for the benefit of eligible dependants may usually be brought by the deceased’s personal representative under the Fatal Accidents Act 1976. If the personal representative does not begin proceedings within six months of the death, an eligible dependant may be able to bring the claim.

Potential dependants can include:

• a husband, wife or civil partner;
• a former spouse or civil partner;
• a qualifying cohabiting partner;
• children and other descendants;
• parents and other ascendants;
• a person treated by the deceased as their parent;
• a sibling, aunt or uncle, and certain descendants of those relatives.

Being within a recognised category does not automatically establish a financial or services dependency claim. The claimant must generally demonstrate that they received, or reasonably expected to receive, a valuable benefit from the deceased.

What compensation can bereaved families claim?

A fatal delayed cancer diagnosis case can involve two related but legally distinct claims.

Claim on behalf of the deceased’s estate

Under the Law Reform (Miscellaneous Provisions) Act 1934, the deceased’s existing cause of action generally survives for the benefit of their estate.

Depending upon the evidence, an estate claim following a fatal accident may include:

• compensation for the deceased’s avoidable pain, suffering and loss of amenity before death;
• earnings lost between the negligent injury and death;
• care and assistance provided before death;
• medical and travel expenses; and
• funeral expenses, where paid by the estate.

The value of the pain and suffering claim will depend upon matters including the symptoms experienced, the deceased’s awareness of their condition, the treatment endured and the period between the negligent harm and death.

Claim for the deceased’s dependants

The Fatal Accidents Act 1976 provides claims for qualifying family members and dependants affected by the death.

These may include:

• loss of financial support;
• loss of pension income;
• loss of employer or employment-related benefits;
• loss of household services;
• loss of childcare and parental services;
• loss of care provided to a spouse or another family member;
• loss of DIY, gardening, transport and household assistance;
• reasonable funeral expenses; and
• statutory bereavement damages for those who qualify.

A fatal accident dependency claim is not limited to the deceased’s wages. The value of unpaid services can be substantial, particularly where the person who died cared for children, supported a disabled partner or performed much of the work required to run the family home.

Can the family claim the statutory bereavement award?

The statutory bereavement award in England and Wales is currently £15,120 for deaths occurring on or after 1 May 2020. It is a fixed award and is separate from dependency compensation, funeral expenses and the estate’s claim.

Eligibility is restricted. Depending upon the circumstances, it may be available to:

• the deceased’s husband, wife or civil partner;
• a qualifying cohabiting partner who lived with the deceased for at least two years immediately before the death in the same household as if married or civil partners; or
• the parents of a child who died before reaching the age of 18, subject to the statutory rules.

Adult children cannot currently recover the bereavement award for the death of a parent. Parents cannot recover it following the death of an adult child. This does not necessarily prevent them from bringing another part of the claim if they qualify as dependants or act for the estate.

Our detailed guide explains who may claim the statutory bereavement award.

How is financial dependency calculated after a cancer death?

The purpose of a dependency award is to compensate eligible family members for the financial benefit they would probably have continued receiving had the deceased lived.

The calculation may take account of:

• the deceased’s earnings and likely career progression;
• employment benefits and bonuses;
• pension income or pension contributions;
• the surviving family’s income;
• the proportion of household income spent for the family’s benefit;
• the ages of the deceased and the dependants;
• how long the dependency would probably have continued; and
• the deceased’s likely life expectancy absent the negligent delay.

Cancer cases require particularly careful medical evidence. If the patient already had a reduced life expectancy, the dependency calculation may be based upon the period they would probably have survived with competent diagnosis and treatment.

This does not mean the claim is without value. Losing even a limited period of financial support, childcare or personal care can have profound practical consequences for a family.

Claims for the services a loved one provided

A family’s loss is not measured solely by income.

A person may have provided extensive unpaid support, including:

• caring for children;
• cooking and cleaning;
• shopping and managing the household;
• transporting family members;
• gardening and DIY;
• providing care to a partner with an illness or disability;
• supporting elderly parents; or
• helping with a family business.

The reasonable cost of replacing those services may form part of the claim. Evidence can include witness statements describing what the deceased did, how frequently the tasks were performed and who now undertakes or pays for that work.

Can funeral expenses be recovered?

Reasonable funeral expenses may be recoverable, either through the dependants’ claim or the estate, depending upon who incurred them.

Recoverable expenses can include reasonable burial or cremation costs and, in appropriate circumstances, a headstone. Families should preserve invoices, receipts and proof of payment.

Not every expense associated with a funeral or memorial will necessarily be recoverable. Our guide to claiming funeral expenses after a wrongful death provides further information.

What evidence is needed for a fatal delayed cancer diagnosis claim?

These claims depend heavily upon medical and factual evidence. Relevant documents may include:

• GP and hospital records;
• referral letters;
• pathology and biopsy reports;
• scan images and radiology reports;
• laboratory results;
• multidisciplinary team meeting records;
• appointment and waiting-list records;
• internal investigation reports;
• complaint correspondence;
• the death certificate;
• the post-mortem report;
• documents produced for an inquest; and
• statements from family members.

Financial evidence may include wage slips, tax returns, bank statements, pension documents, benefit records and evidence of the services the deceased provided.

Specialist solicitors can obtain and organise the medical records before instructing independent experts in the appropriate disciplines. Depending upon the alleged error, this might include experts in general practice, radiology, pathology, dermatology, surgery or oncology.

Will there be an inquest?

A coroner may investigate where there is reason to suspect that a person died an unnatural death, the cause of death is unknown or the person died in state custody or detention.

Not every cancer death will result in an inquest. However, an inquest may be appropriate where concerns exist about a serious failure in diagnosis, communication, treatment or hospital care.

An inquest establishes who died and how, when and where the death occurred. It is not itself a civil claim for compensation, and the coroner does not determine civil liability.

Evidence obtained through an inquest may nevertheless be important to a later fatal medical negligence claim. Families should obtain advice promptly where there are concerns about medical care, particularly before the final inquest hearing.

What is the time limit for a fatal cancer negligence claim?

The usual limitation period for a claim under the Fatal Accidents Act 1976 is three years from:

• the date of death; or
• the date of knowledge of the person for whose benefit the claim is brought, if later.

The position can be more complicated where the deceased had a clinical negligence claim before death, because the estate claim may be affected by the time limit that applied during the deceased’s lifetime.

Different provisions can apply to children and people who lack litigation capacity. A court also has a discretion to permit certain claims to proceed outside the primary limitation period, but families should never assume that an extension will be granted.

Obtaining advice early also allows medical records, scan images, tissue samples and witness evidence to be preserved.

Can a claim be made against the NHS?

Yes. A claim may be brought where negligent care provided by an NHS body caused or contributed to the death under the applicable legal test.

The claim is usually handled on behalf of the relevant NHS organisation by NHS Resolution. Compensation is not ordinarily paid personally by the individual doctor or nurse involved.

Claims can also arise from treatment provided by:

• a private hospital;
• an independent consultant;
• a private GP;
• a diagnostic imaging provider;
• a pathology laboratory; or
• another independent healthcare organisation.

More than one healthcare provider may be responsible. For example, a GP may have delayed referral before a hospital later failed to act upon an abnormal scan.

Fatal cancer negligence solicitors supporting bereaved families

No legal claim can compensate fully for the death of a husband, wife, partner, parent or child. A properly investigated claim can, however, help a family understand what happened, establish accountability and recover financial support that the deceased would have continued to provide.

R James Hutcheon Solicitors acts for bereaved families in complex fatal medical negligence cases. We can:

• obtain the deceased’s complete medical records;
• prepare a detailed chronology of the treatment;
• identify the potential diagnostic or treatment failures;
• instruct appropriate independent medical experts;
• examine whether earlier treatment would probably have prevented or delayed the death;
• represent the family in connection with an inquest where appropriate;
• investigate the estate and dependency claims; and
• calculate the full financial and services losses caused by the death.

We understand that families often approach us while grieving and before they know whether anything went wrong. You do not need to have all the medical records or prove the case before seeking advice. That investigation is part of our role.

If you believe that a failure to diagnose or treat cancer caused or accelerated the death of someone close to you, read our principal guide to fatal medical negligence compensation claims or contact our specialist solicitors for a confidential initial assessment.

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