AstraZeneca lung cancer drug halves death risk from disease, landmark study finds

The new drug acts as an off switch for lung cancer - BSIP
The new drug acts as an off switch for lung cancer - BSIP

A lung cancer drug available on the NHS halves the risk of dying from the disease, a landmark study has found.

A once-daily tablet called osimertinib, which is made by pharmaceutical giant AstraZeneca, was found to slash the risk of dying from a specific form of lung cancer by 51 per cent.

The results have been hailed by experts as a paradigm shift, a game changer and unequivocal.

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and around one in eight have a mutant gene which makes the cancer more aggressive and harder to treat.

People with the so-called EGFR gene, which is carried by up to 15 per cent of Britons, are prone to the disease, whether they have ever smoked or not.

The drug is already in use by the NHS to help prevent lung cancer patients who have had surgery and chemotherapy from getting the disease again, as up to half of these patients will suffer a recurrence.

Approximately 39,000 people are diagnosed with lung cancer each year in the UK, with around 5,000 of them carrying the EGFR mutation.

Now, the fresh data from the ADAURA study, led by Yale University, in the US, has found giving the drug to patients who have had surgery to remove a tumour helps fend off disease progression, increases survival and stops the cancer from spreading to the brain.

Study leader Dr Roy Herbst, deputy director of the Yale Cancer Center, said the results were “thrilling”. He also believes it sets “a new paradigm” for doctors and establishes a precedent for oncologists to use specific drugs as soon as possible.

“Thirty years ago there was nothing we could do for these patients, even 20 years ago,” he told journalists at the American Society of Clinical Oncology annual conference in Chicago, where the results have been presented for the first time.

“Now we have this potent drug, we’re using it early on. This exceeded our high expectations.

“Fifty per cent is a big deal in any disease, but certainly in a disease like lung cancer which has typically been very resistant to therapies.”

Gold-standard data

Prof Herbst hopes that by obtaining this “gold-standard” data on reduction in risk of death clinicians and patients alike will now feel reassured and emboldened to use the drug.

Dr Nathan Pennell, a professor of medicine at the Cleveland Clinic Lerner College of Medicine and an oncology expert at the American Society of Clinical Oncology, said: “It is hard to convey how important this finding is and how long it’s taken to get here.

“This shows an unequivocal, highly significant improvement in survival. We should firmly close the door on the one size fits all treatment for people with non-small cell lung cancer.”

Data show that, over more than six years, the odds of dying from the disease were twice as high in people who took a placebo when compared to a daily Osimertinib tablet.

In the entire study cohort of 682 patients - enrolled at more than 200 centres around the world and ranging from stage one disease to stage three – 12 per cent of people getting Osimertinib had died within five years of first taking the drug. The figure for the placebo group was 22 per cent.

Statistical analysis of this data, and across the entire study period, shows a 51 per cent reduction in risk of death from the disease when taking Osimertinib, which is sold under the brand name Tagrisso.

Dr Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, told journalists at the annual conference that the drug works by targeting a broken molecular switch inside cells which leads to them constantly being turned “on” and constantly growing and dividing.

The EGFR gene makes this switch malfunction and constant growth increases the risk of tumours developing. Osimertinib fixes the broken switch.

Dr Herbst calls the drug “the key in the lock” to stop the cancer developing.

Dr Galbraith explained: “The cancer has an on-switch which is permanently turned on. If you’ve got the on switch permanently on then that is one reason why you can get cancer.

“What the drug does is switches this off and the cancer stops growing. This drug was designed to specifically inhibit the mutation that turns this switch on.”

Experts are now hoping clinicians will improve screening of lung cancer patients to determine if they have the mutation as early as possible in order to expedite access to the drug. The drug is available in the UK and on the NHS via the Cancer Drugs Fund.

An NHS spokesman said: “This treatment, which halves the risk of this particular type of lung cancer returning, is already in use for people following an operation, thanks to a life-saving drug deal struck by the NHS two years ago.

“The NHS continues to offer the most cutting-edge treatments to improve care for patients and will of course look at the wider roll out of this drug for patients if it receives NICE (The National Institute for Health and Care Excellence) approval following this encouraging study.”

It is understood that NICE is paying close attention to the ADAURA results and the data will be used to determine if the guidance needs to be updated in order to formally make Osimertinib the standard of care for all eligible patients.

Angela Terry, chair of charity EGFR Positive UK, called the results “very exciting and hugely significant” and is now calling for wider access to the drug.

Approval for routine use

“These extremely positive statistics call into question the continuation of Osimertinib being available only through the Cancer Drugs Fund,” she said. “The question patients want answering is, ‘how swiftly can we expect approval for routine use in the NHS for all patients who qualify?’

“Having access to a drug whose efficacy is proven and whose side effects are tolerable means patients can be confident of and able to enjoy a good quality of life for longer.

“Osimertinib has been a game changer for our community and we are both excited and grateful for the unprecedented, highly significant progress being made in relation to its use.”

Cancer Research UK’s chief clinician, Professor Charles Swanton, said the results “offer real hope for patients”.

“Lung cancer is the most common cause of cancer death in the UK, and the majority of cases are non-small cell,” he said. “However, treatment options remain incredibly limited and just 10 per cent of people with the disease survive for 10 years or more.

“The treatment landscape of lung cancer has been transformed over the last decade and it’s wonderful to see new treatment strategies coming through the pipeline for this hard-to-treat disease.

“Ultimately, research like this will bring us closer to a world where more people live longer, better lives, free from the fear of cancer.”