Selpercatinib will expand treatment options available for people with RET fusion positive non small cell lung cancer.

Non small cell lung cancer cells stained in pleural effusion sample.

Non small cell lung cancer cells.

The National Institute for Health and Care Excellence (NICE) has recommended the use of selpercatinib (Retevmo) for some people in England with a type of advanced non small cell lung cancer.

The drug will now be available through the Cancer Drugs Fund, which helps provide access to promising medicines, to people whose cancer has abnormalities in a gene called RET.

Selpercatinib will provide an extra option for adults who need additional therapy following treatment with immunotherapy, platinum-based chemotherapy, or both.

Life expectancy for people with RET fusion-positive advanced non small cell lung cancer on standard treatment is less than 2 years.

Clinical trial evidence suggests that selpercatinib could extend life by more than 3 months. However, because the trial has not been running long enough, this is highly uncertain.

Dr Mariam Jamal-Hanjani, a Cancer Research UK-funded lung cancer specialist, said: “I’m very pleased that we now have the opportunity to offer our patients with RET fusion positive non small cell lung cancer treatment with selpercatinib.

“We see this alteration in 1 to 2% of patients with this type of lung cancer and we know that it can be associated with a higher risk of the cancer spreading to the brain, which can have a significant impact on patient survival.”

While the drug was approved to treat some thyroid cancers on the NHS in England earlier this year, it was rejected as a treatment for RET fusion positive advanced non small cell lung cancer in Scotland earlier this month.

A need for new treatments

Currently, if additional treatment is needed, the main option is the chemotherapy drug docetaxel, with some also offered a targeted drug called nintedanib.

Patient and clinical experts explained that the symptoms of advanced non small cell lung cancer – including breathlessness, cough and weight loss – are hard to treat.

They also said the use of docetaxel with nintedanib is decreasing because of its limited benefits and increased side effects compared with docetaxel alone.

Selpercatinib will add an alternative treatment option.

How do you know if your cancer is RET fusion positive?

Testing for RET fusions is available in the NHS, according to the Cancer Drugs Fund clinical lead. However, access to the test is not a routine part of normal screening at the NHS Genomic Medicine Service.

The same source also said that next-generation screening panels would be adapted to include testing for RET fusions when possible.

An ongoing trial

Jamal-Hanjani said previous studies have shown that selpercatinib can lead to durable responses, including antitumour activity in the brain, and that it has an acceptable side effect profile.

However, clinical trial evidence remains highly uncertain because it depends on one single-arm study that hasn’t been running for long enough.

The evidence for the drug comes from LIBRETTO-001, an ongoing phase 1/2 trial in people with advanced solid tumours with RET abnormalities. The trial enrolled 329 people with RET fusion-positive advanced non small cell lung cancer.

63.8% of the first 105 patients responded to selpercatinib, according to the latest trial results. And people lived on average 17 months without their tumour getting bigger. However, despite this high response rate, the short follow-up times meant that there was uncertainty around the drug on survival.

The most common side effects experienced by patients were diarrhoea, dry mouth and hypertension.

Looking to the future

The committee agreed that basing the evidence on one single-arm study meant that there was uncertainty in the data for selpercatinib, particularly because the data was immature.

And because LIBRETTO-001 was a single-arm trial, NICE use indirect comparisons better understand the benefits of the drug.

Because of this uncertainty, the committee couldn’t recommend the drug for routine use. However, it will be made available through the Cancer Drugs Fund, which helps provide access to promising new treatments, while more data is collected on the effectiveness of the treatment.

According to the company, around 150 people are eligible for treatment with selpercatinib.

Drugs approved by NICE for use through the Cancer Drug Fund in England are normally considered in Northern Ireland in line with existing arrangements for endorsement of NICE recommendations.

If more data shows that selpercatinib works well and is cost-effective, the drug will be considered for routine use in the NHS in 2024. If approved by NICE for use in England, this decision will likely then be adopted in Wales and Northern Ireland, while Scotland has a separate process for reviewing drugs.

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