A section of lung tissue stained to reveal cancer on the left and healthy tissue on the right. Credit: Steve Bagley An area of lung tissue showing lung cancer on the left.
Combining an immunotherapy drug, which stimulates the immune system to target lung cancer cells, with chemotherapy has been recommended as a treatment for some patients with lung cancer on the NHS in England.
Cancer Research UK says the decision to approve the pembrolizumab (Keytruda) combination for some adults with a type of untreated non small cell lung cancer is a “welcome step forward”.
The treatment combo, which has been shown to improve survival in patients with squamous non small cell lung cancer that has spread to other part of the body, will now be available on the Cancer Drugs Fund (CDF).
Rose Gray, policy manager at Cancer Research UK, says the decision is “great news” for people affected by this form of the disease.
“Clinical trial evidence suggests using pembrolizumab in this way could extend patients’ lives compared to existing treatments, and because it’s been recommended for the Cancer Drugs Fund, patients will be able to access the drug while more evidence is gathered to confirm its long-term benefits.”
Around 7,500 people in England are diagnosed with this type of lung cancer year. And around 1,700 may be eligible for the pembrolizumab combination, according to the National Institute of Health and Care Excellence (NICE)
Adding a valuable new treatment option
Pembrolizumab is an immunotherapy treatment that aims to boost the immune system’s ability to recognise and kill cancer cells. It works by blocking a molecule often found on cancer cells – called PD-L1 – from interacting with immune cells.
Currently, patients with untreated squamous non small cell lung cancer that’s spread are offered either pembrolizumab on its own, or platinum-based chemotherapy. Which treatment is offered depends on the levels of PD-L1 found in their tumour.
Only patients whose cancer has high levels of the PD-L1 molecule (over 50% of cancer cells) are offered pembrolizumab treatment on its own. But the latest decision by the National Institute for Health and Care Excellence (NICE) gives patients whose tumours have lower levels of PD-L1 the option of having immunotherapy treatment, in combination with the chemotherapy drugs carboplatin and paclitaxel.
“Patients told NICE this new treatment option is important as it could offer some people an alternative to chemotherapy,” said Gray.
It also provides an extra treatment option even where immunotherapy is already available. Clinicians told NICE that while most patients with high levels of PD-L1 will likely continue to receive pembrolizumab on its own to reduce side effects, having the combination as an option will be helpful where a more urgent response is needed.
Trial results suggest pembrolizumab combination improves overall survival compared to standard chemotherapy (15.9 months vs. 11.3 months) – but so far patients have not been followed up for long enough for NICE to be certain of the long-term clinical benefits.
Severe side effects were found in around 7 in 10 people in both the chemotherapy and pembolizumab combination treatment groups. The most common side effects in both groups were low iron levels, hair loss and low levels of a certain type of immune cell, called neutropenia.
The trial did not compare the pembrolizumab combination with pembrolizumab treatment on its own, so NICE compared the two treatments indirectly using the data available.
“The committee heard from the patient experts that people with squamous non small cell lung cancer often have a poor quality of life, and that treatments that have the potential to extend life would be of great importance,” said Meindert Boysen, director of the NICE Centre for Health Technology Evaluation.
More long-term data needed
In making its decision, the National Institute for Health and Care Excellence (NICE) said the uncertainty around clinical benefits means the combination treatment cannot be recommended for routine use, until more data is collected on the long-term benefits.
If the extra data shows pembrolizumab combination treatment offered a significant survival benefit compared to existing treatments, NICE said the combo would likely be a cost-effective use of NHS budgets. It therefore recommended adding the combination to the Cancer Drugs Fund, while long-term data is collected.
The recommendation for the CDF in England – likely to be followed in Wales and Northern Ireland – is made on the basis that pembrolizumab is stopped at two years of uninterrupted treatment, or earlier if the disease progresses. The two-year stopping rule is consistent with the clinical trial and previous NICE guidance for immunotherapies.
Decisions over which drugs should be funded by the NHS in Scotland are made separately by the Scottish Medicines Consortium
NICE (2019) Pembrolizumab with carboplatin and paclitaxel for untreated squamous non-small-cell lung cancer [ID1306]