Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non‑small‑cell lung cancer

1 Recommendations

1.1 Pembrolizumab plus carboplatin and paclitaxel is not recommended, within its marketing authorisation, for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults.

1.2 This recommendation is not intended to affect treatment with pembrolizumab plus carboplatin and paclitaxel that was funded by the Cancer Drugs Fund before final guidance was published. If this applies, when that funding ends, pembrolizumab plus carboplatin and paclitaxel will be funded by the company until the patient and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement for pembrolizumab plus carboplatin and paclitaxel or nab‑paclitaxel (pembrolizumab combination therapy) for untreated metastatic squamous NSCLC (NICE technology appraisal guidance TA600).

Untreated metastatic squamous NSCLC is usually treated with cisplatin or carboplatin plus either gemcitabine, paclitaxel or vinorelbine (platinum-based combination chemotherapy) in people whose tumours express PD‑L1 at less than 50%, or pembrolizumab alone for people whose tumours express PD‑L1 at 50% or more.

Clinical trial evidence shows that pembrolizumab plus carboplatin and paclitaxel or nab-paclitaxel increases how long people with metastatic squamous NSCLC live compared with placebo plus carboplatin and paclitaxel or nab-paclitaxel. But, in the NHS, carboplatin plus gemcitabine is the most commonly used platinum-based chemotherapy, and nab‑paclitaxel is not available. Also, the evidence for people in the PD‑L1 subgroups is uncertain, and pembrolizumab combination therapy has only been indirectly compared with pembrolizumab alone in people whose tumours express PD‑L1 at 50% or more. So, the evidence does not capture how pembrolizumab combination therapy will be used in the NHS.

Pembrolizumab combination therapy is likely to meet the end of life criteria for people with a PD-L1 tumour proportion score of less than 50%. But it is unclear whether the end of life criteria is met in people with a PD-L1 tumour proportion score of 50% or more because of issues around generalisability for this group. The cost-effectiveness estimates are uncertain, and likely to be higher than what NICE considers an acceptable use of NHS resources. Therefore, pembrolizumab combination therapy is not recommended.