Sotorasib is recommended for use within the Cancer Drugs Fund as an option for treating KRAS G12C mutation-positive locally advanced or metastatic non-small-cell lung cancer in adults whose disease has progressed on, or who cannot tolerate, platinum-based chemotherapy or anti-PD-1/PD-L1 immunotherapy. It is recommended only if the conditions in the managed access agreement for sotorasib are followed.
This recommendation is not intended to affect treatment with sotorasib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Current treatment for previously treated KRAS G12C mutation-positive, locally advanced or metastatic non-small-cell lung cancer includes docetaxel or docetaxel plus nintedanib. Sotorasib is a targeted treatment for the KRAS G12C mutation.
Sotorasib has only been indirectly compared with current treatment. The results suggest that, after platinum-based chemotherapy, sotorasib increases the time before the cancer gets worse and how long people live compared with current treatment.
Sotorasib likely meets NICE's criteria to be a life-extending treatment at the end of life. But there is uncertainty in the clinical evidence. Sotorasib has the potential to be cost effective, but more evidence is needed to address the uncertainties before it can be recommended for routine use.
The evidence on sotorasib is promising. But, more data is being collected from the primary clinical trial and from an ongoing randomised controlled trial comparing sotorasib with docetaxel. Collecting additional data through the Cancer Drugs Fund may resolve some uncertainty in the clinical evidence. So, sotorasib is recommended for use in the Cancer Drugs Fund.