A new standard of care is on the horizon for advanced cutaneous squamous cell carcinoma (SCC), a leading Australian medical oncologist has told the ASCO meeting in Chicago.
Professor Danny Rischin, Director of the Division of Cancer Medicine and Head of the Department of Medical Oncology at the Peter MacCallum Cancer Centre, presented the results of phase 1 and 2 trials of cemiplimab.
The phase 2 trial of the PD-1 inhibitor reported an objective response in 29 out of 59 patients (47%) with advanced disease – a partial response in 24 patients and complete response in 4 patients.
The duration of response exceeded six months in 16 of the patients.
The findings, also reported in the NEJM, included a similar level of response in an expansion cohort of the phase 1 study of cemiplimab.
It found 13 of 26 patients (50%) with locally advanced or metastatic disease demonstrated response; with duration of response exceeding six months in 7 patients.
Treatment was IV cemiplimab every two weeks.
Professor Rischin said the rapid and sustained response in patients who had been heavily treated with radiotherapy or chemotherapy led to expectations that cemiplimab would be a new standard of care.
Adverse events included diarrhea, fatigue and nausea with about 7-8% of patients discontinuing treatment.
The researchers said the study of cemiplimab was underpinned by recognition that advanced cutaneous SCCs had a high mutation burden.
“Our results are consistent with an emerging theme regarding the high efficacy of immune checkpoint inhibitors for the treatment of hypermutated cancers, since the mutation burden of cutaneous squamous cell carcinoma is similar to that reported for advanced solid tumours with microsatellite instability.”
“In addition, the dramatically increased risk of cutaneous squamous cell carcinoma among people with immunosuppression pointed to an important role for immune surveillance for this cancer,” they said in the NEJM.
Cemiplimab is also being trialled in patients with advanced basal cell carcinoma.
The studies are sponsored by Regeneron Pharmaceuticals and Sanofi.