This is a phase IV single-arm open-label study of pembrolizumab, carboplatin and paclitaxel used as the first-line treatment option for patients with recurrent or metastatic head and neck squamous cell carcinoma. This study mostly looked at an alternative chemotherapy backbone to the current standard of care of platinum 5FU and pembrolizumab.
As I said, it was an open-label, single-arm study. Patients who were eligible for the study had an untreated head and neck cancer from oral cavity, oropharynx, hypopharynx or larynx. They all accessed the treatment – up to six cycles of chemotherapy and up to 20 cycles of pembrolizumab. We assessed response rate and tolerability. This is an early read-out of the study with survival data not available yet.
The response rate was quite high at 42% and tolerability was as expected for a triplet therapy with no new signals seen. Although the study is still ongoing and further data will be presented later, it appears to be a 5FU-free treatment option for patients treated in the first-line head and neck cancer setting.
This study was obviously a smaller study than the overall KEYNOTE-048 study. However, it does increase the treatment options for patients who face this incurable disease with limited treatment options.
Why is head and neck squamous cell carcinoma a difficult disease to treat?
Responses to immunotherapy have been less than initially expected in this patient population. This is also quite a heavily comorbid patient population with quite significant treatment of surgery and chemoradiotherapy that proceed the relapse. So their performance status, nutrition level, are often lower than other patient groups. This altogether probably compounds the lower efficacy of treatments used so far.