Tanja Obradovic: New option of immunotherapy for HNSCC is on the horizon
Tanja Obradovic, Vice President of Oncology Scientific Affairs at ICON PLCh, shared a post on LinkedIn:
“After decades of no improved treatment options patients that have resectable stage III or IVa head and neck squamous cell carcinoma (HNSCC) new option of immunotherapy is on the horizon.
FDA just granted priority review to Merck for pembrolizumab (Keytruda) sBLA for the treatment of patients with resectable locally advanced HNSCC as neoadjuvant and adjuvant treatment.
In Phase 3 Keynote-689 neoadjuvant pembrolizumab followed by adjuvant pembrolizumab plus radiotherapy with or without cisplatin, and maintenance pembrolizumab, produced a statistically significant improvement in event-free survival (EFS) and in major pathological response (mPR) vs adjuvant radiotherapy with or without cisplatin in patients with newly diagnosed, resected stage III or IVA, locally advanced head and neck squamous cell carcinoma (HNSCC).
Patients treated in Keynote-689 had histologically confirmed, resectable, nonmetastatic squamous cell carcinoma with either a stage III, T4, N0-2, M0, human papillomavirus (HPV)–positive oropharyngeal, stage III or IVa HPV-negative oropharyngeal, or stage III or IVa larynx, hypopharynx, and oral cavity cancer.
The primary endpoint was EFS, and secondary endpoints included OS, mPR, pathological complete response, and safety.
All efficacy endpoints are evaluated according to PD-L1 CPS status. Last year Keynote-689 met primary endpoint of EFS and now mPR is mature and achieved while it remains to be seen if benefit in OS continues to trend in favor of pembrolizumab containing regimen. Just like in metastatic HNSCC setting it will be of interest to see all details of results within different PDL-1 expressing groups.
Great achievement for the Merck team as PDUFA date is now set for June 23, 2025.”
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