FDA Approves Keytruda for First-line Treatment of Head and Neck Squamous Cell Carcinoma

FDA approves Keytruda for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

Keytruda was approved for use in combination with platinum and fluorouracil (FU) for all patients and as a single agent for patients whose tumors express PD‑L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA‑approved test.

Approval was based on KEYNOTE-048, a randomized, multicenter, three-arm, open‑label, active‑controlled trial conducted in 882 patients with metastatic HNSCC who had not previously received systemic therapy for metastatic disease or with recurrent disease who were considered incurable by local therapies.

Patients were randomized (1:1:1) to receive one of the following treatments: Keytruda as a single agent; Keytruda, carboplatin or cisplatin, and FU; or cetuximab, carboplatin or cisplatin, and FU. Randomization was stratified by tumor PD-L1 expression, HPV status according to p16 IHC and ECOG PS (0 vs 1). PD-L1 expression (TPS and CPS) was determined using the PD-L1 IHC 22C3 pharmDx kit.

The trial demonstrated a statistically significant improvement in overall survival in the overall population for patients treated with Keytruda plus chemotherapy compared with cetuximab plus chemotherapy. The median duration of survival was 13.0 months for the Keytruda plus chemotherapy arm and 10.7 months for the cetuximab plus chemotherapy arm.  Results were similar in the for all PD-1 positive patients.

The trial also demonstrated statistically significant improvements in survival for the subgroups of PD-1 and PD-L1 positive patients treated with Keytruda as a single agent compared with cetuximab plus chemotherapy. Median survival was 12.3 months for the Keytruda arm and 10.3 months for chemotherapy arm with CPS >1 14.9 months for the Keytruda arm and 10.7 months for the chemotherapy arm for CPS > 20.

The most common side effects for Keytruda as a single agent in KEYNOTE-048 were fatigue, constipation, and rash.

Reference:

https://search.usa.gov/search?query=keytruda&affiliate=fda1

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