Keytruda Approved as First-Line Therapy for Advanced Head and Neck Cancer with Significant Survival Benefit

Today, MSD announced that its blockbuster immunotherapy Keytruda has secured two new indications. It has received approval from the U.S. FDA as a monotherapy for first-line treatment of patients with advanced head and neck cancer expressing PD-L1. Additionally, it can be used in combination with standard chemotherapy regimens for first-line treatment of patients with advanced head and neck cancer.

As a revolutionary immunotherapy, Keytruda has been approved for the treatment of various cancer types, including recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). In 2016, the U.S. FDA granted accelerated approval for Keytruda, enabling its use in patients with HNSCC whose disease progressed after platinum-based chemotherapy.

It is important to note that the approval granted three years ago was based on objective response rate (ORR) data. Following accelerated approval, the FDA continued to require MSD to provide additional evidence of clinical benefit for Keytruda. In the pivotal Phase 3 KEYNOTE-048 clinical trial, Keytruda indeed demonstrated a significant improvement in overall survival (OS).

Specifically, in patients with tumors expressing PD-L1, Keytruda monotherapy significantly prolonged overall survival (OS) compared to standard therapy (cetuximab plus carboplatin or cisplatin, and fluorouracil). Regardless of PD-L1 expression status, Keytruda in combination with chemotherapy also significantly prolonged OS. Based on these positive survival data, the FDA granted approval. Consequently, Keytruda became the first anti-PD-1 therapy to demonstrate a significant improvement in survival in these patient populations.

“Historically, HNSCC has posed challenges for both physicians and patients. Treatment options are limited, and the disease and its therapy can impact patients’ physiological functions,” said Dr. Jonathan Cheng, Vice President of Clinical Research at MSD Research Laboratories. “This approval represents a significant advance in controlling this aggressive cancer. The clinical results from KEYNOTE-048 support this approval and demonstrate that first-line treatment with Keytruda monotherapy significantly prolongs survival in patients expressing PD-L1. Regardless of PD-L1 expression status, the combination of Keytruda and chemotherapy achieves similar outcomes.”

We congratulate Keytruda on the successful expansion of its indications based on overall survival (OS) data, and we look forward to it bringing greater benefits to more patients.

References:

[1] FDA Approves Two New Indications for Merck’s KEYTRUDA® (pembrolizumab)，Retrieved Jun 11, 2019, from https://www.businesswire.com/news/home/20190611005275/en

Original Title: Flash | Significantly Prolongs Survival! Keytruda Approved for First-Line Treatment of Advanced Head and Neck Cancer

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