Source: www.medscape.com
Author: Roxanne Nelson, RN, BSN

Immunotherapy with pembrolizumab (Keytruda, Merck & Co), either as monotherapy or in combination with chemotherapy, offers a new standard of care for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), say experts discussing the results from the company-sponsored KEYNOTE-48 trial.

Pembrolizumab plus chemotherapy yielded a significant survival benefit in comparison with standard therapy for both the total patient population and for patients whose tumors were positive for programmed cell death–ligand-1 (PD-L1).

Monotherapy with pembrolizumab yielded a significant overall survival benefit for patients with tumors that were PD-L1 positive; and in the total study population, overall survival was noninferior.

“Thus, pembrolizumab monotherapy is a new standard of care, first-line therapy option for patients with PD-L1-positive recurrent or metastatic HNSCC. Pembrolizumab with chemotherapy is also a new option for all patients, regardless of PD-L1 status,” comment Robert L. Ferris, MD, PhD, from the University of Pittsburgh, Pennsylvania, and Lisa Licitra MD, from the University of Milan, Italy, in a commentary that accompanies article in the Lancet.

“The positive results of KEYNOTE-048 represent substantial progress for patients with recurrent or metastatic HNSCC,” Ferris and Licitria add.

These comments echo the reactions from experts when the study was presented earlier this year at the annual meeting of the American Society for Clinical Oncology (ASCO), as reported by Medscape Medical News at that time.

Presenter Danny Rischin, MD, from the Peter MacCallum Cancer Center, Melbourne, Australia, said: “These data support pembrolizumab plus platinum-based CT [chemotherapy] and pembrolizumab monotherapy as new first-line standard-of-care therapies for relapsed/metastatic head and neck squamous cell carcinoma.”

At the ASCO meeting, the study was highlighted as “most important” by Francis P. Worden, MD, of the University of Michigan Rogel Cancer Center, Ann Arbor. He predicted that pembrolizumab in combination with chemotherapy will replace the EXTREME regimen (cetuximab with platinum-based therapy and fluorouracil) as first-line therapy in HNSCC.

However, while agreeing that the data are practice changing, Vinita Noronha, MD, of the Tata Memorial Cancer Center in Mumbai, India, emphasized that several questions remained unanswered.

In a discussion of the paper, Noronha pointed out that the findings do not provide guidance on which patients should receive pembrolizumab alone or in combination with chemotherapy, and there are also questions as to why both the response rate and progression-free survival rate failed to improve. It was also unclear whether there was a role for sequential therapy or whether all patients should receive the combination up front. Some of these questions have been addressed in the commentary to the Lancet article.

Study Details
KEYNOTE-048 was a randomized, phase 3 study that included 882 participants with untreated locally incurable recurrent or metastatic HNSCC. It was conducted at 200 sites in 37 countries.

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