 The 2019 Annual Meeting of the American Society of Clinical Oncology takes place May 31-June 4. |
Merck & Co. Inc. said its blockbuster immunotherapy drug Keytruda alone and in combination with chemotherapy helped patients with head and neck cancer live longer than those taking only chemotherapy.
The final analysis from the study, called Keynote-048, unveiled May 31 at the 2019 Annual Meeting of the American Society of Clinical Oncology, follows interim results announced in October 2018. It was found that Keytruda performed better than the standard of care for patients with head and neck squamous cell carcinoma that had recurred or spread to other parts of the body.
The current standard of care is a combination of cetuximab — marketed by Eli Lilly and Co. as Erbitux — and chemotherapy, a regimen called Extreme.
The new findings from the final results showed that Keytruda and chemotherapy as a combination reduced the risk of death by 40% and helped patients live more than 3.5 months longer than those receiving the Extreme regimen. These patients' tumors expressed high levels of a protein that is part of the pathway Keytruda targets.
However, patients in this population did not live statistically longer without the disease worsening, which was one of the goals of the study.
Of patients whose tumors expressed lower levels of the target protein, the Keytruda-chemo combination reduced risk of death by 35%. The patients lived just over three months longer than with the Extreme regimen.
With Keytruda alone, patients lived almost one month longer than with the Extreme regimen, which was consistent with the earlier results. There was no difference in patients who lived without the disease worsening.
"Patients with recurrent or metastatic head and neck cancer have a poor prognosis with limited treatment options," said Danny Rischin, director of the Department of Medical Oncology at the Peter MacCallum Cancer Centre, in a release. "These findings underscore the potential of Keytruda monotherapy and in combination with platinum-based chemotherapy to become important new treatment options."
Keytruda alone and in combination with chemotherapy for the head and neck cancer indication is under priority review at the U.S. Food and Drug Administration, with an expected completion date of June 10.
The 2019 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from around the world, with more than 2,400 study abstracts to be presented on-site and an additional 3,200 abstracts to be published online.