Keytruda Demonstrates Superior Overall Survival vs. Yervoy in Advanced Melanoma

Image Credit: Adobe Stock Images/Татьяна Креминская

Data from the pivotal Phase III KEYNOTE-006 trial demonstrated that Merck’s Keytruda (pembrolizumab) provided superior overall survival (OS) benefits over Yervoy (ipilimumab) in patients with advanced melanoma. These results, based on 10 years of follow-up data, were presented for the first time during a mini oral session at the European Society for Medical Oncology Congress 2024 and published in the Annals of Oncology.

“Ten years ago, Keytruda became the first anti-PD-1/L1 therapy approved in the United States, setting the stage for transformative breakthroughs in the treatment of advanced melanoma and other types of cancer,” said Marjorie Green, MD, SVP, head, oncology, global clinical development, Merck Research Laboratories, in a press release. “Keytruda has reshaped the treatment of certain types of cancers, extending its benefits to a broader range of tumor types and patients, and we look forward to the prospect of more innovation for patients over the next 10 years and beyond.”

The open-label, randomized KEYNOTE-006 trial compared the efficacy and safety of Keytruda versus Yervoy with dual primary endpoints of OS and progression-free survival (PFS). At the end of the trial, participants were given the opportunity to continue to the KEYNOTE-587 extension study for long-term follow-up. The extension study included 211 patients with a primary endpoint of OS.

Results found that Keytruda demonstrated a 34% ten-year OS rate compared to 23.6% for Yervoy, reducing the risk of death by 29%. Median OS for Keytruda reached 32.7 months, more than doubling Yervoy’s 15.9 months. Results of the KEYNOTE-587 extension demonstrated continued improvements for OS and PFS. The 10-year OS rate was 34.0% for Keytruda versus 23.6% for Yervoy, with the median PFS for Keytruda being 9.4 months compared to 3.8 months for Yervoy.

Keytruda was discontinued in 9% of patients with advanced melanoma due to adverse events (AEs), which included colitis, autoimmune hepatitis, allergic reaction, polyneuropathy, and cardiac failure. Common AEs included fatigue, diarrhea, rash, and nausea. Merck warns that treatment should be monitored or discontinued depending on severity in patients who develop immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, and hepatotoxicity.¹

According to the American Cancer Society, melanoma accounts for only about 1% of skin cancers but causes a large majority of skin cancer deaths. It is estimated that by the end of 2024, there will be 100,640 new melanomas diagnosed in the United States, with around 8,290 estimated deaths. Mainly due to advancements in treatment, death rates declined rapidly between 2013 and 2017, with rates falling between 6% and 7% each year. As a person ages, their risk of getting melanoma increases, and the average age of diagnosis is 66 years. However, it is considered one of the most common cancers in people under the age of 30 years.²

“The prognosis for patients diagnosed with melanoma has been steadily improving, with a 30% reduction in mortality compared to a decade ago,” said Caroline Robert, MD, head, dermatology, Gustave Roussy, Villejuif and Paris-Sud University Cancer Campus, Grand Paris, in the press release. “These latest data from KEYNOTE-006 illustrate the progress we’ve made in patient care. It is remarkable to see that more than one-third of patients treated with Keytruda are still alive today, 10 years after treatment.”

According to Merck, Keytruda has demonstrated efficacy in sustained survival benefits of five years or more across multiple types of cancer, such as melanoma, non-small cell lung cancer, head and neck cancer, and bladder cancer to date. It was approved in 2015 by the FDA for the treatment of patients with unresectable or metastatic melanoma.¹

References

1. Ten-Year Data for Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Sustained Overall Survival Benefit Versus Ipilimumab in Advanced Melanoma. Merck. September 15, 2024. Accessed September 17, 2024. https://www.merck.com/news/ten-year-data-for-mercks-keytruda-pembrolizumab-demonstrates-sustained-overall-survival-benefit-versus-ipilimumab-in-advanced-melanoma/

2. Key Statistics for Melanoma Skin Cancer. American Cancer Society. Accessed September 17, 2024. https://www.cancer.org/cancer/types/melanoma-skin-cancer/about/key-statistics.html