Merck & Co., Inc., a global healthcare leader, has recently unveiled groundbreaking results from its Phase 3 KEYNOTE-564 trial. This pivotal study demonstrates that KEYTRUDA, Merck’s innovative anti-PD-1 therapy, significantly reduces the risk of death by 38% compared to placebo, marking a milestone in adjuvant therapy for patients with renal cell carcinoma (RCC) post-nephrectomy.

Presented at the prestigious 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, these findings are generating substantial interest in the medical community. The KEYNOTE-564 trial is the first Phase 3 study to show a substantial overall survival (OS) advantage with adjuvant therapy over placebo in RCC patients.

Dr. Toni K. Choueiri, a leading oncologist from Dana-Farber Cancer Institute, highlighted the significance of these findings, stating, “For patients with renal cell carcinoma, up to 40% may experience recurrence following surgery, at which point there is a significantly lower chance of survival. Results from KEYNOTE-564 show that pembrolizumab as adjuvant therapy significantly improved overall survival by 38% compared to placebo, becoming the first ever Phase 3 adjuvant trial to show improved survival for renal cancer patients at risk of recurrence after surgery.”

This trial evaluated KEYTRUDA for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy. The third pre-specified interim analysis, with a median follow-up of 57.2 months, revealed that KEYTRUDA improved OS by 38% compared to placebo. At 48 months, the estimated OS rate was 91.2% for KEYTRUDA recipients versus 86.0% for those on placebo.

Dr. Marjorie Green, senior vice president at Merck Research Laboratories, added, “The positive overall survival results from KEYNOTE-564 build upon the disease-free survival data, which supported approvals of KEYTRUDA for this indication worldwide.”

Merck has a robust clinical development program in RCC, exploring KEYTRUDA in various combinations and stages of the disease. KEYTRUDA is already approved for RCC treatment in the U.S., European Union, Japan, and other countries, based on earlier disease-free survival data from this trial.

In addition to its efficacy, KEYTRUDA’s safety profile was consistent with previous studies, with no new safety signals observed. Treatment-related adverse events were manageable and in line with expectations.

In conclusion, the KEYNOTE-564 trial marks a significant advancement in the treatment of renal cell carcinoma, offering new hope for patients at increased risk of recurrence post-surgery. This study not only reinforces the potential of immunotherapy in cancer treatment but also sets a new benchmark for future oncological research.

The success of KEYTRUDA in the KEYNOTE-564 trial is a testament to the ongoing evolution in cancer treatment, particularly in the realm of targeted therapies and immunotherapy. This advancement signifies a leap forward in increasing the survival rate and quality of life for RCC patients, and it underscores the importance of continued research and innovation in oncology.

  Dr. Marjorie Green, Dr. Toni K. Choueiri, KEYNOTE-564 trial, Keytruda, Merck, pembrolizumab, renal cell carcinoma