FDA Approves Keytruda as First Adjuvant Immunotherapy for Early-Stage Renal Cell Carcinoma, Reducing Recurrence Risk by 32%

Today, MSD announced that the U.S. FDA has approved its重磅 PD-1 inhibitor Keytruda as an adjuvant therapy to treat patients with early-stage renal cell carcinoma following surgery. These patients have an intermediate-high or high risk of disease recurrence. The press release noted that this is the first immunotherapy to receive FDA approval for adjuvant treatment of renal cell carcinoma, and it has the potential to change the standard treatment paradigm for these patients.

Renal cell carcinoma is the most common type of kidney cancer, with an estimated over 430,000 new cases diagnosed globally in 2020, and more than 170,000 deaths attributed to it. Up to 40% of patients with localized renal cell carcinoma will develop metastases after initial surgical treatment. The prognosis for patients with metastatic disease is poor, with a 5-year survival rate of approximately 13%.

This approval was based on the results of a pivotal phase 3 clinical trial. The trial showed that, compared with placebo, Keytruda reduced the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010). The median progression-free survival has not been reached in either group.

Moreover, the data presented at this year's ESMO conference showed that Keytruda also demonstrated a positive trend in reducing the risk of patient mortality, decreasing the risk of death by 46% compared to placebo. This trial will continue to evaluate the overall survival of patients.

▲Results of Keytruda in pivotal Phase 3 clinical trial (Image source: MSD official website)

"There are limited adjuvant treatment options for early-stage renal cell carcinoma, and the approval of Keytruda provides a new treatment option for patients at high risk of recurrence," said Dr. Toni K. Choueiri, Professor of Medicine at Harvard Medical School. "It has the potential to become the new standard of care for adjuvant therapy in suitable patients."

Using Immunotherapy to Treat Early-Stage Cancer Patients, Reduce Disease Recurrence, and Improve Cancer Cure Rates is a Research Focus for Multiple Pharmaceutical Companies. MSD has over 120 clinical trials testing Keytruda as an adjuvant therapy or as a neoadjuvant therapy before surgery for the treatment of various cancer types. Prior to 2021, immunotherapy had only received FDA approval for treating early-stage melanoma patients. However, this year, several immunotherapies have gained FDA approval, achieving breakthroughs in treating early-stage triple-negative breast cancer, urothelial carcinoma, esophageal cancer, gastroesophageal junction cancer, and non-small cell lung cancer.

We look forward to the application of immunotherapy in early-stage cancer being combined with more effective early cancer screening methods, allowing more patients to receive earlier diagnosis and effective treatment, paving the way to a cure.

References:

[1] FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery. Retrieved November 18, 2021, from https://www.merck.com/news/fda-approves-mercks-keytruda-pembrolizumab-as-adjuvant-therapy-for-certain-patients-with-renal-cell-carcinoma-rcc-following-surgery/

[2] Merck Oncology Overview. Retrieved November 18, 2021, from https://s21.q4cdn.com/488056881/files/doc_presentations/2021/ESMO-Investor-Event-Slides.pdf

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