Recently, Merck (MSD) announced that the US FDA has approved its heavy PD-1 inhibitor Keytruda as an adjuvant therapy to treat patients with early renal cell carcinoma after surgery. These patients have a moderate to high risk of disease recurrence. The announcement pointed out that this is the first immunotherapy approved by the FDA for the adjuvant treatment of renal cell carcinoma, which is expected to change the standard treatment model for these patients.

Renal cell carcinoma is the most common type of kidney cancer. It is estimated that there will be more than 430,000 newly diagnosed cases worldwide in 2020, and more than 170,000 people will die as a result. As many as 40% of local renal cell carcinoma will metastasize after the initial surgical treatment. The prognosis of patients with metastatic disease is poor, with a 5-year survival rate of about 13%.

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

In addition, the data released at this year's ESMO conference show that Keytruda also shows a good trend in reducing the risk of death in patients, reducing the risk of death in patients by 46% compared with placebo. This trial will continue to evaluate the overall survival of patients.

"The adjuvant treatment options for early renal cell carcinoma are limited, and Keytruda's approval provides a new treatment option for patients with a higher risk of recurrence." said Dr. Toni K. Choueiri, a professor of medicine at Harvard Medical School. "It has the potential to become an adjuvant. The new standard treatment for suitable patients."

The use of immunotherapy to treat early-stage cancer patients, reduce disease recurrence, and improve cancer cure rate is the research direction of many pharmaceutical companies. Merck has more than 120 clinical trials testing the effectiveness of Keytruda as an adjuvant therapy, or neoadjuvant therapy before surgery, to treat a variety of cancer types. Before 2021, immunotherapy was only approved by the FDA for the treatment of patients with early-stage melanoma. However, this year, a variety of immunotherapies have been approved by the FDA, and breakthroughs have been made in the treatment of early-stage triple-negative breast cancer, urothelial cancer, esophageal cancer and gastroesophageal junction cancer, and non-small cell lung cancer.

We look forward to the combination of the application of immunotherapy in early cancer with more effective early cancer screening methods, so that more patients can be diagnosed earlier, receive effective treatment earlier, and embark on the road to cure.