Keytruda receives MHLW (Japan) approval for adjuvant treatment of renal cell carcinoma following nepphrectomy

Keytruda as monotherapy for the adjuvant treatment of certain patients with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, based on data from the KEYNOTE-564 trial.

The approval of Keytruda for the adjuvant treatment of certain patients with RCC at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions is based on results from the Phase III KEYNOTE-564 trial, in which Keytruda as adjuvant treatment demonstrated a statistically significant improvement in disease-free survival, reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) compared to placebo.

The Japanese package insert states that in KEYNOTE-564, adverse reactions were observed in 386 patients (79.1%) out of the safety analysis set of 488 patients receiving Keytruda at a dose of 200 mg every three weeks or 400 mg every six weeks for up to 12 months. The most common adverse reactions (?10%) were fatigue (20.3%), pruritus (18.6%), hypothyroidism (17.6%), diarrhea (15.8%), rash (15.0%) and hyperthyroidism (10.2%).

Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCCs. Renal cell carcinoma is about twice as common in men than in women. In Japan, it is estimated there were more than 25,000 new cases of kidney cancer diagnosed and more than 8,000 deaths from the disease in 2020.