ASCO Heavy Kidney Cancer: Immunotherapy may become a new standard for postoperative adjuvant treatment of high-risk renal cancer!

The 2021 American Society of Clinical Oncology (ASCO) Annual Meeting will be held online from June 4th to 8th.
As one of the largest and most popular events in oncology, the ASCO Annual Meeting will showcase the latest cutting-edge developments to scholars from all walks of life
.

The five studies in this year’s plenary session involved breast cancer, nasopharyngeal cancer, cervical cancer, prostate cancer, and renal cell carcinoma
.

Let's take a look at the KEYNOTE-564 study on renal cell carcinoma
.

Background: Postoperative recurrence of high-risk clear cell renal cell carcinoma (ccRCC) is associated with shortened life expectancy
.

Effective perioperative treatment to reduce the risk of recurrence is still an unmet clinical need
.

For these patients, adjuvant immunotherapy is a potential treatment strategy
.

The KEYNOTE-564 study aims to explore the efficacy and safety of pembrolizumab versus placebo in adjuvant treatment of renal cancer
.

At this ASCO conference, the KEYNOTE-564 study announced the results of the first interim analysis
.

Methods: KEYNOTE-564 is a randomized, double-blind, phase III clinical trial designed to evaluate pembrolizumab versus placebo for adjuvant treatment of intermediate and high risks after nephrectomy (pT2, Gr4 or sarcoma-like, N0 M0; or pT3) , Any Gr, N0 M0), high-risk (pT4, any Gr, N0 M0; or pT any stage, any Gr, N+ M0) or M1 no evidence of disease (M1 NED) histologically confirmed efficacy of ccRCC patients
.

The patient underwent surgery within 12 weeks before randomization, had not received systemic treatment before, and had an ECOG PS of 0 or 1
.

Give up to 17 cycles of treatment (approximately 1 year)
.

The primary endpoint is the disease-free survival (DFS) assessed by the investigator in all randomized patients (ITT population)
.

The key secondary endpoint is overall survival (OS)
.

Study design results: Between June 30, 2017 and September 20, 2019, 994 patients were randomly assigned to receive pembrolizumab or placebo treatment at a 1:1 ratio.
As of December 14, 2020, median follow-up The duration is 24.
1 months
.

The baseline characteristics of the two groups of patients were balanced and comparable
.

In the first interim analysis, the study reached the primary study endpoint DFS, and the median DFS in both groups did not reach (HR=0.
68, P=0.
001)
.

The expected 2-year DFS rates for pembrolizumab and placebo groups were 77.
3% and 68.
1%, respectively, and consistent DFS benefits were observed in each subgroup
.

ITT population DFS results subgroup analysis results The median OS of the pembrolizumab group and the placebo group did not reach (HR=0.
54, P=0.
0164), and the estimated 2-year OS rates of the two groups were 96.
6% and 93.
5%, respectively
.

Median OS results in ITT population 470 (96.
3%) and 452 (91.
1%) patients in the pembrolizumab group and placebo group had adverse events ≥1, and 32.
4% and 17.
7% of the patients had 3~ Grade 5 adverse events
.

Safety analysis conclusion: Compared with placebo, pembrolizumab can significantly improve the DFS of patients with medium to high risk, high risk or M1 NED RCC
.

KEYNOTE-564 is the first phase III clinical study of immune checkpoint inhibitors used in RCC adjuvant therapy with positive results.
The results support that pembrolizumab may become a new standard for RCC adjuvant therapy
.

Reference: Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for patients with renal cell carcinoma: Randomized, double-blind, phase III KEYNOTE-564 study.
Abstract LBA 5.