Heavy! Merck announced that the 10th indication of K drug was approved in China for the treatment of triple-negative breast cancer

Previously, pembrolizumab has been approved for 6 major tumors and 9 indications in China, and this time it is approved for the 7th tumor type and 10th indication.

The 9 previously approved indications for pembrolizumab are as follows:

1.
Unresectable or metastatic melanoma that has failed first-line treatment;

2.
Combination of pemetrexed and platinum-based chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) with negative epidermal growth factor receptor (EGFR) gene mutation and anaplastic lymphoma kinase (ALK)-negative;

3.
Locally advanced or metastatic NSCLC single-line monotherapy with EGFR gene mutation-negative and ≥ALK-negative EGFR gene mutation-negative and ALK-negative as assessed by NMPA-approved testing;

4.
Combination carboplatin and paclitaxel for first-line treatment of patients with metastatic squamous NSCLC;

5.
Monotherapy for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma who have previously failed first-line systemic therapy and have failed previous first-line systemic therapy for NMPA-approved tests to evaluate tumors expressing PD-L1 [comprehensive positive score (CPS) ≥10];

6.
Combination platinum and fluorouracil chemotherapy drugs for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal or gastroesophageal junction cancer;

7.
Single-agent for first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 [CPS≥20] by a fully validated assay;

8.
Single agent for the first-line treatment of colorectal cancer patients with wild-type, unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair gene deficiency (dMMR) with KRAS, NRAS and BRAF genes;

9.
Monotherapy for the treatment of hepatocellular carcinoma (HCC)
that has previously received sorafenib or oxaliplatin-containing chemotherapy.

Pembrolizumab (Keytruda, trade name: Keytruda; Commonly known as: K drug) is a PD-1 humanized monoclonal antibody independently developed by Merck, which can block the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes that may affect tumor cells and healthy cells, thereby enhancing the ability of the human immune system to
find and destroy cancer cells.

The approval of the new indication for pembrolizumab is based on positive data
from the Phase III clinical trial KEYNOTE-522.
KEYNOTE-522 WAS THE FIRST TO BE EXPLORED IN THE EARLY TNBC A prospective, randomized, double-blind, multicenter phase III study of the efficacy of adding pembrolizumab to neoadjuvant/adjuvant chemotherapy in patients to evaluate the neoadjuvant therapy of pembrolizumab in combination with chemotherapy and subsequent pembrolizumab monotherapy in
patients with high-risk early-stage triple-negative breast cancer (TNBC).

The KEYNOTE-522 study enrolled a total of 1174 patients with previously untreated, nonmetastatic, T1c/N1-2, or T2-4/N0-2 stages of TNBC on a 2:1 basis Proportion randomised to either pembrolizumab or placebo (paclitaxel + carboplatin 4 cycles, sequential doxorubicin or epidoxorubicin + cyclophosphamide 4 cycles), with postoperative patients receiving adjuvant pembrolizumab or placebo9 Cycle or to tumor recurrence or intolerable toxicity
.

After a median follow-up of 39.
1 months, event-free survival (EFS) was 84.
5% and 76.
8%,
respectively.
Safety data are consistent with previous toxicity profiles of each drug to assist immune-related AEs during pembrolizumab is 10.
2% of cases, with 2.
9%
of grade 3 and above.

KEYNOTE-522 RESEARCH PROTOCOL

Based on the excellent results of KEYNOTE-522, both FDA and EMA approved pembrolizumab in combination with chemotherapy for neoadjuvant therapy and subsequent adjuvant therapy
for high-risk early triple-negative breast cancer.

According to public information, in September 2014, pembrolizumab was approved for the first time in the United States for the treatment of advanced melanoma, becoming the first PD-1 inhibitor approved by the FDA; On July 16, 2015, it was approved for listing in the European Union; On September 28, 2016, it was approved for listing in Japan; On July 20, 2018, Keytruda was approved for listing
in China.
At present, the drug has been approved for more than 30 indications in the United States, from advanced melanocytoma to non-small cell lung cancer, metastatic gastric cancer, esophageal cancer, kidney cancer, and breast and liver cancer
.

According to Merck's 2021 financial report, the global sales of K drugs were about 17.
2 billion US dollars, a year-on-year increase of 20%.

In the first three quarters of 2022, the sales of K drugs reached 15.
487 billion US dollars, and some institutions predict that K drugs will exceed 20 billion US dollars this year, which is expected to compete for the position
of "drug king".

In addition, according to the China Clinical Trial Registration and Information Disclosure Platform, there are more than 50 pembrolizumab-related clinical trials underway
.
Many of them belong to international multi-center (including China) phase 3 clinical trials and cover a number of indications that have not yet been approved in China, including: endometrial cancer, bladder cancer, esophageal cancer, breast cancer, prostate cancer, hepatocellular carcinoma, small cell lung cancer, biliary tract cancer, ovarian, fallopian tube cancer or primary peritoneal cancer.

It is expected that the follow-up clinical research of pembrolizumab will proceed smoothly and benefit more patients
as soon as possible.