Nasopharyngeal cancer treatment "Chinese plan" or rewrite global standards

my country's innovative drug research results were first recommended on the cover of "Nature Medicine"

Nasopharyngeal cancer treatment "Chinese plan" or rewrite global standards

Our reporter Ma Aiping

Recently, "Nature Medicine" recommended on the cover for the first time in 26 years since its inception the research results of China's innovative drug-Teriplimumab combined with chemotherapy for the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma

On September 15, the results of the first-line treatment of relapsed/metastatic nasopharyngeal carcinoma (JUPITER-02 study) with teriprizumab combined with chemotherapy led by Professor Xu Ruihua, director of the Sun Yat-sen University Cancer Center The journal "Nature Medicine", this is the first time that "Nature Medicine" has recommended China's innovative drug research on the cover in the past 26 years

"This is not the first C-bit debut of

Develop a "Chinese program" for high-incidence tumors

Xu Ruihua introduced: "Nasopharyngeal carcinoma is a highly aggressive malignant tumor, especially for patients with recurrent or metastatic nasopharyngeal carcinoma.

"Recurrence and metastasis are the main reasons for the failure of nasopharyngeal cancer treatment.

In the research and development of the "Chinese solution" for high-incidence tumors in China, Xu Ruihua's team and others have been exploring innovative clinical solutions that combine emerging immunotherapies with traditional chemotherapy since 2016

"In the early stages of the study, by consulting the literature, we listed the tumors for which immunotherapy may be effective, and made a basket research design, which included nasopharyngeal carcinoma as an important disease

After analyzing a large number of molecular markers in the tissues, the researchers were pleasantly surprised to see that the expression level of PD-L1 in nasopharyngeal carcinoma tissues was extremely high and contained a large number of infiltrating lymphocytes

Multi-center study verifies the effect of treatment

Teriplizumab is the first domestically-made monoclonal antibody targeting PD-1 that has been approved for marketing in China

At first, the research team only conducted exploratory studies with a small sample size in the second phase of the Phase I trial, Phase Ib/II

As the positive results of the latter-line treatment were verified in a larger sample, the research team pushed the drug to the earlier first-line treatment

Mai Haiqiang said: “The reason why this research has to be carried out in different places at the same time is because from the pathological classification of nasopharyngeal carcinoma in Southeast Asian countries, about 95% of them are undifferentiated non-keratinizing cancers.

Based on the above research, in February of this year, Teriplizumab was approved by the National Medical Products Administration for the treatment of patients with relapsed or metastatic nasopharyngeal carcinoma who had previously failed second-line and above systemic treatments, becoming the world's first Approval of immunotherapy drugs for nasopharyngeal carcinoma indications

"The development of indications for new drugs is often full of challenges.

This study was enrolled from November 2018 to October 2019.

Innovative solutions allow local new drugs to go abroad

The JUPITER-02 study-this research, which is led by Chinese researchers, uses local new drugs, and aims at the high incidence of Chinese tumors, has achieved breakthrough results

"Treplimumab combined with GP chemotherapy in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma is expected to change the global treatment standard
.
" Xu Ruihua said, it is worth mentioning that the JUPITER-02 study is a registration in China and the United States.
Phase III clinical trials
.
The nasopharyngeal carcinoma patients included in this study were all Asians, and their pathological types were mainly non-keratinizing carcinomas, which were the main pathological subtypes in Asia
.
Subsequently, the U.
S.
Food and Drug Administration (FDA) based on the clinical evidence of the JUPITER-02 study, granted teriplizumab the second breakthrough therapy designation
.

In March of this year, based on the breakthrough therapy designation granted by the FDA, Junshi Bio announced the rolling submission to the FDA for a biologics license application for terreplimumab for the treatment of relapsed or metastatic nasopharyngeal carcinoma, and terreplimumab became the first Domestic anti-PD-1 monoclonal antibody submitted to FDA for marketing application
.

Xu Ruihua said: "China's clinical oncology has developed by leaps and bounds in the past 10 years
.
More and more Chinese clinical research results have been highly recognized by the world's authoritative academic platforms.
The research and development of Chinese oncology drugs has also reached the forefront of the world.
It proves that Chinese experts can also bring guidance and direction to colleagues in the world
.
With the improvement of China's scientific and technological innovation capabilities, there will be more and more Chinese programs that can lead the world's cancer treatment standards
.
"

Glossary

First-line drugs: drugs that can be selected first or selected based on the patient's condition
.

Second-line drugs: drugs that are not as frequently used clinically as first-line drugs or whose effects are not as obvious as first-line drugs and have many adverse reactions
.

Clinical trial staging: After completing animal experiments, the drug needs to be tested in humans
.
Phase I is the safety test of the drug, the number of subjects is small, mainly depends on whether the subjects tolerate the side effects of the drug; Phase II is to expand the test population on the basis of Phase I, this stage mainly depends on the drug What is the efficacy of the drug, and continue to observe the safety of the drug; Phase III will further expand the test population and observe the drug efficacy in more subjects.
If the effect is obvious compared with the control group, the researcher will submit it based on the results of the Phase III study After the application for marketing is approved by the Food and Drug Administration, the drug can be marketed
.

Progression-free survival time: refers to the period of time between the start of treatment and the observation of disease progression or death of cancer patients
.