Professor Zhou Caicun: Serplulimab has been approved as a first-line indication for lung squamous cell carcinoma, and two high-level international studies have led PD-1 inhibitors

Take into account efficacy, accessibility, and safety

To bring reliable medication options to Chinese patients with squamous cell carcinoma

Lung cancer is the cancer with the highest incidence and mortality in China, including non-small cell lung cancer (NSCLC, accounting for about 85%) and small cell lung cancer (SCLC).

NSCLC is divided into two subtypes
: lung squamous cell carcinoma (accounting for 20%~30%) and non-squamous non-small cell lung cancer.

Professor Zhou Caicun introduced: "The vast majority of lung squamous cell carcinoma patients are smokers, while most lung adenocarcinoma patients do not smoke
.
Unlike lung adenocarcinoma patients with common driver gene mutations, targeted therapy can be used, lung squamous cell carcinoma patients basically have no targeted drugs available, and because most of them are central characteristics, the risk of bleeding is high, so patients with lung squamous cell carcinoma cannot use antiangiogenic drugs, so the previous treatment method is mainly chemotherapy, and the median overall survival (mOS) of advanced patients often does not exceed one year
.
"Another sadness of lung squamous cell carcinoma patients is that even if it is an early tumor, after surgery + adjuvant chemotherapy, half of the patients will recur.

Where is the "way out" for lung squamous cell carcinoma patients? The advent of immunotherapy has given hope
to lung squamous cell carcinoma patients.
Professor Zhou Caicun said: "Patients with lung squamous cell carcinoma who smoke have a higher tumor mutation burden (TMB), which means that the number of neoantigens is high, and after the use of immunotherapy, there is also a greater
chance of developing an anti-tumor immune response.
" The emergence of immunotherapy has directly changed the diagnosis and treatment status of lung squamous cell carcinoma patients, and immunotherapy + chemotherapy has become the first-line standard treatment plan
for lung squamous cell carcinoma patients.

At present, more than 10 PD-1 and PD-L1 products have been approved for marketing in China, and how to choose among many drugs has become a difficult problem
in front of clinicians.
Professor Zhou pointed out three indicators to measure drugs: efficacy, safety and accessibility
.
Among them, whether the progression-free survival was significantly prolonged, whether the response rate was significantly improved, and whether the overall survival was effectively improved, were the three main factors
in evaluating the efficacy.

Firstly, compared with a number of sqNSCLC first-line registration clinical studies, the ASTRUM004 phase III clinical study of serplulimab stood out
.
The primary endpoint of the study was median progression-free survival (mPFS), and first-line treatment with serplulimab + albumin paclitaxel + carboplatin in the experimental group extended the mPFS of patients to 9.
79 months (Asian population data), HR=0.
44, and there was a trend of benefit in overall survival (OS) for interim analysis; The objective response rate (ORR) of 75% and the duration of response (DoR) of 10.
6 months were gratifying
.
Secondly, in terms of safety, compared with chemotherapy alone, there was no significant increase in adverse events of first-line treatment of serplulimab combined with chemotherapy, and the safety was good
.
Third, price is one of the important factors affecting the accessibility of drugs for patients, Professor Zhou Caicun pointed out: "The pricing of domestic PD-1 inhibitors, including serplulimab, is lower, which also makes them more accessible, coupled with excellent efficacy data, making serplulimab combined with albumin paclitaxel and carboplatin a reliable drug choice
for Chinese patients with advanced lung squamous cell carcinoma.
" ”

Study design from a high starting point

Chinese research benefits the world

In recent years, more and more Chinese studies have appeared on the international stage
.
The registration study led by Professor Zhou Caicun has a global focus at the beginning of the trial design, aiming to bring better treatment options to lung cancer patients around the world, so the study includes many research centers around the world, including China, the European Union, Poland, Turkey, etc.
, which is currently the largest international phase III clinical study
of lung squamous cell carcinoma led by Chinese researchers.

Professor Zhou Caicun said that the study strictly follows international standards and uses the globally recognized best efficacy sqNSCLC chemotherapy regimen (carboplatin + albumin paclitaxel) as a control, which is more in line with the clinical practice
of lung squamous cell carcinoma patients.
At the same time, the trial is a global multicenter, randomized, double-blind clinical study, the efficacy results are evaluated by an independent imaging evaluation committee, the data results are more objective and fair, and the global multicenter research layout also lays the foundation
for the global application of serplulimab.

Helping sqNSCLC patients to obtain "maximizing the benefits of efficacy and safety" is Professor Zhou Caicun's long-term wish
as an oncologist.
The approval of the first-line therapeutic indication of serplulimab for lung squamous cell carcinoma is expected to reshape the immunotherapy landscape in the field of lung cancer, and also puts forward higher expectations
for the future research of shrullimab.
For future research, Professor Zhou Caicun also proposed: "Chinese experts should apply China's own products more, accumulate drug experience, and explore better drug combination methods, chronological sequence, dosage and other clinically close research protocols to improve the treatment effect of patients, so as to make clinical application more convenient
.
" "In the future, it is necessary to explore the mechanism of immune drug resistance, how to break through primary drug resistance and acquired drug resistance after immunotherapy, and provide new options
for patients after immunotherapy failure.
" In addition, the most important thing is to further improve the efficacy of immunotherapy and explore immune combination treatment options, such as double exemption, immune + radiotherapy and chemotherapy, immune + VEGFR inhibitors, immune + cell therapy, etc
.

Layout of lung cancer for the whole population

Small cell lung cancer and lung squamous cell carcinoma both benefit

Lung squamous cell carcinoma and small cell lung cancer are two recognized "hard bones" in lung cancer, and they are also areas that need to be broken through
clinically.
Since the beginning of this year, serplulimab has made good news in the field of lung cancer: in April, it was included in the "2022 CSCO Small Cell Lung Cancer Diagnosis and Treatment Guidelines" with IA evidence, in June Professor Cheng Ying brought the results of ASTRUM005 research to the ASCO conference, in September the ASTRUM005 study won the top international medical journal "Journal of the American Medical Association" (JAMA), and the indication for lung squamous cell carcinoma was successfully approved
in November.
Serplulimab is an innovative biologic drug with independent intellectual property rights in China, which can help lung cancer patients benefit
comprehensively.

Professor Zhou Caicun pointed out that two high-level phase III international multicenter clinical studies of serplulimab in the two major fields of lung squamous cell carcinoma and small cell lung cancer have laid a solid foundation
for its application in these two disease fields.
The reason why these two different lung cancer subtypes have achieved good results may first be because this innovative PD-1 inhibitor drug has better efficacy; In addition, this is also the result of decades of
continuous research and in-depth cultivation by Chinese lung cancer experts in these two lung cancer subtypes.
Only by enduring loneliness and constantly trying can we have a better treatment plan and finally achieve satisfactory treatment results
.

In the future, it is expected that Chinese experts and pharmaceutical companies can bring more drugs and treatment programs with international quality to different cancer patients to help patients survive in
the long term.

Expert profiles

Professor Zhou Caicun

Director of the Department of Oncology, Shanghai Pulmonary Hospital, Tongji University

Director of the Institute of Oncology, School of Medicine, Tongji University

Executive member of the Chinese Society of Clinical Oncology

Chairman of the Non-Small Cell Committee of the Chinese Society of Clinical Oncology

Chairman of the Thoracic Tumor Branch of the Chinese Association for the Promotion of Medical Care

Board Member of the International Society for the Study of Lung Cancer (IASLC BOD)

Member of the Standing Committee of the Lung Cancer Professional Committee of the Chinese Anti-Cancer Association

Vice Chairman of the Oncology Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association

Member of the Standing Committee of the Oncology Branch of the Chinese Medical Doctor Association

Vice Chairman of Shanghai Anti-Cancer Association

Chairman of the Molecular Targeting and Immunotherapy Committee for Lung Cancer of Shanghai Anti-Cancer Association

Vice President of Oncology Branch of Shanghai Medical Association

Vice Chairman of Oncology Branch of Shanghai Medical Association