"Li" creates extraordinary, "Da" has promising │ Daboshu® new indication is launched, rewriting the first-line treatment pattern of non-squamous NSCLC in China

Foreword Lung cancer is currently the number one malignant tumor in China in terms of morbidity and mortality1.

Among all types of lung cancer, 80%-85%2 belong to non-small cell lung cancer (NSCLC), and about 60%3 of Chinese NSCLC patients are non-squamous NSCLC, and more than 50%4 of patients have no EGFR sensitive mutations or ALK gene rearrangement, this part of advanced lung cancer patients cannot benefit from targeted therapy, treatment methods are relatively limited, and there are huge unmet medical needs.

Daboshu® (sintilimab injection) is an innovative PD-1 inhibitor drug of international quality jointly developed by Eli Lilly and Cinda Biopharmaceuticals in China.

The phase III clinical study ORIENT-11 confirmed the efficacy and safety of sintilimab combined with pemetrexed and platinum-based chemotherapy for the first-line treatment of non-squamous NSCLC.

In February 2021, Sintilimab was approved by the National Medical Products Administration (NMPA), and its indication is combined with pemetrexed and platinum-based chemotherapy for non-squamous NSCLC without EGFR sensitive mutations or ALK gene rearrangement First-line treatment.

On March 21, 2021, the China Health Promotion Foundation 2021 Lung Cancer Immunity Summit Forum and Daboshu® (sintilimab injection) first-line treatment of non-squamous NSCLC new indications will be held in Shanghai.

A number of top domestic lung cancer experts visited the site to witness Sintilimab's opening of a new chapter in the first-line treatment of non-squamous NSCLC in China.

After the meeting, Yimaitong was fortunate to interview the leading PI Professor Zhang Li from the ORIENT-11 research on "The clinical significance and application prospects of Daboshu® (sintilimab injection) for the first-line treatment indication for non-squamous NSCLC" Make a wonderful interpretation.

Expert profile Professor Zhang Li, director of the Department of Internal Medicine, Sun Yat-sen University Tumor Hospital, PhD supervisor, chief expert on lung cancer, member of the Chinese Anti-Cancer Association Tumor Rehabilitation and Palliative Care Professional Committee, Vice-Chairman of the Chinese Anti-Cancer Association Clinical Trial Professional Committee, Chinese Society of Clinical Oncology (CSCO) Standing Director CSCO-Immuno Therapy Expert Committee Designated Chairman, Guangdong Anti-Cancer Association Tumor Chemotherapy Professional Committee, Deputy Chairman, Guangdong Anti-Cancer Association Lung Cancer Professional Committee, Guangdong Province Medical Leading Talents, "Special Support Program" Outstanding Talents (Nan Yue Bai Jie) National Key Research and Development Program "Precision Medicine Research" Lung Cancer Diagnosis and Treatment Specifications and Application Program Precision Research Project Leader ORIENT-11 Research: Sintilimab combined with chemotherapy significantly improves the emergence of PFS immunotherapy for non-squamous NSCLC in China It brings new hope for the treatment of patients with advanced non-squamous NSCLC.
However, the data on imported drugs for Asian patients, including the Chinese population, are very limited.
The KEYNOTE-189 study only included about 3%5 Asian patients.

In order to explore whether Asians can benefit from immunization combined with chemotherapy, the researchers conducted the ORIENT-11 study in China.

ORIENT-11 Study 6 is the first randomized controlled, double-blind phase III clinical study in China for PD-1 inhibitors combined with chemotherapy for the first-line treatment of non-squamous NSCLC.

Taking into account the interests of patients, the ORIENT-11 study was designed with a randomization ratio of 2:1.

A total of 397 patients were enrolled in the study, and they were randomly assigned to the sintilimab combined chemotherapy group (experimental group, n=266) and placebo combined chemotherapy group (control group, n=131).

The main study endpoint is progression-free survival (PFS).

The results showed that the median PFS of the sintilimab combined chemotherapy group was significantly longer than that of the placebo combined chemotherapy group (8.
9 months vs.
5.
0 months; HR, 0.
482, 95% CI, 0.
362-0.
643; p<0.
00001).

In different PD-L1 TPS expression subgroups, sintilimab combined with chemotherapy can achieve PFS benefits.

 Sintilizumab combined with chemotherapy as first-line treatment significantly prolonged PFS in patients with non-squamous NSCLC.
The final results of the ORIENT-11 study showed that the median PFS of the experimental group was 8.
9 months, and the control group was 5.
0 months.
The experimental group achieved PFS has improved in the past 4 months; the risk of disease progression has decreased by 52%, and the HR is 0.
48.

" Professor Zhang Li said, "The results of this study are actually similar to those of the K drug study, so in February this year, Xindili single-handedly Anti-squamous NSCLC has been approved by the National Food and Drug Administration as an indication for non-squamous NSCLC.

"Sintilimab: Improves the availability of immunotherapy drugs and rewrites the first-line treatment pattern of non-squamous NSCLC in China when doctors and patients choose treatment drugs, It is generally based on a comprehensive consideration of the four aspects of efficacy, safety, accessibility, and impact on the subsequent treatment.

"From these four directions, the safety and effectiveness of imported drugs are basically not much different from those of domestically produced drugs.

According to the current market prices, the proportion of imported drugs that really chooses imported drugs will not exceed 5%, which is 95%.
In fact, the patient cannot afford the high price.

"Professor Zhang Li pointed out, "Daboshu® was negotiated by the state, so its price is only more than 2,800 yuan for a course of treatment, and the overall treatment cost per year is about 30,000 to 4 about million.

at present we believe that it is on the inside several PD-1 is a relatively low price.

"" after the letter Dealey monoclonal antibody market, we have one domestic drug, non-squamous NSCLC therapy and medication can be greatly improved.

In the future, chemotherapy combined with immunotherapy is likely to become our mainstream first-line treatment.

"Professor Zhang Li said frankly, "In the past, we were only recommended in the guidelines, but because the people can't afford it, chemotherapy will be the mainstay.

So the next 1-2 In 2010, the overall NSCLC, especially non-squamous NSCLC treatment pattern will have a big change, that is, to keep up with the world trend.

"Sino-foreign cooperation: Chinese innovative pharmaceutical companies join hands with international pharmaceutical companies to make Chinese manufacturing enter the international market.
Sintilimab is an innovative PD-1 inhibitor drug jointly developed by Cinda Biologicals and Eli Lilly in China.
Cinda Biologicals and Li Lilly Lai Pharm has reached a comprehensive cooperation in the process development, quality control, production, and clinical research of Sintilimab, realizing a truly international quality.

"Sino-foreign cooperation actually has several benefits: First, our domestic companies have used Foreign funds are used for development.

Second, Eli Lilly is currently promoting the registration and listing of Sintilizumab in the United States.
Our Chinese drugs will enter the United States market.
I think this is a major benefit.

Because ordinary people always have concerns about the quality of our domestic drugs, in fact, Sintilimab is now applying for registration in the US FDA, which is very good for the entire medical industry and benefits all mankind.

"Professor Zhang Li said, "If Sintilimab can be marketed in the United States, its future market share may not only be in China, but in the global market.
This is also very important for Chinese pharmaceutical companies to enter the international market.
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She-Juan An, Zhi-Hong Chen, Jian Su, et al.
Identification of Enriched Driver Gene Alterations in Subgroups of Non-Small Cell Lung Cancer Patients Based on Histology and Smoking Status [J].
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Yunpeng Yang, Zhehai Wang,