Infineon combined with chemotherapy triples the 3-year survival rate of patients with extensive-stage small cell lung cancer

Shanghai, September 22, 2021/PRNewswire/ - The latest results of the CASPIAN Phase III trial show that AstraZeneca’s Infineon (generic name: duvalizumab) is combined with etoposide and carboplatin or cis The platinum treatment plan, the first-line treatment of adult extensive-stage small cell lung cancer (ES-SCLC), showed sustained and clinically significant overall survival (OS) benefits during the three-year follow-up period
.

These data have been announced at the small oral presentation at the 2021 European Society for Medical Oncology Annual Meeting (ESMO Conference) held on September 18, 2021, and updated the historical reports of PD-1/PD-L1 small cell lung cancer research.
The longest survival period
.

The CASPIAN trial reached the primary endpoint of overall survival in June 2019, and the risk of death was reduced by 27% (based on a risk rate of 0.
73 [HR]; 95% confidence interval [CI] of 0.
59-0.
91; p=0.
0047), based on These data have been approved by the regulatory authorities of many countries around the world for listing
.

The latest results of duvalizumab combined with chemotherapy showed that after a median follow-up of more than three years, compared with chemotherapy alone, the risk of death was reduced by 29% (based on a risk rate of 0.
71 [HR]; 95% confidence interval [CI ] Is 0.
60-0.
86; p=0.
0003)
.

The results include the results of a pre-exploratory analysis that among patients who received duvalizumab combined with chemotherapy, 17.
6% of patients survived within three years, compared with 5.
8% of patients who received chemotherapy alone.

.

Luis Paz Ares, MD, director of the Department of Oncology at 12 de Octubre University Hospital in Madrid, Spain, and the main investigator of the CASPIAN Phase III trial, said: “Historically, patients with extensive-stage small cell lung cancer have limited treatment options, and they still face The prognosis is extremely poor.
Therefore, the data that the number of patients who have received duvalizumab surviving after three years is three times that of the chemotherapy alone group is particularly meaningful
.

Susan Galbraith, Executive Vice President of Oncology Research and Development, AstraZeneca, said: “For patients with extensive-stage small cell lung cancer, this significant three-year improvement in survival is an unprecedented achievement
.

Duvalizumab combined with chemotherapy continues to show good tolerance consistent with the known characteristics of these drugs
.

Duvalimab combined with etoposide plus carboplatin or cisplatin has been approved in more than 55 countries (including the United States, Japan, China and the entire European Union) for the first-line treatment of extensive-stage small cell lung cancer
.

As part of the overall research and development plan, duvalizumab is also undergoing a phase III ADRIATIC study to explore the maintenance treatment of limited-stage small cell lung cancer combined with concurrent radiotherapy and chemotherapy
.

About small cell lung cancer

Lung cancer is the leading cause of cancer deaths in men and women, accounting for about one-fifth of all cancer deaths[1]
.

Small cell lung cancer is a very aggressive and fast-growing lung cancer.
It has a good initial response to chemotherapeutic drugs, but it still recurs and deteriorates rapidly [3], [4]
.
About two-thirds of SCLC patients are diagnosed with extensive-stage small cell lung cancer (ES-SCLC).
The cancer of these patients has spread to the entire lung or other parts of the body [5]
.

The prognosis of small cell lung cancer is extremely poor.
Before the approval of the immunotherapy regimen for extensive-stage small cell lung cancer, only 7% of small-cell lung cancer patients and 3% of patients with extensive-stage lung cancer were still alive within five years after diagnosis [5]
.

About the CASPIAN study

The CASPIAN study is a randomized, open-label global multicenter phase III clinical trial, enrolling 805 patients with extensive-stage small cell lung cancer who are treated as first-line treatment
.
The trial compared duvalimab with standard chemotherapy (etoposide + cisplatin or carboplatin), duvalimab + tremelimumab + chemotherapy, and chemotherapy alone
.

In both experimental groups, patients received four cycles of chemotherapy
.
In the control group, patients received up to 6 cycles of chemotherapy, and selected intracranial preventive radiotherapy according to the situation
.

The clinical trial is conducted in more than 200 medical centers in 23 countries around the world, including the United States, Europe, South America, Asia and the Middle East
.
The main endpoint of this clinical trial is overall survival
.

In June 2019, AstraZeneca announced that the scheduled interim analysis of the CASPIAN trial indicated that duvalizumab combined with chemotherapy has reached the primary end point of overall survival (OS)
.
In March 2020, the company announced that the group receiving tremelimumab had not reached its primary end point of overall survival (OS)
.

About Duvalizumab

Duvalizumab is a humanized PD-L1 monoclonal antibody that can block the binding of PD-L1 to PD-1 and CD80, thereby blocking tumor immune escape and releasing suppressed immune responses
.

In addition to extensive-stage small cell lung cancer and stage III non-resectable non-small cell lung cancer indications, duvalizumab is also approved in many countries for the treatment of previously treated patients with advanced bladder cancer
.
Since its first approval in May 2017, more than 100,000 patients have been treated with duvalizumab
.

As part of the overall research and development plan, duvalizumab is currently being explored in the form of a single drug or in combination with other anti-cancer drugs in non-small cell lung cancer, small cell lung cancer, bladder cancer, hepatocellular carcinoma, and cholangiocarcinoma (a kind of Liver cancer), esophageal cancer, gastric cancer and gastroesophageal junction cancer, cervical cancer, ovarian cancer, endometrial cancer and other solid tumors
.

About AstraZeneca's research in the field of lung cancer

AstraZeneca is working hard to bring lung cancer patients closer to cure through early disease detection and treatment, and continues to push the boundaries of science to improve drug resistance and the prognosis of advanced lung cancer
.
The company aims to bring drugs to patients who benefit the most by defining new treatment goals and researching innovative therapies
.

The company's comprehensive product portfolio covers leading lung cancer drugs and new-generation innovative drugs, including osimertinib and gefitinib; duvalizumab and tremelimumab; and trastuzumab deruxtecan and datopotamab deruxtecan developed in cooperation with Daiichi Sankyo ; Saivotinib, developed in cooperation with Hutchison Pharmaceuticals; and a product pipeline of new drugs and their combinations across various mechanisms of action
.

AstraZeneca is a founding member of the global Lung Ambition Alliance, which is committed to accelerating innovation and bringing meaningful improvements beyond treatment and treatment to lung cancer patients
.

About AstraZeneca's tumor immunotherapy research

Tumor immunotherapy is a treatment strategy that attacks tumors by activating the patient's immune system
.
Our immunotherapy drug combination is designed to overcome tumor suppression of the immune system
.
AstraZeneca invests in tumor immunotherapy and is committed to providing long-term survival benefits for new patient groups of various tumor types
.

AstraZeneca is exploring a comprehensive clinical trial project to use duvalimab monotherapy or duvalimab combined with tremelimumab and other new antibodies for a variety of tumor types, disease stages and treatment lines, and When appropriate, PD-L1 biomarkers are used to assist treatment decisions in order to provide patients with the best treatment strategy
.
In addition, our immunotherapy drugs combined with radiotherapy, chemotherapy, and small molecule targeted drugs from our company and partners will have the potential to provide new treatment strategies for a wider range of cancer patients
.

About AstraZeneca's research in the field of oncology

AstraZeneca is leading a revolution in the oncology field and is committed to providing diversified oncology treatment solutions, scientifically exploring the complexity of the oncology field, discovering, developing and providing life-changing drugs to patients
.

AstraZeneca’s oncology business focuses on the most challenging oncology diseases.
Through continuous innovation, AstraZeneca has established a diversified product portfolio and pipeline leading the entire industry, continuously promoting changes in medical practice and improving patient experience
.

AstraZeneca aims to redefine cancer treatment and conquer cancer in the future
.

About AstraZeneca

AstraZeneca is a science-first global biopharmaceutical company focusing on the R&D, production and marketing of prescription drugs for oncology, rare diseases and biopharmaceuticals (including cardiovascular, renal and metabolic, respiratory and immunology) prescription drugs
.
AstraZeneca, headquartered in Cambridge, England, has operations in more than 100 countries, and innovative drugs benefit millions of patients worldwide
.
For more information, please visit
.

About AstraZeneca China

Since entering China in 1993, AstraZeneca has insisted on the supremacy of science and innovation to meet China's growing health needs and realize the grand vision of "pioneering and innovating, benefiting patients, and becoming China's most trusted medical partner"
.
AstraZeneca’s China headquarters is located in Shanghai, and has established regional headquarters in Beijing, Guangzhou, Wuxi, Hangzhou, and Chengdu
.
It has more than 18,000 employees nationwide .
The company has invested in production bases in Wuxi and Taizhou, Jiangsu, and established a China logistics center in Wuxi
.
In China, AstraZeneca's business focus is mainly on the treatment areas most urgently needed by Chinese patients, including respiratory, cardiovascular, metabolism, tumor, digestion, and kidney diseases
.
In 2017, the China Health Internet of Things Innovation Center was launched in Wuxi, aiming to explore innovative health Internet of Things diagnosis and treatment integrated whole-course management solutions
.
In the same year, AstraZeneca and SDIC Innovations jointly established Dizhe (Jiangsu) Pharmaceutical Co.
, Ltd.
to accelerate the pace of local new drug research and development
.
In 2019, AstraZeneca announced that it will cooperate with Wuxi to build the Wuxi International Life Science Innovation Park, bringing together global wisdom and benefiting Chinese patients
.
In the same year, AstraZeneca announced the establishment of a global R&D China center in Shanghai and a joint establishment of a global medical industry fund with CICC Capital
.
In 2020, AstraZeneca and Hillhouse Ventures announced a strategic cooperation to jointly support the "Internet Hospital" project
.

statement

The use of some drugs in the study has not been approved for indications in China, and AstraZeneca does not recommend the use of any unapproved drugs
.

references:

1.
World Health Organization.
International Agency for Research on Cancer.
Lung Fact Sheet.
Available at http://gco.
iarc.
fr/today/data/factsheets/cancers/15-Lung-fact-sheet.
pdf.
Accessed September 2021 .

2.
LUNGevity Foundation.
Types of Lung Cancer.
Available at https://lungevity.
org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed September 2021.

3.
National Cancer Institute.
NCI Dictionary – Small Cell Lung Cancer.
Available at https:// Accessed September 2021.

4.
Kalemkerian GP, ​​et al.
Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? JCO Oncol Pract.
2018;14:369-370.

5.
Cancer.
Net.
Lung Cancer-Small Cell.
Available at https:// Accessed September 2021.

Source: AstraZeneca