JAMA: The world's first clinical study of small cell lung cancer immunotherapy on JAMA, the positive results of Henlius H drug combined with chemotherapy for first-line treatment of extensive-range small cell lung cancer were released

On September 27, 2022, ASTRUM-005, an international multicenter research led by Professor Cheng Ying of Jilin Provincial Cancer Hospital, was published in the Journal of the American Medical Association (JAMA), one of the world's four major medical journals, becoming the world's first clinical research on
small cell lung cancer immunotherapy in the main journal of JAMA.

ASTRUM-005 research is Fuhong Henlius self-developed anti-PD-1 monoclonal antibody H drug Hans-like? The Phase III clinical research of (slullizumab) combined with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), after Professor Cheng Ying's first report at the 2022 ASCO Annual Meeting, has attracted widespread attention from global peers, and now it has once again appeared on the international top academic stage, reflecting the high recognition of the international academic community, highlighting the wisdom of Chinese researchers and the world-class independent innovation strength and clinical operation ability
in the field of biomedicine.

Professor Cheng Ying

Professor Cheng Ying, the corresponding author and first author, the main investigator of the ASTRUM-005 study, and the Jilin Provincial Cancer Hospital, said: The combination of slulizumab in the ASTRUM-005 study obtained the longest OS result of the first-line immune treatment of generalized small cell lung cancer, which can prolong the survival of 4.

OS reached 15.

Small cell lung cancer (SCLC), which accounts for about 15% of the total number of lung cancers, is the most aggressive subtype of lung cancer, divided into limited-stage small cell lung cancer (LS-SCLC) and generalized stage small cell lung cancer (ES-SCLC
).

ASTRUM-005 is a randomized, double-blind, international multicenter, phase III clinical study comparing the clinical efficacy and safety of H-drug combined chemotherapy and placebo combination chemotherapy in patients with ES-SCLC who have not received previous treatment, and has opened 128 trial centers in China, Turkey, the European Union, Poland, Georgia and other countries, of which 114 trial centers have subjects participating in screening, with a total of 585 participants, about 31.

As of October 22, 2021, the median follow-up time was 12.

It is expected to benefit patients around the world and fill the clinical gap in the next five years

The success of the ASTRUM-005 study is a major breakthrough in the treatment of ES-SCLC with PD-1 inhibitors, based on which the State Drug Administration (NMPA) has accepted a marketing application for the first-line treatment of ES-SCLC indications for H drugs; The CSCO Guidelines for the Diagnosis and Treatment of Small Cell Lung Cancer (2022 Edition) also added slulizumab combined with chemotherapy EC as a first-line treatment recommendation for ES-SCLC, providing more options
for first-line ES-SCLC treatment in China.

Not only that, H drugs for the treatment of SCLC were certified as orphan drugs by the U.

Original Source:

Ying Cheng， et al.