The world's first clinical study of immunotherapy for small cell lung cancer published in the international journal JAMA, and the positive results of H drug Hans-shaped (R) combined with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer were released

On September 27, 2022, the ASTRUM-005 study, an international multicenter study led by Professor Cheng Ying, was published online in the Journal of the American Medical Association (JAMA, impact factor: 157.
3), one of the world's top four medical journals, becoming the world's first clinical study
of small cell lung cancer immunotherapy in the main issue of JAMA.
ASTRUM-005 study is a phase III clinical study of anti-PD-1 monoclonal antibody H drug independently developed by Henlius Hans-form ^® (serplulimab) combined with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), after Professor Cheng Ying reported the results for the first time at the 2022 ASCO Annual Meeting, which attracted widespread attention from global peers, and now has once again appeared on the international top academic stage, reflecting the high recognition of the international academic community.
It demonstrates the intelligence of Chinese researchers and the world-class independent innovation strength and clinical operation ability
in the field of biomedicine.

Professor Cheng Ying of Jilin Cancer Hospital and corresponding author and first author of ASTRUM-005 study, principal investigator of the ASTRUM-005 study, said: "The combination chemotherapy of serplulimab in ASTRUM-005 obtained the longest OS results of the current first-line immune therapy for extensive-stage small cell lung cancer, which can prolong survival by 4.
5 months compared with chemotherapy, the lowest HR to date: 0.
63, and the results of short-term and long-term efficacy are consistent, and it has a good safety profile
。 This study is the first to confirm that PD-1 inhibitors combined with chemotherapy can also improve the survival of extensive-stage small cell lung cancer, which is also the first international multi-center clinical phase III study for immunotherapy for ES-SCLC indications led by our Chinese investigators, which fully demonstrates the strength of
Chinese researchers.
Thanks to all the patients and their families who contributed to this study, as well as to other researchers, this study has opened a new page for first-line immunotherapy for extensive-stage small cell lung cancer and brought good news
to the majority of patients.
"

OS reached 15.
4 months, setting a new record for overall survival of first-line small cell lung cancer

Small cell lung cancer (SCLC) accounts for about 15% of the total number of lung cancers and is the most aggressive subtype of lung cancer, divided into limited-stage small cell lung cancer (LS-SCLC) and ES-SCLC
.
What they have in common is high degree of malignancy, early metastasis, rapid disease progression, and poor
overall prognosis.
In recent years, the emergence of immune checkpoint inhibitors has brought new hope for the treatment of ES-SCLC, and anti-PD-L1 monoclonal antibody combined with chemotherapy has been recommended by authoritative guidelines at home and abroad as the first-line treatment plan for ES-SCLC, which has improved the overall survival of patients to a certain extent compared with chemotherapy, but the degree of improvement is relatively limited, and more effective treatment options
are still needed.

ASTRUM-005 is a randomized, double-blind, international multicenter, phase III clinical study comparing the clinical efficacy and safety of H drug combined with chemotherapy and placebo combined chemotherapy in patients with ES-SCLC who have not received prior treatment, with a total of 128 trial centers in China, Turkey, the European Union, Poland, Georgia and other countries, of which 114 trial centers have participants participating in the screening, and a total of 585 subjects are enrolled, about 31.
5% of whom are white
。 As of October 22, 2021, the median follow-up of the serplulimab group (n=389) and placebo group (n=196) was 12.
3 months
.
The median OS in the serplulimab and placebo groups was 15.
4 months (95% CI 13.
3–NE) and 10.
9 months (95% CI 10.
0–14.
3), and the risk ratio (HR) was 0.
63 (95% CI 0.
49–0.
82; p<0.
001),
respectively.
The 24-month overall survival rates for both groups were 43.
1% and 7.
9%,
respectively.
The median PFS assessed by the Independent Imaging Evaluation Committee (IRRC) according to RECIST v1.
1 in the serplulimab and placebo groups was 5.
7 and 4.
3 months, respectively (HR 0.
48, 95% CI 0.
38–0.
59).

In terms of safety, the incidence of immune-related adverse events (irAEs) in the serplulimab group was similar
to that of approved PD-1/PD-L1 monoclonal antibodies.

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 National Medical Products Administration (NMPA) has accepted a marketing application for the first-line treatment of ES-SCLC for H drugs; The Guidelines for the Diagnosis and Treatment of CSCO Small Cell Lung Cancer (2022 Edition) also added serplulimab combined with chemotherapy EC regimen as the first-line treatment recommendation for ES-SCLC, providing more options
for the first-line treatment of ES-SCLC in China.
Not only that, drug H for the treatment of SCLC was designated
as an orphan drug by the US Food and Drug Administration (FDA) in April 2022.
At the same time, based on the positive feedback from the FDA on the marketing application for the treatment of ES-SCLC for the treatment of H drugs and the discussion results of the FDA Class C consultation meeting, the company will initiate a bridging clinical trial in the United States and intends to submit the corresponding marketing application
in the United States by Q1 2024.
At present, no anti-PD-1 monoclonal antibody for the first-line treatment of SCLC has been approved in the world, and H drug is expected to become the world's first anti-PD-1 monoclonal antibody for the first-line treatment of SCLC, filling the clinical gap
of PD-1 inhibitors in the first-line treatment of small cell lung cancer in the next five years.

In the future, Henlius will continue to innovate and take clinical needs as the guide, and continue to efficiently provide more affordable and better-effective treatment options
for patients around the world.