Cemiplimab new breakthrough: the total survival of 2 times the effect of single-drug treatment is still strong

This sBLA is based on an open label, random, multi-center Phase III EMPOWER-Lung 1 study.
study included 710 patients with local late stage IIIB/C NSCLC who were not suitable for surgical excision or existing chemotherapy programmes, who progressed after receiving existing course of chemotherapy, or patients with previously untreated metastasis phase ≥ IV NSCLC;
All patients were randomly divided into two groups in a 1:1 ratio, receiving Cemiplimab 350 mg (intravenous drug, q3w) for 108 weeks, or the platinum-containing two-drug chemotherapy option chosen by the researchers, which lasted 4-6 cycles (accompanied or not accompanied by pythons to maintain chemotherapy).
allow cross-group treatment if any group of patients' condition deteriorates significantly.
second interim analysis in March 2020, 355 and 342 patients were treated with Cemiplimab and chemotherapy, respectively.
73.9 per cent (150/203) of patients with disease progression in the chemotherapy group received Cimiplimab cross-treatment, and 31.6 per cent (50/158) of patients in the Cemiplimab group received chemotherapy on top of Cemiplimab treatment.
283 and 280 patients received Cemiplimab and chemotherapy treatment, respectively, in the PD-L1≥50% intentional therapy (ITT) population.
88 of these cases did not follow the group entry standard for PD-L1 testing before August 2018, and the PD-L1≥50% was detected again, and 475 cases followed the group entry standard for PD-L1≥50% after August 2018≥
in the ITT population, the middle follow-up time was 13.1 months for both the Cemiplimab group and the chemotherapy group, with a significant increase in OS in the Cemiplimab group (22.1 vs 14.3 months) and a 32% reduction in the risk of death (HR s 0.68; 95% CI:0.53-0.87, p s 0.002).
in the PD-L1≥50% ITT population, the middle follow-up time in the Cemiplimab and chemotherapy groups was 10.8 and 10.2 months, respectively, and OS was not reached and 1 At 4.2 months, the former had a 43% reduced risk of death (HR s 0.57; 95% CI: 0.42-0.77, p s 0.002).
of the second secondary study, in the ITT population, the Cemiplimab group had a significant increase in PFS (6.2 vs 5.6 months) and a 41% reduced risk of disease progression (HR s 0.59; 95% CI: 0.49-0.72, p<0.001).
PD-L1≥50% of ITT population, the medium PFS was 8.2 months and 5.7 months, respectively, and the risk of disease progress was reduced by 46% (HR s 0.54; 95% CI:0.43-0.68, p<0.001).
For patients with advanced non-small cell lung cancer with PD-L1 expression ≥50% and no target mutation, the use of PD-1/PD-L1 inhibitors or combination chemotherapy alone is the preferred treatment.
, choosing the least toxic and most effective treatment remains a challenge.
50% of patients ≥ PD-L1 need additional treatment options to improve survival and optimize chemotherapy-free options.
Cemiplimab is a highly affinity, highly potent human-based PD-1 inhibitor that works by targeting cell pathfectal PD-1 (a protein found in human immune cells and certain cancer cells).
the drug helps the body's immune system fight cancer cells by blocking the path.
EMPOWER-Lung 1 study data provide a theoretical basis for Cemiplimab as a PD-L1 expression ≥50% of patients with advanced NSCLC a new first-line single-drug treatment option.
Cemiplimab is currently being developed jointly within the framework of a global partnership between Regenerative Andi and Sanofi for the treatment of a wide range of cancers.
a wide range of clinical programs at Cemiplimab focus on hard-to-treat cancers, including skin, cervical, solid and blood cancers.
expect more breakthroughs from Cemiplimab.
: 1.; 2.Migden, M.R., et al., PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med, 2018. 3.Rogers, H.W., et al., Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012. JAMA Dermatol, 2015. 151(10): p. 1081-6. 4.Stratigos, A., et al., Diagnosis and treatment of invasive squamous cell carcinoma of the skin: European consensus-based interdisciplinary guideline. Eur J Cancer, 2015. 51(14): p. 1989-2007.