(Lung Cancer) Is Sugemalimab Effective?
(Lung Cancer) Is Sugemalimab Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
(Lung Cancer) Is Sugemalimab Effective?
- January 31, 2022
- 1 min read
On January 11, 2022, Qing Zhou et al. from Guangdong Provincial People's Hospital published results in The Lancet on the efficacy and safety of Sugemalimab (not yet approved in Japan) in the GEMSTONE-301 Phase III clinical trial for unresectable stage III non-small cell lung cancer patients after chemoradiotherapy.
The GEMSTONE-301 Phase III clinical trial was a randomized, double-blind, controlled study that enrolled unresectable stage III non-small cell lung cancer patients (N=381) who were randomized in a 2:1 ratio into the Sugemalimab group (1200 mg every three weeks, N=255) and the placebo group (N=126), with a maximum treatment duration of 24 months. The primary endpoint was progression-free survival, and secondary endpoints included safety.
At a median follow-up of 14.3 months for the Sugemalimab group / 13.7 months for the placebo group, the primary endpoint median progression-free survival was 9.0 months for the Sugemalimab group / 5.8 months for the placebo group, with Sugemalimab demonstrating a significant 36% reduction in the risk of death (progression-free survival).
Regarding safety, the incidence of grade 3-4 adverse events was 9% (N=22/255) for the Sugemalimab group / 6% (N=7/126) for the placebo group. The most common adverse event was pneumonia or immune-related pneumonitis at 3% (N=7) for the Sugemalimab group / less than 1% (N=1) for the placebo group.
The incidence of serious adverse events was 15% (N=38) for the Sugemalimab group / 10% (N=12) for the placebo group. Treatment-related deaths were 4 in the Sugemalimab group / 1 in the placebo group.
Based on the GEMSTONE-301 results, Qing Zhou et al. stated that Sugemalimab improved progression-free survival in unresectable stage III non-small cell lung cancer patients after chemoradiotherapy and may be an effective treatment option for these patients.
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00630-6/fulltext#%20
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※ The drug Sugemalimab mentioned in this article is currently not approved in Japan. This content is only a summary of published research. To learn about the options that can be considered now, we suggest talking first with your attending physician.