Evaluating the effectiveness and safety of sugemalimab after chemoradiotherapy in patients with unresectable stage III non-small cell lung cancer.

This study investigated the effectiveness and safety of sugemalimab (Cejemly) after treatment with concurrent or sequential chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC). The data showed that sugemalimab significantly increased the survival without cancer worsening with manageable side effects in these patients.

NSCLC is the most common form of lung cancer. It is responsible for around 85% of all lung cancer cases worldwide. Standard treatment for advanced NSCLC involves surgical removal of solid tumors and chemoradiotherapy (CRT). CRT involves administering both chemotherapy (CT) and performing radiation therapy (RT). There are two strategies for delivering CRT in NSCLC.

The first strategy is called concurrent CRT (cCRT). This involves administering both CT and RT during the same treatment period. The second approach is called sequential CRT (sCRT). This involves first administering CT. Once completed, RT is performed. This can also mean giving RT first followed by CT. sCRT may be better tolerated than cCRT in many patients with unresectable stage III NSCLC.

Immunotherapy has been found to be effective in advanced NSCLC. Immune checkpoint inhibitors are a type of immunotherapy used to treat a wide variety of cancers. Tumor cells try to avoid death by switching off our immune system. ICIs work by blocking the off switch of the immune system. Sugemalimab is an ICI that works by inhibiting (blocking) PD-1, an important protein in the immune system. This inhibition triggers the immune system to attack tumor cells and kills them. ICI plus chemotherapy has been shown to be an effective first-line treatment for patients with metastatic NSCLC. However, the effectiveness and safety of sugemalimab after treatment with cCRT or sCRT in patients with unresectable stage III NSCLC are still unknown.

This study involved 381 patients with unresectable stage III NSCLC. Patients were randomly assigned into 2 groups after treatment with cCRT or sCRT. Group 1 included 255 patients who received sugemalimab. Group 2 included 126 patients who received placebo. The average follow-up time was 14.3 months for group 1 and 13.7 months for group 2.

The average survival without cancer worsening was 9 months in group 1 compared to 5.8 months in group 2. Sugemalimab reduced the risk of cancer progression by 36% compared to placebo. After 1 year, 45.4% of patients in group 1 were alive without cancer worsening compared to 25.6% of patients in group 2.

Treatment-related and serious side effects were similar between the 2 groups. The most common side effect was inflammation of the lung tissue.

This study concluded that sugemalimab significantly increased the survival without cancer worsening with manageable side effects after treatment with cCRT or sCRT in patients with unresectable stage III NSCLC.

This study was funded by CStone Pharmaceuticals, the manufacturers of sugemalimab. This study was conducted only at institutions in China. The follow-up period was too short to fully evaluate the benefit of sugemalimab on overall survival.  Data for PD-L1 expression is not included in this study.