Evaluating the effectiveness and safety of sugemalimab plus platinum-based chemotherapy for first-line treatment of metastatic squamous and non-squamous non-small cell lung cancer.

This study investigated the effectiveness and safety outcomes of sugemalimab (Cejemly) in combination with platinum-based chemotherapy as first-line treatment for patients with metastatic squamous (Sq) and non-squamous (non-Sq) non-small cell lung cancer (NSCLC). The data showed that sugemalimab plus platinum-based chemotherapy combination 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. There are 2 main types of NSCLC, squamous (Sq) and non-Sq. In SqNSCLC, the cancer forms in the thin, flat cells lining the inside of the lung. Non-SqNSCLC includes other types of NSCLC such as adenocarcinoma or large-cell lung cancer. Standard treatment for advanced NSCLC involves surgical removal of tumors, chemotherapy, and radiotherapy.

Standard chemotherapy regimens usually contain drugs such as carboplatin (Paraplatin), which belong to the class of drugs called platinum drugs. These chemotherapeutic drugs inhibit the formation of new cells, thus delaying tumor growth and spread.

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 combining sugemalimab with platinum-based chemotherapy for patients with metastatic squamous and non-squamous NSCLC are still unknown.

This study involved 479 patients with squamous and non-squamous NSCLC. Patients were randomly assigned into 2 groups. Group 1 included 320 patients who received sugemalimab plus platinum-based chemotherapy combination. Group 2 included 159 patients who received a placebo plus platinum-based chemotherapy combination. The average follow-up time was 17.8 months.

The average survival without cancer worsening was 9 months in group 1 compared to 4.9 months in group 2. Sugemalimab plus platinum-based chemotherapy combination reduced the risk of cancer progression by 52% compared to placebo plus platinum-based chemotherapy combination. After 1 year, 36.4% of patients in group 1 were alive without cancer worsening compared to 14.8% of patients in group 2. At 1 year, 72.4% of patients in group 1 were alive compared to 62% in group 2. 

Treatment-related side effects were similar between the 2 groups. The most common side effects were low white blood cell counts, low platelet counts, and low red blood cell counts.

This study concluded that sugemalimab plus platinum-based chemotherapy as first-line treatment significantly increased the survival without cancer worsening with manageable side effects in patients with metastatic squamous and non-squamous 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. A longer follow-up is necessary to evaluate the benefit of sugemalimab on overall survival.