Evaluating the effectiveness and safety of toripalimab in combination with chemotherapy as a first-line treatment for advanced NSCLC.

This study investigated the effectiveness and safety outcomes of toripalimab (Tuoyi) in combination with chemotherapy as a first-line treatment in patients with advanced non-small cell lung cancer (NSCLC). The data showed that toripalimab in combination with chemotherapy significantly improved overall survival and 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 tumors, chemotherapy, and radiotherapy.

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. ICI work by blocking the off switch of the immune system. Toripalimab 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. However, the effectiveness and safety of combining toripalimab with chemotherapy as a first-line treatment for advanced NSCLC are still unknown.

This study involved 465 patients with advanced NSCLC. Patients were randomly assigned into 2 groups. Group 1 included 309 patients who received toripalimab plus chemotherapy. Group 2 included 156 patients who received placebo plus chemotherapy.

The average overall survival for group 1 was not reached (exceeded the average follow-up time) versus 17.1 months for group 2. Patients in group 1 were 31% more likely to have a better survival compared to patients in group 2. This difference was statistically significant.

The average survival without cancer worsening for group 1 was 8.4 months versus 5.6 months for group 2. Patients in group 1 were 51% more likely to survive without cancer worsening compared to patients in group 2. This difference was statistically significant.

Overall, 65.7% of the patients in group 1 responded to the treatment compared to 46.2% of the patients in group 2. Serious side effects were similar between the two groups (44.8% in group 1 versus 35.3% in group 2).

This study concluded that toripalimab in combination with chemotherapy significantly improved overall survival and survival without cancer worsening with manageable side effects in patients with advanced NSCLC.

The sample size was very small. This study was funded by Shanghai Junshi Biosciences, the manufacturer of toripalimab.