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Adding toripalimab to chemotherapy slows the growth of advanced non-small cell lung cancer and helps patients live longer

Posted on March 19, 2022

Who does this study affect:

People with untreated, advanced non-small cell lung cancer (NSCLC).

What did this study find:

Results from the phase III CHOICE-01 clinical trial in China show that adding the immunotherapy drug toripalimab (TuoYi) to chemotherapy in people with untreated, advanced NSCLC slowed cancer growth and helped them live longer, particularly if their tumors had certain biomarkers, which are mutations, genes, or patterns found in a tumor’s DNA.

NSCLC is the most common kind of lung cancer, and treatment for advanced NSCLC often includes immunotherapy. Toripalimab targets the PD-1 protein expressed on immune cells. PD-1 interacts with a protein called PD-L1. PD-L1 helps cancer cells hide from the immune system, and people with advanced NSCLC often have higher levels of PD-L1. By blocking the interaction between the PD-1 and PD-L1 proteins, toripalimab helps immune cells find and destroy cancer cells.

This study included 465 Chinese participants with untreated advanced NSCLC with no specific mutations, or changes, in the epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genes. Of the participants, 309 received chemotherapy with toripalimab and 156 received chemotherapy with a placebo. The median age of the participants was 63 in the toripalimab combination group and 61 in the chemotherapy plus placebo group, and the majority of participants in both groups were men.

The study found that, regardless of PD-L1 expression levels, adding toripalimab to chemotherapy stopped the cancer from growing for a median of 8.4 months, compared with 5.6 months for chemotherapy alone. At 1 year, the cancer had stopped growing in nearly 37% of participants receiving toripalimab plus chemotherapy, compared with about 17% of participants who received chemotherapy plus placebo. The toripalimab combination also helped patients live longer than those who received chemotherapy alone, but the researchers did not have enough data to calculate the difference between the 2 treatments.

The researchers also found that the toripalimab combination worked better if the cancer cells had a high overall number of gene mutations, which is called high tumor mutational burden. Among participants with cancer with a high tumor mutational burden who received toripalimab plus chemotherapy, the cancer stopped growing for a median of 13.1 months, compared with 5.5 months among those with a high tumor mutational burden who received chemotherapy alone.

Serious side effects occurred at similar rates in both groups. The most common side effects for each treatment were blood-related problems. However, more participants in the toripalimab combination group stopped treatment because of the side effects (about 14% of participants) than those receiving chemotherapy plus placebo (about 3% of participants). Serious side effects led to death among 5.5% of participants receiving the toripalimab combination, compared with 2.6% of participants in the other group.

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