A phase III study has shown that the addition of an investigational anti-PD-1 drug to perioperative chemotherapy has resulted in improved event-free survival in patients with resectable, stage III non-small cell lung cancer (NSCLC). The study, called Neotorch, found that patients who received toripalimab had a greater benefit and higher rates of major pathologic response and pathologic complete response compared to the placebo group, with a favorable trend in overall survival.
Consistent EFS Results
In the Neotorch trial, 404 patients receiving perioperative chemotherapy were randomly assigned to receive neoadjuvant platinum-based chemotherapy plus either toripalimab or placebo every 3 weeks for three cycles. After surgery, patients received one postsurgical cycle of combination therapy, followed by maintenance therapy with toripalimab or placebo every 3 weeks for up to 13 cycles. The median investigator-assessed event-free survival (EFS) was not reached in patients assigned to toripalimab, as compared with 15.1 months for those in the placebo arm. The EFS results, at a median follow-up of 18.3 months, were consistent across key subgroups, with a greater benefit observed in patients with stage IIIB disease, PD-L1 positive tumors, or squamous cell histology.
Optimal Number of Cycles?
The study has raised questions about the optimal number of cycles of chemoimmunotherapy needed in this setting. While two to four cycles of neoadjuvant chemoimmunotherapy have been used in most trials, there is no consensus on the optimal number and sequence. The Neotorch trial tested four cycles of chemoimmunotherapy, but with different perioperative schedules that may impact long-term survival outcomes.
Comparable Results
Despite the different schedules and/or numbers of cycles of chemoimmunotherapy used in the current study, the major pathologic response and pathologic complete response rates were comparable to those in other phase III randomized perioperative trials. The study also found that the investigational drug had higher rates of adverse events compared to the placebo group.
The results of the Neotorch trial have shown that the addition of toripalimab to perioperative chemotherapy has improved event-free survival in patients with resectable, stage III non-small cell lung cancer. The study has raised questions about the optimal number of cycles of chemoimmunotherapy needed in this setting, but the major pathologic response and pathologic complete response rates were comparable to those in other phase III randomized perioperative trials. The investigational drug had higher rates of adverse events compared to the placebo group, but the results have shown a favorable trend in overall survival.
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