Perioperative toripalimab regimen extends EFS in resectable stage III NSCLC
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Key takeaways:
- Results showed an HR for investigator-assessed EFS of 0.4 (95% CI, 0.277-0.56).
- Researchers observed an EFS benefit with toripalimab across subgroups.
A combination of toripalimab and perioperative chemotherapy significantly extended EFS compared with chemotherapy alone among patients with resectable stage III non-small cell lung cancer, according to results of a randomized phase 3 study.
The findings of the Neotorch study, presented during an ASCO Plenary Series session, also showed the addition of toripalimab (Junshi Biosciences) to chemotherapy appeared well tolerated, with no new safety signals and a manageable safety profile.
“The toripalimab arm also demonstrated higher [major pathologic complete response] and [pathologic complete response rates], and the OS results show a favorable trend toward toripalimab,” Shun Lu, MD, of Shanghai Lung Cancer Center and Shanghai Chest Hospital of Shanghai Jiao Tong University in China, said during a presentation.
Methodology
The Neotorch study assessed the safety and efficacy of perioperative toripalimab, an anti-PD-1 monoclonal antibody, plus platinum-based chemotherapy and toripalimab maintenance vs. chemotherapy alone among patients with newly diagnosed resectable stage II or stage III NSCLC and no EGFR/ALK alterations.
Investigator-assessed EFS and major pathologic response per blinded independent pathologic review served as the primary endpoints. Secondary endpoints included OS, DFS, and safety and feasibility of surgery.
The interim analysis of EFS included 404 patients (median age, 62 years; 91.6% men) with stage III disease randomly assigned in a 1:1 ratio to the toripalimab or placebo regimen. Median follow-up as of data cutoff Nov. 30 was 18.3 months.
Results
Results showed an HR for investigator-assessed EFS of 0.4 (95% CI, 0.27-0.56), with 2-year EFS rates of 64.7% in the toripalimab group and 38.7% in the placebo group. An analysis of EFS according to independent committee review showed similar results (2-year EFS rate, 66.7% vs. 46.1%).
Researchers observed an EFS benefit with toripalimab across subgroups, including those based on PD-L1 expression levels.
The toripalimab group also had significantly higher rates (P < .0001) of major pathologic complete response (48.5% vs. 8.4%) and pathologic complete response assessed by local pathologist (28.2% vs. 1%) and by blinded independent central review (24.8% vs. 1%). OS results showed a trend in favor of toripalimab (2-year rate, 81.2% vs. 74.3%).
The groups had similar rates of grade 3 or higher treatment-related adverse events (63.4% with toripalimab vs. 54% with placebo), fatal treatment-related adverse events (3% vs. 2%) and events leading to toripalimab/placebo discontinuation (9.4% vs. 7.4%). Immune-related adverse events occurred about twice as often in the toripalimab vs. placebo group (42.1% vs. 22.8%).
Implications
Discussant Tina Cascone, MD, PhD, of the department of thoracic-head and neck medical oncology at The University of Texas MD Anderson Cancer Center, said Neotorch could shed light on several unanswered questions amid ongoing trials of neoadjuvant and perioperative immunotherapy approaches in resectable NSCLC.
“Cross-trial comparisons, while not ideal, will continue as the perioperative treatment landscape for resectable NSCLC evolves,” she said.
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Lu S, et al. Abstract 425126. Presented at: ASCO Plenary Series: April 2023 Session; April 20, 2023.
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