In a Chinese phase II trial (TD-FOREKNOW) reported in JAMA Oncology, Lei et al found that the addition of neoadjuvant camrelizumab to platinum-based chemotherapy resulted in a higher pathologic complete response rate among patients with resectable stage IIIA or IIIB (T3N2) non–small cell lung cancer (NSCLC).
Study Details
In the open-label trial, 88 patients (modified intent-to-treat population; those who received study treatment) from two centers were randomly assigned between April 2020 and January 2022 to receive camrelizumab at 200 mg every 3 weeks for three cycles plus chemotherapy (n = 43; nab-paclitaxel at 130 mg/m2 and cisplatin at 75 mg/m2, carboplatin area under the curve = 5, or nedaplatin at 100 mg/m2) or chemotherapy alone (n = 45) followed by surgery after 4 to 6 weeks.
The primary endpoint was pathologic complete response rate.
Key Findings
Pathologic complete response was achieved in 14 (32.6%, 95% confidence interval [CI] = 19.1%–48.5%) of 43 patients in the camrelizumab group vs 4 (8.9%, 95% CI = 2.5%–21.2%) of 45 in the control group (odds ratio [OR] = 4.95, 95% CI = 1.35–22.37, P = .008).
Major pathologic response was observed in 28 (65.1%, 95% CI = 49.1%–79.0%) of 43 patients in the camrelizumab group vs 7 (15.6%, 95% CI = 6.5%–29.5%) of 45 in the control group (OR = 10.13, 95% CI = 3.32–32.76, P < .001). Radiographic objective response was observed in 72.1% (95% CI = 56.3%–84.7%) of the camrelizumab group vs 53.3% (95% CI = 37.9%–68.3%) of the control group (OR = 2.26, 95% CI = 0.85–6.08, P = .08); complete response was observed in 25.6% vs 8.9%.
At a median follow-up of 14.1 months, median event-free survival and median disease-free survival were not reached in either group.
Grade ≥ 3 treatment-related adverse events occurred in 25.6% of the camrelizumab group vs 11.1% of the control group; the most commonly reported adverse events were decreased white blood cell count (14.0% vs 4.4%) and decreased neutrophil count (7.0% vs 11.1%). There were no treatment-related deaths.
The investigators concluded, “This randomized clinical trial found that among patients with resectable stage IIIA or IIIB (T3N2) NSCLC, camrelizumab plus chemotherapy, compared with chemotherapy alone, significantly improved the pathologic complete response rate with manageable toxic effects.”
Tao Jiang, MD, and Xiaolong Yan, MD, of the Department of Thoracic Surgery, The Second Affiliated Hospital of Air Force Medical University, Xi’an, are the corresponding authors for the JAMA Oncology article.
Disclosure: For full disclosures of the study authors, visit jamanetwork.com.
