Neoadjuvant nivolumab plus chemotherapy in resectable non‐small‐cell lung cancer in Japanese patients from CheckMate 816

• Published in: Cancer science 2024-02, Vol.115 (2), p.540-554
• Main Authors: Mitsudomi, Tetsuya, Ito, Hiroyuki, Okada, Morihito, Sugawara, Shunichi, Shio, Yutaka, Tomii, Keisuke, Okami, Jiro, Sakakura, Noriaki, Kubota, Kaoru, Takamochi, Kazuya, Atagi, Shinji, Tsuboi, Masahiro, Oizumi, Satoshi, Ikeda, Norihiko, Ohde, Yasuhisa, Ntambwe, Ives, Mahmood, Javed, Cai, Junliang, Tanaka, Fumihiro
• Format: Article
• Language: English
• Subjects: Cancer therapies; Chemotherapy; Immunotherapy; Japanese; Lung cancer; Lymphatic system; Metastasis; minimally invasive surgical procedure; neoadjuvant therapy; nivolumab; Non-small cell lung carcinoma; Original; Patients; Safety; Small cell lung carcinoma; Statistical analysis; Surgery; Surgical outcomes
• ISSN: 1347-9032; 1349-7006
• DOI: 10.1111/cas.16030

In the open‐label, phase III CheckMate 816 study (NCT02998528), neoadjuvant nivolumab plus chemotherapy demonstrated statistically significant improvements in event‐free survival (EFS) and pathological complete response (pCR) versus chemotherapy alone in patients with resectable non‐small‐cell lung cancer (NSCLC). Here we report efficacy and safety outcomes in the Japanese subpopulation. Patients with stage IB–IIIA, resectable NSCLC were randomized 1:1 to nivolumab plus chemotherapy or chemotherapy alone for three cycles before undergoing definitive surgery within 6 weeks of completing neoadjuvant treatment. The primary end‐points (EFS and pCR) and safety were assessed in patients enrolled at 16 centers in Japan. Of the Japanese patients randomized, 93.9% (31/33) in the nivolumab plus chemotherapy arm and 82.9% (29/35) in the chemotherapy arm underwent surgery. At 21.5 months' minimum follow‐up, median EFS was 30.6 months (95% confidence interval [CI], 16.8–not reached [NR]) with nivolumab plus chemotherapy versus 19.6 months (95% CI, 8.5–NR) with chemotherapy; hazard ratio, 0.60 (95% CI, 0.30–1.24). The pCR rate was 30.3% (95% CI, 15.6–48.7) versus 5.7% (95% CI, 0.7–19.2), respectively; odds ratio, 7.17 (95% CI, 1.44–35.85). Grade 3/4 treatment‐related adverse events were reported in 59.4% versus 42.9% of patients, respectively, with no new safety signals identified. Neoadjuvant nivolumab plus chemotherapy resulted in longer EFS and a higher pCR rate versus chemotherapy alone in Japanese patients, consistent with findings in the global population. These data support nivolumab plus chemotherapy as a neoadjuvant treatment option in Japanese patients with resectable NSCLC. We report efficacy and safety outcomes in the Japanese subpopulation of patients with resectable non‐small‐cell lung cancer (NSCLC) in the global, randomized, open‐label, phase III CheckMate 816 study (NCT02998528). At a minimum follow‐up of 21.5 months, neoadjuvant nivolumab plus chemotherapy versus chemotherapy alone resulted in longer event‐free survival (median, 30.6 [95% CI, 16.8–not reached] vs. 19.6 [95% CI, 8.5–not reached] months) and a higher pathological complete response rate (30.3% [95% CI, 15.6–48.7] vs. 5.7% [95% CI, 0.7–19.2]) in Japanese patients, consistent with findings in the global population; no new safety signals were identified. Results support the use of neoadjuvant nivolumab plus chemotherapy in Japanese patients with resectable NSCLC.