Abstract 14P
Background
NIVO is approved in China as 2L tx for advanced NSCLC via weight-based 60-minute (min) infusion. We further investigated the safety and efficacy of the more convenient flat dosing via a 30-min infusion in pts with advanced NSCLC, including those with hepatis B virus (HBV) due to its prevalence in China.
Methods
Asian (mostly Chinese) pts with previously treated advanced NSCLC received NIVO 240 mg over 30 min every 2 weeks (Q2W) for up to 2 years (y). High-grade (G3–5) select tx-related adverse events (sTRAE) were analysed by HBV infection status (primary endpoint). Secondary and exploratory endpoints included efficacy and patient-reported outcomes (PROs) among pt subgroups.
Results
Overall, 400 pts were treated: 383 non-HBV infected; 34 EGFR positive (+); 168 and 174 had PD-L1 ≥1% and <1%, respectively. Median (med) age was 61 y. Most pts were male (78.5%), had non-squamous histology (65.8%), and stage IV (77.3%) disease. Minimum follow-up (f/u) was 35.4 months (mo) and med tx duration was 3.24 mo. At a med f/u of 37.6 mo, occurrence of G3–4 sTRAE was low regardless of HBV status. No G5 sTRAEs were reported. Med overall survival was 14.2 (12.3–18.1) and 22.3 (10.0–NA) mo for non-HBV and HBV-infected, 19.3 (11.2–31.7) and 13.7 (11.5–18.1) mo for EGFR+ and negative, and 19.3 (12.9–23.5) and 13.3 (10.9–17.7) mo for PD-L1 ≥1% and <1% subgroups. No notable changes from baseline were observed in PROs among those subgroups. Table: 14P
| Non-HBVN=383 | HBVN=17 | |
| G3−4 sTRAEs, n (%) | ||
| Endocrine | 3 (0.8) | 1 (5.9) |
| Gastrointestinal | 2 (0.5) | 0 |
| Hepatic | 8 (2.1) | 0 |
| Pulmonary | 5 (1.3) | 0 |
| Renal | 2 (0.5) | 0 |
| Skin | 7 (1.8) | 1 (5.9) |
| Hypersensitivity | 0 | 0 |
| Efficacy | ||
| mOS, mo (95% CI) | 14.16 (12.25−18.07) | 22.31 (10.02−NA) |
| 2-year OS rate, % (95% CI) | 34 (29−39) | 44 (19−67) |
| mPFS, mo (95% CI) | 3.61 (2.33−3.75) | 2.04 (1.64−10.22) |
| 2-year PFS rate, % (95% CI) | 10 (07−13) | 10 (01−34) |
| ORR, % (95% CI) | 14.88 (11.47−18.85) | 17.65 (3.80−43.43) |
| DOR, mo (95% CI) | 19.38 (11.04−24.97) | NA (8.15−NA) |
Conclusions
NIVO 240 mg 30-min infusion Q2W was well-tolerated in Asian pts with previously treated advanced NSCLC, regardless of HBV, EGFR and PD-L1 status. Results were consistent with CheckMate 078 study. Data should be interpreted with caution given the small subgroup sample size.
Clinical trial identification
Protocol CA209870.
Editorial acknowledgement
Medical writing assistance was provided by Alice Carruthers BSc (Hons), PhD, and Julia Ventura BScBiotech, MSc, of Nucleus Global, funded by Bristol Myers Squibb.
Legal entity responsible for the study
Bristol Myers Squibb Company.
Funding
Bristol Myers Squibb.
Disclosure
S. Lu: Financial Interests, Personal and Institutional, Sponsor/Funding, Lu S disclosed the Grants from AstraZeneca, Hutchison, Bristol Myers Squibb, Heng Rui Beigene and Roche, Hansoh, and Consulting fee from AstraZeneca, Pfizer, Boehringer Ingelheim, Hutchison MediPharma, Simcere, ZaiLab, GenomiCare, Yuhan Corporation, PrIME Oncology, Menarini, InventisBio Co. Ltd., and Roche, and Payment or honoraria from AstraZeneca, Roche, Hansoh, Hengrui Therapeutics, and Advisory Board for Roche, Regenron, AstraZeneca, Xcovery Holding, and leadership or fiduciary role in Chinese Lung Cancer Associate, CSCO.: Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University. Y. Cheng: Financial Interests, Institutional, Sponsor/Funding: Jilin Cancer Hospital. J. Zhou: Financial Interests, Institutional, Sponsor/Funding: First Affi liated Hospital, College of Medicine, Zhejiang University. M. Wang: Financial Interests, Institutional, Sponsor/Funding: Peking Union Medical College Hospital. J. Zhao: Financial Interests, Institutional, Sponsor/Funding: Beijing Cancer Hospital. B. Wang: Financial Interests, Institutional, Sponsor/Funding: Jinan Military General Hospital. G. Chen: Financial Interests, Institutional, Sponsor/Funding: Affiliated Cancer Hospital of Harbin Medical University. J. Feng: Financial Interests, Institutional, Sponsor/Funding: Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital. Z. Ma: Financial Interests, Institutional, Sponsor/Funding: Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital,. L. Wu: Financial Interests, Institutional, Sponsor/Funding: Hunan Cancer Hospital (The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University). C. Wang: Financial Interests, Institutional, Sponsor/Funding: Tianjin Medical University Cancer Institute & Hospital. K. Ma: Financial Interests, Institutional, Sponsor/Funding: The First Hospital of Jilin University. S. Zhang: Financial Interests, Institutional, Sponsor/Funding: Beijing Chest Hospital. J. Liang: Financial Interests, Institutional, Sponsor/Funding: Peking University International Hospital. Y. Song: Financial Interests, Institutional, Sponsor/Funding: Nanjing General Hospital. J. Wang: Financial Interests, Institutional, Sponsor/Funding: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences. Y. Wu: Financial Interests, Personal and Institutional, Invited Speaker, Wu YL disclosed personal fees from Honorarium received from AstraZeneca, Beigen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, MSD, Pfizer, Roche, Sanofi, grants from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, outside the submitted work. : Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital & Guangdong Academy of Medical Sciences. A. Li: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Bristol Myers Squibb Company. Y. Huang: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. J. Chang: Financial Interests, Institutional, Sponsor/Funding: Shanghai Cancer Center Fudan University.