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Poster Display session

61P - First-line camrelizumab (Camre) plus carboplatin (Carbo) and pemetrexed (Pem) for advanced non-squamous NSCLC: 5-yr outcomes of CameL phase III study

Date

22 Mar 2024

Session

Poster Display session

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Caicun Zhou

Citation

Annals of Oncology (2024) 9 (suppl_3): 1-53. 10.1016/esmoop/esmoop102569

Authors

C. Zhou1, G. Chen2, Y. Huang3, J. Zhou4, L. Lin5, J. Feng6, Z. Wang7, Y. Shu8, J. Shi9, Y. Hu10, Q. Wang11, Y. Cheng12, F. Wu1, J. Chen13, X. Lin14, Y. Wang15, J. Huang16, J. Cui17, Z. Wang18, X. Ma18

Author affiliations

  • 1 Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai/CN
  • 2 Harbin Medical University Cancer Hospital, Harbin/CN
  • 3 Yunnan Cancer Hospital and The Third Affiliated Hospital of Kunming Medical University and Yunnan Cancer Center, Kunming/CN
  • 4 The First Affiliated Hospital of Zhejiang University, Hangzhou/CN
  • 5 The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou/CN
  • 6 Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research and The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing/CN
  • 7 Shandong Cancer Hospital and Institute, Jinan/CN
  • 8 Jiangsu Province Hospital, Nanjing/CN
  • 9 Linyi Cancer Hospital, Linyi/CN
  • 10 General Hospital of Chinese People’s Liberation Army, Beijing/CN
  • 11 Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou/CN
  • 12 Jilin Cancer Hospital, Changchun/CN
  • 13 Hunan Cancer Hospital, Changsha/CN
  • 14 Fujian Medical University Union Hospital, Fuzhou/CN
  • 15 West China Hospital, Sichuan University, Chengdu/CN
  • 16 First Affiliated Hospital of Suzhou University, Suzhou/CN
  • 17 The First Bethune Hospital of Jilin University, Changchun/CN
  • 18 Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai/CN

Resources

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Abstract 61P

Background

In the CameL phase III study (NCT03134872), Camre + Carbo-Pem was superior to Carbo-Pem for PFS in patients (pts) with previously untreated, advanced non-squamous NSCLC without EGFR/ALK alterations. Here, we present the updated outcomes after a follow-up of approximately 5 yrs.

Methods

Pts were randomized (1:1) and received 4–6 cycles of Camre (200 mg) plus Carbo-Pem (n=205) or Carbo-Pem (n=207) Q3W, followed by maintenance Camre + Pem or Pem only. Crossover from Carbo-Pem group to Camre monotherapy was permitted after disease progression. Total Camre exposure was up to 2 yrs.

Results

As of May 28, 2023, with a median follow-up duration (i.e., time from randomization to data cutoff) of 65.2 mo (range, 59.7‒72.2), there were 139 (67.8%) deaths in the Camre + Carbo-Pem group and 157 (75.8%) in the Carbo-Pem group. Median OS was 27.1 mo (95% CI, 21.9‒31.5) with Camre + Carbo-Pem vs. 19.8 mo (95% CI, 15.9‒23.7) with Carbo-Pem (HR, 0.74 [95% CI, 0.58–0.93]; 1-sided p=0.0043). The 5-yr OS rate was also higher with Camre + Carbo-Pem compared with Carbo-Pem (31.2% [95% CI, 24.7%‒37.9%] vs. 19.3% [95% CI, 13.9%‒25.3%]). Totally, 95 (45.9%) pts crossed over from the Carbo-Pem group to receive Camre monotherapy. After adjustment for crossover, the OS benefit with Camre + Carbo-Pem was more pronounced (adjusted HR, 0.62 [95% CI, 0.49–0.79]; 1-sided p<0.0001). Among the 33 pts in the Camre + Carbo-Pem group who completed 2 yrs of Camre, ORR was 97.0%; median DoR was 59.6 mo (95% CI, 31.3–not reached); and 5-yr OS rate was 84.3% (95% CI, 66.4%–93.2%). No new safety signals were noted, and no obvious evidence of cumulative toxicity was found with long exposure to Camre.

Conclusions

Camre + Carbo-Pem as first-line therapy continued to exhibit a clinically meaningful improvement in OS over Carbo-Pem, with manageable toxicity. Pts who completed 2 yrs of Camre had durable response and remarkable OS benefit. The 5-yr updated analysis further supports Camre + Carbo-Pem as a standard-of-care for previously untreated, advanced non-squamous NSCLC without EGFR/ALK alterations.

Clinical trial identification

NCT03134872.

Legal entity responsible for the study

Jiangsu Hengrui Pharmaceuticals.

Funding

Jiangsu Hengrui Pharmaceuticals.

Disclosure

C. Zhou: Financial Interests, Personal, Other, lectures, presentations, speakers’ bureaus, manuscript writing, or educational events: Amoy Diagnostics, Boehringer Ingelheim, C-Stone, Hengrui, Innovent Biologics, Lilly China, LUYE Pharma, Merck Sharp & Dohme, Qilu, Roche, Sanofi, and TopAlliance Biosciences Inc; Financial Interests, Personal, Other, on data safety monitoring boards or advisory boards: Hengrui, Innovent Biologics, Qilu, and TopAlliance Biosciences Inc. Z. Wang, X. Ma: Financial Interests, Personal, Full or part-time Employment: Jiangsu Hengrui Pharmaceuticals. All other authors have declared no conflicts of interest.

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