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Proffered Paper session

96O - Camrelizumab or placebo plus carboplatin and paclitaxel as first-line treatment for advanced squamous NSCLC (CameL-sq): A randomized, double-blind, multicenter, phase III trial

Date

25 Mar 2021

Session

Proffered Paper session

Presenters

Caicun Zhou

Citation

Journal of Thoracic Oncology (2021) 16 (suppl_4): S748-S802.

Authors

C. Zhou1, S. Ren2, J. Chen3, X. Xu4, Y. Cheng5, G. Chen6, Y. Pan7, Y. Fang8, Q. Wang9, Y. Huang10, W. Yao11, R. Wang12, X. Li13, W. Zhang14, Y. Zhang15, S. Hu16, R. Guo17, Z. Yang18, L. Wang18

Author affiliations

  • 1 Shanghai Pulmonary Hospital, Tongji University, 200433 - Shanghai/CN
  • 2 Shanghai Pulmonary Hospital, Tongji University, Shanghai/CN
  • 3 Hunan Cancer Hospital, Changsha/CN
  • 4 Northern Jiangsu People's Hospital, Yangzhou/CN
  • 5 Jilin Provincial Cancer Hospital, Changchun/CN
  • 6 Harbin Medical University Cancer Hospital, Harbin/CN
  • 7 The First Affiliated Hospital of USTC, Anhui Provincial Hospital, 230000 - Hefei/CN
  • 8 Sir Run Run Shaw Hospital ZheJiang University School Of Medicine, Hangzhou/CN
  • 9 Henan Cancer Hospital, Zhengzhou/CN
  • 10 Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center, Kunming/CN
  • 11 Sichuan Provincial Cancer Hospital, 610000 - Chengdu/CN
  • 12 Anhui Chest Hospital, Hefei/CN
  • 13 The First Affiliated Hospital of Zhengzhou University, Zhengzhou/CN
  • 14 The First Affiliated Hospital of Nanchang University, Nanchang/CN
  • 15 Shaanxi Provincial Cancer Hospital, Xian/CN
  • 16 Hubei Cancer Hospital, Wuhan/CN
  • 17 Jiangsu Province Hospital/The First Affiliated Hospital of Nanjing Medical University, Nanjing/CN
  • 18 Jiangsu Hengrui Medicine Co., Ltd., Shanghai/CN
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Resources

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Abstract 96O

Background

Cytotoxic agents may potentiate immune-checkpoint inhibitors with immunological effects. Camrelizumab plus pemetrexed and platinum is a current standard of care for Chinese patients (pts) with advanced non-squamous NSCLC and negative EGFR/ALK mutation. Here we evaluated first-line camrelizumab plus chemotherapy (chemo) for pts with squamous NSCLC.

Methods

In this double-blind, multicenter, phase III trial, previously untreated pts with histologically or cytologically confirmed stage IIIB-IV squamous NSCLC were randomized 1:1 to receive 4–6 cycles of carboplatin (AUC 5) plus paclitaxel (175 mg/m²) with camrelizumab (200 mg) or placebo every 3 weeks, followed by maintenance therapy with camrelizumab or placebo. The primary endpoint was PFS per IRC. Cross-over after disease progression was allowed for pts allocated placebo plus chemo

Results

Totally, 389 pts (camrelizumab plus chemo, n = 193; placebo plus chemo, n = 196) were included. As of Nov. 06, 2020, pts treated with camrelizumab plus chemo were associated with significantly prolonged IRC-assessed PFS versus placebo plus chemo (median, 8.5 [95% CI 6.9–10.4] vs 4.9 [95% CI 4.2–5.5] months; HR, 0.37 [95% CI 0.29–0.47], one-sided P < 0.0001), with benefit observed in pts with both PD-L1 TPS <1% (HR, 0.49 [95% CI 0.35–0.68]) and ≥1% (HR, 0.34 [95% CI 0.24–0.49]). There was also significant improvement in OS for the camrelizumab plus chemo group (median, NR [18.4–NR] vs 14.5 [95% CI 13.2–16.6] months; HR, 0.55 [95% CI 0.40–0.75], one-sided P < 0.0001). Consistently, confirmed ORR (64.8% [95% CI 57.6%–71.5%] vs 36.7% [95% CI 30.0%–43.9%], P < 0.0001) and DoR (median, 13.1 [95% CI 9.3–15.7] vs 4.4 [95% CI 4.2–4.9] months) per IRC favored the camrelizumab plus chemo group. Grade ≥3 treatment-related adverse events occurred in 73.6% of pts in the camrelizumab plus chemo group and 71.9% in the placebo plus chemo group, with no unexpected adverse effects.

Conclusions

The addition of camrelizumab to chemotherapy significantly prolonged PFS and OS in the first-line setting with an acceptable safety profile, supporting this combination as an additional first-line treatment option for pts with advanced squamous NSCLC.

Clinical trial identification

NCT03668496.

Legal entity responsible for the study

Jiangsu Hengrui Medicine Co., Ltd.

Funding

Jiangsu Hengrui Medicine Co., Ltd.

Disclosure

C. Zhou: Honoraria (self): Roche; Honoraria (self): Lily China; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Merck; Honoraria (self), Advisory/Consultancy: Hengrui; Honoraria (self), Advisory/Consultancy: Qilu; Honoraria (self): Sanofi; Honoraria (self): Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Innovent Biologics; Honoraria (self): C-Stone; Honoraria (self): Luye Pharma; Honoraria (self), Advisory/Consultancy: TopAlliance Biosciences; Honoraria (self): Amoy Diagnositics. Z. Yang: Full/Part-time employment: Jiangsu Hengrui Medicine. L. Wang: Full/Part-time employment: Jiangsu Hengrui Medicine. All other authors have declared no conflicts of interest.

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