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Poster Display session

13P - Tislelizumab (TIS) plus chemotherapy (chemo) with or without bevacizumab (beva) for patients with EGFR-mutated nonsquamous non-small cell lung cancer (nsq-NSCLC) after progression on EGFR tyrosine kinase inhibitor (TKI) therapy

Date

22 Mar 2024

Session

Poster Display session

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Baohui Han

Citation

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

Authors

B. Han1, H. Zhong2, Q. Guo3, P. Tian4, Y. Zhao5, X. Yu6, Z. Yu7, X. Zhang8, Y. Zhang9, Y. Li4, L. Chen10, X. Shi11, J. Wang7

Author affiliations

  • 1 Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai/CN
  • 2 Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai/CN
  • 3 Shandong Cancer Hospital Affiliated to Shandong First Medical University, Jinan/CN
  • 4 West China Hospital, Sichuan University, Chengdu/CN
  • 5 The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou/CN
  • 6 Hunan Cancer Hospital, Changsha/CN
  • 7 The Affiliated Hospital of Qingdao University, Qingdao/CN
  • 8 Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, 200030 - Shanghai/CN
  • 9 West China Medical Center of Sichuan University, Chengdu/CN
  • 10 The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital, Zhengzhou/CN
  • 11 Cancer Hospital of University of Chinese Academy of Sciences & Zhejiang Cancer Hospital, Hangzhou/CN

Resources

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Abstract 13P

Background

This multicenter, open-label, phase II study evaluated TIS plus platinum-based chemo (cohort 1) or TIS plus mono-chemo and beva (cohort 2) in EGFR-mutated nsq-NSCLC patients (pts) who progressed on EGFR-TKI therapies. Our previous results showed that cohort 1 met its primary endpoint (1-year PFS rate, 23.8%). Here, we reported the primary analysis results of cohort 2 and updated results of cohort 1.

Methods

In cohort 2, pts received TIS plus nab-paclitaxel and beva (induction), followed by TIS plus beva (maintenance). Primary endpoint was 1-year PFS rate; we planned to enroll 54 pts (85% power to detect an increase from historical control of 7% to 23% at a one-side 0.05 significance level). Updated efficacy analysis was provided for cohort 1.

Results

For cohort 2 (median follow-up:10.5 months [mo]), 54 pts were enrolled. Among 52 pts in efficacy analysis set, 1-year PFS rate was 46.1% (90% CI 32.5-58.7), which met the primary endpoint. Median PFS was 10.9 (95% CI 6.4-15.1) mo. The ORR and DCR were 55.8% (95% CI 41.3-69.5) and 96.2% (95% CI 86.8-99.5), respectively. Grade 3-4 TRAEs occurred in 31.5% (17/54) of pts. 38.9% (21/54) of pts experienced irAEs. For cohort 1 (median follow-up: 20.4 mo), median PFS and OS were 7.6 (95% CI 5.8-9.4) mo and 27.1 (95% CI 16.1-NE) mo, respectively. Pts with EGFR exon 19 deletion or progressed on 1st/2nd and 3rd generation (G) EGFR-TKIs have significant shorter PFS compared to pts with EGFR exon 21 L858R mutation or progressed on 1st/2nd G EGFR-TKIs in cohort 1; while no significant differences were observed in cohort 2 (Table).

Table: 13P

Subgroup analysis of PFS by cohort

Cohort 1 Cohort 2
Median PFS (mo) HR (95% CI) P Median PFS (mo) HR (95% CI) P
Overall 7.6 / / 10.9 / /
Prior EGFR mutation type
Exon 21 L858R mutation 11.7 0.33 (0.17, 0.63) <0.001 10.9 1.37 (0.61,3.09) 0.438
Exon 19 deletion 6.5 14.8
Prior EGFR TKI treatment
1st/2nd+3rd G 6.0 1.83 (1.00,3.36) 0.049 6.7 2.18 (0.77,6.23) 0.136
3rd G 5.7 1.21 (0.44, 3.27) 0.726 14.8 1.18 (0.39, 3.54) 0.767
1st/2nd G 9.8 14.2

PFS, progression-free survival; mo, months; HR, hazard ratio; CI, confidence interval; G, generation; NE, not estimable.

Conclusions

For pts with EGFR-mutated nsq-NSCLC after EGFR-TKI failure, TIS plus mono-chemo and beva (cohort 2) was effective with favorable safety profile; TIS plus platinum-based chemo (cohort 1) demonstrated encouraging OS benefit. This study provides extended treatment options for this patient population.

Clinical trial identification

NCT04405674.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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