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Proffered Paper session - NSCLC, metastatic 2

LBA48 - DUBLIN-3 (BPI-2358-103): A global phase (Ph) III trial with the plinabulin/docetaxel (Plin/Doc) combination vs. Doc in 2nd/3rd Line NSCLC patients (pts) with EGFR-wild type (wt) progressing on a prior platinum-based regimen

Date

20 Sep 2021

Session

Proffered Paper session - NSCLC, metastatic 2

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Trevor Feinstein

Citation

Annals of Oncology (2021) 32 (suppl_5): S1283-S1346. 10.1016/annonc/annonc741

Authors

T. Feinstein1, B. Han2, Y. Shi3, D. Feng4, D. Mitchell5, Y. Lelorier6, L. Du7, L. Huang8, R. Mohanlal8, Y. Sun9

Author affiliations

  • 1 Hematology/oncology, Piedmont Cancer Institute, 30318 - Atlanta/US
  • 2 Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, 200030 - Shanghai/CN
  • 3 Medical Oncology Dept., Chinese Academy of Medical Sciences - National Cancer Center, Cancer Hospital, 100021 - Beijing/CN
  • 4 Statistics, TCM Groups, Inc., 07922 - Berkeley Heights/US
  • 5 Health Economics, Medicus Economics, LLC, Logimétrix Inc, Repentigny/CA
  • 6 Health Economics, BeyondSpring Pharmaceuticals, 10005 - New York/US
  • 7 Clinical Research & Development, Dalian Wanchun Bulin Pharmaceutical Co. Ltd., 116620 - Dalian/CN
  • 8 Clinical Research & Development, BeyondSpring Pharmaceuticals, 10005 - New York/US
  • 9 Oncology, Cancer Hospital Chinese Academy of Medical Sciences, 100021 - Beijing/CN

Resources

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Abstract LBA48

Background

PD1-i therapy is standard of care in 1st line, and Doc-based regimens in 2nd/3rd line EGFR-wt NSCLC pts. Doc improves survival, however, may negatively impact safety and quality of life (QoL). Plin, a novel immune-enhancing small molecule enhances dendritic cell maturation and T-Cell proliferation. Final survival, safety and QoL data of DUBLIN-3 are reported.

Methods

DUBLIN-3(NCT02504489) was a randomized, single-blinded (pts only), active controlled Ph3 study in 2nd/3rd line stage IIIB/IV, EGFR wt NSCLC pts with a measurable lesion (RECIST 1.1) in the lung, and ECOG ≤ 2, conducted in US, Australia and China. Pts (n=559) were randomized 1:1 to Plin/Doc or Doc/Placebo (21 day (D) cycle (C)). Doc (75 mg/m2 on D1 and Plin 30 mg/m2 on D1 and D8 were given by IV infusion. Primary endpoint was Overall Survival (OS). Secondary endpoints were ORR, PFS, OS rate at 24, 36 months (M), Grade (Gr) 4 neutropenia (N) rate on C1 D8 (N nadir with Doc is on D8), QoL (EORTC QLQ C30, QLQ-LC13), Q-TWiST (a measure integrating Survival, QoL, Safety), and Safety (adverse events (AE).

Results

Baseline characteristics were balanced between both groups. Plin/Doc was well tolerated. Primary and key secondary objectives were met (Table). Investigator-assessed ORR (12.2% versus (vs) 6.8%; p=0.0275) and mean PFS (6.0M vs 4.4M; p=0.006); median PFS (3.6 M vs 3.0 M; p=0.008; HR=0.76 (0.63, 0.93) favored Plin/Doc. Q-TWiST with Plin/Doc vs Doc was statistically and clinically better (p=0.026 with relative gain of 18.4%). Gr4 AE rate (95% CI) per year was 1.69 (1.4;2.0) for Plin/Doc and 3.08 (2.7;3.5) for Doc (p<0.001). Table: LBA48

ITT Population OS (mean) OS (median) OS**: pts with ≥4 cycles (median) OS**: pts with ≥8 cycles (median) OS rate 24M OS rate 36M OS rate 48M Gr4 Neutro-penia rate Q-TWiST (95% CI) Gr3/4 AE rate/pt/ year (95% CI)
Plin/Doc (n=278) 15.1 M 10.5 M 18.3 M (n=133) 28.2 M (n=45) 22.1% 11.7% 10.6% 5.3% 12.4 M (11.0, 13.8) 9.9 (9.2, 10.5)
Doc (n=281) 12.8 M 9.4 M 13.5 M (n=128) 19.3 M (n=31) 12.5% 5.3% 0% 27.8% 10.5 M (9.3, 11.6) 10.9 (10.2, 11.7)
p-value* 0.0332 0.0399 HR: 0.82 (0.68,0.99) 0.0022 HR: 0.63 (0.47,0.85) 0.0121 HR: 0.45 (0.24,0.85) 0.0072 0.0393 NA <0.001 0.0263 0.0381

∗All p-values favor Plin/Doc over Doc alone; ∗∗Data based on ITT population, but summarizing OS for pts with ≥4 or ≥8 cycles.

Conclusions

The addition of Plin to Doc resulted in superior overall survival, safety and QoL vs Doc alone, offering 2nd/3rd line NSCLC pts the prospect of living longer and well.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

BeyondSpring Pharmaceuticals Inc.

Funding

BeyondSpring Pharmaceuticals Inc.

Disclosure

T. Feinstein: Financial Interests, Personal and Institutional, Advisory Role: Beyond Spring Pharmaceuticals; Financial Interests, Personal and Institutional, Speaker’s Bureau: Beyond Spring Pharmaceuticals. L. Huang: Financial Interests, Personal and Institutional, Stocks/Shares: Beyond Spring Pharmaceuticals; Financial Interests, Personal and Institutional, Ownership Interest: Beyond Spring Pharmaceuticals; Financial Interests, Personal and Institutional, Funding: Beyond Spring Pharmaceuticals; Financial Interests, Personal and Institutional, Royalties: Beyond Spring Pharmaceuticals. R. Mohanlal: Financial Interests, Personal and Institutional, Full or part-time Employment: Beyond Spring Pharmaceuticals; Financial Interests, Personal and Institutional, Stocks/Shares, Beyond Spring Pharmaceuticals: Beyond Spring Pharmaceuticals; Financial Interests, Personal and Institutional, Leadership Role: Beyond Spring Pharmaceuticals. All other authors have declared no conflicts of interest.

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