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Proffered paper session - Non-metastatic NSCLC and other thoracic malignancies

4526 - Neoadjuvant nivolumab (N) or nivolumab plus ipilimumab (NI) for resectable non-small cell lung cancer (NSCLC)

Date

21 Oct 2018

Session

Proffered paper session - Non-metastatic NSCLC and other thoracic malignancies

Topics

Immunotherapy

Tumour Site

Presenters

Tina Cascone

Authors

T. Cascone1, W.N. William1, A. Weissferdt2, C.H. Leung3, L. Federico4, C. Haymaker4, C. Bernatchez4, F.V. Fossella1, F.E. Mott1, V.A. Papadimitrakopoulou1, L. Byers5, V.K. Lam1, M.C. Godoy6, B. Carter6, J.J. Lee3, A. Vaporciyan7, D.L. Gibbons5, S.G. Swisher7, J.V. Heymach5, B. Sepesi7

Author affiliations

  • 1 Thoracic Head And Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 2 Pathology, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 3 Biostatistics, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 4 Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 5 Thoracic Head And Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030 - HOUSTON/US
  • 6 Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 7 Thoracic And Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
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Abstract 4526

Background

Neoadjuvant N induces a 45% major pathologic response (MPR) in resected NSCLCs. We report preliminary results of NEOSTAR (NCT03158129) - a phase 2 trial evaluating neoadjuvant N or NI in resectable NSCLC pts.

Methods

Pts with stage I-IIIA (single N2) resectable NSCLC (AJCC 7th), ECOG PS 0-1, were randomized 1:1 to N (3 mg/kg IV Q2 weeks, on D1, 15, 29) or NI (N plus I, 1 mg/kg IV on D1) followed by surgery (n=22/arm). Primary endpoint is MPR (≤10% viable tumor cells at surgery), hypothesized to be higher than MPR to induction chemotherapy historical controls. Immune infiltrates were assessed by flow cytometry on checkpoint inhibitor (CPI)-treated tumors and compared to untreated resected samples (ICON set).

Results

As of 9/6/2018, 33 pts were randomized, 17 to N, 16 to NI: mean age 65, 67% males, 21% never smokers, stage I n=10, II n=15, III n=8, 58% adenocarcinomas. 30 pts completed neoadjuvant therapy (2 ongoing, 1 G3 hypoxia [N]) & 26 had surgery (5 unresectable [2 N, 3 NI], 2 pending). Overall MPR rate was 26% (8/31). MPR rate to N and NI were 25% (4/16) and 27% (4/15), respectively. Median % of viable tumor cells was lower in tumors resected post NI vs. N (28% vs. 65%, p=0.32). There were 5 pathologic CRs (2 N, 3 NI). Radiographic ORR by RECIST v1.1 was 19% (5 PR [N], 1 CR [NI]). 19% of pts had PD (6/31, 3 N, 3 NI). Surgical complications included 1 bronchopleural fistula (BPF). Treatment-related AEs included G5 death due to BPF post steroid-treated pneumonitis (n=1, N); G3 pneumonia (n=1, N), hypoxia (n=1, N); G2 cough (n=3, NI), rash (n=1, N), fatigue (n=1, N). CPIs increased proliferative (Ki67+) & activated (ICOS+) effector CD8+ & CD4+ TILs in treated vs. untreated tumors (p<0.0001). CD27+CD28+ effector memory CD8+ TILs were higher in N vs. NI (49% vs. 33%, p=0.06). Ki67+CD103+ tissue resident effector CD8+ (98% vs. 65%, p=0.1) & CD4+ (99% vs. 40%, p=0.03) TILs and Tregs (97% vs. 47%, p=0.06) were higher in NI vs. N.

Conclusions

Neoadjuvant CPI is overall safe and induces a 26% MPR rate, with a trend towards less viable tumor after NI. Preliminary results suggest neoadjuvant CPIs induce higher TIL proliferation and activation vs. untreated tumors. NI may induce higher proliferation of different T cell subsets vs. N, which may lead to distinct antitumor immune responses.

Clinical trial identification

NCT03158129

Editorial Acknowledgement

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