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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

5465 - Immune prognostic index (IPI) and Hyper-Progressive disease (HPD) in patients (pts) exposed to targeted agents (TAs) in Phase 1 trials (Ph1T): can lessons from immune checkpoint inhibitors (ICIs) be translated to other scenarios?

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Presenters

Ignacio Matos Garcia

Citation

Annals of Oncology (2018) 29 (suppl_8): viii14-viii57. 10.1093/annonc/mdy269

Authors

I. Matos Garcia1, A. Azaro2, C. Viaplana3, C. Hierro2, J. Martin-Liberal4, I. Brana5, I. Gardeazabal6, P. Gomila7, M. Vieito Villar4, M. Ochoa De Olza Amat5, E. Elez Fernandez5, M. Oliveira6, A. Oaknin8, H. Verdaguer6, A. Navarro Mendivil2, M. Alsina5, J. Tabernero8, T. Macarulla Mercade6, R. Dienstmann9, E. Garralda10

Author affiliations

  • 1 Department Of Medical Oncology, Vall D’Hebron Institute of Oncology, Barcelona/ES
  • 2 Oncology Department, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 3 Oncology Data Science (odyssey) Group, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 4 Oncology, Vall d`Hebron Institute of Oncology (VHIO)-Cellex Center, 08035 - Barcelona/ES
  • 5 Medical Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 6 Medical Oncology, Vall d`Hebron Institute of Oncology (VHIO)-Cellex Center, 08035 - Barcelona/ES
  • 7 Oncology, Hospital de la Santa Creu i Sant Pau, 08041 - Barcelona/ES
  • 8 Medical Oncology, Vall d’Hebron University Hospital and Vall d'Hebron Institue of Oncology, 08035 - Barcelona/ES
  • 9 Oncology Data Science, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 10 Early Drug Development Unit, Vall d`Hebron Institute of Oncology (VHIO)-Cellex Center, 08035 - Barcelona/ES
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Resources

Abstract 5465

Background

IPI score (derived neutrophil/(leukocytes minus neutrophils)ratio [dNLR]>3 plus LDH>upper limit normal) is a emerging tool to predict overall survival (OS) with ICIs in different tumor types. HPD has been reported in 15% of pts on ICIs using different criteria, including ours (PD at first restaging with ≥40% increase in sum of target lesions or ≥ 20% with appearance of multiple new lesions; Matos et al, ASCO 2018). We aimed to assess the prognostic value of IPI and the relevance of HPD in pts enrolled in Ph1T with TAs.

Methods

Retrospective analysis of a consecutive cohort of pts treated with experimental TAs at VHIO Ph1T Unit over the last 3 years (we excluded pts in the first dose escalation cohorts of each trial as well as TAs matched to validated biomarkers). Overall survival (OS) was correlated with VHIO HPD criteria and IPI.

Results

In total, 180 pts were treated with TAs (34% FGFR, 26% PI3K, 19% MET, 13% NOTCH, 5% IDH, 3% RAF). In 39% of the cases, TAs were matched to an emerging enrichment molecular alteration. Median age 59y, 58% female, most common tumor types: 20% colorectal, 17% breast, 9% gynecological, 8% biliary tract. Best response was PD in 55%, SD in 41%, PR in 4%. Our HPD criteria was met in 10% of the cases, across all tumor types and targets (highest prevalence in colorectal pts treated with PI3K inhibitors, 5/18, 28%). Median progression-free survival was 1.8 months (m) [95% CI 1.7-2.2], not affected target selected, molecular match or IPI score (p > 0.2). Median OS was 7.9 m [6.7-10], significantly different as per IPI score (IPI0 18 m [7.8-NA]; IPI1 7.7 m [6.5-9.9]; IPI2 2.6 m [1.7-NA]; p < 0.001). Importantly, in pts with PD as best response while on TAs, HPD did not negatively affect OS (p = 0.43).

Conclusions

Our results show that a prognostic score developed in cohorts treated with ICIs also predicts long-term outcome with TAs in Ph1T. HPD criteria can be met with TAs treatment, but the lack of survival impact (different from internal and external cohorts exposed to ICIs) suggests that it is not a relevant clinical finding.

Clinical trial identification

Legal entity responsible for the study

Vall d´Hebron Institute Oncology.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

J. Tabernero: Advisory boards: Bayer, Boehringer Ingelheim, Genentech/Roche, Lilly, MSD, Merck Serono, Merrimack, Novartis, Peptomyc, Roche, Sanofi, Symphogen and Taiho. E. Garralda: Advisory role: Roche, NeoMed Therapeutics, Ellypses Pharma. All other authors have declared no conflicts of interest.

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