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Poster Discussion – Developmental therapeutics

4548 - Precision Medicine: Preliminary Results from the Initiative for Molecular Profiling and Advanced Cancer Therapy 2 (IMPACT 2) Study.

Date

28 Sep 2019

Session

Poster Discussion – Developmental therapeutics

Presenters

Apostolia Maria Tsimberidou

Citation

Annals of Oncology (2019) 30 (suppl_5): v159-v193. 10.1093/annonc/mdz244

Authors

A.M. Tsimberidou1, D.S. Hong2, S. Fu3, D. Karp4, S.A. Piha-Paul5, M. Kies6, V. Ravi7, V. Subbiah8, S. Patel9, S. Tu10, F. Janku8, J. Heymach11, A. Johnson12, L. Zhao13, J. Zhang13, D.A. Berry14, D. Vining15, A. Futreal13, V.A. Miller16, F. Meric-Bernstam8

Author affiliations

  • 1 Investigatonal Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 2 Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 3 Department Of Investigational Cancer Therapeutics, MD Anderson Cancer Center, Houston/US
  • 4 Investigational Cancer Therapeutics, UT MD Anderson Cancer Center, TX 77030 - Houston/US
  • 5 Department Of Investigational Cancer Therapeutics, The University of Texas, MD Anderson Cancer Center, 77030 - Houston/US
  • 6 Thoracic, Head And Neck Medical Oncology, MD Anderson, 77030 - Houston/US
  • 7 Department Of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 8 Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 9 Medical Oncology, MD Anderson Cancer Center, 77030 - Houston/US
  • 10 Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 11 The University Of Texas Md Anderson Cancer Center, Thoracic/head & Neck Medical Oncology, MD Anderson, 77030 - texas/US
  • 12 Ipct, MD Anderson, 77030 - Houston/US
  • 13 Genomic Medicine, MD Anderson, 77030 - Houston/US
  • 14 Biostatistics, MD Anderson, 77030 - Houston/US
  • 15 Diagnostic Imaging, MD Anderson, 77030 - Houston/US
  • 16 Clinical Development, Foundation Medicine, 02141 - Cambridge/US
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Resources

Abstract 4548

Background

Precision medicine is associated with favorable outcomes in selected patients. We initiated IMPACT 2, a randomized study to compare PFS in patients with metastatic cancer treated on the basis of tumor genomic profiling results vs. those whose treatment was not selected based on genomic analysis. Herein, we assessed the association between patient characteristics and overall survival (OS).

Methods

Patients with advanced, metastatic cancer underwent tumor biopsy and genomic profiling (Foundation One). Variants were filtered to eliminate germline mutations (annotation, ANNOVAR) and artifacts. Patients were presented at tumor board and were randomized if they met criteria for clinical trials. OS was measured from enrollment on study until last follow-up or death from any cause.

Results

From 5/2014 to 4/2017, 320 of 391 enrolled patients completed tumor profiling. Baseline characteristics (n = 320) were as follows: men, 47%; median age, 63 yrs (range, 25-83); performance status 1, 88%; median no. of prior therapies, 3 (range, 0-14); liver metastases, 40%; albumin < 3.5 g/L, 12%; LDH > 618 IU/L, 29%; platelet count > or < the normal limits, 15%. Most common tumor types were head and neck, 19%; gastrointestinal, 16%; and lung, 11%. Most frequently mutated genes: TP53, 42%; KRAS,16%; PIK3CA,12%; and CDKN2A, 11%. Of 320 patients, 69 (22%) were randomized; of the remaining 251 patients, 153 (61%) received other treatment (investigational or standard). Results of multivariate analyses for OS are displayed below.Table:

449PD

Multivariate analysis, OS
Risk FactorHR95% CIP
Age ≥ 60 yrs1.021.00-1.03.009
Liver metastases1.431.07-1.91.02
LDH > 618 IU/L2.191.61-2.97< .0001
Albumin < 3.5 g/dL1.901.26-2.87.002
KRAS mutated2.271.57-3.28< .0001
TP53 mutated1.381.04-1.84.03

Conclusions

In patients with metastatic cancer, age < 60 yrs, absence of liver metastases, normal albumin and LDH levels, and absence of KRAS or TP53 mutations were independent factors predicting longer OS. We demonstrated the feasibility of molecular profiling using newly obtained tumor biopsies and treating patients prospectively. The study is ongoing. Outcomes for randomized patients are awaited upon completion of the study.

Clinical trial identification

www.clinicaltrials.gov NCT02152254, First posted June 2, 2014.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Foundation Medicine.

Disclosure

A.M. Tsimberidou: Research grant / Funding (institution): IMMATICS; Research grant / Funding (institution): Tempus; Research grant / Funding (institution): Parker Institute for Cancer Immunotherapy; Research grant / Funding (institution): EMD Serono; Research grant / Funding (institution): Baxalta; Research grant / Funding (institution): Foundation Medicine; Research grant / Funding (institution): Boston Biomedical; Research grant / Funding (institution): Placon Therapeutics; Research grant / Funding (institution): Karus Therapeutics; Research grant / Funding (institution): Tvardi; Research grant / Funding (institution): OBI Pharma; Advisory / Consultancy: Roche, Europe; Advisory / Consultancy: Covance; Advisory / Consultancy: Genentech. D.S. Hong: Research grant / Funding (self): Adaptimmune; Research grant / Funding (institution): Abbvie; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (self): Bayer; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Daichi-Sanko; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): Genmab; Research grant / Funding (institution): Ignyta; Research grant / Funding (institution): Infinity; Research grant / Funding (institution): Kite; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): LOXO; Research grant / Funding (institution): Mirati; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Medimmune; Research grant / Funding (institution): Molecular Template; Research grant / Funding (institution): Novartis. All other authors have declared no conflicts of interest.

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