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Immuno-Oncology Requires a More Comprehensive Approach for the Assessment of Clinical Endpoints

  • The criteria used to assess the potential benefit of cancer therapies are based on traditional treatments such as surgery, radiation therapy, and chemotherapy1
  • Because I-O is a fundamentally different way to fight cancer,2 a more comprehensive approach to endpoint assessment is needed to recognize its potential benefit3-6

Immune Pathways

See where our I-O research into immune pathways is heading

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I-O Biomarkers

Read about I-O biomarkers we're currently investigating

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References–Endpoint considerations for I-O research

1. Chen T-T. Statistical issues and challenges in immuno-oncology. J Immunother Cancer. 2013. doi:10.1186/2051-1426-1-18. 2. Scagliotti GV, Bironzo P, Vansteenkiste JF. Addressing the unmet need in lung cancer: the potential of immune-oncology. Cancer Treat Rev. 2015;41(6):465-475. 3. Friedman LM, et al. Survival analysis. In: Fundamentals of Clinical Trials. 4th ed. New York, NY: Springer; 2010:269-291. 4. Rich JT, Neely JG, Paniello RC, Voelker CCJ, Nussenbaum B, Wang EW. A practical guide to understanding Kaplan-Meier curves. Otolaryngol Head Neck Surg. 2010;143(3):331-336. 5. Spruance SL, Reid JE, Grace M, Samore M. Hazard ratio in clinical trials. Antimicrob Agents Chemother. 2004;48(8):2787-2792. 6. Uno H, Claggett B, Tian L, et al. Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis. J Clin Oncol. 2014;32(22):2380-2385. 7. Pazdur R. Endpoints for assessing drug activity in clinical trials. Oncologist. 2008;13(suppl 2):19-21. 8. Wilson MK, Karakasis K, Oza AM. Outcomes and endpoints in trials of cancer treatment: the past, present, and future. Lancet Oncol. 2015;16(1):e32-e42. 9. Gillespie TW. Understanding waterfall plots. J Adv Pract Oncol. 2012;3(2):106-111.
10. Brody T. Biostatistics. In: Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. London: Academic Press; 2012:165-190. 11. Akobeng AK. Understanding measures of treatment effect in clinical trials. Arch Dis Child. 2005;90:54-56. 12. Clark TG, Bradburn MJ, Love SB, Altman DG. Survival analysis part I: basic concepts and first analyses. Br J Cancer. 2003;89(2):232-238. 13. US Food and Drug Administration. Guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics. https://www.fda/.gov/downloads/Drugs/
Guidances//ucm071590.pdf Published May 2007. Accessed November 13, 2018. 14. Bland JM, Altman DG. The logrank test. BMJ. 2004;328:1073. 15. Regan MM, Werner L, Tarhini AA, et al. Treatment-free survival, a novel outcome applied to immuno-oncology agents in advanced melanoma. Poster presentation at ASCO 2018. 16. Gelber RD, Goldhirsch A, Cole BF, International Breast Cancer Study Group. Evaluation of effectiveness: Q-TWiST. Cancer Treat Rev. 1993;19:73-84. 17. Harrison ML, Gore ME, Spriggs D, et al. Duration of second or greater complete clinical remission in ovarian cancer: exploring potential endpoints for clinical trials. Gynecol Oncol. 2007;106(3):469-475. 18. Eng KH, Hanlon BM, Bradley WH, Szender JB. Prognostic factors modifying the treatment-free interval in recurrent ovarian cancer. Gynecologic oncology. 2015;139(2):228-235. 19. LeBlanc TW, Abernethy AP. Patient-reported outcomes in cancer care—hearing the patient voice at greater volume. Nat Rev Clin Oncol. 2017;14(12):763-772. 20. Fiteni F, Westeel V, Pivot X, Borg C, Vernerey D, Bonnetain F. Endpoints in cancer clinical trials. J Visc Surg. 2014;151(1):17-22. 21. Anagnostou V, Yarchoan M, Hansen AR, Wang H, Verde F, et al. Immuno-oncology trial endpoints: capturing clinically meaningful activity. Clin Cancer Res. 2017;23(17):4959-4969.22. Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011;2(4):137-144. 23. Apolone G, Filiberti A, Cifani S, Ruggiata R, Mosconi P. Evaluation of the EORTC QLQ-C30 questionnaire: a comparison with SF-36 Health Survey in a cohort of Italian long-survival cancer patients. Ann Oncol. 1998;9(5):549-557.