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CML Research for better treatment

CML Research for better treatment. Steve O ’ Brien Northern Institute for Cancer Research Newcastle University Medical School. CML patient meeting, 11 th October 2014. Clinical trials. Phase I studies designed to find out the most effective dose of the

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CML Research for better treatment

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  1. CMLResearch for better treatment • Steve O’Brien • Northern Institute for Cancer Research • Newcastle University Medical School CML patient meeting, 11th October 2014

  2. Clinical trials • Phase I studies designed to find out the most effective dose of the • drug and the possible side effects of the drug. • Phase II studies carried out on different cancers so that the • research team can find out how active a particular drug is. Only • about 20 to 30 patients with each cancer. • Phase III studies to compare a new treatment with the best • treatment currently available. • Phase III trials are usually randomised and may include a double • blind procedure. • Others include – Sample banking; Epidemiological and phase IV • long term safety monitoring usually post approval

  3. csg.ncri.org.uk/groups-list/

  4. CML trials in the UK • Destiny • low level disease (MMR) • reduce then stop if possible • pilot study • CHOICES • SPIRIT trials

  5. Around the world • Germany – nilotinib • France – interferon alpha • US – dasatinib, early response • India – efficacy of generics

  6. Thank you…

  7. Acknowledgements

  8. 814 patients recruited • Recruitment closed Feb 2013 • 172 hospitals set up • 145 recruited patients

  9. SPIRIT 2: study design Arm A Imatinib400 R Chronic phase CML within 3 months of diagnosis N=407 n=814 Arm B Dasatinib100 N=407 Randomised, open label Primary endpoint: 5 year EFS Secondary: cytogenetic, PCR response, toxicity

  10. SPIRIT 2 summary • Largest investigator-conducted randomised trial of dasatinib vs imatinib • n=814 • median follow up 3 years • Both drugs generally well tolerated • 523 of 812 (64.4%) continue on study medication • Imatinib: GI tox; Dasatinib: pleural effusions, headaches • No difference in cardiovascular events • MR3 rate at one year is: imatinib 43%, dasatinib 58% • 783/812 (96.4%) remain alive overall • No difference in progression or overall survival

  11. ⅔

  12. Overall Survival (OS)BCR-ABL (IS) at 3 months ≤1% vs. 1-10% vs. >10% ≤1% 1-10% >10% BCR-ABL (IS) n 5Y-OS ≤1% 218 97% 1-10% 283 94% >10% 191 87% p-value n.s. 0.012 Hanfstein et al. Leukemia. 2012 Mar 26. doi: 10.1038/leu.2012.85

  13. risk benefit

  14. Stage 1 Randomise (500 to each group) Stage 2 Selective switch (3 months or later) Stage 3 Reduce dose, stop (after minimum 3 years) Imatinib Imatinib Group I Imatinib n=500 Ponatinib Ponatinib R Aim to reduce and stop (if MR3 for at least 1 year) Ponatinib Ponatinib Group N Nilotinib n=500 Nilotinib Nilotinib Primary endpoint MR3 at 3 years

  15. www.spirit-cml.org

  16. CMLResearch for better treatment • Steve O’Brien • Northern Institute for Cancer Research • Newcastle University Medical School CML patient meeting, 11th October 2014

  17. csg.ncri.org.uk/groups-list/

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