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Pomalidomide therapy in relapsed/refractory myeloma: A UK multi-centre experience

Pomalidomide therapy in relapsed/refractory myeloma: A UK multi-centre experience. Neil Rabin Consultant Haematologist o n behalf of Dr Nicola Maciocia University College London Hospitals, UK 4 th November 2015.

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Pomalidomide therapy in relapsed/refractory myeloma: A UK multi-centre experience

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  1. Pomalidomide therapy in relapsed/refractory myeloma: A UK multi-centre experience Neil Rabin Consultant Haematologist on behalf of Dr Nicola Maciocia University College London Hospitals, UK 4th November 2015 Maciocia N, Sharpley F, Belsham E, Schey S, Benjamin R, Streetly M, Jenner M, Ramasamy K, Yong KL, Rabin N. IMW 2015

  2. Poor outcome for patients with Relapsed Refractory Myeloma Kumar et al, Leukemia 2011

  3. Background • Pomalidomide + Dexamethasone licensed in Europe August 2013 for patients with relapsed/refractory myeloma, who have received at least two prior therapies (lenalidomide/bortezomib) and have progressed on their last therapy. San Miguel J, et al. Lancet Oncol. 2013.

  4. Pomalidomide treatment for patients with RRMM MedainPFS 4.0 vs 1.9 mo MedainPFS 12.7 vs 8.1 mo San Miguel et al, Lancet Oncology 2013

  5. Background • Pomalidomide available in England from December 2013 via National Cancer Drugs Fund: • Adequate treatment with bortezomib, lenalidomide, alkylator • Refractory to last line of therapy • Failed treatment with bortezomib OR lenalidomide (different to MM-003 trial) • Performance Status 0-2 • No resistance to high dose dexamethasone • No peripheral neuropathy of grade 2 or more

  6. Aim • To assess the real-world clinical efficacy of POMA-DEX within its licensed indication in a retrospective analysis of patients treated at 5 UK centres

  7. Oxford University Hospitals NHS Foundation Trust University College London Hospitals NHS Foundation Trust Guy’s and St.Thomas’ NHS Foundation Trust King’s College London Foundation NHS Trust University Hospital Southampton NHS Foundation Trust

  8. Methods • All patients who received Pomalidomide + Dexamethasone (until Feb 2015, data updated for this meeting) • Data collected retrospectively using a pre-defined proforma • Prior myeloma therapy, and whether refractory to last Rx • Relapsed or refractory to Lenalidomide or Bortezomib • Measurable disease (serum/urine paraprotein, SFLC analysis) • Renal function • Cytogenetic (FISH) data • International Staging System • Response to Pomalidomide • Toxicities – non haematological / haematological to Pomalidomide

  9. Methods • To be included in response analyses patients had to have IMWG measurable disease, and have received at least one cycle of Pomalidomideand Dexamethasone • Response assessed using IMWG criteria • High risk disease defined as per IMWG (ISS II/III and t(4;14) or 17p13del).

  10. Results • 79 patients identified from August 2013 onwards. Followed until Feb 2015(IMW abstract, updated for this meeting) • 62 (78.5%) suitable to be included in response analyses. • All patients received Pomalidomide(2-4mg D1-21) plus Dexamethasone. • 30/79 (38%) received another agent(s): clarithromycin (23); cyclophosphamide (9); carfilzomib (1); bortezomib(1). In 15 (50%) the third agent was added from start of therapy. In 15(50%) it was added midway through treatment.

  11. Results • Median FU was 13.7 months (0.9-42.8). • Median no of cycles was 4 (range 1-32). • Median dose Pomalidomide 4 mg (range 2-4). • In those with starting GFR <45ml/min, 50% (7/14) received < 4mg Pomalidomide.

  12. Response Rates • ORR (≥ PR) was 53%, VGPR 5%, and >/= SD 94%.

  13. Survival

  14. Results • PFS 4.8 mo, OS 16.3 mo. • Median duration of response (DoR) 3.9 mo. • 25/79 (32%) patients received further therapy • Median time to next treatment (TNT) 6.2 mo (0.3 – 18.5 mo.).

  15. PFS OS RENAL FUNCTION CYTOGENETIC RISK DOUBLE VS TRIPLE THERAPY

  16. Toxicities • Grade 3/4 non-haem toxicities occurred in 27/79 (34%) patients:

  17. Toxicities • Grade 3/4 haematological toxicities • Neutropenia 28 patients (35%) • Thrombocytopenia in 17 patients (22%) • Anaemia in 8 patients (10%). • 54 patients came off treatment during study period. • 11/54 (20%) stopped due to toxicities • 41/54 (76%) stopped due to PD • One patient developed lung ca, one death of unknown cause

  18. Conclusion • POMA-DEX is effective in relapsed/refractory myeloma, with outcomes comparable to results from the phase 3 NIMBUS study (MM-003). • Improved OS compared to published data (16.3 movs 12.7 mo), equivalent PFS (4.8 movs 4.0 mo) • Reduced renal function and adverse genetics do not appear to influence outcomes. The addition of a third agent should be explored prospectively in ongoing clinical trials. • Our rates of infection slightly higher than published data but toxicity still acceptable in this heavily pre-treated population.

  19. Acknowledgements University College London Hospitals NHS Foundation Trust • Nicola Maciocia, Andrew Melville, Simon Cheesman, RakeshPopat, Shirley D’Sa, Ali Rismani, Kwee Yong, Neil Rabin Guy’s and St.Thomas’ NHS Foundation Trust • Matthew Streetly King’s College London Foundation NHS Trust • Reuben Benjamin, Steve Schey, Hanna Renshaw Oxford University Hospitals NHS Foundation Trust • KarthikRamasamy, Faye Sharpley University Hospital Southampton NHS Foundation Trust • Matthew Jenner, Edward Belshom UK Myeloma Forum

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