969P - Evaluation of safety, tolerability and efficacy of temsirolimus in patients with relapsed or refractory mantle cell lymphoma (rel/refr MCL) in rout...

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Lymphomas
Presenter Gabriele Krekeler
Citation Annals of Oncology (2014) 25 (suppl_4): iv327-iv339. 10.1093/annonc/mdu339
Authors G. Krekeler1, M.H. Dreyling2, G. Hess3, D. Kalanovic4
  • 1Medical Oncology, Pfizer Pharma GmbH, 10785 - Berlin/DE
  • 2Dept. Of Medicine Iii, Ludwig Maximilians University - Grosshadern, 81377 - München/DE
  • 3Iii. Med.,hematology And Oncology, Johannes-Gutenberg Universität, 55101 - Mainz/DE
  • 4Medical Affairs, Pfizer Pharma GmbH, Berlin/DE

Abstract

Aim

Temsirolimus (TEMS), an mTOR-inhibitor, is approved in the EU for the treatment of patients (pts) with relapsed or refractory (rel/refr) MCL. A pivotal study demonstrated significantly longer progression free survival with TEMS (175 mg weekly for 3 weeks followed by 75 mg weekly) in rel/refr MCL pts compared to investigatoŕs choice therapy (4.8 mo vs 1.9 mo; P = .0009). To evaluate safety and efficacy of TEMS in an unselected patient population during clinical routine, a prospective non-interventional study with TEMS in rel/refr MCL pts is useful. Here we report on interim results of the study.

Methods

A German multicenter registry for rel/refr MCL pts treated with TEMS was started in Oct 2009 (NCT00700258). Objectives are evaluation of the safety profile of TEMS, tolerability and anti-tumor activity of TEMS, patientś profile and the sequence of systemic therapies.

Results

From Oct 2012 to Feb 2014, 21 study sites recruited 38 pts. Baseline characteristics are available for 38 pts: 73.7% male; median age 73.6 yrs; ECOG PS 0 or 1 in 81.1%, ECOG PS 2 in 18.9% of the pts; MIPI score: 25.0%, 30.6%, and 44.4% of the pts are classified as low, intermediate and high risk at the time of enrollment, bone marrow involvement: 44.7% of the pts. Median time between diagnosis and start oft treatment with TEMS is 3.4 yrs (range 0.4 - 14.9). The median number of prior therapies is 2.5 (range 1 - 9) with 50% of the pts treated in ≥4th line. Most common adverse events (≥ 15%) are thrombocytopenia (39.5%), anemia (15.8%) and general physical health deterioration (18.4%). Severe adverse events (drug related) are general, metabolic, psychiatric, skin, renal, gastrointestinal and blood system disorders (in 1 pt each) and infections (in 2 pts). Preliminary efficacy analyses are available for 27 assessable pts and show an objective response in 8 pts (1CR and 7 PR, 29.6%), a clinical benefit (CR, PR, MR and SD) in 16 pts (59.3%) and PD in 11 pts (40.7%). Median PFS is 4.2 months.

Conclusions

The registry was started to evaluate the safety and efficacy of TEMS in pts with rez/refr MCL in the routine clinical practice. In this here included patient collective with 44.4% high-risk pts, TEMS shows a predictable, manageable tolerability profile and efficacy remains comparable with phase III data.

Disclosure

G. Krekeler: Employee of Pfizer GmbH, Germany; M.H. Dreyling: membership on an advisory board; G. Hess: membership on an advisory board, cooperate-sponsored research; D. Kalanovic: Employee of Pfizer GmbH.