Abstract
Background: In November, 2013 obinutuzumab (obin) was approved in combination with chlorambucil (chlor), as 1st line therapy (Rx) for patients (pts) with chronic lymphocytic leukemia (CLL). In February, 2014, ibrutinib was approved in CLL for pts who had received > 1 prior therapy. In April, 2014 ofatumumab (ofa) + chlor was approved as 1st line Rx for pts with CLL for whom fludarabine-based therapy is considered inappropriate. During 2014 we studied PPrefs of 180 U.S-based hematology-oncology physicians (HOPs) for 1stline Rx across a range of clinical scenarios varying by age, co-morbidities, and selected laboratory features.
Methods: PPrefs were assessed through a validated, proprietary, live, case-based market research tool (Challenging Cases®). Assessment dates were 3/08/14 and 4/26/14. Data were acquired using blinded, audience-response technology. A core scenario (CS) and 3 variant scenarios (VS) were utilized to evoke physician PPrefs. CS: 63-year-old male; 1-2 cm diffuse adenopathy, spleen 3 cm below costal margin. Presented with recent fatigue/ low grade fevers; no relevant co-morbidities; CD 38=12%. No FISH abnormalities. PS1. VS1: All equal except 17p deletion and CD 38 = 42%; VS2: CS (age 63; no abnormal FISH) plus co-morbidities (medication-controlled hypertension, type II diabetes, and mild COPD); VS3: VS2 BUT age 73 with same co-morbidities.
Results: PPrefs by scenario shown below:
| PPref . | CS . | VS1 . | VS2 . | VS3 . | ||||
|---|---|---|---|---|---|---|---|---|
| 3/8/14 | 4/26/14 | 3/8/14 | 4/26/14 | 3/8/14 | 4/26/14 | 3/8/14 | 4/26/14 | |
| Bendamustine + rituximab[BR] | 61% | 63% | 52% | 51% | 72% | 68% | 66% | 64% |
| Bendamustine + Obinutuzumab | 0% | 2% | 2% | 6% | 0% | 1% | 3% | 2% |
| Chorambucil + Obinutuzumab | 1% | 3% | 2% | 3% | 2% | 5% | 8% | 17% |
| FCR | 20% | 16% | 25% | 19% | 5% | 8% | 1% | 2% |
| Ibrutinib + additional agent(s) | 2% | 3% | 11% | 16% | 7% | 8% | 6% | 7% |
| Other | 2% | 2% | 4% | 2% | 2% | 2% | 3% | 2% |
| Observe | 14% | 10% | 3% | 3% | 11% | 6% | 12% | 5% |
| PPref . | CS . | VS1 . | VS2 . | VS3 . | ||||
|---|---|---|---|---|---|---|---|---|
| 3/8/14 | 4/26/14 | 3/8/14 | 4/26/14 | 3/8/14 | 4/26/14 | 3/8/14 | 4/26/14 | |
| Bendamustine + rituximab[BR] | 61% | 63% | 52% | 51% | 72% | 68% | 66% | 64% |
| Bendamustine + Obinutuzumab | 0% | 2% | 2% | 6% | 0% | 1% | 3% | 2% |
| Chorambucil + Obinutuzumab | 1% | 3% | 2% | 3% | 2% | 5% | 8% | 17% |
| FCR | 20% | 16% | 25% | 19% | 5% | 8% | 1% | 2% |
| Ibrutinib + additional agent(s) | 2% | 3% | 11% | 16% | 7% | 8% | 6% | 7% |
| Other | 2% | 2% | 4% | 2% | 2% | 2% | 3% | 2% |
| Observe | 14% | 10% | 3% | 3% | 11% | 6% | 12% | 5% |
Conclusions: As of March-April 2014 BR is the 1st line PPref of 51% -72% of US-based HOPs across 4 plausible newly diagnosed CLL scenarios. In VS1 (age 63; 17p deletion) ibrutinib based Rx is emerging despite lack of 1st line indication. In VS 3 (age 73, multiple co-morbidities present, neither high risk FISH nor CD 38 positivity) 1st line PPref for Chlor + Obin is emerging. Prior to ASH 2014, we will assess PPrefs of approximately 180 additional HOPs related to these scenarios (with ofatumumab + chlorambucil added as a treatment option) and have aggregate PPref data (N > 350) across all of 2014 for ASH.
Williams:Pharmacyclics, Janssen: Consultancy, Research Funding.
Author notes
Asterisk with author names denotes non-ASH members.
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