Roche to present clinical data from six different medicines at ASH
Posted: 9 December 2014 |
Presentations include data on Roche’s broad portfolio of hematology medicines as well as emerging investigational agents including ACE910 (RG6013) in hemophilia A…
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data on four investigational medicines and investigational uses for two approved hematology medicines will be presented during the 56th American Society of Hematology (ASH) Annual Meeting, which starts on 6 December. Of the 49 abstracts representing the breadth and depth of Roche’s hematology portfolio, nine have been accepted for oral presentation during the meeting.
“We are excited about our contribution to ASH this year because we are presenting data across a range of diseases and treatment settings, including combinations with Gazyva in a variety of blood cancers,” said Sandra Horning MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Blood diseases go beyond the oncology setting, and we will provide an update on our investigational hemophilia A medicine, ACE910, which is being developed to improve outcomes for people with this rare but serious life- long condition.”
Data to be presented at ASH in part focus on Roche’s anti-CD20 medicines, Gazyva®/Gazyvaro® (obinutuzumab) and MabThera®/Rituxan® (rituximab). Results from the maintenance phase of the phase Ib study (GAUDI), investigating Gazyva in combination with chemotherapy or bendamustine in follicular lymphoma as well as preliminary safety results from the phase IIIb study (GREEN) of Gazyva alone or in combination with chemotherapy for previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL) will be featured. In addition to updated data on the use of MabThera in CLL, results from the phase Ib (SAWYER) study of MabThera subcutaneous in previously untreated CLL will be available.
Beyond Roche’s anti-CD20 medicines, data from multiple studies will be shown for venetoclax (GDC- 0199/ABT-199), an investigational BCL-2 inhibitor being developed in collaboration with AbbVie, across a range of blood cancers. Roche will also present new data on the investigational MDM2 antagonist RG7388 and updated data on the anti-CD79b antibody drug conjugate polatuzumab vedotin.
Data from a phase Ib study of ACE910 in people with hemophilia A, including those who have developed inhibitors against factor VIII, will also be presented. ACE910 is an investigational bispecific antibody allowing for subcutaneous administration. ACE910 was initially developed by Chugai Pharmaceutical Co., Ltd. and was opted into by Roche Pharma Research and Early Development earlier in 2014.
| Medicine | Description of study | Abstract number |
|---|---|---|
ACE910 (RG6013) (investigational) | Safety and Prophylactic Efficacy Profiles of ACE910, a Humanized Bispecific Antibody Mimicking the FVIII Cofactor Function, in Japanese Hemophilia A Patients Both without and with FVIII inhibitors: First-in-Patient Phase 1 Study | Abstract #691 |
| Gazyva/Gazyvaro (investigational use) | Obinutuzumab (GA101) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or bendamustine for the first-line treatment of follicular NHL: final results from the maintenance phase of the phase Ib GAUDI study | Abstract #1743 |
| Gazyva/Gazyvaro (investigational use) | Preliminary safety results from the phase IIIb GREEN study of obinutuzumab (GA101) alone or in combination with chemotherapy for previously untreated or R/R CLL | Abstract #3345 |
| Gazyva/Gazyvaro (investigational use) | A phase Ib study of obinutuzumab combined with lenalidomide for relapsed/refractory follicular B-cell lymphoma | Abstract #4458 |
| MabThera/Rituxan (investigational use) | Value of minimal residual disease (MRD) negative status at response evaluation in chronic lymphocytic leukemia (CLL): a review of response of two phase III studies of the German CLL Study Group (GCLLSG) | Abstract #23 |
MabThera (investigational use) | Non-inferior pharmacokinetics (PK) and comparable safety and response rates for subcutaneous (SC), compared with intravenous (IV), rituximab in combination with fludarabine and cyclophosphamide (FC) in patients (Pts) with untreated CLL: part 2 of the phase Ib SAWYER study (BO25341) | Abstract #1995 |
| Polatuzumab vedotin (investigational) | Updated results of a phase II randomized study (ROMULUS) of polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed/refractory non-Hodgkin lymphoma | Abstract #4457 |
RG7388 (investigational) | Phase 1/1b study of RG7388, a potent MDM2 antagonist, in acute myelogenous leukemia (AML) patients (pts) | Abstract #116 |
| Venetoclax (investigational) | A Phase 2 Study of ABT-199 (GDC-0199) in Patients with Acute Myelogenous Leukemia (AML) | Abstract #118 |
| Venetoclax (investigational) | Determination of Recommended Phase 2 Dose of ABT-199 (GDC-0199) Combined with Rituximab (R) in Patients with Relapsed / Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) | Abstract #325 |
| Venetoclax (investigational) | The BCL-2 Inhibitor ABT-199 (GDC-0199) in Combination with Bendamustine and Rituximab in Patients with Relapsed or Refractory Non-Hodgkin’s Lymphoma | Abstract #1722 |
| Venetoclax (investigational) | Preliminary Results of a Phase 1b Study (GO28440) Combining GDC-0199 (ABT-199) with Bendamustine/Rituximab in Patients with Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia | Abstract #3337 |
| Venetoclax (investigational) | Preliminary results of a phase 1b study (GP28331) combining GDC-0199 (ABT-199) and obinutuzumab in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL) | Abstract #4687 |
