Genentech to Present Data From Multiple Clinical Trials on Myeloma and Other Blood Cancers

Genentech to Present Data From Multiple Clinical Trials on Myeloma and Other Blood Cancers
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Genentech will present results on several approved or investigational therapies for blood cancers, including lymphoma and myeloma, in the upcoming 58th American Society of Hematology (ASH) Annual Meeting in San Diego, Dec. 3-6.

Results, which include data for Gazyva (obinutuzumab), Rituxan (rituximab), Venclexta (venetoclax) and emicizumab, will be presented in 60 abstracts, more than 20 of which will be presented orally. Six of these abstracts include results from the Phase 3 study GALLIUM (NCT01332968) evaluating Gazyva as a possible therapy for lymphoma.

“The breadth of data we are presenting at ASH this year reflects our deep commitment to people with blood diseases,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a press release. “We are excited to share the results of the pivotal GALLIUM study in previously untreated follicular lymphoma, which showed that people treated with Gazyva plus chemotherapy lived significantly longer without their disease worsening than those treated with Rituxan plus chemotherapy,” she said.

Results from other Genentech studies to be presented at the meeting include follow-up from early studies on the use of Venclexta (developed by AbbVie and Genentech) as a therapy for multiple myeloma (MM) and acute myeloid leukemia (AML), as well as:

  • an update on the overall survival from the Phase 3 GADOLIN study (NCT01059630) testing the effectiveness of Gazyva in patients with relapsing non-Hodgkin’s lymphoma (NHL) after Rituxan treatment;
  • preliminary results from the Phase 3 GOYA study (NCT01287741) evaluating the effect of Gazyva in previously untreated patients with diffuse large B-cell lymphoma (DLBCL);
  • an update on the Phase 3 SABRINA trial comparing subcutaneous and intravenous administration of Rituxan in previously untreated follicular lymphoma;
  • early results of combining Venclexta with either Gazyva or Rituxan in chronic lymphocytic leukemia (CLL) and certain types of NHL;
  • safety and efficacy data on three studies testing emicizumab as a therapy for children and adults with hemophilia.

The anti-CD20 monoclonal antibody Rituxan already has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis and granulomatosis with polyangiitis. Now the FDA has accepted a Biologics License Application (BLA) for the subcutaneous formulation of Rituxan, with an action date of June 26, 2017.

Venclexeta, the Bcl-2 inhibitor, was approved by the FDA for patients with chronic lymphocytic leukemia (CLL) patients with a specific genetic deletion, following the Breakthrough Therapy status granted in 2015.

Gazyva, another CD20-directed antibody is approved in combination with Leukeran (chlorambucil) for previously untreated chronic lymphocytic leukemia patients and in combination with Levact (bendamustine) for follicular lymphoma patients who relapsed or are refractory to a Rituxan-containing regimen.

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