Genentech Will Present New Clinical Data on Blood Diseases at ASH 2016
Genentech will present more than 60 abstracts at the 58th American Society of Hematology Annual Meeting (ASH 2016). Nine of Genentech’s approved or investigational medicines will be featured, including Gazyva (obinutuzumab), Rituxan (rituximab), Venclexta (venetoclax) and emicizumab, the company’s investigational drug in hemophilia.
More specifically, Genentech will present new results from the Phase 3 GALLIUM clinical trial (NCT01332968), comparing Gazyva plus chemotherapy to Rituxan plus chemotherapy in previously untreated follicular lymphoma; updated results for Venclexta and emicizumab in the treatment of hemophilia A, and will announce the acceptance of the Biologics License Application (BLA) for a subcutaneous formulation of Rituxan (rituximab/hyaluronidase) by the U.S. Food and Drug Administration (FDA).
The results from the Phase 3 GALLIUM clinical trial were handpicked by the organization committee during the Plenary Scientific Session.
“The breadth of data we are presenting at ASH this year reflects our deep commitment to people with blood diseases,” Sandra Horning, MD, Genentech’s 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.
Other studies that analyzed Gazyva also will be presented at ASH 2016, including results from the Phase 3 GADOLIN clinical trial (NCT01059630), in Rituxan-refractory indolent (slow-growing) non-Hodgkin’s lymphoma (NHL); preliminary results from the Phase 3 GOYA clinical trial (NCT01287741) in previously untreated diffuse large B-cell lymphoma (DLBCL); and updated results from the Phase 3 SABRINA trial (NCT01200758), comparing subcutaneous and intravenous Rituxan in previously untreated follicular lymphoma.
Furthermore, Genentech will present real world safety and effectiveness data from the first group of a non-interventional study of hemophilia patients with inhibitions to factor VIII replacement therapy treated with current standard of care (SoC) to routine clinical practice.
There are three ongoing clinical studies exploring the safety and effectiveness of emicizumab (created by Chugai Pharmaceutical and co-developed by Genentech) in the treatment of hemophilia A, including a Phase 3 study in hemophilia A: patients no younger than 12 years old with factor VIII inhibitors, to investigate weekly dosing; a Phase 3 study in people no older than 12 years old with factor VIII inhibitors, to investigate weekly dosing; and a Phase 3 study in people no younger than 12 years old without factor VIII inhibitors to investigate weekly and alternate weeks dosing.
In addition, preliminary results will be shared for combination therapies of Venclexta with Gazyva or Rituxan in chronic lymphocytic leukemia (CLL) and some forms of NHL. Follow-up data from other early studies in multiple myeloma (MM) and acute myeloid leukemia (AML), supporting further investigation of Venclexta (developd by Genentech and AbbVie), also will be shared at ASH 2016.
Genentech said it will use the occasion to announce that the FDA has accepted its BLA for the subcutaneous formulation of Rituxan, with an action date of June 26, 2017.
The annual ASH meeting will take place Dec. 3-6 in San Diego, Calif. Among the 60 abstracts, the company will present 20 of them as oral communications, covering a comprehensive list of medicines and combination therapies. Key abstracts can be found in the table presented here.