Genentech Touts Hematology Data for Gazyva and Venetoclax in CLL
December 16, 2015
By Alex Keown, BioSpace.com Breaking News Staff
ORLANDO, Fla. – With advances in its clinical pipeline, Genentech has taken aim at knocking out chronic lymphocytic leukemia (CLL) with multiple approaches.
During the American Society of Hematology (ASH) meeting in Orlando, Fla., Genentech revealed data from several studies, which demonstrated efficacy in treating the deadly blood cancer, including its combination treatment Gazyva and Venetoclax, a treatment being co-developed with Illinois-based AbbVie Inc. . Stephanie Huang, senior manager of corporate relations at Genentech, discussed Genentech’s advances in treating blood cancers like CLL and non-Hodgkin’s Lymphoma, with BioSpace .
Huang said Genentech is excited about the data presented at ASH regarding Gazyva, which showed people were able to remain treatment-free for approximately four years on average following the six-month regimen of treatment.
“Gazyva gives people with CLL an important initial treatment option, given for a set six-month period in combination with chemotherapy,” Huang told BioSpace.
Huang said the company’s goal with Gazyva is to “improve upon existing treatments, including our own medicine Rituxan, which is why we studied the Gazyva and Rituxan regimens head-to-head in the Phase III CLL11 study.”
CLL is one of the most common forms of blood cancer. It is expected that approximately 4,650 people in the United States will die from CLL complications. There are some CLL medications on the market, including Rituxan, Campeth, AbbVie’s Imbruvica (acquired earlier in 2015 from Pharmacyclics, Inc. ) and Arzerra.
Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor that is being investigated for the treatment of CLL and other blood disorders. The drug works by blocking the BCL-2 protein and “telling” the cancer cells to die, giving the healthy cells room to grow. The drug is currently in Phase III clinical trials.
During a presentation at ASH, Genentech and AbbVie presented Phase II data, which showed Venetoclax achieved primary efficacy endpoints with 79.4 percent of patients showing an overall response rate. Additionally, 7.5 percent of people achieved a complete response with or without complete recovery (complete response without normal blood counts) in the bone marrow. Of the patients treated with Venetoclax, 84.7 percent of patients maintained a duration of response for approximately 12 months. Perhaps most notably, 18 patients who took Venetoclax achieved minimal residual disease-negativity, which means no cancer could be detected by using a specific test. Ten of these 18 people also had bone marrow assessments and six were MRD-negative.
Based on the results of the trial, Abbvie submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for Venetoclax under breakthrough therapy designation.
Genentech is also exploring how Venetoclax will work in combination with Gazyva and Rituxan, Huang said. Gazyva is also being studied for the treatment of non-Hodgkin’s Lymphoma (NHL). Data from a Phase III trial showed Gazyva significantly increased progression-free survival for people with indolent NHL whose disease no longer responded to, or relapsed shortly after, Rituxan therapy. Based on the results of the study, Huang said the FDA accepted a supplemental Biologics License Application for Gazyva, with priority review.
In addition to Gazyva, Genentech’s NHL development program includes two additional Phase III studies that are evaluating Gazyva regimens head-to-head with Rituxan in aggressive and slow-growing NHL, respectively, Huang said.