June 1, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
An executive with Genentech , a member of Swiss drug maker Roche , told BioSpace Monday that recent data presented at the American Society of Clinical Oncology (ASCO)’s annual meeting from a Phase III study mark “a clear advance” in the reduction of the risk of disease progression for people with indolent non-Hodgkin’s lymphoma.
The study, dubbed GADOLIN, showed that Genentech’s drug Gazyva (obinutuzumab) plus bendamustine, followed by Gazyva alone, provided significant benefit for people with indolent non-Hodgkin’s lymphoma that is refractory to Rituxan (rituximab)-based treatment. It also highlighted that Gazyva plus bendamustine followed by Gazyva alone reduced the risk of disease worsening or death by 45 percent, compared to bendamustine alone.
“We have a broad clinical study program to better understand Gazyva’s potential in different treatment settings, and in combination with different chemotherapies, targeted medicines and immunotherapies,” Nancy Valente, a medical doctor and vice president of Global Hematology Development at Genentech, told BioSpace Monday. “We have already seen the benefit of Gazyva over Rituxan in chronic lymphocytic leukemia (CLL), and received FDA approval for this indication (previously-untreated CLL in combination with chlorambucil) in 2013.”
Indolent non-Hodgkin’s lymphoma (NHL) is a slow-growing form of lymphoma and considered incurable, so expanding and improving on current treatment options for people with the disease is important. The anti-CD20 antibody Rituxan and Rituxan-based regimens have demonstrated significant improvements in progression-free survival in patients with this disease and have become a standard of care.
Those are significant milestones for the treatment of the disease, Valente said.
“However, people with indolent NHL have recurrent disease, and with each relapse, the disease becomes increasingly resistant to treatment and more difficult to treat over time. In the GADOLIN study, we evaluated whether Gazyva could help people with indolent NHL whose disease had progressed during or following Rituxan-based therapy,” she said.
“The GADOLIN results mark a clear advance because they show there was a significant reduction in risk of disease progression, and a doubling of the amount of time before disease progression, when Gazyva was combined with bendamustine and followed by Gazyva alone, compared to bendamustine alone.”
The study was stopped early because the high level of benefit seen in the Gazyva arm compared to the bendamustine arm was large enough to warrant a halt. There were no unexpected safety signals identified with Gazyva.
“The GADOLIN data are the first pivotal data for Gazyva in NHL, and they have demonstrated the potential of Gazyva in this setting,” Valente told BioSpace. “We plan to share these results with health authorities for approval consideration later this year and look forward to results from two other large Phase III studies that are ongoing that compare Gazyva-based treatment head-to-head with Rituxan-based treatment in people with previously untreated indolent and aggressive NHL.”
Valente said that Genentech has been studying blood cancers for more than 20 years, which gives it some perspective on how to best tackle diseases in a rapidly changing and competitive field.
“Rituxan was the first therapeutic antibody ever approved in oncology, and Gazyva is our second anti-CD20 antibody,” she said. “Gazyva is thought to have an increased ability to induce direct cell death and induces greater activity in how it recruits the body’s immune system to attack B-cells (antibody dependent cellular cytotoxicity; ADCC) when compared to Rituxan.”
Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”
Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.
“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”
We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?
