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  • First Phase III study to show superior progression-free survival compared to Rituxan-based standard of care treatment for most common slow-growing form of non-Hodgkin’s lymphoma
  • Results will be presented during the Plenary Scientific Session at 58th American Society of Hematology Annual Meeting

SOUTH SAN FRANCISCO, CA, USA I December 4, 2016 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced data from the positive, pivotal Phase III GALLIUM study that compared Gazyva® (obinutuzumab) plus chemotherapy followed by Gazyva alone head-to-head against Rituxan® (rituximab) plus chemotherapy followed by Rituxan alone for people with previously untreated follicular lymphoma. At a pre-planned interim analysis in May 2016, an independent data monitoring committee determined that the study met its primary endpoint early. The results showed Gazyva-based treatment reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) by 34 percent compared to Rituxan-based treatment (HR=0.66; 95% CI 0.51-0.85, p=0.0012). Median PFS was not yet reached. Adverse events with either Gazyva or Rituxan were consistent with those seen in previous studies.

“Follicular lymphoma, the most common slow-growing form of non-Hodgkin’s lymphoma, is an incurable blood cancer characterized by cycles of remission and disease progression, and becomes harder to treat with every relapse,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “This study of Gazyva-based treatment is the first and only Phase III trial to date to show superior progression-free survival compared to Rituxan-based treatment, the current standard of care, in previously untreated follicular lymphoma.”

The primary results from the GALLIUM study (Abstract #6) will be presented during the Plenary Scientific Session of the 58th American Society of Hematology (ASH) Annual Meeting in San Diego by Dr. Robert Marcus, King’s College Hospital, London and the National Cancer Research Institute (NCRI), on Sunday, December 4 at 2:00 P.M. PST. Additionally, an analysis of minimal residual disease (MRD) status in the GALLIUM study (Abstract #613) will be presented in a separate oral session by Dr. Christiane Pott, University Hospital Schleswig-Holstein, Kiel, Germany, and the German Low Grade Lymphoma Study Group (GLSG) on Monday, December 5 at 7:00 A.M. PST.

GALLIUM is the third positive Phase III study for Gazyva, following the CLL11 study in patients with previously untreated chronic lymphocytic leukemia (CLL) and the GADOLIN study in patients with indolent (slow-growing) non-Hodgkin’s lymphoma whose disease progressed during or within six months of prior Rituxan-based therapy. The results of the GALLIUM study will be submitted to health authorities around the world for approval consideration.

About the GALLIUM study

GALLIUM (NCT01332968) is a global Phase III open-label, multicenter, randomized two-arm study examining the efficacy and safety of Gazyva plus chemotherapy followed by Gazyva alone for up to two years, as compared head-to-head against Rituxan plus chemotherapy followed by Rituxan alone for up to two years. Chemotherapies used were CHOP, CVP or bendamustine and were selected by each participating study site prior to beginning enrollment. GALLIUM included 1401 patients with previously untreated indolent non-Hodgkin’s lymphoma (iNHL), of which 1202 patients had follicular lymphoma. The primary endpoint of the study was investigator-assessed PFS in patients with follicular lymphoma, with secondary endpoints including PFS assessed by independent review committee (IRC), PFS in the overall study population (iNHL), response rate (overall response, ORR; and complete response, CR), overall survival (OS) and safety. The GALLIUM study is being conducted in cooperation with the GLSG (Germany), the East German Study Group Hematology and Oncology (OSHO; Germany) and the NCRI (United Kingdom).

A summary of the GALLIUM study results presented at ASH is included below.

Study Group   Patients with previously untreated follicular lymphoma
Treatment Group   Gazyva + chemotherapy,
followed by Gazyva alone		  

Rituxan + chemotherapy,
followed by Rituxan alone
N=   601   601
PFS (primary and secondary endpoints)1
PFS   Investigator: HR=0.66 (0.51, 0.85), p=0.0012 Independent: HR=0.71 (0.54, 0.93), p=0.0138

PFS Rate

at 3 Years

   Investigator: 80.0%
Independent: 81.9%		   Investigator: 73.3%
Independent: 77.9%
OS (secondary endpoint)
OS   HR=0.75 (0.49, 1.17), p=0.21

OS Rate

at 3 Years

   94.0%   92.1%
Time to Next Treatment (TTNT; secondary endpoint)
TTNT   HR=0.68 (0.51, 0.91), p=0.0094
TTNT at 3 Years   87.1%   81.2%
Response Rates (at end of induction; secondary endpoints)2
ORR   88.5%   86.9%
CR   19.5%   23.8%
Partial Response (PR)   69.1%   63.1%
Minimal Residual Disease (MRD; exploratory endpoint) [Pott et al.]
N=   351   345
MRD-Negativity3 (in blood and/or bone marrow at end of treatment with Gazyva or Rituxan plus chemotherapy)   92.0%   84.9%
  p=0.0041
Safety (secondary endpoint)
N=   595   597
Adverse Events (AEs)  
  • AEs observed with Gazyva and Rituxan were consistent with those seen in previous clinical trials when each was combined with various chemotherapies.
  • The overall rate of Grade 3 or higher AEs occurring in the Gazyva and Rituxan arms was 74.6% and 67.8%, respectively.
  • The most common Grade 3 or higher AEs that occurred more often in the Gazyva versus Rituxan arm were low white blood cell counts (neutropenia, 43.9% vs. 37.9%; leukopenia, 8.6% vs. 8.4%), low white blood cell count with fever (febrile neutropenia, 6.9% vs. 4.9%), infusion-related reactions4 (12.4% vs. 6.7%), low platelet count (thrombocytopenia, 6.1% vs. 2.7%), infections (20.0% vs. 15.6%) and second neoplasms (4.7% vs. 2.7%).
  • Fatal AEs occurred in 4.0% of people in the Gazyva arm compared to 3.4% of people in the Rituxan arm.

1 Primary endpoint is PFS as assessed by investigator; median follow-up of 34.5 months
2 Measured by computerized tomography (CT) scans
3 MRD-negativity means no cancer can be detected in the blood or bone marrow using a specific highly sensitive test
4 Defined as any AE occurring during or within 24 hours of infusion of Gazyva or Rituxan and considered drug-related

About Follicular Lymphoma

Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin’s lymphoma (NHL), accounting for about one in five cases of NHL. It is considered incurable and relapse is common. In the United States, it is estimated that more than 14,000 new cases of follicular lymphoma will be diagnosed in 2016.

About Gazyva

Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body’s immune system. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, Gazyva is part of a collaboration between Genentech and Biogen.

Combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are planned or underway across a range of blood cancers.

Gazyva U.S. Indications

Gazyva® (obinutuzumab) is a prescription medicine used:

  • With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
  • With the chemotherapy drug, bendamustine, followed by Gazyva alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.

Please visit http://www.Rituxan.com for the Rituxan full Prescribing Information, including Boxed WARNINGS and Medication Guide, for additional Important Safety Information.

About Genentech In Hematology

For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. In addition to approved medicines, Genentech’s pipeline of investigational hematology medicines includes an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule antagonist of MDM2 (idasanutlin/RG7388). Genentech’s dedication to developing novel medicines for blood diseases expands beyond oncology, with the development of the investigational hemophilia A treatment emicizumab (ACE910). For more information visit http://www.gene.com/hematology.

About Genentech

Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

SOURCE: Genentech

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