Breaking News
January 20, 2018 - MSU scientists seek to identify brain mechanisms related to psychosis
January 20, 2018 - Syndax Pharmaceuticals Announces Clinical Collaboration to Evaluate Entinostat in Combination with anti-PD-L1 Cancer Immunotherapy in Breast Cancer
January 20, 2018 - Endoscopes Over Microscopes in Retinal Surgery: Ophthalmology Times
January 20, 2018 - Technology not taking over children’s lives despite screen-time increase
January 20, 2018 - Study finds extensive contamination around lead battery recycling plants in 7 African countries
January 20, 2018 - Flu may pass to others through exhaled breath, study shows
January 20, 2018 - Neuronal loss very limited in Alzheimer’s disease, new study shows
January 20, 2018 - Novel robot can aid treatment of rare birth defect
January 19, 2018 - TherapeuticsMD Announces Submission of New Drug Application for TX-001HR
January 19, 2018 - Fighting Infant Mortality | Medpage Today
January 19, 2018 - Researchers offer new evidence on four-year-old children’s knowledge about ecology
January 19, 2018 - Analysis finds overlooked crucial factor in determining prognosis for DIPGs
January 19, 2018 - Review explores consequences of genetic testing and cancer risk-reducing surgery
January 19, 2018 - Morning Break: HHS Div. of Religious Freedom; Trump’s Heart Health; Minister of Loneliness
January 19, 2018 - Parkinson’s disease ‘jerking’ side effect detected by algorithm
January 19, 2018 - New analysis finds dramatic increases in maternal mortality rates
January 19, 2018 - Weight-Loss Surgery’s Benefits Wane Over Time for Diabetics
January 19, 2018 - Cath Lab Recap: Sapien 3 Delivery System Recall; Transatlantic PCI Smackdown
January 19, 2018 - Parkinson’s treatment could be more effective, student finds
January 19, 2018 - New vaccine approach offers effective protection against tuberculosis
January 19, 2018 - Home care agencies often wrongly deny Medicare help to the chronically ill
January 19, 2018 - One hundred percent fruit juice does not alter blood sugar levels
January 19, 2018 - Prebiotics could enhance learning and memory skills in infants
January 19, 2018 - CMS May Cover MRI With Cardiac Devices Across the Board
January 19, 2018 - As income rises, women get slimmer—but not men
January 19, 2018 - Researchers develop adhesive materials to prevent bracket stains on teeth
January 19, 2018 - Flu can be spread without coughs and sneezes
January 19, 2018 - AMSBIO’s new recombinant protein shows great promise for organoid culture
January 19, 2018 - AbbVie’s Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis
January 19, 2018 - ASH: Pomalidomide Dose Escalation Improves Response
January 19, 2018 - Is your child’s school an obesity risk?
January 19, 2018 - Scientists describe groundbreaking training effect on the innate immune system
January 19, 2018 - MAST announces new AmpC, ESBL & Carbapenemase Detection Set
January 19, 2018 - Signaling molecules likely involved in concussions, rodent studies show
January 19, 2018 - Mast introduces Carba plus for CPE and OXA-48 confirmation
January 19, 2018 - Paleolithic diet helps overweight women maintain weight loss
January 19, 2018 - Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Relapsed/Refractory AML and an IDH1 Mutation
January 19, 2018 - This Flu Season, Don’t Forget About Tamiflu
January 19, 2018 - Amsterdam wins battle to host EU medicines agency after Brexit
January 19, 2018 - Study suggests movement as accurate method to diagnose neurodevelopmental disorders
January 19, 2018 - Maximize resolution in deep imaging for neuroscience research with Olympus TruResolution objectives
January 19, 2018 - Bilingualism may benefit children with ASD
January 19, 2018 - FDA Alert: Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall
January 19, 2018 - USPSTF Not Backing Ankle-Brachial Index, CRP, or Coronary Calcium
January 19, 2018 - Higher omega-3 fatty acid intake tied to lower glaucoma risk
January 19, 2018 - Findings reveal conventional cancer therapy as double-edged sword
January 19, 2018 - Health Highlights: Jan. 16, 2018
January 19, 2018 - Morning Break: Anti-Emetic Warning; Uninsured Rate Jumps; Flu Worsens Saline Shortage
January 19, 2018 - Increased use of ambulatory surgery centers for cataract surgery
January 19, 2018 - Not-for-profit hospitals coming up with their own generic medicines to combat shortages
January 19, 2018 - $500 cancer detection blood tests may soon become reality
January 19, 2018 - Chronic traumatic encephalopathy may start early even without signs of concussions
January 19, 2018 - Warm-up program for children cuts soccer injuries by 50%
January 19, 2018 - ‘You’re Old and You Need Tests’: What We Heard This Week
January 19, 2018 - Egg-preserving hysterectomy raises heart risks later: study
January 19, 2018 - GA-map Dysbiosis Test identifies IBS patients who respond to FODMAP diet, study shows
January 19, 2018 - Study explores mortality and health-related habits in former elite athletes and their brothers
January 19, 2018 - New biodegradable sensors could assist doctors
January 19, 2018 - Modular gene enhancers may be suitable target in treatment of blood cancer
January 18, 2018 - New precision medicine trial for metastatic pancreatic cancer
January 18, 2018 - Shire Receives FDA Breakthrough Therapy Designation for Maribavir, an Investigational Treatment for Cytomegalovirus (CMV) Infection in Transplant Patients
January 18, 2018 - Pre-Existing Patient-Valve Mismatch Trips Up ViV Implant
January 18, 2018 - Adolescents: health risks and solutions
January 18, 2018 - US woman delivers baby from embryo frozen for 24 years
January 18, 2018 - Study identifies new target for treatment of depression
January 18, 2018 - LJI study reveals key player that promotes skin inflammation in atopic dermatitis
January 18, 2018 - Study devises efficient and economical strategy to screen breast and ovarian cancer gene mutations
January 18, 2018 - Agile Therapeutics, Inc. Receives a Complete Response Letter from the FDA for Twirla (AG200-15) for the Prevention of Pregnancy
January 18, 2018 - Gene Therapy for Inherited Retinal Dystrophy Gets FDA Clearance
January 18, 2018 - Researchers identify a new chemical pathway that helps the brain detect sweet, savory and bitter flavors
January 18, 2018 - IBV develops platform that helps companies to diagnose wellbeing of their workforce
January 18, 2018 - Study to test new precision medicine approach for metastatic pancreatic cancer
January 18, 2018 - World’s first vaccine relieves grass pollen allergy symptoms by at least 25%, study shows
January 18, 2018 - FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC
January 18, 2018 - Oncologists Dish on Top Issues for 2018
January 18, 2018 - Researchers identify new potential drug target for Huntington’s disease
January 18, 2018 - Metrohm USA welcomes employees to new headquarters in Florida
January 18, 2018 - Human waste remains main source of fecal pollution in the river Danube
January 18, 2018 - Expert discusses how to stay healthy during flu season
January 18, 2018 - New biomaterials-based system improves T-cell production
Phase II Data Showed Genentech’s Investigational Polatuzumab Vedotin Plus Bendamustine and Rituxan (BR) Increased Complete Response Rates Compared to BR Alone in Previously Treated Aggressive Lymphoma

Phase II Data Showed Genentech’s Investigational Polatuzumab Vedotin Plus Bendamustine and Rituxan (BR) Increased Complete Response Rates Compared to BR Alone in Previously Treated Aggressive Lymphoma

image_pdfDownload PDFimage_print

South San Francisco, CA — December 10, 2017 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the randomized Phase II GO29365 study that compared polatuzumab vedotin in combination with bendamustine plus Rituxan® (rituximab) (BR) against BR alone in people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for hematopoietic stem cell transplant. The study met its primary endpoint, demonstrating that the addition of polatuzumab vedotin to BR increased complete response (CR) rates from 15 percent to 40 percent (p=0.012) at the end of treatment, as measured by positron emission tomography (PET) and assessed by an independent review committee (IRC). No unexpected safety signals were observed with the addition of polatuzumab vedotin to BR.

“As many as 40 percent of people with diffuse large B-cell lymphoma do not respond to initial therapy or experience the return of their disease, at which point their treatment options are limited and the prognosis is very poor,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The promising efficacy observed for polatuzumab vedotin in this study supports its potential as a new treatment option for people previously treated for this aggressive blood cancer, and we look forward to discussing the results with health authorities.”

The data will be presented in a poster session on Sunday, December 10 at the 59th American Society of Hematology (ASH) Annual Meeting by Laurie Sehn, M.D., British Columbia Cancer Agency/University of British Columbia. The results showed:

  • Polatuzumab vedotin plus BR significantly improved CR rates from 15 percent with BR alone to 40 percent (p=0.012), as measured by PET and assessed by IRC. A CR means no cancer could be detected at that time.
  • The benefit observed was consistent across secondary endpoints, including improvements in investigator-assessed best objective response (OR; CR and partial response, PR) and CR with polatuzumab vedotin plus BR (70.0 percent OR, 57.5 percent CR) compared to BR alone (32.5 percent OR, 20.0 percent CR).
  • Exploratory endpoints also improved with the addition of polatuzumab vedotin to BR:
    • Patients treated with polatuzumab vedotin plus BR lived longer than those receiving BR alone (median overall survival; 11.8 months vs. 4.7 months; HR=0.35; 95 percent CI 0.19-0.67; p=0.0008).
    • The addition of polatuzumab vedotin also increased the time until disease worsening or death (median progression-free survival: 6.7 months vs. 2.0 months; HR=0.31; 95 percent CI 0.18-0.55; p
  • No unexpected safety signals were observed with the addition of polatuzumab vedotin to BR. The most common Grade 3-4 adverse events with polatuzumab vedotin plus BR compared to BR alone, respectively, were low white blood cell count (46.2 percent vs. 35.9 percent), low white blood cell count with fever (10.3 percent vs. 5.1 percent), low platelet count (33.3 percent vs. 20.5 percent), anemia (25.6 percent vs. 12.8 percent) and infections (17.9 percent vs. 17.9 percent).

Based on results from this study, polatuzumab vedotin was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration and PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of people with relapsed or refractory DLBCL. There are a number of ongoing studies evaluating the efficacy and safety of polatuzumab vedotin for several types of non-Hodgkin’s lymphoma, including combinations with Gazyva® (obinutuzumab), Rituxan, Venclexta™ (venetoclax) and Tecentriq® (atezolizumab).

About the GO29365 study

GO29365 is a global, Phase Ib/II randomized study evaluating the safety, tolerability and activity of polatuzumab vedotin in combination with Rituxan or Gazyva plus bendamustine in relapsed or refractory (R/R) follicular lymphoma or diffuse large B-cell lymphoma (DLBCL). The Phase II stage randomized 80 patients with heavily pre-treated R/R DLBCL to receive either bendamustine plus Rituxan (BR), or BR in combination with polatuzumab vedotin. Patients enrolled had received a median of two prior therapies (a range of 1-7 prior therapies in the polatuzumab vedotin arm and range of 1-5 prior therapies in the BR alone arm). The primary endpoint was complete response (CR) at the end of treatment, as measured by positron emission tomography (PET) and assessed by an independent review committee (IRC). Secondary endpoints included objective response (OR; CR and partial response, PR) by investigator assessment and best objective response at the end of treatment by investigator and IRC assessment. Exploratory endpoints included duration of response (DOR), progression-free survival (PFS), event-free survival (EFS) and overall survival (OS).

About polatuzumab vedotin

Polatuzumab vedotin is a first-in-class anti-CD79b antibody drug conjugate (ADC) currently being investigated for the treatment of several types of non-Hodgkin’s lymphoma (NHL). The CD79b protein is highly specific and expressed in the majority of types of B-cell NHL, making it a promising target for the development of new therapies. Polatuzumab vedotin binds to CD79b and destroys these B-cells via a targeted approach, which is thought to minimize the effects on normal cells while maximizing tumor cell death. Polatuzumab vedotin is being developed by Genentech, a member of the Roche Group, utilizing Seattle Genetics ADC technology.

About DLBCL

Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin’s lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive (fast-growing) type of NHL. As many as 40 percent of patients will relapse, at which point their prognosis is poor. In the United States, it is estimated that more than 21,000 new cases of DLBCL will be diagnosed in 2017.

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 polatuzumab vedotin (RG7596) and a small molecule antagonist of MDM2 (idasanutlin/RG7388). For more information visit http://www.gene.com/hematology.

About Genentech

Founded more than 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

Posted: December 2017

Tagged with:

About author

Related Articles