05/23/2022 | Press release | Distributed by Public on 05/23/2022 23:18
Monday, May 23, 2022
Pivotal data on glofitamab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody in heavily pre-treated patients with aggressive lymphoma, will be presented as part of our industry-leading hematology portfolio
Further studies exploring broad genomic testing to support informed treatment decisions for patients and advance cancer care approaches will be presented
South San Francisco, CA -- May 23, 2022 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data from clinical trials of 18 approved and investigational medicines across more than 20 cancer types will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 3-7, 2022. Genentech and its partners will present clinical studies across medicines, comprehensive genomic tests, and real-world data at this year's meeting.
"At ASCO this year, progress from our portfolio, partnerships and collaborations showcase our commitment to advance innovation in cancer care," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We're especially pleased to present data from our broad hematology portfolio, including pivotal data for glofitamab, a potential first-in-class bispecific antibody that may improve the lives of people with heavily pre-treated aggressive lymphoma."
Focusing on improving outcomes in non-Hodgkin lymphoma
New and updated data in non-Hodgkin lymphoma will be presented at ASCO. This includes pivotal data from the Phase II NP30179 study investigating glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, in heavily pre-treated patients with diffuse large B-cell lymphoma (DLBCL). DLBCL is an aggressive form of lymphoma, where as many as 40% of patients will relapse, at which point treatment options are limited and survival is shortened. Glofitamab is part of Genentech's broad bispecific antibody development program, which may offer a new immunotherapy-based approach to tackle a range of blood cancers. It is being investigated in several clinical trials including the STARGLO Phase III study, evaluating glofitamab in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in autologous stem-cell transplant ineligible relapsed or refractory DLBCL. In addition, key findings from an analysis of the Asia subpopulation from the pivotal Phase III POLARIX study investigating Polivy® (polatuzumab vedotin) in combination with MabThera/Rituxan plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with newly diagnosed DLBCL will be featured. Polivy plus R-CHP is the first treatment regimen to significantly improve outcomes in previously untreated DLBCL in more than 20 years, potentially transforming treatment for people with this disease.
Driving innovation in personalized cancer care
More than 20 new pieces of research from partnerships with Foundation Medicine will be presented, which continue to support innovation as well as progress in personalized cancer care. This includes new data from the Phase II Profiler02 study,* which investigates the use of a comprehensive genomic profiling testing panel from Foundation Medicine, with the aim of informing possible treatment decisions for patients based on their tumor's unique genomic information.
Data from the imCORE network
Additionally, three abstracts from the Immunotherapy Centers Of Research Excellence (imCORE) Network will be presented at ASCO: a Phase I study** investigating autogene cevumeran (an mRNA-based individualized neoantigen-specific immunotherapy [iNeST]***) in the adjuvant setting of pancreatic ductal adenocarcinoma; a data mining study** evaluating intermediate endpoints for survival in metastatic breast cancer in the real-world setting; and a study identifying mechanisms of acquired resistance to immune checkpoint blockade.**
imCORE is an academic-industry network for scientific collaboration. Established by Genentech and connecting experts from 26 leading institutions around the globe, imCORE is committed to advancing and accelerating cancer immunotherapy research. imCORE is an example of Genentech's dedication to collaborating with the global cancer community to further understand cancer biology and immunology, help inform the development of potential future treatment, and transform patients' lives.
Genentech's data presented at ASCO will feature its efforts to drive innovation and commitment to health equity through delivery of pioneering medicines and personalized cancer care that together improve outcomes for every patient while reducing the cost to society, inclusive clinical trials that remove barriers to participation, partnerships that multiply our ability to address challenges in cancer care, and bringing innovation into earlier stages of disease to maximize a chance of cure.
Overview of key presentations featuring Genentech medicines
Medicine |
Abstract title |
Abstract number |
Blood cancer |
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Glofitamab |
Glofitamab in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and ≥2 prior therapies: Pivotal Phase II expansion results |
#7500 |
Mosunetuzumab |
CELESTIMO: a Phase III trial evaluating the efficacy and safety of mosunetuzumab plus lenalidomide versus rituximab plus lenalidomide in patients with relapsed or refractory follicular lymphoma who have received ≥1 line of systemic therapy |
#TPS7588 |
Polivy |
Asia subpopulation analysis from the Phase III POLARIX trial |
#7558 |
Initial safety run-in results of the Phase III POLARGO trial: polatuzumab vedotin plus rituximab, gemcitabine, and oxaliplatin in patients (pts) with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) |
#7551 |
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Lung cancer |
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Tiragolumab |
SKYSCRAPER-02: primary results of a Phase III, randomized, double-blind, placebo-controlled study of atezolizumab (atezo) plus carboplatin plus etoposide (CE) with or without tiragolumab (tira) in patients (pts) with untreated extensive-stage small cell lung cancer (ES-SCLC) |
#LBA8507 |
Breast cancer |
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Giredestrant |
Neoadjuvant giredestrant (GDC-9545) plus palbociclib (P) versus anastrozole (A) plus P in postmenopausal women with estrogen receptor-positive, HER2-negative, untreated early breast cancer (ER+/HER2- eBC): final analysis of the randomized, open-label, international Phase 2 coopERA BC study |
#589 |
Inavolisib |
Long-term safety of inavolisib (GDC-0077) in an ongoing Phase 1/1b study evaluating monotherapy and in combination (combo) with palbociclib (palbo) and/or endocrine therapy in patients (pts) with PIK3CA-mutated, hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer (BC) |
#1052 |
Tumor agnostic treatment and personalized healthcare |
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Rozlytrek |
Efficacy/safety of entrectinib in patients (pts) with ROS1-positive (ROS1+) advanced/metastatic NSCLC from the Blood First Assay Screening Trial (BFAST) |
#LBA9023 |
Rozlytrek |
Trial in progress: a randomized Phase 3 study of entrectinib vs crizotinib in patients (pts) with locally advanced/metastatic ROS1 fusion-positive (fp) NSCLC with or without baseline CNS metastases (mets) |
#TPS9141 |
Comprehensive genomic profiling (IIS, Centre Léon Bérard) |
Increasing targeted therapy options for patients with relapsed cancer with broader somatic gene panel analysis from the primary tumor: The Profiler02 randomized Phase II trial* |
#3130 |
Comprehensive genomic profiling |
Clinical and genomic characteristics of patients with durable benefit from immune checkpoint inhibitors (ICI) in advanced non-small cell lung cancer (aNSCLC) |
#9048 |
Comprehensive genomic profiling |
ctDNA Shed as a Tool to Select Immune Checkpoint Inhibitors (ICPI) with or without Chemotherapy for Patients (pts) with advanced Non-small Cell Lung Cancer (aNSCLC) |
#9045 |
Comprehensive genomic profiling |
Trial in progress: LCMC LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers |
#TPS8596 |
Real world data |
A real world (rw) evidence study quantifying the clinical value of multi-gene testing in early-stage lung adenocarcinoma (LUAD) |
#8525 |
Real world data |
Real world analysis of quantitative MET copy number (CN) as a biomarker in advanced NSCLC (aNSCLC) |
#9123 |
Real world data |
Ancestry-based differences in gene alterations in non-small cell lung cancer: real-world data using genetic ancestry analysis |
#9125 |
imCORE, ISR, Genentech |
Identifying mechanisms of acquired immune escape from sequential, paired biopsies** |
#2519 |
imCORE ISR, Dana-Farber Cancer Institute |
Real-World Progression-Free Survival (rwPFS) and Time to Next Line of Therapy (TTNT) as Intermediate Endpoints for Survival in Metastatic Breast Cancer: A Real World Experience** |
#6520 |
imCORE ISR, Memorial Sloan Kettering Cancer Center |
Phase I Trial of Adjuvant Autogene Cevumeran, an Individualized mRNA Neoantigen Vaccine, for Pancreatic Ductal Adenocarcinoma** |
#2516 |
About Polivy® (polatuzumab vedotin-piiq)
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin's lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL.
Polivy U.S. Indication
Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have progressed after at least two prior therapies.
The accelerated approval of Polivy is based on a type of response rate. There are ongoing studies to confirm the clinical benefit of Polivy.
Important Safety InformationNerve problems in arms and legs: This may happen as early as after the first dose and may worsen with every dose. If a patient already has nerve pain, Polivy may make it worse. The patient's doctor will monitor for signs and symptoms, such as changes in sense of touch, numbness or tingling in hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to walking patterns
These may not be all the side effects. Patients should talk to their healthcare provider for more information about the benefits and risks of Polivy treatment.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at (888) 835-2555. Please visit http://www.Polivy.com for the full Prescribing Information for additional Important Safety Information.
About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Tecentriq U.S. Indications
Tecentriq is a prescription medicine used to treat adults with:
A type of lung cancer called non-small cell lung cancer (NSCLC).
A type of lung cancer called small cell lung cancer (SCLC).
It is not known if Tecentriq is safe and effective in children.
Important Safety InformationPatients should call or see their healthcare provider right away if they develop any new or worse signs or symptoms, including:
Lung problemsProblems can also happen in other organs.
These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Tecentriq when used alone include:
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.
Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at 1-888-835-2555.Please see http://www.Tecentriq.com for full Prescribing Information and additional Important Safety Information.
Rozlytrek™ U.S. Indication (pronounced roz lye' trek)
Rozlytrek is a prescription medicine used to treat:
It is not known if Rozlytrek is safe and effective for use in children less than 12 years of age.
Rozlytrek was approved in NTRK gene fusion-positive solid tumors through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm benefit of Rozlytrek for this use.
Important Safety InformationRozlytrek may cause serious side effects, including:
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Before taking Rozlytrek, patients should tell their healthcare provider about all their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
Certain other medicines may affect how Rozlytrek works causing side effects. Patients should know the medicines they take. Patients should keep a list of them to show to their healthcare provider and pharmacist when they get a new medicine.
The most common side effects of Rozlytrek include:
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These are not all the possible side effects of Rozlytrek. For more information, patients should ask their healthcare provider or pharmacist.
Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please see http://www.Rozlytrek.com for the full Prescribing
Information, including Patient Information.
About GenentechFounded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and 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.###