SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May 24, 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 years 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. Were 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 Genentechs 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 tumors 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 Genentechs 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.

Genentechs 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

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

Lung cancer

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

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

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 Lon Brard)

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

* IIS, investigator-initiated study

** ISR, institution-sponsored research

*** jointly developed by Genentech and BioNTech

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-Hodgkins 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 Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so its important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. A patients doctor may stop or adjust a patients treatment if any serious side effects occur. Patients must contact their healthcare team if there are any signs of these side effects.

Nerve 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 patients 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

Side effects seen most often

The most common side effects during treatment were:

Polivy may not be for everyone. A patient should talk to their doctor if they are:

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)

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Data at the 2022 ASCO Annual Meeting Highlight Genentech's Continued Commitment to Innovation in Oncology and Personalized Healthcare - Valdosta Daily...

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