Business Wire | Nov 23, 2021 09:15AM EST

Genentech to Present New Pivotal Data at ASH 2021 From Broad and Comprehensive Portfolio, Challenging Treatment Standards for People With Blood Disorders

Nov. 23, 2021

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 23, 2021--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its extensive hematology portfolio will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from December 11-14, 2021. Genentech molecules will be featured in more than 90 abstracts, including 17 oral presentations, showcasing new immunotherapies, unique treatment combinations, the application of novel endpoints, and fixed-duration regimens.

Results from three pivotal studies will be featured:

* First presentation of efficacy and safety data from the Phase III POLARIX study as a late-breaking abstract and in the ASH press program. POLARIX met its primary endpoint of improving progression-free survival, showing Polivy(r) (polatuzumab vedotin-piiq) plus Rituxan(r) (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) reduced the likelihood of disease worsening or death versus the standard-of-care, Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), for people with newly diagnosed diffuse large B-cell lymphoma (DLBCL). The safety profile was comparable for Polivy plus R-CHP versus R-CHOP. * Pivotal results from the Phase I/II GO29781 study, presented for the first time and featured in the ASH press program, showing mosunetuzumab, a CD20xCD3 T-cell engaging bispecific antibody immunotherapy, achieved high response rates with a manageable safety profile. These data suggest that it could be a new treatment option for people with relapsed or refractory (R/R) follicular lymphoma (FL) who have received two or more prior therapies. FL is the most common indolent (slow growing) form of non-Hodgkin's lymphoma (NHL), a type of blood cancer, which often returns after initial therapy. * Interim data from the Phase III HAVEN 6 study, which demonstrated the favorable safety and efficacy profile of Hemlibra(r) (emicizumab-kxwh) in people with moderate or mild hemophilia A without factor VIII inhibitors. This patient population has historically not used prophylactic (preventative) treatments, likely due to delayed or missed diagnosis and a lack of treatments and treatment guidelines, meaning these patients have a significant unmet clinical need.

"For 20 years, we have remained committed to deepening our understanding of many benign and malignant blood disorders in order to better meet the urgent needs of patients with these diseases," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Our data at ASH reinforce our conviction that following the science and developing versatile treatment approaches leads to improved outcomes for patients in increasingly meaningful ways."

Data presented at ASH by Genentech span numerous blood diseases, including lymphoma, leukemia, multiple myeloma and hemophilia. Additional data to be presented include updated results for three T-cell engaging bispecific antibody immunotherapies: glofitamab and mosunetuzumab, targeting CD20 and CD3; and cevostamab, targeting FcRH5 and CD3. Further information on the key abstracts featuring Genentech medicines presented at ASH can be found in the table below.

Follow Genentech on Twitter via @Genentech and LinkedIn and keep up to date with ASH Annual Meeting news and updates by using the hashtag #ASH21.??

AbstractMedicine Abstract title number/ presentation details

The POLARIX Study: Polatuzumab Vedotin with LBA-1 oral Rituximab, Cyclophosphamide, Doxorubicin, and presentation Prednisone (pola-R-CHP) Versus Rituximab, Session: Cyclophosphamide, Doxorubicin, Vincristine and Late-BreakingPolivy Prednisone (R-CHOP) Therapy in Patients with Abstracts Previously Untreated Diffuse Large B-Cell Lymphoma Tuesday, December 14, POLARIX is being conducted in collaboration with 2021 The Lymphoma Study Association (LYSA) and The 9:00-10:30 AM Lymphoma Academic Research Organization (LYSARC). ET

#127 oral Mosunetuzumab Monotherapy Is an Effective and presentation Well-Tolerated Treatment Option for Patients with Session: 623 Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Saturday, Who Have Received ?2 Prior Lines of Therapy: December 11, Pivotal Results from a Phase I/II Study 2021 12:00-1:30 PM ET

#533 oral Mosunetuzumab Plus Polatuzumab Vedotin has presentation Promising Efficacy and a Favorable Safety Profile Session: 627 in Patients with Relapsed/Refractory Aggressive Sunday, B-Cell Non-Hodgkin Lymphoma: Updated Results from a December 12, Phase Ib/II Study 2021 4:30-6:00 PMMosunetuzumab ET

#129 oral Mosunetuzumab in Combination with Lenalidomide Has presentation a Manageable Safety Profile and Encouraging Session: 623 Activity in Patients with Relapsed/Refractory Saturday, Follicular Lymphoma: Initial Results from a Phase December 11, Ib Study 2021 12:00-1:30 PM ET

#3573 poster Subcutaneous (SC) Administration of Mosunetuzumab presentation with Cycle 1 Step-up Dosing Is Tolerable and Active Session: 626 in Patients with Relapsed/Refractory B-Cell Monday, Non-Hodgkin Lymphomas (R/R B-NHL): Initial Results December 13, from a Phase I/II Study 2021 6:00-8:00 PM ET

#130 oral Glofitamab Step-up Dosing Induces High Response presentation Rates in Patients (pts) with Relapsed or Refractory Session: 623 (R/R) Mantle Cell Lymphoma (MCL), Most of Whom Had Saturday, Failed Prior Bruton's Tyrosine Kinase Inhibitor December 11, (BTKi) Therapy 2021 12:00-1:30 PM ET

#525 oral Glofitamab (Glofit) in Combination with Polatuzumab presentation Vedotin (Pola): Phase Ib/II Preliminary Data Session: 626 Support Manageable Safety and Encouraging Efficacy Sunday, in Relapsed/Refractory (R/R) Diffuse Large B-Cell December 12, Lymphoma (DLBCL) 2021 4:30-6:00 PM ET

#128 oral presentation Session: 623Glofitamab Glofitamab As Monotherapy and in Combination with Saturday, Obinutuzumab Induces High Complete Response Rates December 11, in Patients (pts) with Multiple Relapsed or 2021 Refractory (R/R) Follicular Lymphoma (FL) 12:00-1:30 PM ET



#2478 poster presentation Glofitamab Monotherapy Provides Durable Responses Session: 626 after Fixed-Length Dosing in Relapsed/Refractory (R Sunday, /R) Non-Hodgkin Lymphoma (NHL) Patients (pts) December 12, 2021 6:00-8:00 PM ET

Glofitamab Plus R-CHOP Induces High Response Rates #2479 poster with Minimal Cytokine Release Syndrome (CRS) in presentation Patients (pts) with Relapsed/Refractory (R/R) Session: 626 Non-Hodgkin Lymphoma (NHL) and Previously Untreated Sunday, (1L) Diffuse Large B-Cell Lymphoma (DLBCL): December 12, Preliminary Results from a Dose-Escalation and 2021 Safety Run-in Phase Ib Study 6:00-8:00 PM ET

#157 oral Cevostamab Monotherapy Continues to Show Clinically presentationCevostamab Meaningful Activity and Manageable Safety in Session: 653 Patients with Heavily Pre-Treated Relapsed/ Saturday, Refractory Multiple Myeloma (RRMM): Updated Results December 11, from an Ongoing Phase I Study 2021 12:00-1:30 PM ET

#1345 poster presentationGazyva Obinutuzumab Short Duration Infusion is Preferred Session: 623 by Healthcare Providers and has Minimal Impact on Saturday, Patient-Reported Symptoms Among Patients with December 11, Untreated, Advanced Follicular Lymphoma 2021 5:30-7:30 PM ET

#241 oral presentation Molecular Responses Are Observed across Mutational Session: 637 Spectrum in Treatment-Na?ve Higher-Risk Saturday, Myelodysplastic Syndrome Patients Treated with December 11, Venetoclax Plus Azacitidine 2021 2:00-3:30 PM ET

#224 oral presentationVenclexta Outcomes in Patients with Poor-Risk Cytogenetics Session: 617 with or without TP53 Mutations Treated with Saturday, Venetoclax Combined with Hypomethylating Agents December 11, 2021 2:00-3:30 PM ET

#1551 poster Chronic Lymphocytic Leukemia (CLL) Clonal Growth presentation Rate is Slower Following Venetoclax-Rituximab Session: 642 (VenR): Results From a Minimal Residual Disease Saturday, (MRD) Model from the Randomized Phase 3 MURANO December 11, Trial 2021 5:30-7:30 PM ET

#343 oral presentation Emicizumab Prophylaxis in Persons with Mild or Session: 322 Moderate Hemophilia A: Results from the Interim Sunday, Analysis of the HAVEN 6 Study December 12, 2021 9:30-11:00 AMHemlibra ET

#3186 poster presentation Evaluation of the Safety of Emicizumab Prophylaxis Session: 322 in Persons with Hemophilia A: An Updated Summary of Monday, Thrombotic Events and Thrombotic Microangiopathies December 13, 2021 6:00-8:00 PM ET

Two Currently Recruiting Randomized Phase III Trials: COMMODORE 1 and 2 Evaluating Crovalimab vs #4313 Eculizumab in Patients With Paroxysmal Nocturnal publication Hemoglobinuria with or without Current only Anti-Complement Therapy

#3108 poster Trial in Progress: The Randomized, Double-Blind, presentation Placebo-Controlled Phase Ib CROSSWALK-a Trial Session: 114 Evaluating the Safety of Crovalimab for the Monday,Crovalimab Management of Acute Uncomplicated Vaso-Occlusive December 13, Episodes (VOEs) in Patients with Sickle Cell 2021 Disease (SCD) 6:00-8:00 PM ET

#3111 poster Trial in Progress: The Randomized, Double-Blind, presentation Placebo-Controlled Phase IIa CROSSWALK-c Trial Session: 114 Evaluating the Efficacy of Crovalimab As Adjunct Monday, Treatment in the Prevention of Vaso-Occlusive December 13, Episodes (VOEs) in Patients with Sickle Cell 2021 Disease (SCD) 6:00-8:00 PM ET

About Polivy(r) (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 Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it's important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. A patient's doctor may stop or adjust a patient's 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 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 * Infusion-related reactions: A patient may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of the infusion * Infections: Patients should contact their healthcare team, if they experience a fever of 100.4F or higher, chills, cough, or pain during urination. Also, a patient's doctor may give medication before giving Polivy, which may prevent some infections, and monitor blood counts throughout treatment with Polivy. Treatment with Polivy can cause severe low blood cell counts * Rare and serious brain infections: A patient's doctor will monitor the patient closely for signs and symptoms of these types of infections. Patients should contact their doctor if they experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes * Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy * Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of the skin or the white part of the eyes. Patients may be at higher risk if they already have liver problems or are taking other medication

Side effects seen most often

The most common side effects during treatment were:

* Low blood cell counts (platelets, red blood cells, white blood cells) * Nerve problems in arms and legs * Tiredness or lack of energy * Diarrhea * Nausea * Fever * Decreased appetite * Infections

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

* Pregnant or may be pregnant: Data have shown that Polivy may harm an unborn baby * Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for at least 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for at least 5 months after their last Polivy treatment * Breastfeeding: Women should not breastfeed while taking Polivy and for at least 2 months after the last dose

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.comfor the full Prescribing Information for additional Important Safety Information.

About Hemlibra(r) (emicizumab-kxwh)

Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins required to activate the natural coagulation cascade and restore the blood clotting process for hemophilia A patients. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once weekly, every two weeks or every four weeks. Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech.

Hemlibra U.S. Indication

Hemlibra is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A with or without factor VIII inhibitors.

Important Safety Information

What is the most important information to know about Hemlibra?

Hemlibra increases the potential for blood to clot. Patients should carefully follow their healthcare provider's instructions regarding when to use an on-demand bypassing agent or factor VIII, and the dose and schedule to use for breakthrough bleed treatment. Hemlibra may cause the following serious side effects when used with activated prothrombin complex concentrate (aPCC; FEIBA(r)), including:

* Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to one's kidneys, brain, and other organs. Patients should get medical help right away if they have any of the following signs or symptoms during or after treatment with Hemlibra: confusion weakness swelling of arms and legs yellowing of skin and eyes stomach (abdomen) or back pain nausea or vomiting feeling sick decreased urination * Blood clots (thrombotic events). Blood clots may form in blood vessels in the arm, leg, lung, or head. Patients should get medical help right away if they have any of these signs or symptoms of blood clots during or after treatment with Hemlibra: swelling in arms or legs pain or redness in the arms or legs shortness of breath chest pain or tightness fast heart rate cough up blood feel faint headache numbness in the face eye pain or swelling trouble seeing

If aPCC (FEIBA(r)) is needed, patients should talk to their healthcare provider in case they feel they need more than 100 U/kg of aPCC (FEIBA(r)) total.

Before using Hemlibra, patients should tell their healthcare provider about all of their medical conditions, including if they:

* are pregnant or plan to become pregnant. It is not known if Hemlibra may harm an unborn baby. Females who are able to become pregnant should use birth control (contraception) during treatment with Hemlibra. * are breastfeeding or plan to breastfeed. It is not known if Hemlibra passes into breast milk.

Patients should tell their healthcare provider about all the medicines they take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements. Patients should keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.

How should patients use Hemlibra?

Patients should see the detailed "Instructions for Use" that comes with Hemlibra for information on how to prepare and inject a dose of Hemlibra, and how to properly throw away (dispose of) used needles and syringes.

* Stop (discontinue) prophylactic use of bypassing agents the day before starting Hemlibra prophylaxis. * Patients may continue prophylactic use of factor VIII for the first week of Hemlibra prophylaxis.

What should patients know about lab monitoring?

Hemlibra may interfere with laboratory tests that measure how well blood is clotting and may cause a false reading. Patients should talk to their healthcare provider about how this may affect their care.

The most common side effects of Hemlibra include: redness, tenderness, warmth, or itching at the site of injection; headache; and joint pain.

These are not all of the possible side effects of Hemlibra. Patients should speak to their healthcare provider for medical advice about side effects.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Patients should not use Hemlibra for a condition for which it was not prescribed. Patients should not give Hemlibra to other people, even if they have the same symptoms that they have. It may harm them. Patients can ask their pharmacist or healthcare provider for information about Hemlibra that is written for health professionals.

Side effects may be reported to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Side effects may also be reported to Genentech at (888) 835-2555.

Please see the Hemlibra full Prescribing Information and Medication Guide for more important safety information including Serious Side Effects.

About Hemophilia A

Hemophilia A is an inherited, serious disorder in which a person's blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. Hemophilia affects around 20,000 people in the United States, with hemophilia A being the most common form and approximately 50-60 percent of people living with a severe form of the disorder.

People with hemophilia A either lack or do not have enough of a clotting protein called factor VIII. In a healthy person, when a bleed occurs, factor VIII brings together the clotting factors IXa and X, which is a critical step in the formation of a blood clot to help stop bleeding. Depending on the severity of their disorder, people with hemophilia A can bleed frequently, especially into their joints or muscles. These bleeds can present a significant health concern as they often cause pain and can lead to chronic swelling, deformity, reduced mobility and long-term joint damage.

A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies. Inhibitors are antibodies developed by the body's immune system that bind to and block the efficacy of replacement factor VIII, making it difficult, if not impossible, to obtain a level of factor VIII sufficient to control bleeding,

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. 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 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.

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