Genentech to Present Data at ASH 2022 Showcasing Strength of Hematology Portfolio and Expanding Into New Areas to Address More Patient Needs

– Interim data from Phase III HAVEN 7 study reinforce Hemlibra’s efficacy and safety in infants with severe hemophilia A without factor VIII inhibitors –

– New and updated data support use of Polivy in diffuse large B-cell lymphoma, including its potential as a treatment option for previously untreated patients –

– New and updated data for innovative CD20xCD3 T-cell engaging bispecific antibodies mosunetuzumab and glofitamab further enhance their potential as effective, off-the-shelf, fixed-duration treatment options for people with lymphoma –

– First Phase III data for crovalimab show the co-primary efficacy endpoints were met, with subcutaneous injections achieving disease control in people with paroxysmal nocturnal hemoglobinuria as shown in COMMODORE 3 study in China –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that it will present new data from its industry-leading hematology portfolio at the 64th American Society of Hematology (ASH) Annual Meeting from December 10-13, 2022. The data to be presented span numerous blood diseases, including hemophilia A, paroxysmal nocturnal hemoglobinuria (PNH), and various types of blood cancers, including non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM). Genentech’s approved and investigational medicines will be featured in more than 50 abstracts, including more than 15 oral presentations.

“We continually strive to improve patient outcomes by exploring new treatment options across blood disorders, such as lymphomas and rare blood diseases, where unmet needs remain high,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The data we are presenting reinforce our ongoing commitment to redefining treatment paradigms, improving on existing standards of care and addressing a diversity of patient and healthcare system needs.”

Genentech’s Continued Commitment to Reinforcing Strength of Current Portfolio

With 25 years of expertise in blood diseases, Genentech has developed new medicines that changed the standard of care in several blood disorders with high unmet need. The data at this year’s meeting exemplify Genentech’s commitment to investing in its current portfolio to further improve patient outcomes.

• Interim data from the Phase III HAVEN 7 study reinforce the efficacy and safety of Hemlibra^® (emicizumab-kxwh) in infants with severe hemophilia A without factor VIII inhibitors. For this population, early prophylaxis may prevent long-term damage to joints and muscles and potentially reduce the risk of intracranial hemorrhage, which can be life-threatening.
• New data evaluating Polivy^® (polatuzumab vedotin-piiq) that underscore the potential impact of this treatment for the diffuse large B-cell lymphoma (DLBCL) patient community will be shared at the meeting. Health-related quality of life (HRQoL) data from the Phase III POLARIX study will be presented, highlighting the potential impact of Polivy in combination with MabThera^®/Rituxan^® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) on reducing the need for subsequent treatments in people with previously untreated DLBCL, a population where multiple subsequent treatments can be a significant treatment burden. Based on data from the POLARIX study, this Polivy combination has been approved in the EU and recently, Japan, for the treatment of adult patients with previously untreated DLBCL.
• Genentech is presenting updated data from the broadest and most comprehensive CD20xCD3 bispecific antibody development program in the industry. This aims to provide off-the-shelf, fixed-duration treatment options, which address the unique and diverse needs of people with blood cancers. Data include updated analyses for mosunetuzumab, the first CD20xCD3 T-cell engaging bispecific antibody approved by the European Commission to treat follicular lymphoma (FL), and glofitamab, for which data have been submitted for approval to the European Medicines Agency, and submissions to additional health authorities worldwide, including the U.S. Food and Drug Administration (FDA), are ongoing.
  • An updated analysis from the pivotal Phase II GO29781 study of mosunetuzumab in people with relapsed or refractory (R/R) FL after two or more prior therapies will show continued durable responses across multiple key efficacy endpoints in addition to offering the potential to be administered in an outpatient setting. In addition, studies evaluating mosunetuzumab as a monotherapy and in novel combinations for the treatment of DLBCL in earlier lines of treatment will be presented, highlighting the potential of mosunetuzumab in other settings.
  • Updated results from the Phase II NP30179 study will show a fixed course of glofitamab monotherapy can deliver durable complete responses in people with heavily pre-treated aggressive lymphomas. Results from the pivotal R/R DLBCL cohort indicate patients can maintain durable responses following fixed-duration treatment with glofitamab, potentially allowing them to benefit from a treatment-free period.

Exploring and Innovating in New Areas of Unmet Need

Genentech is applying its scientific expertise to expand its hematology clinical development program by exploring additional blood diseases and bringing innovations that address the various needs of patients in areas of high unmet need.

• The first Phase III clinical data for crovalimab from the COMMODORE 3 study in China will be presented at ASH. These data demonstrate that crovalimab met the co-primary efficacy endpoints, suggesting that crovalimab is efficacious and well-tolerated in people with PNH, a rare and life-threatening blood condition, where healthy red blood cells are targeted and destroyed by the body's complement system. There are currently no effective treatment options for PNH broadly available in China.
• Spark Therapeutics, a member of the Roche Group, will share updated long-term follow-up data from the ongoing Phase I/II clinical trial of SPK-8011, an investigational AAV-based gene therapy being developed for the treatment of hemophilia A. The acquisition of Spark Therapeutics brought new capabilities in hemophilia A to address the high unmet medical need for people living with this disease and endeavor to create additional benefit beyond current treatment options.
• Positive data on cevostamab will be presented at ASH, including data from the Phase I GO39775 study, which suggest that patients with heavily pre-treated multiple myeloma can maintain durable responses with fixed-duration cevostamab. Additionally, Phase I data from Genentech’s GPRC5DxCD3 T-cell engaging bispecific antibody, RG6234, showing encouraging preliminary activity in people with R/R multiple myeloma, will be presented. With this pipeline, Genentech is committed to advancing treatments for multiple myeloma, which remains an incurable disease characterized by multiple relapses.

Further information on the key abstracts featuring Genentech medicines that will be 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 #ASH22.

About Hemlibra

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. People who use activated prothrombin complex concentrate (aPCC; Feiba^®) to treat breakthrough bleeds while taking Hemlibra may be at risk of serious side effects related to blood clots.

These serious side effects include:

• Thrombotic microangiopathy (TMA), a condition involving blood clots and injury to small blood vessels that may cause harm to one’s kidneys, brain, and other organs
• Blood clots (thrombotic events), which may form in blood vessels in the arm, leg, lung, or head

Patients should talk to their doctor about the signs and symptoms of these serious side effects, which can include:

• Confusion
• Stomach, chest, or back pain
• Weakness
• Nausea or vomiting
• Swelling, pain, or redness
• Feeling sick or faint
• Decreased urination
• Swelling of arms and legs
• Yellowing of skin and eyes
• Eye pain, swelling, or trouble seeing
• Fast heart rate
• Numbness in your face
• Headache
• Shortness of breath
• Coughing up blood

If patients experience any of these symptoms during or after treatment with Hemlibra, they should get medical help right away.

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

Patients’ bodies may make antibodies against Hemlibra, which may stop Hemlibra from working properly. Patients should contact their healthcare provider immediately if they notice that Hemlibra has stopped working for them (e.g., increase in bleeds).

The most common side effects of Hemlibra include: injection site reactions (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 can speak with their healthcare provider for more information.

What else should patients know about 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.

• Patients should stop taking their prophylactic bypassing therapy the day before they start Hemlibra
• Patients may continue taking their prophylactic factor VIII for the first week of Hemlibra

Hemlibra may interfere with laboratory tests that measure how well blood is clotting and create an inaccurate result. Patients should speak with their healthcare provider about how this may affect their care.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Patients should only use Hemlibra for the condition it was prescribed. Patients should not give Hemlibra to other people, even if they have the same symptoms that they have. It may harm them.

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.

Before using Hemlibra, patients should tell their healthcare provider about all of their medical conditions, including if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

Since Hemlibra was tested in males, there is no information on whether Hemlibra may impact an unborn baby or breast milk. Females who are able to become pregnant should use birth control during treatment.

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 Important Safety Information, including Serious Side Effects, as well as the Hemlibra full Prescribing Information and Medication Guide.

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 is designed to bind to CD79b on B cells and destroys them 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 100.4°F 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.com for the full Prescribing Information 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. 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.

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