Genentech to Present New Data From Its Broad and Innovative Hematology Portfolio at ASH 2025

– Findings further demonstrate the effectiveness of Genentech’s approved medicines in advancing treatment standards for people with blood disorders –

– Data from innovative pipeline signals progress toward improved outcomes in hemophilia A, lymphoma, and multiple myeloma –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it will showcase 46 abstracts, including 12 oral presentations, from its industry-leading hematology portfolio at the 67^th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 6-9, 2025 in Orlando, Florida.

“The data we will present at this year’s ASH meeting underscore our commitment to driving innovation across hematology and reflect meaningful progress towards improved treatment of multiple blood disorders,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.

Key presentations include:

Hemophilia A

• Hemlibra^® (emicizumab-kxwh): New post-marketing data from the Beyond ABR study show that, in the first year after switching to Hemlibra prophylaxis from factor VIII prophylaxis, people with various levels of baseline joint impairment had low bleeding rates, associated with overall improvements in joint health, and a shift towards higher activity levels. These findings add to the wealth of clinical and real-world evidence in support of Hemlibra as it continues to redefine standards of care for people living with hemophilia A.
• NXT007: Positive Phase I/II results, including new data from a global study in people with hemophilia A with and without factor VIII inhibitors, suggest the potential of Genentech’s next-generation investigational bispecific antibody to normalize hemostasis. These data support the progression of NXT007 into Phase III clinical development planned for 2026, including a head-to-head study against Hemlibra.
• SPK-8011QQ: Pre-clinical data on Genentech’s next-generation investigational AAV gene therapy, show significantly enhanced hemostatic potency compared with SPK-8011 (dirloctocogene samoparvovec) in ex vivo and in vivo mouse models. Findings support the ongoing evaluation of SPK-8011QQ, furthering previous learnings on the safety and durability of SPK-8011, with Phase IIb study initiation planned for 2026.

Lymphoma

• Lunsumio^® (mosunetuzumab-axgb): Preliminary data from the U.S. extension arm of the Phase III CELESTIMO study investigating Lunsumio plus lenalidomide, in people with second-line or later (2L+) relapsed or refractory (R/R) follicular lymphoma, support its potential as an effective and well-tolerated outpatient treatment option.
• Lunsumio plus Polivy^® (polatuzumab vedotin-piiq): Long-term follow-up data from the Phase Ib/II GO40516 study demonstrate sustained improvements in objective response rate (ORR) and progression-free survival with this combination in people with 2L+ large B-cell lymphoma (LBCL). Additionally, patient-reported outcomes from the Phase III SUNMO study show treatment with Lunsumio plus Polivy was associated with delayed deterioration in physical function and improvements in fatigue, pain, and emotional function, in people with transplant-ineligible R/R LBCL.
• Columvi^® (glofitamab-gxbm): Three-year follow-up and subgroup analyses from the Phase III STARGLO study show continued superior survival outcomes with Columvi in combination with gemcitabine and oxaliplatin (GemOx) for people with R/R diffuse large B-cell lymphoma (DLBCL) compared with Rituxan^® (rituximab) and GemOx, including people with second-line DLBCL and primary refractory disease or early relapse.*

Multiple myeloma

• Cevostamab: Clinical and exploratory biomarker analysis from the Phase Ib CAMMA-1 study shows investigational cevostamab in combination with pomalidomide and dexamethasone induces high ORR, very good partial response or better rates, and durable remissions, in R/R multiple myeloma.
• First data from the Phase Ib CAMMA-3 study highlight that subcutaneous cevostamab monotherapy delivers deep and durable responses in people with late-line R/R multiple myeloma.
• These data support the progression of cevostamab in combination with pomalidomide and dexamethasone into Phase III clinical development for people with 2L+ R/R multiple myeloma, with study initiation planned for 2026.

Overview of key presentations featuring Genentech medicines

*Based on the STARGLO data, Columvi in combination with GemOx is approved in 49 countries for the treatment of R/R DLBCL including the EU, UK, Australia and Canada. On July 2, 2025, the U.S. Food and Drug Administration issued a Complete Response Letter for the supplemental Biologics License Application for Columvi in combination with GemOx for this indication.

**Venclexta is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and commercialized by AbbVie outside of the U.S.

About Hemlibra^® (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. 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 or visit https://www.hemlibra.com/.

About Lunsumio^® (mosunetuzumab-axgb)

Lunsumio is a first-in-class CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other indications.

Lunsumio U.S. Indication

Lunsumio (mosunetuzumab-axgb) is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer.

It is not known if Lunsumio is safe and effective in children.

The conditional approval of Lunsumio is based on response rate. There are ongoing studies to establish how well the drug works.

What is the most important information I should know about Lunsumio?

Lunsumio may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Lunsumio and can also be severe or life-threatening.

Get medical help right away if you develop any signs or symptoms of CRS at any time, including:

• fever of 100.4°F (38°C) or higher
• chills
• low blood pressure
• fast or irregular heartbeat
• tiredness or weakness
• difficulty breathing
• headache
• confusion
• feeling anxious
• dizziness or light-headedness
• nausea
• vomiting

Due to the risk of CRS, you will receive Lunsumio on a “step-up dosing schedule.”

• The step-up dosing schedule is when you receive smaller “step-up” doses of Lunsumio on Day 1 and Day 8 of your first cycle of treatment
• You will receive a higher dose of Lunsumio on Day 15 of your first cycle of treatment
• If your dose of Lunsumio is delayed for any reason, you may need to repeat the step-up dosing schedule
• Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS

Your healthcare provider will check you for CRS during treatment with Lunsumio and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Lunsumio, if you have severe side effects.

What are the possible side effects of Lunsumio?

Lunsumio may cause serious side effects, including:

• neurologic problems. Lunsumio can cause serious and life-threatening neurological problems. Your healthcare provider will check you for neurologic problems during treatment with Lunsumio. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with Lunsumio, including:
  • headache
  • numbness and tingling of the arms, legs, hands, or feet
  • dizziness
  • confusion and disorientation
  • difficulty paying attention or understanding things
  • forgetting things or forgetting who or where you are
  • trouble speaking, reading, or writing
  • sleepiness or trouble sleeping
  • tremors
  • loss of consciousness
  • seizures
  • muscle problems or muscle weakness
  • loss of balance or trouble walking
  • tiredness
• serious infections. Lunsumio can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or sympt

Media Contact:
Kristen Ingram
(650) 467-6800

Advocacy Contact:
Katie Creme Henry
(202) 258-8228
Gina Truslow
(703) 861-0678

Investor Contacts:
Loren Kalm
(650) 225-3217
Bruno Eschli
+41 616875284