New Pivotal Data Demonstrate Clinical Benefit of Genentech’s Glofitamab, a Potential First-in-Class Bispecific Antibody for People With Aggressive Lymphoma

– Data to be presented for the first time at ASCO and EHA 2022 show glofitamab induces high and durable complete response rates in people with heavily pre-treated diffuse large B-cell lymphoma –

– Glofitamab has the potential to offer a readily available, fixed-duration CD20xCD3 bispecific antibody treatment approach for people with aggressive lymphoma –

– Glofitamab is part of Genentech’s industry-leading CD20xCD3 bispecific antibody development program, which aims to address the diverse needs and preferences of people with blood cancers –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7 and the European Hematology Association (EHA) 2022 Congress from June 9-12. Data from the Phase II NP30179 expansion study demonstrated that, after a median follow-up of more than 12 months, fixed-duration glofitamab (given for a fixed amount of time, and not taken until disease progression) induces durable complete responses (CRs) in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had received a median of three prior therapies.

“These data bring us one step closer towards our goal of finding solutions for people with heavily pre-treated diffuse large B-cell lymphoma, which often relapses and becomes more aggressive each time it returns,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The potential of glofitamab as a new fixed-duration, readily available treatment could be instrumental to improving outcomes for people with this difficult-to-treat cancer who otherwise have limited options.”

The pivotal Phase II NP30179 expansion study included patients with heavily pre-treated and highly refractory DLBCL, with 58.3% of patients refractory to their initial therapy and about one-third (33.1%) having received prior CAR T-cell therapy. After a median follow-up of 12.6 months, 39.4% of patients (n=61/155) achieved a CR (primary efficacy endpoint) and half of them (51.6%; n=80/155) achieved an overall response (the percentage of patients with a partial or complete response; secondary efficacy endpoint), as assessed by an independent review committee. The majority (77.6%) of complete responses were durable and ongoing at 12 months and the median duration of complete response had not yet been reached (not evaluable [16.8 months, not evaluable]). Cytokine release syndrome (CRS) was the most common adverse event occurring in 63.0% of patients. CRS events were predictable, generally low grade (mainly Grade 1 [47.4%] or 2 [11.7%]), occurred at initial doses, and only one patient discontinued glofitamab due to CRS. Incidence of Grade 3+ CRS was low (3.9%), with no Grade 5 events.

“I’m encouraged by these data as they signify new hope for these patients who otherwise have limited effective treatment options and have faced disappointment from not responding to multiple rounds of treatments,” said Associate Professor Michael Dickinson, Hematologist and Lead of the Aggressive Lymphoma Disease Group within Clinical Haematology at Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Australia. “These glofitamab data suggest that patients may be able to achieve durable responses with a set course of treatment that they don’t have to take continuously until disease progression.”

Data from the NP30179 study have been submitted for approval to the European Medicines Agency (EMA), and submissions to additional health authorities worldwide, including to the U.S. Food and Drug Administration (FDA), are planned this year. Glofitamab is being investigated in several clinical trials and explored in earlier lines of lymphoma treatment.

Genentech is committed to improving standards of care to enhance the treatment experience and outcomes for people with blood cancers and the scientific data we are sharing at ASCO and EHA from our portfolio propels us further towards this goal. Genentech is investigating its CD20xCD3 T-cell engaging bispecific antibodies glofitamab and mosunetuzumab further as subcutaneous formulations and in additional Phase III studies that will expand the understanding of their impact in earlier lines of treatment, with the aim of providing people with different types of lymphomas with robust and durable treatment outcomes. Additionally, the European Commission (EC) recently granted approval of Polivy^® (polatuzumab vedotin) in combination with Rituxan^® (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL), and the EMA’s Committee for Medicinal Products for Human Use recommended mosunetuzumab for approval for patients with R/R follicular lymphoma, who have received at least two prior systemic therapies.

About Glofitamab

Glofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. Glofitamab is based on a novel structural format called ‘2:1’. It is engineered to have two ‘Fab’ regions which bind to CD20, and one ‘Fab’ region which binds to CD3. 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 glofitamab is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin's lymphomas, including diffuse large B-cell lymphoma and mantle cell lymphoma, and other blood cancers.

About the NP30179 Study

The NP30179 study [NCT03075696] is a Phase I/II, multicenter, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of glofitamab in people with relapsed or refractory diffuse large B-cell lymphoma. Outcome measures include complete response rate by independent review committee (primary endpoint), overall response rate, duration of response, progression-free survival, safety and tolerability (secondary endpoints).

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 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. 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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