– Updated data from the Phase III POLARIX study continue to demonstrate a statistically significant reduction in the risk of disease worsening or death for people with previously untreated diffuse large B-cell lymphoma (DLBCL) –

– Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes, during and after fixed-duration treatment, to those receiving the current standard-of-care, with superior progression-free survival –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new and updated data for its first-in-class anti-CD79b antibody-drug conjugate Polivy^® (polatuzumab vedotin-piiq) were presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, December 10-13. Data from the POLARIX study support the potential benefit of Polivy in combination with Rituxan^® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to improve outcomes for people with previously untreated diffuse large B-cell lymphoma (DLBCL).

“Too many patients with diffuse large B-cell lymphoma see their cancer relapse or progress after initial treatment. This highlights the need to improve on a standard-of-care that has remained unchanged for the last two decades,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “These updated POLARIX data indicate the potential benefits that this Polivy based-regimen could bring to people living with this aggressive type of lymphoma, and demonstrate our commitment to developing new treatment options.”

After a median follow up of three years, progression-free survival (PFS) data continued to show a statistically significant reduction in the risk of disease worsening or death with Polivy plus R-CHP compared with Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP; [hazard ratio (HR) 0.76; 95% confidence interval (CI): 0.60-0.97]). After a median follow-up of 39.7 months, overall survival (OS) data was immature with few events in each arm and remained similar between Polivy plus R-CHP and R-CHOP (HR 0.94; 95% CI: 0.67-1.33; p=0.73). In the longer follow-up analysis, no new safety signals were identified.

Health-related quality of life (HRQoL) data from the POLARIX study were also presented, showing that most patients with previously untreated DLBCL receiving Polivy plus R-CHP or R-CHOP reported clinically meaningful improvements in lymphoma symptoms after the first cycle of treatment across both arms (82.3% and 81.3% of patients, respectively). Improvements in fatigue and physical functioning were similar with Polivy plus R-CHP versus R-CHOP, with 74.8% versus 68.2% of patients reporting improvements in fatigue and 42.4% versus 39.6% of patients reporting clinically meaningful improvements in physical functioning at any time point. Reported improvements were sustained during and after first-line therapy, up to the 24-month follow-up. This HRQoL analysis of the POLARIX study demonstrates that these patient-reported outcomes are not compromised with improved PFS, highlighting the potential of Polivy to help manage the burden of DLBCL.

The need for more effective treatments for patients with previously untreated DLBCL was underscored in an economic analysis of the total cost of care in relapsed or refractory (R/R) DLBCL. The study evaluated healthcare costs and resources in the second-line setting and beyond, and found that total healthcare costs increased with each additional line of treatment. Separately, an analysis of the POLARIX study also presented at ASH showed that over the next ten years, Polivy plus R-CHP has the potential to reduce the number of patients receiving second-line treatment by 27% compared to R-CHOP, potentially improving the chance of a positive outcome for more patients and significantly reducing the overall treatment burden of DLBCL.

Based on the pivotal data from the POLARIX study, more than 50 countries have approved Polivy in combination with R-CHP for the treatment of adult patients with previously untreated DLBCL, including the EU, Japan and, most recently, Canada. The company's supplemental Biologics License Application was accepted by the U.S. Food and Drug Administration, and a decision is expected by April 2, 2023. Polivy is currently approved in more than 80 countries and regions worldwide, including in the U.S. and Europe, as a readily available, fixed-duration treatment option for R/R DLBCL in combination with bendamustine and Rituxan, after at least two prior therapies.

Genentech continues to explore areas of unmet need where Polivy has the potential to deliver additional benefit, including in ongoing studies investigating combinations of Polivy with CD20xCD3 T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, including the Phase III SUNMO study in combination with mosunetuzumab, and with Rituxan in combination with gemcitabine and oxaliplatin in the Phase III POLARGO study.

About the POLARIX Study

POLARIX [NCT03274492] is an international Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of Polivy^® (polatuzumab vedotin-piiq) plus Rituxan^® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) versus rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Eight-hundred and seventy-nine patients were randomized 1:1 to receive either Polivy plus R-CHP plus a vincristine placebo for six cycles, followed by rituximab for two cycles; or R-CHOP plus a Polivy placebo for six cycles, followed by two cycles of rituximab. The primary outcome measure is progression-free survival (PFS) as assessed by the investigator using the Lugano Response Criteria for malignant lymphoma. POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC). Other clinical investigators from around the world also participated in the trial.

About Diffuse Large B-cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin’s lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive (fast-growing) type of NHL. While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year.

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. 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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