Genentech Presents Latest Advances With Immunotherapies in Non-Hodgkin’s Lymphoma

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data on its investigational CD20xCD3 T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, and its first-in-class anti-CD79b antibody-drug conjugate, Polivy (polatuzumab vedotin), in non-Hodgkin’s lymphoma (NHL) will be presented at the 2021 ASCO Annual Meeting from June 4-8, 2021.

“People with difficult-to-treat blood cancers such as non-Hodgkin’s lymphoma still need more options to help improve outcomes,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are encouraged by promising data from our emerging T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, and the antibody-drug conjugate, Polivy, that demonstrate the potential of these novel immunotherapeutic approaches for various groups of patients.”

While approximately 500,000 people worldwide are diagnosed with NHL each year, treatment options are currently limited and resistance to existing therapies or relapse following treatment is common. The most prevalent form of NHL, accounting for about 40% of newly diagnosed NHL cases, is an aggressive form called diffuse large B-cell lymphoma (DLBCL), that comes with a life expectancy of weeks or months if left untreated.

In clinical trials to date, the investigational CD20xCD3 T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, have shown promising responses across multiple types of NHL, including relapsed or refractory (R/R) DLBCL and follicular lymphoma (FL). Pivotal data for these medicines are expected this year and Genentech is targeting a regulatory filing for mosunetuzumab in FL by the end of 2021, following its U.S. Food and Drug Administration Breakthrough Therapy designation granted in June 2020. Key data on mosunetuzumab and glofitamab to be presented at the meeting include:

• Phase I NP30179 study investigating step-up dosing of glofitamab in heavily pre-treated R/R NHL showed high, ongoing complete responses (CRs) and an acceptable safety profile. After a median follow-up of 6.3 months, results showed that glofitamab achieved a complete metabolic response rate, defined as the disappearance of metabolic tumor activity, of 71.4% in patients with aggressive (fast-growing) NHL. The most common adverse events (AEs) were cytokine release syndrome (CRS) (63.5%), neutropenia (38.5%), and pyrexia (32.7%); CRS events were mostly low grade and confined to the first cycle of treatment. Abstract #7519, poster discussion.

• Phase I/II GO40516 study of mosunetuzumab in combination with Polivy in R/R NHL showed promising efficacy and an acceptable safety profile. The regimen achieved a CR of 54.5% in all patients. Eighty six percent of patients evaluated had aggressive NHL, and these patients achieved a CR rate of 47.4%. The most frequent treatment-related AEs were neutropenia (45.4%), fatigue, nausea, and diarrhea (all 36.4%) and CRS (9.1%; all Grade 1). Abstract #7520, poster discussion.

Broad development programs are ongoing for mosunetuzumab and glofitamab, including the Phase III GO42909 trial investigating mosunetuzumab plus lenalidomide versus Rituxan (rituximab) plus lenalidomide in R/R FL, which will soon be enrolling patients. For glofitamab, the Phase III GO41944 open-label, randomized trial designed to evaluate the safety and efficacy of glofitamab plus gemcitabine and oxaliplatin (glofit-GemOx) versus Rituxan plus GemOx in patients with R/R DLBCL, is also ongoing.