Genentech Announces Positive Data from Broad Blood Cancer Portfolio at European Hematology Association Annual Meeting

– Long-term data at the European Hematology Association (EHA) 2022 Congress expands understanding of the impact of Genentech medicines in early-stage blood cancers with the goal of providing patients with robust and durable outcomes from their first treatment–

– Updated data from Phase III CLL14 study of Venclexta (venetoclax) plus Gazyva (obinutuzumab) showed more than 60% of previously untreated people with chronic lymphocytic leukemia remained in remission five years after starting treatment–

– Final analysis of Phase III GALLIUM study showed meaningful improvement in progression-free survival was maintained with Gazyva plus chemotherapy in people with previously untreated follicular lymphoma after eight years of follow-up –

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it is presenting new long-term follow-up results and subanalyses from clinical trials of its approved therapies, as well as data on investigational medicines from its broad blood cancer portfolio, at the European Hematology Association (EHA) 2022 Congress in Vienna. Data include five-year results from the Phase III CLL14 study of fixed-duration Venclexta^® (venetoclax) plus Gazyva^® (obinutuzumab) in previously untreated chronic lymphocytic leukemia (CLL); the final analysis of the Phase III GALLIUM study of Gazyva plus chemotherapy in people with previously untreated advanced-stage follicular lymphoma (FL); and subanalyses from the Phase III POLARIX study of Polivy^® (polatuzumab vedotin) in combination with Rituxan^® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Genentech will also present data from its investigational T-cell engaging bispecific antibody development programs including mosunetuzumab and glofitamab in patients receiving later lines of therapy for non-Hodgkin’s lymphoma (NHL) and cevostamab and RG6234 in relapsed or refractory (R/R) multiple myeloma (MM).

“Blood cancers remain challenging to treat at all stages, but by improving frontline treatment options we aim to increase the likelihood of meaningful clinical outcomes for these patients,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “With these new long-term data and other studies of fixed-duration therapies in our portfolio, we are working to lessen the treatment burdens associated with long-term cancer care.”

Improving Clinical Outcomes with Effective Frontline Treatment Options

Five-Year Results of Phase III CLL14 Study of Venclexta Plus Gazyva

After a median of 65.4 months following treatment with Venclexta plus Gazyva, results confirm the combination continues to be an effective fixed-duration and chemotherapy-free option for patients with previously untreated CLL and coexisting conditions. The estimated investigator-assessed progression-free survival (PFS) rate at this follow-up was 62.6% with Venclexta plus Gazyva and 27.0% with Gazyva plus chlorambucil, and the estimated overall survival (OS) rate was 81.9% versus 77.0% (HR 0.72; 95% CI: 0.48-1.09; p=0.12). In addition, the analysis found that 72.1% of patients in the Venclexta plus Gazyva arm did not require another treatment for CLL in the five years following initial treatment (HR 0.42; 95% CI: 0.31-0.57; p<0.0001). No new safety signals were observed. The CLL14 study is being conducted in cooperation with the German CLL Study Group, headed by Michael Hallek, M.D., University of Cologne.

Final Analysis of Phase III GALLIUM Study of Gazyva

After eight years of follow-up in people with previously untreated FL, a meaningful improvement in PFS was maintained with Gazyva plus chemotherapy, confirming its role as a standard of care for first-line treatment. Seven-year investigator-assessed PFS was significantly improved with Gazyva plus chemotherapy (63.4%) compared with Rituxan plus chemotherapy (55.7%; HR 0.77; 95% CI: 0.64-0.93; p=0.006). This translated into a longer time to next anti-lymphoma treatment. At seven years, 74.1% of patients receiving Gazyva plus chemotherapy had not started new anti-lymphoma therapy compared to 65.4% receiving Rituxan plus chemotherapy (HR 0.71; 95% CI: 0.58-0.87; p=0.001). The incidence of serious adverse events was 48.9% with Gazyva plus chemotherapy and 43.4% with Rituxan plus chemotherapy.

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