Phase III MURANO study of Venclexta plus Rituxan shows disease progression benefits in chronic lymphocytic leukemia.- Genentech/Roche

Genentech/Roche announced updated data from a pivotal Phase III MURANO study that highlights the impact of Venclexta (venetoclax) plus Rituxan (rituximab) in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). Four-year, follow-up data from the study showed sustained OS and PFS benefits with Venclexta plus Rituxan compared to bendamustine plus Rituxan (BR). No new safety events were reported in the study.

Specifically results showed that Venclexta plus Rituxan significantly reduced the risk of disease progression or death by 81 percent (HR=0.19; 95 percent CI: 0.14, 0.25; p<0.0001) compared to br with four-year pfs estimates of 57.3 percent 95 percent ci: 49.4 65.3 vs. 4.6 percent 95 percent ci: 0.1 9.2 respectively. venclexta plus rituxan also reduced the risk of death by 59 percent hr="0.41;" 95 percent ci: 0.26 0.65 p><0.0001), compared to br with the venclexta plus rituxan treatment arm demonstrating greater sustained os compared to the br arm with four-year os rates of 85.3 percent vs. 66.8 percent respectively. venclexta plus rituxan showed that people who achieved mrd-negativity showed an improvement in pfs at the end of treatment. no new safety signals were identified with the combination in this extended follow-up. common grade 3-4 adverse events with venclexta plus rituxan compared to br respectively were low white blood cell count 58.8 percent vs. 39.9 percent anemia 11.3 percent vs. 13.8 percent and low platelet count 5.7 percent vs. 10.1 percent.>

Results from the MURANO study were the basis of regulatory approvals for Venclexta plus Rituxan as a treatment option for people with R/R CLL around the world. These data will be featured at the 61st American Society of Hematology (ASH) Annual Meeting.

Comment: Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia. In the United States, it is estimated that more than 20,000 new cases of CLL will be diagnosed in 2019. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of cancerous cells.