Venclexta (venetoclax) is used for the treatment of individuals with chronic lymphocytic leukemia (or CLL) with 17p deletion who previously underwent at least one therapy. Presently, the approval of Venclexta is under accelerated approval based on the overall response rate. Venclexta is jointly developed and marketed by AbbVie (ABBV) and Roche (RHHBY). AbbVie and Roche jointly commercialize the drug in the US, while AbbVie commercializes Venclexta outside the US.
Phase 3 MURANO trial
In December 2017, Roche presented the results from the pivotal phase three MURANO trial, which evaluated the safety and efficacy of Venclexta and Rituxan combination therapy compared to bendamustine and Rituxan combination for relapsed or refractory CLL treatment.
In the phase three MURANO trial, Venclexta and Rituxan combination therapy demonstrated a significant reduction in progression-free survival by 83% compared to bendamustine and Rituxan combination therapy. In the phase three MURANO trial, 84.9% of patients on Venclexta and Rituxan combination therapy did not experience disease progression compared to 36.3% patients on bendamustine and Rituxan combination therapy.
According to an IRC (Independent Review Committee) assessment, Venclexta and Rituxan therapy reduced the risk of disease progression or death by 81% compared to bendamustine and Rituxan therapy.
In the MURANO trial, 93.3% of patients on Rituxan and Venclexta combination therapy achieved the ORR (objective response rate) compared to 67.7% of patients on bendamustine and Rituxan combination therapy. Also, Rituxan and Venclexta demonstrated a complete response rate (with or without complete blood count recovery) of 26.8% compared to 8.2% for patients on bendamustine and Rituxan. These strong results from clinical trials will likely help in the label expansion of Roche’s Venclexta.
Venclexta’s peers include Johnson & Johnson’s (JNJ) Imbruvica, Gilead Sciences’ (GILD) Zydelig, and Novartis’s (NVS) Arzerra. In 3Q17, Imbruvica and Zydelig reported revenues of $512 million and $40 million, respectively. The Pharmaceutical ETF (PPH) invests ~4.8% and 4.6% of its total portfolio holdings in Novartis and Johnson & Johnson, respectively.