Leukemia Treatment with Ibutinib and Obinutuzumab for the First-line

The results of the Phase III GALLIUM study from the American Society of Hematology (ASH) Congress show that the combination of obizumab (Gazyva) and chemotherapy in first-line treatment reduces the risk of blood cancer disease deterioration or death by 34%. Rituxan and chemotherapy can treat patients with follicular lymphoma. The phase III GALLIUM study included 1401 patients with asymptomatic non-Hodgkin's lymphoma for the first time, including 1202 patients with follicular lymphoma. Randomly divide these patients into combination therapy with albuzumab, chemotherapy with obertuzumab or rituximab alone, and then rituximab alone.

The results also showed that patients who received obinutuzumab plus chemotherapy had a 32% longer relapse time compared to rituximab plus chemotherapy.

The FDA approves the new indication for Imbruvica (Ibutinib), combined with Roche's Gazyva (obinutuzumab) for first-line treatment of adult chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Prior to this, Ibutinib has been approved by the FDA as a single drug or in combination with bendamustine + rituximab (BR) for adult CLL/SLL.

Venetoclax (400mg) combined with obinutuzumab is safe for the treatment of R/R and 1L CLL. Regardless of the risk of cytogenetics, Venetoclax-obinutuzumab can induce a higher remission rate, and patients with R/R and 1L CLL can obtain better remission. Abstract: Ian W. Flinn et al. conducted a one-arm, open phase 1b study to evaluate the maximum tolerated dose (MTD) of venetoclax in combination with obinutuzumab and its application in complex.

In summary, venetoclax combined with obinutuzumab in the treatment of patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia has good safety, durable remission, and a high MRD negative rate.

Ibutinib is the world's first once-daily oral BTK inhibitor on the market, and this FDA approval provides an anti-CD20 combination therapy without chemotherapy for the first time for the first treatment of CLL/SLL patients. The FDA's approval is mainly based on the results of the phase III iLLUMINATE (PCYC-1130) study, which shows that Ibutinib + Gazyva can significantly prolong the untreated CLL/SLL patients over 65 years of age compared to bendamustine + Gazyva PFS reduces the risk of disease progression or death by 77%. For high-risk (carrying 17p deletion/TP53 mutation, 11q deletion, or IGHV wild type) patients, the risk of disease progression or death can be reduced by 85%.

CLL is an incurable chronically progressing hematological tumor that occurs frequently between the ages of 65 and 70. There are 14,260 newly diagnosed cases of CLL each year in the United States. The survival time of CLL patients with p17 deletion mutations after diagnosis is usually no more than 3 years. 3% to 10% of all CLL patients carry p17 deletion mutations, and 50% of patients with advanced/recurrent CLL carry p17 deletion mutations.

In 2018, Imbruvica's global sales were $6.215 billion. The approval will help AbbVie continue to expand Imbruvica's coverage in the United States. At the same time, it is also a good thing for Roche that encountered the threat of rituximab analogues. Gazyva can continue to amplify its performance as an upgraded version of merova.