2018 was also a busy year for chronic lymphocytic leukemia (CLL) and chronic myeloid leukemia (CML).
In September, the FDA approved duvelisib for use in patients with relapsed or refractory CLL (as well as follicular lymphoma and small lymphocytic lymphoma [SLL]) based on the results of the phase II DYNAMO trial and the phase III DUO.
DYNAMO evaluated 129 patients with non-Hodgkin lymphoma, including 83 with follicular lymphoma. The ORR in patients with follicular lymphoma was 41%, and the median overall survival (OS) was 18.4 months. In DUO, duvelisib was compared with ofatumumab in patients with relapsed or refractory CLL/SLL. In these patients, duvelisib significantly improved median PFS to 13.3 months with duvelisib compared with 9.9 months on ofatumumab. The ORR for patients receiving duvelisib was 74%, compared with 45% in patients who received ofatumumab.
Earlier in June, the FDA granted the regular approval of venetoclax for patients CLL or SLL with or without 17p deletion who have received at least one prior therapy. This approval was based on the phase III MURANO trial, in which 389 patients were randomized to receive venetoclax or bendamustine, both in combination rituximab. After a median follow-up of 23 months, the median PFS had not been reached in the venetoclax arm compared with 18.1 months in patients receiving bendamustine. The ORR was 92% and 72% for venetoclax and bendamustine, respectively.
For CML, new approvals came in March of 2018 when the FDA approved the use of nilotinib for the first- and second-line treatment of pediatric patients aged 1 year and older with Philadelphia chromosome–positive CML in the chronic phase. This approval was based on a cohort of 69 pediatric patients with Ph+ CML-CP enrolled across 2 trials. Patients were either newly diagnosed or resistant/intolerant to prior treatment with a tyrosine kinase inhibitor.
The major molecular response (MMR) in newly diagnosed patients was 60% at 12 cycles, and the median time to first MMR was 5.6 months. In the resistant/intolerant group, the MMR rate was 40.9% at 12 cycles, and the median time to first MMR was 2.8 months.
This combined with the approvals of dasatinib and bosutinib in late 2017 have transformed the way we treat this disease and will be discussed at the Winter Hematology® meeting.