ASCO 2016 – AbbVie’s Imbruvica Phase 3 Trials in Leukemia and Lymphoma Patients Show Long-Term Favorable Responses

ASCO 2016 – AbbVie’s Imbruvica Phase 3 Trials in Leukemia and Lymphoma Patients Show Long-Term Favorable Responses

AbbVie has just presented long-term data on Imbruvica (ibrutinib) effects in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), revealing its therapeutic potential in these diseases. The results have been revealed in two distinct posters at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting, going on now in Chicago.

Imbruvica is a therapy that inhibits a key signaling molecule called Bruton’s tyrosine kinase (BTK) involved in the survival and proliferation of B-cells. By inhibiting BTK, Imbruvica blocks the signals that induce malignant B-cells’ proliferation and spread.

Two randomized, multi-center Phase 3 trials, RESONATE and RESONATE-2, have addressed ibrunitib vs. ofatumumab in relapsed/refractory patients with CLL/SLL who had received at least one prior therapy, and ibrutinib vs. chlorambucil in treatment-naive patients with CLL/SLL ages 65 or older, respectively.

Both trials demonstrated high overall response rate, as well as favorable progression-free survival and overall survival, both in treatment-naive and previously treated CLL/SLL patients, regardless of line of therapy, serving as the basis for FDA approvals of Imbruvica for patients with CLL/SLL.

AbbVie has also presented longer-term follow-up data from the HELIOS trial, a randomized, multi-center, double-blind, placebo-controlled study, that enrolled 578 patients with CLL/SLL who had received at least one prior systemic therapy to assess the effects of Imbruvica vs. placebo in combination with bendamustine and rituximab (BR). The new data reveals that Imbruvica plus BR continued to demonstrate superiority over time when compared to the placebo plus BR arm.

After a median follow-up of 25.4 months, the progression-free survival of relapsed/refractory CLL/SLL patients taking Imbruvica was 74.8 percent, vs. 20.9 percent in patients in the placebo group. The updated overall response rate was also higher in the Imbruvica group (87.2 percent) compared to the placebo group (66.1 percent).

“Our clinical data presented at this year’s ASCO from several randomized studies demonstrate solid durability of response with Imbruvica in patients with CLL/SLL with additional follow-up of up to three years,” Danelle James, M.D., MS, head of oncology at Pharmacyclics, said in a press release.

“This evidence of deepening responses with continued therapy and long-term survival with Imbruvica over time, used either as a single agent or in combination, positions this therapy as a potentially beneficial treatment option for a variety of patients with CLL or SLL, regardless of when it is prescribed in the treatment journey,” James said.

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