Verastem Oncology to Present New COPIKTRA(TM) (Duvelisib) Dose Modification Data from Patients Treated in the Phase 3 DUO Study
5:16 pm ET May 15, 2019 (BusinessWire) Print
--Dose Interruptions of a Median 15 days Do Not Significantly Impact Response or PFS
--Data Demonstrate That Dose Modifications Can be Used to Effectively Manage Adverse Events
Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, today announced a poster highlighting dose modification data from the Phase 3 DUO study evaluating COPIKTRA (duvelisib) in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. The poster, entitled "Effect of dose modifications on response to duvelisib in patients with relapsed/refractory (R/R) CLL/SLL in the DUO trial," will be presented at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting, taking place May 31 - June 4, 2019, in Chicago. COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, received approval from the U.S. Food and Drug Administration (FDA) for this same indication in September 2018.
"Duvelisib is a potent oral dual inhibitor of PI3K-delta and -gamma with robust activity in patients with CLL/SLL after at least two prior therapies," commented Ian Flinn, MD, PhD, Director, Lymphoma/CLL Program at Sarah Cannon Research Institute and lead investigator of the DUO study. "These new data demonstrate that dose modifications may be used to manage treatment-emergent adverse events (TEAEs) while allowing patients to remain on therapy, and that dosing interruptions of a median 15 days do not appear to negatively impact response to Duvelisib or progression-free-survival (PFS)."
"Notably, these data also show that when adverse events of special interest (AESIs) occur, they tend to show up in the first few months of treatment, then the proportion of patients experiencing AESIs decreases," said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. "We look forward to sharing these data with the scientific and medical communities at ASCO this year."
Effect of Dose Modification on Response to COPIKTRA in Patients with Relapsed or Refractory CLL/SLL in the Phase 3 DUO Study
The randomized, multicenter, open-label, Phase 3 DUO study, compared COPIKTRA versus ofatumumab in 319 adult patients with CLL (n=312) or SLL (n=7) after at least one prior therapy. The study randomized patients with a 1:1 ratio to receive either COPIKTRA 25mg twice daily until disease progression or unacceptable toxicity, or ofatumumab, an approved standard of care treatment for use in CLL/SLL, for 7 cycles. This analysis examined dose modification patterns and their impact on response to COPIKTRA. Dose interruptions (DI) or dose reductions (DR) to 15mg, 10mg or 5mg twice daily were permitted per study protocol to manage TEAEs. Responses were assessed per an Independent Review Committee (IRC).
Among the 158 COPIKTRA-treated patients in the DUO study, the median duration of exposure was 11.6 months, versus 5.3 months for patients treated with ofatumumab. The most common cause of DI was diarrhea (23%), followed by neutropenia (12%) and pneumonia or colitis (11% each). Among responders (n=118), median time to first response on COPIKTRA was 1.9 months and the estimated median duration of response was 11.1 months. Median time to first DI was 3.9 months and median duration of DI was 15 days (range 1 to 133 days). Response to COPIKTRA was improved or maintained in most patients evaluated for response who had at least one DI for >1 week (84%) or >2 weeks (82%) followed by at least 3 weeks on COPIKTRA. In a landmark analysis, median PFS was similar in patients with DI and those without DI for >1 week (17.8 versus 16.3 months) or >2 weeks (17.8 versus 16.3 months) within the first 3 months. The median time to DR after a complete response or partial response was 5.6 months (n=25) and median duration was 3.4 months. Median time to onset across AESIs after starting COPIKTRA ranged from 2.2 to 4.3 months. Median time to resolution was within 4 weeks across AESIs. Proportions of patients experiencing AESIs were stable or decreased over time after 3-6 months: 0-3 months, 64%; >3-6 months, 63%; >6-9 months, 47%; >9-12 months, 52%, and seldom led to discontinuation of COPIKTRA (less-than or equal to10%). These findings support the thesis that DI or DR can be useful in effectively managing TEAEs with COPIKTRA and that DI of >1-2 weeks or more do not appear to significantly impact response to COPIKTRA or PFS.
A PDF copy of this poster presentation will be available here following the conclusion of the presentation.
Details for the ASCO 2019 presentation is as follows:
Title: Effect of dose modifications on response to
duvelisib in patients with relapsed/refractory (R/R) CLL/SLL in
the DUO trial
Lead author: Ian Flinn, Sarah Cannon Research Institute
Session: Hematologic Malignancies - Lymphoma and Chronic
Lymphocytic Leukemia
Poster Board#: 277
Abstract #: 7523
Location: McCormick Place, Hall A
Date and Time: Monday, June 3, 8:00 - 11:00 a.m. CT
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