Verastem, Inc. ( VSTM Quick Quote VSTM - Free Report) presented encouraging data from phase I study that evaluated its leukemia drug, Copiktra (duvelisib), in patients with relapsed or refractory peripheral T-cell lymphoma ("PTCL") at the International Conference on Malignant Lymphoma ("ICML").
The phase I study evaluated twice-daily 25mg or 75mg doses of Copiktra monotherapy or lead-in monotherapy to a combination regimen with romidepsin or Takeda's (
TAK Quick Quote TAK - Free Report) Velcade (bortezomib) in PTCL patients. Data from the phase I study demonstrated that Copiktra achieved compelling clinical activity.
The 75mg dose of drug achieved an objective response rate ("ORR") of 54% as monotherapy and 44% as lead-in monotherapy before romidepsin. The complete response rate ranged between 15% and 22%. The drug's 25mg dose as lead-in monotherapy before bortezomib achieved an ORR of 57%. The drug achieved a median progress-free-survival of 8.3 months and median overall survival was 16.2 months.
Following the announcement, shares of the company gained 13.8% on Jun 21. So far this year, Verastem has declined 46.1% against the
industry's 6.3% increase.
Please note that the company has successfully completed the phase I study evaluating Copiktra in the PTCL patient population. A phase II study, PRIMO, is currently evaluating the drug as monotherapy in similar patient population.
We remind investors that Copiktra was approved for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and refractory follicular lymphoma in September 2018.
Apart from PTCL, Verastem is developing the drug in non-Hodgkin lymphoma, lung cancer, mesothelioma, ovarian cancer and pancreatic cancer.
In 2016, Verastem had in-licensed Copiktra from Infinity Pharmaceuticals (
INFI Quick Quote INFI - Free Report) . Last year, Verastem entered into an exclusive collaboration and license agreement with China’s CSPC Pharmaceutical Group to develop and commercialize Copiktra for treating different types of cancer indications in China.
Furthermore, Verastem is developing an oral small molecule kinase inhibitor, defactinib, as treatment for ovarian cancer, pancreatic cancer, mesothelioma, non-small cell lung cancer, and other solid tumors. A phase Ib study is evaluating the candidate in combination with Merck's (
MRK Quick Quote MRK - Free Report) PD-1 inhibitor Keytruda as well as Eli Lilly’s Gemzar for treating patients with advanced pancreatic cancer. Zacks Rank
Verastem currently carries a Zacks Rank #3 (Hold). You can see
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