Aiming to accelerate the development of Copiktra (duvelisib) for treatment of peripheral T-cell lymphoma (PTCL) — an aggressive type of non-Hodgkin’s lymphoma — Verastem has announced a collaboration with the Leukemia & Lymphoma Society (LLS).
The treatment was selected for the LLS’s Therapy Acceleration Program, which funds projects that have the potential to change the standard of care for people with blood cancers.
“The selection of duvelisib for a TAP collaboration with the LLS underscores the potential of this innovative, oral monotherapy for patients with relapsed or refractory PTCL,” Robert Forrester, president and chief executive officer of Verastem Oncology, said in a press release.
“This collaboration provides important funding to accelerate the advancement of duvelisib as a potential new treatment for patients battling PTCL, either as a monotherapy or in combination with other anti-cancer agents. We look forward to collaborating with the LLS team on the exciting work ahead in order to advance duvelisib through the clinic and ultimately to the patients and families suffering from this devastating cancer,” Forrester said.
Duvelisib is an investigational oral therapy that inhibits phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma — two enzymes that promote the survival and growth of malignant B- and T-cells. It is already approved in the U.S. for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma and follicular lymphoma.
In PTCL, the treatment has also shown promise. An open-label Phase 1 trial (NCT01476657), including 16 patients who had failed prior treatment regimens, showed an overall response rate of 50%, including three (19%) complete responses.
Now, Verastem is conducting a larger trial to confirm the findings. The follow-up Phase 2 trial, called PRIMO (NCT03372057), will evaluate the efficacy and safety of Copiktra in adults with hard-to-treat PTCL.
Aiming to enroll 120 patients, the trial has two phases — a dose optimization phase to test two Copiktra regimens, and an expansion phase.
Funds from the TAP will also support the expansion of a Phase 1 study (NCT02783625) evaluating Copiktra, in combination with either Celgene’s Istodax (romidepsin) or Velcade (bortezomib), in patients with hard-to-treat T-cell lymphomas, including PTCL.
Data presented last December at the ASH 2017 Annual Meeting showed that the Copiktra-Istodax combination is safe and shrank the tumors of 64% of patients, including 34% whose tumors disappeared.
“The mission of our TAP program is to identify and fund the most promising investigational therapies that have the potential to change the standard of care for patients with blood cancers, with a particular focus on areas of the highest unmet medical need, such as relapsed or refractory PTCL,” said Lee Greenberger, PhD, chief scientific officer of LLS.
“Our partnership with Verastem Oncology is an excellent fit with our key initiative to accelerate development of new and cutting-edge therapies like duvelisib, which specifically inhibits only certain PI3K family members, that have shown promising early clinical results in PTCL,” Greenberger said.
The clinical studies with duvelisib will be conducted in collaboration with the Memorial Sloan Kettering Cancer Center, The Dana-Farber Cancer Institute, The Washington University in St. Louis and Stanford University.