The drug was approved for adults with chronic lymphocytic leukemia and small lymphocytic lymphoma. And was granted an accelerated approval for follicular lymphoma.
The Food and Drug Administration (FDA) approved Copiktra (duvelisib) for the treatment of adults patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have had at least two prior therapies. Additionally, Copiktra was also granted an accelerated approval for adults with relapsed or refractory follicular lymphoma (FL) who had two or more prior systemic therapies.
“Patients living with CLL/SLL or FL are in need of additional treatment options, and new therapies such as COPIKTRA are crucial because each patient’s treatment journey is unique,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation, in a statement. “We appreciate the commitment from companies like Verastem Oncology that research and develop these therapies with the goal of reaching a day when lymphoma is managed as a chronic disease – and eventually cured.”
A randomized, multicenter, open-label trial (NCT02004522
) led to the approvals for CLL and SLL. It randomized patients in a 1 to 1 ratio to receive either Copiktra or Arzerra (ofatumumab). Patients in the Copiktra group were given 25 mg of the drug orally each day, while those in the Arzerra arm received the drug intravenously, initially at 300 mg at week one, and then 2,000 mg once weekly for seven doses, and then 2,000 mg once every four weeks for another four doses.
For the 196 patients who had at least two prior therapies, estimated median progression-free survival (PFS) was 16.4 months in the Copiktra arm compared with 9.1 months in the Arzerra arm. The overall response rate (ORR) for Copiktra was 78 percent and 39 percent for Arzerra.
The accelerated approval for patients with FL was based on the results from a single-arm, multicenter trial (NCT02204982
), which included 83 patients who were refractory to Rituxan (rituximab) and also to either chemotherapy or radioimmunotherapy. The trial showed a 42 percent ORR, and 41 percent of patients had a partial response. There was even one patient who had a complete response.
In the group of 35 responding patients, 15 of them (43 percent) maintained a response that lasted six months or longer. Six patients (17 percent) had responses that lasted for at least 12 months.
“Continued approval for the FL indication may be contingent upon verification of clinical benefit demonstrated in a planned randomized trial,” the FDA wrote in a release.
Serious side effects of the drug include: serious infections, diarrhea or colitis, skin reactions and pneumonitis, as well as neutropenia and hepatotoxicity (liver damage). Sixty-five percent of patients who were treated with Copiktra at the approved dose had serious side effects, most commonly infections, diarrhea or colitis and pneumonia.
The most common side effects from the drug that occurred in at least 20 percent of the patients include: diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain and anemia. Thirty-five percent of patients discontinued the drug due to side effects, while 24 percent of patients had dose reductions.