Discoveries in Leukemia
Discoveries in Leukemia
Source/Disclosures
Source:

Lancet JE, et al. Abstract 7510. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.

Disclosures: Lancet reports consulting or advising for Agios, Daiichi Sankyo, Jazz Pharmaceuticals and Pfizer.
June 17, 2020
2 min read
Save

CPX-351 produces long-term remission in older patients with AML

Source/Disclosures
Source:

Lancet JE, et al. Abstract 7510. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.

Disclosures: Lancet reports consulting or advising for Agios, Daiichi Sankyo, Jazz Pharmaceuticals and Pfizer.
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

After 5-years follow-up, more patients with newly diagnosed high-risk/secondary acute myeloid leukemia achieved remission with CPX-351 than with 7 + 3 chemotherapy, according to data presented at ASCO20 Virtual Scientific Program.

Further, median overall survival was longer with CPX-351 than with 7 + 3 chemotherapy in those who achieved remission, the results showed.

“CPX-351 is a dual-drug liposomal encapsulation of both cytarabine and daunorubicin in a synergistic 5-to-1 molar ratio and it has been approved by the FDA and the European Medicines Agency for the treatment of adults with newly diagnosed therapy-related AML or AML with MDS-related changes,” Jeffrey E. Lancet, MD, of the Moffitt Cancer Center & Research Institute, said during his ASCO presentation.

Lancet presented final 5-year follow-up results from a pivotal phase 3 study that found CPX-351 significantly improved median overall survival vs. conventional 7 + 3 chemotherapy with a comparable safety profile.

Investigators randomly assigned patients 1:1 to receive either two or less induction cycles of CPX-351 (cytarabine 100 mg/m2 plus daunorubicin 44 mg/m2 as a 90-minute infusion on days 1, 3 and 5), or 7 + 3 (cytarabine 100 mg/m2/d continuously for 7 days plus daunorubicin 60 mg/m2 on days 1 to 3), according to the abstract. Follow-up was until death or up to 5 years after randomization.

Researchers reported 153 patients received CPX-351 and 156 received 7 + 3.

Lancet and colleagues found that survival rates were higher with CPX-351 than 7 + 3 at 5 years (18% vs. 8%). Forty-eight percent of patients in the CPX-351 arm and 33% of patients in the 7 + 3 arm achieved either CR or CRi. Among patients who achieved remission, median overall survival was longer with CPX-351 than with 7 + 3 at both 3 years and 5 years, according to the presentation.

Fifty-three patients and 39 patients received hematopoietic cell transplant after CPX-351 and 7 + 3. Kaplan-Meier estimates showed that the survival rate among these patients was higher for CPX-351 vs. 7 + 3 (52% vs 23%).

“These data indicated the potential for long-term survival following transplant amongst patients who were treated with CPX-351 as initial therapy,” Lancet said during the presentation.

During the follow-up, 81% of patients in the CPX-351 arm and 93% of patients in the 7 + 3 arm had died and the most common primary cause of death was progressive leukemia in both arms (CPX-351 = 56%; 7 + 3 = 53%). Also, early mortality rates were lower with CPX-351 than 7 + 3 at day 30 and day 60, according to the poster.

PAGE BREAK

“The final 5-year follow-up results from this phase 3 study support the prior evidence that CPX-351 has the ability to produce or contribute to long-term remission and survival in older patients with newly diagnosed high-risk or secondary AML,” Lancet said.