Positive results for Blincyto, Imbruvica and a bispecific antibody presented at 2022 ASH

Results for Amgen’s Blincyto (blinatumomab) suggest it has efficacy as a treatment for Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia.

Research presented at the annual meeting of the American Society of Hematology (ASH) earlier this month included promising results for treatment of leukemia and lymphoma.

Here are three important findings:

Positive results for Blincyto

Mark R. Litzow, M.D., with the division of hematology at Mayo Clinic, shared results from a study showing that Amgen’s Blincyto (blinatumomab) in addition to consolidation chemotherapy reduced the risk of death by 58% in newly diagnosed adult patients with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (B-ALL) who were measurable residual disease (MRD)-negative following induction and intensification chemotherapy compared to chemotherapy alone.

Adults with newly diagnosed ALL can achieve a high rate of complete remission with chemotherapy but frequently relapse and have disappointing survival rates, said Selina M. Luger, M.D., professor at the University of Pennsylvania's Abramson Cancer Center and Perelman School of Medicine and chair of the ECOG-ACRIN Leukemia Committee and an investigator on the study, in a news release.

With a median follow up of 43 months, the study met its primary endpoint with a significant improvement in overall survival (OS) favoring the Blincyto arm while median OS was not reached versus 71.4 months in the control arm. After about 3.5 years of follow-up, 83% of the patients who went on to receive additional standard consolidation chemotherapy plus experimental Blincyto were alive compared with 65% of those who received chemotherapy only.

Imbruvica beats Calquence

Patients with chronic lymphocytic leukemia (CLL) treated with first-line Calquence (acalabrutinib) monotherapy were 89% more likely to start a next-line treatment than those treated with Imbruvica (ibrutinib), Janssen executives said at the meeting.

“These data suggest the potential that first-line treatment with Imbruvica in routine practice may provide patients with the ability to use once-daily, all-oral Imbruvica as a monotherapy treatment for a longer period without the need to start the next line of therapy,” Janssen said in a news release.

In the study, the researchers found that, at 15 months, 94.6% of patients treated with Imbruvica had not initiated next line therapy compared 88.3% of patients treated with Calquence.

Regeneron reports positive results for a odronextamab, a bispecific antibody

Regeneron Pharmaceuticals presented positive first data from a cohort of a pivotal Phase 2 trial evaluating investigational odronextamab in patients with heavily pre-treated, relapsed/refractory (R/R) follicular lymphoma grades 1 to 3a. The results will form the basis of planned submissions to regulatory authorities in 2023, including the FDA, Regeneron said in a new release.

Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and the killing of cancer cells

In the phase 2 trial, 82% of patients taking odronextamab had an objective response rate (ORR), with 75% achieving a complete response (CR). The median duration of complete response (mDOCR) was 20.5 months. Median progression-free survival was 20 months, while median overall survival was not reached.

"There is high unmet need for follicular lymphoma treatments that can improve tumor control and extend survival, given that there is no cure for this cancer and patients will experience multiple relapses," said Tae Min Kim, M.D, Ph.D., Department of Internal Medicine, Seoul National University Hospital in Seoul, South Korea, and a trial investigator. "These positive pivotal Phase 2 results investigating odronextamab in heavily pre-treated, relapsed/refractory follicular lymphoma patients showed deep and durable response – confirming earlier findings in this program – with the highest complete response rates seen in this patient population to date.”