FDA Approval in Myeloma, Priority Review in DLBCL, Application Accepted of a Biosimilar, and More
Today-
An FDA approval in multiple myeloma, a priority review designation in diffuse large B-cell lymphoma, an application accepted of a biosimilar, encouraging findings in multiple myeloma and Hodgkin lymphoma, and disappointing results in acute myeloid leukemia.
Welcome to OncLive News Network! I'm Gina Columbus.
The FDA has approved isatuximab-irfc, known by the trade name Sarclisa, for use in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor.
The approval is based on results of the phase III ICARIA-MM trial, in which the addition of isatuximab to pomalidomide and low-dose dexamethasone led to a greater than 40% reduction in the risk of disease progression or death versus pomalidomide and dexamethasone alone in patients with relapsed/refractory disease. Moreover, the objective response rates were 60.4% and 35.3%, respectively.
At a median follow-up of 11.6 months, the median progression-free survival per independent review was 11.53 months with the isatuximab regimen compared with 6.47 months with Pd alone. While overall survival data were immature at the time of analysis, there was a trend toward improved survival for the isatuximab arm. The PFS benefit held up across multiple patient subgroups.
The median OS was not reached in either arm. The 1-year OS rate was 72% with the isatuximab triplet compared with 63% with pomalidomide/dexamethasone alone.
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In diffuse large B-cell lymphoma, the FDA has granted a priority review designation to a biologics license application for the combination of tafasitamab and lenalidomide for the treatment of patients with relapsed/refractory disease.
The application is based partly on findings from a primary analysis of the L-MIND trial, which showed that the combination elicited an objective response rate of 54%, including a 32% complete response rate, as assessed by an independent review committee, in this patient population.
The BLA is also based on results of RE-MIND, a retrospective observational matched control cohort evaluating real-world efficacy outcomes of relapsed/refractory patients with DLBCL who received single-agent lenalidomide, and compared them with the L-MIND data.
The FDA will make a decision on the application by August 30, 2020.
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The FDA has accepted a biologics license application for a proposed biosimilar for bevacizumab.
Mylan, the company that developers the biosimilar with Biocon, stated that the application is under review by the FDA, with an action date of December 27, 2020. The company also announced that it had submitted a European application for the bevacizumab biosimilar that is currently in the validation stage with authorities.
Mylan and Biocon co-develop the bevacizumab biosimilar MYL-1402O, known by the trade name Abevmy, which was approved by the Drug Controller General of India in November 2017 for all indications of reference bevacizumab, including as a treatment for patients with metastatic colorectal cancer, non—small cell lung cancer, glioblastoma, ovarian cancer, cervical cancer, and renal cell carcinoma, as part of specific regimens for Indian patients.
Results of a single-center, randomized, double-blind, 3-arm, parallel-group study evaluating MYL-1402O also demonstrated biosimilarity between the biosimilar and both EU Union-sourced and US-sourced bevacizumab.
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In multiple myeloma, topline findings from the phase III BOSTON trial showed that selinexor in combination with bortezomib and low-dose dexamethasone led to a statistically significant increase in progression-free survival versus bortezomib/dexamethasone alone in patients who have received 1 to 3 prior lines of therapy.
Results showed that the median progression-free survival in the selinexor arm was 13.93 months compared with 9.46 months with bortezomib/dexamethasone alone, leading to a 30% reduction in the risk of disease progression or death. Additionally, no new safety signals were reported with selinexor, and there were no imbalance in deaths between the 2 arms.
Full findings will be presented at an upcoming medical meeting.
In July 2019, the FDA approved selinexor for use in combination with dexamethasone for the treatment of adult patients with relapsed/refractory myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 or more immunomodulatory drugs, and a CD38-targeted monoclonal antibody.
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Pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with brentuximab vedotin in adult patients with relapsed/refractory classical Hodgkin lymphoma, meeting 1 of the dual primary endpoints of the phase III KEYNOTE-204 trial.
The topline findings were part of the interim analysis that was conducted by an Independent Data Monitoring Committee. Per a prespecified analysis plan, overall survival, which is the study's other dual primary endpoint, was not formally tested at this analysis. The study will continue to evaluate for OS.
Moreover, the safety profile with pembrolizumab was found to be consistent with prior studies of the PD-1 inhibitor, and no new safety signals were identified.
Full findings will be presented at an upcoming medical meeting and will also be submitted to regulatory authorities.
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In acute myeloid leukemia, results from the phase III VIALE-C trial showed that the combination of venetoclax and low-dose cytarabine did not lead to a statistically significant improvement in overall survival versus low-dose cytarabine alone in newly diagnosed patients who are ineligible for intensive chemotherapy.
Data showed that the combination did lead to a 25% reduction in the risk of death, with a median OS of 7.2 months compared with 4.1 months with LDAC alone. However, this was not found to be statistically significant.
Moreover, a posthoc analysis after an additional 6 months of follow-up showed a median OS of 8.4 months with the combination versus 4.1 months in the control arm.
In November 2018, the FDA granted an accelerated approval to venetoclax for use in combination with azacitidine or decitabine or LDAC for the treatment of adult patients with newly diagnosed AML who are at least 75 years old, or who have comorbidities that preclude use of intensive induction chemotherapy.
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This week, we sat down Dr. Sergio Giralt, of Memorial Sloan Kettering Cancer Center, to discuss clinical trials of narsoplimab in the management of transplant-associated thrombotic angiopathy.
That's all for today.
Thank you for watching OncLive News Network! I'm Gina Columbus.
