A pivotal phase 3 trial evaluating the safety and efficacy of investigational ixazomib (Takeda), the first oral proteasome inhibitor (PI), conducted in patients with relapsed or refractory multiple myeloma achieved its primary end point of improving progression-free survival (PFS) at the first pre-specified interim analysis.
A pivotal phase 3 trial evaluating the safety and efficacy of investigational ixazomib (Takeda), the first oral proteasome inhibitor (PI), conducted in patients with relapsed or refractory multiple myeloma achieved its primary end point of improving progression-free survival (PFS) at the first pre-specified interim analysis.
Read next: FDA grants breakthrough status to investigational proteasome inhibitor for AL amyloidosis
In the international, randomized, double-blind, placebo-controlled TOURMALINE-MM1 trial, patients treated with ixazomib plus lenalidomide and dexamethasone lived without their disease worsening for a significantly longer time compared to patients who received placebo plus lenalidomide/dexamethasone.
The study (n=722) was designed to compare the efficacy and safety of 2 treatment regimens administered until progression-ixazomib plus lenalidomide and dexamethasone versus placebo plus lenalidomide and dexamethasone-in adult patients with relapsed and/or refractory multiple myeloma.
Participants included in the study had a confirmed diagnosis of multiple myeloma, received 1 to 3 prior therapies and meet other outlined eligibility criteria. Patients who were refractory to lenalidomide or proteasome inhibitor-based therapy were excluded.
Patients were randomly assigned to receive ixazomib 4.0 mg days 1, 8 and 15 or placebo with lenalidomide 25 mg days 1 through 21 and dexamethasone 40 mg days 1, 8, 15 and 22. Treatment was given every 28 days until disease progression or unacceptable toxicity. Evaluation was based on the International Myeloma Working Group (IMWG) Uniform Response Criteria.
Dr Esseltine
“Proteasome inhibition is a mechanism underpinning an established standard of care in the treatment of multiple myeloma; however, the current biweekly parenteral administration of proteasome inhibitors may pose challenges to patients,” said Dixie-Lee Esseltine, MD, FRCPC, vice president, Oncology Clinical Research, Takeda. “The ability to demonstrate that an oral, once-weekly PI can extend PFS is a potentially important finding in the effort to address these challenges.”
FDA Approves Subcutaneous Tecentriq to Treat Multiple Cancers
September 13th 2024Tecentriq Hybreza can be administered over seven minutes, compared with 30 to 60 minutes for IV infusion of Tecentriq. There is no word yet on when Tecentriq Hybreza will be available or what the price will be.
Read More
FDA Warns of Liver Injury with Veozah for Hot Flashes
September 12th 2024The FDA has identified a probable case of serious drug induced liver injury that occurred in a woman in the United States who had received Veozah. The agency is requiring additional liver blood testing after starting therapy.
Read More