Key takeaways:
- The remedy is permitted for closely pretreated sufferers.
- Researchers reported an goal response fee of 70% with linvoseltamab-gcpt.
- Remedy ought to be administered by way of step-up doses.
The FDA granted accelerated approval of linvoseltamab-gcpt for sure sufferers with a number of myeloma.
Particularly, the approval is for sufferers with relapsed or refractory a number of myeloma who’ve acquired at the least 4 prior strains of remedy together with a proteasome inhibitor, an immunomodulatory agent and an antiCD38 monoclonal antibody.
Linvoseltamab-gcpt (Lynozyfic, Regeneron Prescribed drugs) is a bispecific B-cell maturation antigen-directed CD3 T-cell engager.
“The FDA approval of Lynozyfic represents significant progress for the a number of myeloma neighborhood,” Sundar Jagannath, MD, community director of the Middle of Excellence for A number of Myeloma at Mount Sinai in New York Metropolis, mentioned in a company-issued press launch. “Lynozyfic has a handy response-adapted dosing routine, which offers the potential to increase time between doses. This can be a vital patient-centric development that might assist cut back remedy burden.”
The approval was primarily based on outcomes of the part 1/part 2 multicohort LINKER-MM1 trial, which included 80 sufferers within the efficacy inhabitants who had beforehand acquired at the least 4 prior therapies.
Researchers measured goal response fee and period of response utilizing Worldwide Myeloma Working Group standards.
Outcomes confirmed an ORR of 70% (95% CI, 59%-80%), with 45% attaining an entire response or higher.
At median follow-up of 11.3 months, median period of response had not been reached; 89% (95% CI, 77%-95%) of the inhabitants remained in response at 9 months and 72% (95% CI, 54%-84%) at 12 months.
General, musculoskeletal ache, cytokine launch syndrome, cough, higher respiratory tract an infection, diarrhea, fatigue, pneumonia, nausea, headache and dyspnea have been the commonest antagonistic results reported ( 20%). Decreases in lymphocytes, neutrophils, hemoglobin and white blood cell depend have been the commonest grade 3 to grade 4 laboratory abnormalities ( 30%).
Forty-six p.c of sufferers who acquired the really helpful dose developed CRS (grade 3, < 1%) and 54% developed neurologic toxicity, together with immune effector cell-associated neurotoxicity (ICANS; grades 3-4, 8%).
The prescribing info for linvoseltamab-gcpt carries a boxed warning concerning life-threatening CRS and neurologic toxicity, together with ICANS. Due to these dangers, the remedy is just out there by way of a restricted program, the Lynozyfic Danger Analysis and Mitigation Technique.
In response to the FDA, linvoseltamab-gcpt ought to be administered by way of step-up IV doses beginning at 5 mg, 25 mg and 200 mg, adopted by 200 mg weekly for 10 doses, after which 200 mg biweekly. From there, the dosage might be decreased to 200 mg each 4 weeks if sufferers preserve an excellent partial response or higher after week 24 and acquired at the least 17 doses at 200 mg.
Reference:
Sources/Disclosures
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Disclosures:
Healio couldn’t verify Jagannath’s related monetary disclosures on the time of reporting.
