Regeneron Pharmaceuticals has received the US Food and Drug Administration (FDA) accelerated approval for Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory multiple myeloma.
Lynozyfic is a fully human BCMAxCD3 bispecific antibody, developed by Regeneron using its VelocImmune technology.
The drug is designed to connect B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to activate T cells and eliminate cancer cells.
Lynozyfic is indicated for people who have taken at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
The drug is initially administered with a step-up dosing regimen, followed by a full 200mg dose weekly, followed by transitioning patients to biweekly dosing by week 14.
A response-adapted regimen allows patients to shift to four-week dosing if they achieve and maintain a very good partial response or better after 24 weeks of therapy.
The regimen involves hospitalisation for safety during the step-up dosing period.
Hospitalisation for 24 hours is required after the first and second step-up doses, with potential additional hospitalisation for adverse events.
The FDA’s decision is based on the response rate and durability of response in a Phase 1/2 trial, and a continued approval is expected, based on clinical benefits in a confirmatory trial.
Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody allowing biweekly dosing from week 14, and four-week dosing if a partial response is achieved after 24 weeks.
Regeneron board co-chair, president and chief scientific officer George Yancopoulos said: “The FDA approval of Lynozyfic reinforces the strength of our bispecific antibody programme as well as our commitment to delivering critical medicines to the cancer community.
“With a 70% overall response rate in heavily pre-treated patients, we believe Lynozyfic is poised to potentially become a new standard of care for multiple myeloma.
“Furthermore, given the strength of the data, we are rapidly advancing our broad clinical development programme for Lynozyfic, exploring its use in earlier lines of therapy as monotherapy and in novel combinations.”
The FDA approval is supported by the positive results from the Phase 1/2 LINKER-MM1 trial, which showed a 70% objective response rate, with 45% achieving a complete response.
The median time to first response was 0.95 months, and the median duration of response was not reached.
The estimated duration of response was 89% at nine months and 72% at twelve months among responders.
Lynozyfic’s prescribing information includes a Boxed Warning for cytokine release syndrome and neurologic toxicity, along with warnings for infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity.
Common adverse reactions include musculoskeletal pain, cytokine release syndrome, cough, upper respiratory tract infection, diarrhoea, fatigue, pneumonia, nausea, headache, and dyspnoea.
The most common Grade 3 or 4 laboratory abnormalities were decreased lymphocyte count, decreased neutrophil count, decreased haemoglobin, and decreased white blood cell count.
Regeneron is offering Lynozyfic through a restricted programme, the Lynozyfic Risk Evaluation and Mitigation Strategy.
Also, the US drugmaker has launched the Lynozyfic Surround initiative, providing financial and educational resources to support patients throughout their treatment journey.
Clinical trial investigator Sundar Jagannath said: “The FDA approval of Lynozyfic represents meaningful progress for the multiple myeloma community.
“Lynozyfic demonstrated early, deep and durable responses in heavily pre-treated patients, which I saw firsthand in clinical trials. Lynozyfic has a convenient response-adapted dosing regimen, which provides the potential to extend time between doses.
“This is a significant patient-centric advancement that could help reduce treatment burden.”
