Linvoseltamab, now Lynozyfic, earns EU’s conditional OK to treat RRMM
Approval supported by 71% treatment response rate in clinical trial
The European Commission (EC) has conditionally approved Regeneron Pharmaceuticals’ linvoseltamab, now Lynozyfic, to treat adults with relapsed or refractory multiple myeloma (RRMM).
With this approval, RRMM patients in the European Union who have already received at least three other prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and continued to experience disease progression on the last one will be eligible for the treatment.
Conditional approval is a regulatory pathway that enables patients to have early access to treatments that fulfill an unmet need. Conversion to full approval is usually contingent on the completion of clinical trials assessing the therapy’s safety and efficacy.
An application seeking the therapy’s approval for a similar indication is currently under review in the U.S., where a decision is expected in July.
“We are excited by the potential of Lynozyfic and its differentiated clinical profile, dosing and administration,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in a company press release. “Given the strength of the data, we are pursuing a robust clinical development program exploring its use — in earlier lines of therapy as monotherapy and in novel combinations – with the hope of further advancing care for patients.”
How Lynozyfic works in RRMM
Myeloma is a blood cancer that occurs when plasma cells, a type of immune cell, grow uncontrollably. Cancerous plasma cells, called myeloma cells, proliferate in the bone marrow, the spongy interior part of some bones where blood cells are produced.
When myeloma cells accumulate in more than one area of the bone marrow, the condition is referred to as multiple myeloma. Multiple myeloma that recurs after a period of remission or does not respond to treatment is referred to as RRMM.
“Despite treatment advances, patients with multiple myeloma inevitably endure relapses, reduced responses to subsequent therapies, and increasingly shorter remissions,” said Paula Rodriguez-Otero, a hematologist at the Cancer Center ClĂnica Universidad de Navarra in Spain. “For those who develop relapsed and refractory disease after having been exposed to the three major drug classes, it’s important to have new therapies with different mechanisms of action like linvoseltamab.”
Lynozyfic is a bispecific antibody, meaning that it binds to two targets simultaneously. One part attaches to BCMA, a protein found on the surface of myeloma cells, while the other binds to the CD3 protein on immune T-cells, which can kill cancerous cells. This dual binding mechanism bridges the gap between T-cells and myeloma cells, helping T-cells to attack and destroy myeloma cells more effectively.
Complete response seen in half of adults on Lynozyfic
The EC’s decision to approve Lynozyfic was supported by data from the Phase 1/2 LINKER-MM1 trial (NCT03761108), which is assessing the safety and efficacy of the medication in more than 300 adult RRMM patients who had already received at least three prior lines of therapy.
Among 117 participants given the full 200 mg dose of Lynozyfic once a week for 14 weeks, followed by dosing every other week, 71% responded to treatment. Half had no signs of cancer after a median follow-up period of 14.3 months, indicating a complete response or better.
These results represented “compelling and impressive efficacy with the potential for complete remission in this patient population, including those with high disease burden,” Rodriguez-Otero said.
[Trial results] demonstrated compelling and impressive efficacy with the potential for complete remission in this patient population, including those with high disease burden.
Infections were seen in 74.4% of the patients given the full dose of Lynozyfic, although their frequency and severity declined as treatment continued. Over half (52%) of participants reported musculoskeletal pain, and nearly half (46%) experienced cytokine release syndrome, a severe type of immune response.
Recruitment is also underway for three other clinical studies testing Lynozyfic in patients with multiple myeloma. The Phase 1 LINKER-MM2 trial (NCT05137054) will examine how the therapy works when given in combination with other cancer treatments to treat RRMM. In the Phase 3 LINKER-MM3 trial (NCT05730036), also enrolling RRMM patients, researchers will compare the safety and efficacy of Lynozyfic when given as a standalone therapy with a combination of other therapies.
Another Phase 1/2 trial called LINKER-MM4 (NCT05828511) is testing Lynozyfic in people with recently diagnosed multiple myeloma who have not previously received treatment.
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