Key Takeaways
- FDA Accelerated Approval for Lynozyfic: Lynozyfic (linvoseltamab-gcpt) received FDA accelerated approval for relapsed or refractory multiple myeloma after at least four prior lines of therapy.
- Strong Clinical Data from LINKER-MM1 Trial: Phase I/II results showed a 70% objective response rate and 45% complete response rate in heavily pre-treated patients.
- Risk Evaluation and Mitigation Strategy (REMS) Program and Dosing Flexibility: Lynozyfic is available only through a REMS program and offers response-adapted dosing that may reduce treatment burden over time.
The FDA has granted accelerated approval to Regeneron’s Lynozyfic (linvoseltamab-gcpt), a BCMAxCD3 bispecific antibody, for adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The approval is based on response rate and durability data from the Phase I/II LINKER-MM1 trial (NCT03761108).1
What Makes Lynozyfic a Meaningful Advancement in Multiple Myeloma Treatment?
“The FDA approval of Lynozyfic represents meaningful progress for the multiple myeloma community,” said trial investigator Sundar Jagannath, MD, network director, center of excellence for multiple myeloma, Mount Sinai, NYC, in a press release. “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.”
Key Design Elements and Endpoints of the LINKER-MM1 Trial
- Phase I of the ongoing, open-label, multicenter, dose-escalation and expansion LINKER-MM1 trial evaluated the safety, tolerability, and dose-limiting toxicities of Lynozyfic across nine dose levels in 300 patients with R/R MM.
- The intravenous dose-expansion Phase II portion of the trial is currently assessing the safety and anti-tumor activity of Lynozyfic.
- The primary endpoint of the trial is objective response rate (ORR), with key secondary endpoints including progression-free survival, duration of response (DOR), minimal residual disease negativity, and overall survival.1,2
Efficacy Outcomes
- Results showed that patients treated with Lyzozyfic demonstrated a 70% ORR.
- Forty-five percent of patients demonstrated a complete response or better.
- The median time to first response was 0.95 months, with a range of 0.5 to 0.6 months.
- At the time of data readout, median DOR was not reached. DOR was estimated to be 89% at nine months and 72% at one year in responders who had a median follow-up of 13 months.
Safety Profile and Adverse Events (AEs)
- Common AEs included musculoskeletal pain, cytokine release syndrome, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea.
- Common grade 3 or 4 lab abnormalities included lymphocyte count, decreased neutrophil count, decreased hemoglobin and decreased white blood cell count.1
Regeneron's Broader Development Strategy
“The FDA approval of Lynozyfic reinforces the strength of our bispecific antibody program as well as our commitment to delivering critical medicines to the cancer community,” said George D. Yancopoulos, MD, PhD, board co-chair, president, chief scientific officer, Regeneron, in the press release. “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 program for Lynozyfic—exploring its use in earlier lines of therapy as monotherapy and in novel combinations—as we aim to meaningfully advance care for patients.”
Disease Context and Demographics
According to the American Cancer Society, the risk of developing MM in the United States is less than 1%, with the disease most commonly diagnosed in individuals aged 65 years and older. The median age at diagnosis is 69 years, and fewer than 1% of MM cases occur in individuals under 35 years of age.3
REMS Program and Access
Currently, Lynozyfic is only available through the Lynozyfic Risk Evaluation and Mitigation Strategy program.1
Community Perspective
“Even though the number of treatment options for multiple myeloma has expanded in recent years, it remains an incurable disease with considerable unmet need, especially among patients who have undergone multiple lines of treatment,” said Diane Moran, RN, MA, EdM, interim CEO, SVP, strategic planning, International Myeloma Foundation, in the press release. “The FDA approval of Lynozyfic is a welcome milestone. It provides appropriate multiple myeloma patients and their care teams with a novel patient-centric treatment option that includes a dosing schedule that can be adapted based on patient response. We appreciate Regeneron’s continued research to further advance treatment for this community.”
References
1. Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma. Regeneron. July 2, 2025. Accessed July 7, 2025. https://investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-gcpt-receives-fda-accelerated-approval
2. Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma (LINKER-MM1). Clinicaltrials.gov. Accessed July 7, 2025. https://www.clinicaltrials.gov/study/NCT03761108
3. Key Statistics About Multiple Myeloma. American Cancer Society. Accessed July 7, 2025. https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html
