Lynozyfic(linvoseltamab)
Oncology· 686 cited findings· 1 source document
Company: Regeneron Pharmaceuticals, Inc. →
What the regulatory reviews say
Lynozyfic (linvoseltamab) is indicated as monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. It has received a Conditional Marketing Authorisation.
In a Phase 3, open-label, randomised, active controlled trial with 83 patients, the Overall Response Rate (ORR) was 71%, with a Complete Response (CR) rate of 50% and a median Duration of Response (DOR) of 29 months. Another reported ORR was 73.4% with a stringent Complete Response (sCR) rate of 32.8% and a median DOR of 10.6 months. For safety, common adverse events included Fatigue (36%), Pyrexia (17%), and Hypophosphataemia (14%). Chills were reported in 10% of patients. The incidence of treatment-emergent ADA response in Phase 1 DL7 (5/25/200 mg) was 1.8%.
Key figures — cited to the source page
| Overall Response Rate (ORR) | 71% | Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR public, p.14 |
| Complete Response (CR) rate | 50% | Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR public, p.14 |
| median Duration of Response (DOR) | 29 months | Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR public, p.14 |
| Fatigue (All grades) | 36% | Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR public, p.105 |
| Pyrexia (All grades) | 17% | Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR public, p.105 |
| Hypophosphataemia (All grades) | 14% | Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR public, p.105 |
| Chills (All grades) | 10% | Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR public, p.105 |
| Regulatory status | Conditional Marketing Authorisation | Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR public, p.13 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.