Oncopeptides AB (publ), a biotech firm targeted on difficult-to-treat cancers, at this time proclaims that two abstracts highlighting real-world scientific outcomes for Pepaxti (melflufen) in relapsed, refractory a number of myeloma (RRMM) have been accepted for presentation on the 68th American Society of Hematology (ASH) Annual Assembly, happening in New Orleans, USA, December 12–15, 2026.
The 2 impartial multicenter retrospective research – carried out in Spain and Italy – present real-world proof (RWE) in a complete of 82 closely pretreated RRMM sufferers. Collectively, the analyses reinforce the scientific utility and manageable security profile of Pepaxti together with dexamethasone throughout real-world European scientific follow, together with the more and more related setting following T-cell-redirecting immunotherapies comparable to anti-BCMA and anti-GPRC5D brokers, in addition to between immunotherapies.
Because the remedy panorama in a number of myeloma evolves with earlier use of novel immunotherapies, physicians more and more face the problem of managing sufferers who relapse after anti-BCMA or anti-GPRC5D remedies. The impartial real-world information from Spain and Italy to be introduced at ASH show that Pepaxti delivers clinically significant effectiveness and a predictable, manageable security profile in on a regular basis scientific follow – each as an lively remedy choice post-immunotherapy and as a viable choice in between immunotherapies.”
Stefan Norin, Chief Medical Officer at Oncopeptides
Actual-world outcomes from the Spanish Registry (AMHH)
An evaluation from the registry of the Asociación Madrileña de Hematología y Hemoterapia (AMHH) evaluated 40 sufferers with full follow-up information throughout 26 Spanish facilities handled with melflufen and dexamethasone between 2023 and 2026. The cohort displays a closely pretreated inhabitants with a median of 4 prior strains of remedy (vary 1–13), the place 85% of sufferers had been triple-refractory, 57.5% had been penta-refractory, and 42.5% had extramedullary illness. Notably, 57.5% (n=23) had beforehand obtained immunotherapy, together with anti-BCMA and/or anti-GPRC5D focused therapies.
Key highlights embrace:
Clinically significant exercise: Within the full cohort (N=40), melflufen-dexamethasone achieved an total response charge (ORR) of 32.5%, with a median period of response (mDoR) of 8.3 months, median progression-free survival (mPFS) of three.2 months, and a median total survival (mOS) of 15.7 months.
Publish-immunotherapy efficacy: Amongst evaluable sufferers beforehand uncovered to anti-BCMA and/or anti-GPRC5D therapies (n=21) – representing a very superior, later-line subgroup the place Pepaxti was typically used as a last-resort choice after exhausting different options – the ORR was 26%, with a mDoR of 5.8 months, mPFS of three.0 months, and an encouraging mOS of 23.2 months.
Manageable security profile: Adversarial occasions had been in step with earlier scientific trials and primarily hematologic. Everlasting remedy discontinuation as a consequence of antagonistic occasions was low, occurring in solely 2 sufferers (5%).
Efficacy and feasibility in an Italian multicenter examine
The second summary reviews preliminary outcomes from a retrospective examine of 42 RRMM sufferers handled with melflufen and dexamethasone inside an Early Entry Program throughout 8 Italian facilities. Sufferers had a median age of 71 years and had obtained a median of 4 prior strains of remedy. All sufferers had been triple-class uncovered (40% triple-class refractory, 35% penta-refractory), and 23% had been refractory to prior anti-BCMA remedy.
Key highlights embrace:
Sturdy response and survival outcomes: Sufferers obtained a median of 5 remedy cycles, attaining an ORR of 48%, together with 14% with deep hematologic responses (CR or VGPR) and 20% attaining secure illness. Median PFS was 5.02 months and median OS was 13.51 months.
Sequencing and bridging to novel therapies: Following remedy, 67% (n=28) of sufferers had been capable of proceed to subsequent remedy, together with anti-BCMA bispecific antibodies (19%), anti-GPRC5D bispecific antibodies (5%), and CAR-T cell remedy (5%) after melflufen-dexamethasone bridging. The investigators conclude that melflufen-dexamethasone “supplied illness management on this difficult inhabitants, whereas permitting chosen sufferers to proceed to subsequent novel therapies, together with bispecific antibodies and CAR-T cell remedy”.
Predictable tolerability: Adversarial occasions had been predominantly hematologic and manageable by way of dose reductions (26%), with no everlasting discontinuations as a consequence of hematologic toxicity and seven% (n=3) discontinuing as a consequence of non-hematologic antagonistic occasions.
Abstract of ASH abstracts
Summary quantity
Summary title
First / Lead creator
Class
Session particulars
abs26-10913
Melflufen plus dexamethasone for relapsed/refractory a number of myeloma, together with sufferers beforehand uncovered to immunotherapy: Actual-world outcomes from a spanish registry (amhh)
David Martínez-Campuzano (First) / Javier De La Rubia (Senior)
907. Outcomes Analysis: Plasma Cell Problems
Hyperlink
abs26-10377
Efficacy and feasibility of melflufen in an early entry program for relapsed/refractory a number of myeloma sufferers: Preliminary Outcomes from an Italian multicenter retrospective examine
Anna Maria Cafro (First) / Roberto Cairoli (Senior)
653. A number of Myeloma: Medical and Epidemiological
Hyperlink
