Professor CHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d’Hématologie, Toulouse, France, Midi-Pyrenees, France
Introduction: Acces précoce (AP) is a French procedure facilitating patient (pt) access to innovation addressing high unmet medical needs. Teclistamab (TEC) is a humanized IgG-4 bispecific antibody that binds to B-cell maturation antigen (BCMA) and CD3 and was approved in Europe in August 2022. AP for TEC monotherapy was granted in September 2022, by French health authorities for the treatment of adult patients (pts) with relapsed and refractory multiple myeloma (RRMM), who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody after all treatment options have been exhausted. Here we describe the patient’s characteristics included in AP.
Methods: Data were collected from 14OCT22 to 20APR23 (data cut off) at 2 timepoints (treatment request and discontinuation). AP eligibility criteria were: RRMM, triple-class exposed, ≥3 prior lines of therapies, and all treatment options exhausted (excluding cellular therapies). The approved dose of TEC 1.5mg/kg by subcutaneous injection weekly, preceded by step-doses of 0.06 and 0.3mg/kg was used.
Results: At data cutoff, 572 treatment request forms were approved. The median age of pts with an approved treatment request was 71 years, with 31.5% over 75 years old. The Median time since diagnosis was 6.3 years. ECOG score ≥ 2 was reported for 18.9% and 33,4 % of pts presented with clinically significant comorbidities including hypertension (25,1%), cardiopathy (18%) and renal insufficiency (17,8%). The cytogenetic risk profile was unknown for 35.1% of pts and 21.7% presented with cytogenetic high-risk features, defined as one or more of del17p, t(4,14) or t(14,16). Extramedullary disease was present in 21.2 % of pts. The median number of previous lines of therapy was 4 [3-11]. The percentages of pts having received 3, 4, 5 and ≥6 prior lines were 31.3%, 25.9%, 18.9% and 24% respectively. Pts were previously exposed to lenalidomide and bortezomib (≥97%), daratumumab and pomalidomide (>87%) and carfilzomib (83.2%). 8.6 % pts had been previously treated with a BCMA-targeted therapy. 69.6% pts had triple-class refractory disease and 32 % penta-drug refractory disease. Pts had been included by 230 physicians from 100 different sites: 28 academic hospitals and 72 non-academic centers. The median follow-up was 2.9 [0;6.2] months. As of data cut-off, 38 treatment discontinuations were reported due to disease progression (78.9% with a fatal outcome for 16/30 patients) or toxicity (10.5%). 4 patients died from a treatment-related adverse event.
Conclusions: This is the largest population of teclistamab patients characterized outside of the clinical trial setting (572 pts included in 6 months). French AP population was heavily pre-treated with clinically significant comorbidities and was slightly older, more frail than patients in the Majestec-1 study population. Academic and non-academic centers have included patients. Only a limited number of treatment discontinuations reported to date.
