O041 - OUTPATIENT TREATMENT WITH LISOCABTAGENE MARALEUCEL IN 3 CLINICAL STUDIES OF RELAPSED/REFRACTORY LARGE B-CELL NHL, INCLUDING SECOND-LINE TRANSPLANT NONELIGIBLE PATIENTS: TRANSCEND NHL 001, OUTREACH, AND PILOT (ID 1162)
- C. Bachier
- M. Palomba
- J. Abramson
- C. Andreadis
- A. Sehgal
- J. Godwin
- G. Hildebrandt
- T. Siddiqi
- D. Stevens
- T. Farazi
- A. Kostic
- N. Trede
- L. Wang
- J. Lymp
- T. Thelen
- K. Ogasawara
- D. Maloney
Background: CAR T cell therapy has generally been limited to inpatient treatment. Infusion and management of CAR T cell therapy in the outpatient setting may lead to wider use in nonuniversity centers and improved access. We report on patients with relapsed/refractory large B-cell non-Hodgkin lymphoma (NHL) treated with lisocabtagene maraleucel (liso-cel) in the outpatient setting in TRANSCEND NHL 001 (NCT02631044) and 2 phase 2 studies (≥3rd-line therapy: OUTREACH [NCT03744676]; 2nd-line transplant noneligible: PILOT [NCT03483103]).
Methods: Eligible patients had relapsed/refractory large B-cell NHL (TRANSCEND/OUTREACH: ≥2 lines of prior therapy and ECOG PS ≤1; PILOT: 1 line of prior therapy and deemed TNE for autologous HSCT based on age, ECOG PS, or organ function). After lymphodepletion with fludarabine/cyclophosphamide, liso-cel was administered. All studies allowed outpatient treatment at nonuniversity (OUTREACH) or university and nonuniversity medical centers (TRANSCEND/PILOT), with hospitalization at the first sign of fever or neurological events (NEs) per management guidelines.
Results: At data cutoff, 44 patients across studies received liso-cel on study Day 1 and were monitored as outpatients, including patients ≥65 years of age (n=18) and those with SPD ≥50 cm2 (n=12) or LDH ≥500 U/L (n=6). Results are shown in the Table. Seventeen patients had any-grade cytokine release syndrome (CRS) and 13 had any-grade NEs (20 had CRS and/or NEs). Only 2 patients had grade 3/4 CRS or NEs, which were reversible. Three patients received tocilizumab and corticosteroids for CRS (none received tocilizumab alone; 2 received corticosteroids only). Five patients received corticosteroids for NEs. Overall, 55% of patients (n=24/44; all from TRANSCEND or OUTREACH) required hospitalization at any time. Of 44 patients, 9 (20%) were admitted on study Day 4 or earlier (for CRS and/or NE) and 2 (5%) required ICU-level care (median length of stay, 4 days). Median time to initial hospitalization after liso-cel infusion was 5 (range, 2‒22) days; median length of stay was 6.5 (range, 2‒23) days. Across all studies, most patients achieved an objective response (80%), including complete responses (55%).
Conclusions: A subset of patients with relapsed/refractory large B-cell NHL were successfully treated with liso-cel and monitored for CAR T cell-related toxicity in the outpatient setting, including elderly patients and patients with high tumor burden. Incidences of severe CRS, NEs, and early hospitalization were low; 45% of patients did not require hospitalization at any time after liso-cel infusion. Overall, 80% of patients achieved an objective response.
[Patient Characteristics and Outcomes]
Clinical Trial Registry: ClinicalTrials.gov identifier NCT02631044; ClinicalTrials.gov identifier NCT03744676; ClinicalTrials.gov identifier NCT03483103.
Disclosure: Funding Statement: This study was funded by Juno Therapeutics, a Bristol-Myers Squibb Company. Medical writing and editorial assistance were provided by The Lockwood Group (Stamford, CT, USA), and was funded by Bristol-Myers Squibb.
Complete conflict of interest list provided via email.