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An expert panel hosted by
Customizing first-line BTK inhibitors for CLL
with Gilles Salles, Paolo Ghia, and Francesc Bosch
Wednesday, October 23, 2024
18:30-19:30 BST
This independent educational activity is supported by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech. All content is developed independently by the faculty. The funder is allowed no influence on the content of this activity.
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Peripheral T-cell lymphoma (PTCL) is a heterogeneous disease associated with poor prognosis. In Western countries, PTCL accounts for 5–10% of non-Hodgkin lymphomas, with a higher incidence in China (25–30%).1 Despite the recent development of several novel agents, including anti-CD30 immunoconjugate, antifolate and histone deacetylase inhibitors, patients with relapsed or refractory (R/R) disease experience modest improvement in clinical outcomes. Therefore, the need for a more active treatment remains.
One of the features of PTCL is overexpression of programmed death-ligand 1 (PD-L1). Yuankai Shi and colleagues explored whether targeting PD-L1 with a monoclonal antibody against PD-1, geptanolimab (GB226), could improve outcomes of patients with R/R PTCL. The efficacy and safety results of this multicenter, open-label, single-arm, phase II trial (NCT03502629) were presented during the American Association for Cancer Research (AACR) Virtual Annual Meeting I 2020.1
Figure 1. Reasons for treatment discontinuation.
Patients and disease characteristics are presented in Table 1
Characteristics | Geptanolimab (N = 102) |
---|---|
Median age (range), years | 52.5 (18–78) |
Male gender, % | 68.6 |
Prior lines of treatment, % 1 2 ≥ 3 |
41.2 33.3 25.5 |
Stage of disease, % I–II III–IV |
16.7 82.4 |
PTCL subtype, % PTCL-NOS ALCL ALK+ ALCL ALK- ENKTL Other |
38.2 6.9 11.8 21.6 21.6 |
ALCL, anaplastic large cell lymphoma; ENKTL, extranodal NK/T-cell lymphoma nasal type; NK, natural killer; PTCL, peripheral T-cell lymphoma; PTCL-NOS, PTCL-not otherwise specified |
Table 2. Overall geptanolimab efficacy at data cut off
Efficacy |
Investigator assessed (N = 102) |
IRC assessed (N = 102) |
Best overall response, % CR PR SD PD Unable to evaluate Not evaluated |
6.9 28.4 18.6 35.2 1.0 9.8 |
10.8 25.5 19.6 33.3 0 10.8 |
ORR (95% CI), %* All subsets PTCL-NOS ENKTL ALCL ALK+ ALCL ALK- Others |
35.3 (26.09–45.38) NA NA NA NA NA |
36.3 (26.96–46.39) 28.2 40.9 42.9 58.3 31.8 |
DCR (95% CI), %† All subsets PTCL-NOS ENKTL ALCL ALK+ ALCL ALK- Others |
53.9 (43.77–63.84) NA NA NA NA NA |
55.9 (45.71–65.71) 46.2 68.2 71.4 66.7 50.0 |
Medium DOR (95% CI), months |
4.14 (1.45–NR) |
6.83 (5.13–NR) |
Medium TTR (95% CI), months |
2.79 (2.66–5.65) |
4.04 (1.48–8.25) |
ALCL, anaplastic large cell lymphoma; CI, confidence interval; CR, complete response; DCR, disease control rate; DOR, duration of response; ENKTL, extranodal NK/T-cell lymphoma nasal type; IRC, independent review committee; NA, not assessed; NR, not reached; ORR, objective response rate; PD, progressive disease; PR, partial response; PTCL-NOS, peripheral T-cell lymphoma not otherwise specified; SD, stable disease; TTR, time to response *defined as CR + PR †defined as CR + PR + SD |
The results of the study demonstrate that geptanolimab has promising clinical activity in patients with R/R PTCL. The benefit was seen across different subtypes, with ORR especially high in ALCL and ENKTL. The correlation of response with the level of PD-L1 expression suggests that this could be used to select patients most likely to respond. The safety profile was manageable. However, further studies evaluating efficacy and safety are needed.
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