S869 TIPIFARNIB IN RELAPSED OR REFRACTORY ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (AITL) AND CXCL12+ PERIPHERAL T-CELL LYMPHOMA (PTCL): PRELIMINARY RESULTS FROM AN OPEN-LABEL, PHASE 2 STUDY

Abstract Background Peripheral T cell lymphoma (PTCL) is a rare disease and recent approved drugs for relapsed/refractory (r/r) PTCL provided limited clinical benefit. We conducted this study to evaluate the efficacy and safety of geptanolimab (GB226), an anti-PD-1 antibody, in r/r PTCL patients. Methods We did this single-arm, multicenter phase 2 study across 41 sites in China. Eligible patients with r/r PTCL received geptanolimab 3 mg/kg intravenously every 2 weeks until disease progression or intolerable toxicity. All patients who received at least one dose of geptanolimab and histological confirmed PTCL entered full analysis set (FAS). The primary endpoint was objective response rate (ORR) in FAS assessed by the independent radiological review committee (IRRC) per Lugano 2014 criteria. Results Between July 12, 2018, and August 15, 2019, 102 patients were enrolled and received at least one dose of geptanolimab. At the data cutoff date (August 15, 2020), the median follow-up was 4.06 (range 0.30–22.9) months. For 89 patients in FAS, 36 achieved objective response (40.4%, 95% CI 30.2–51.4), of which 13 (14.6%) were complete response and 23 (25.8%) had partial response assessed by IRRC. The median duration of response (DOR) was 11.4 (95% CI 4.8 to not reached) months per IRRC. Patients with PD-L1 expression ≥ 50% derived more benefit from geptanolimab treatment compared to < 50% ones (ORR, 53.3% vs. 25.0%, p = 0.013; median PFS 6.2 vs. 1.5 months, p = 0.002). Grade ≥ 3 treatment-related adverse events occurred in 26 (25.5%) patients, and the most commonly observed were lymphocyte count decreased (n = 4) and platelet count decreased (n = 3). Serious adverse events were observed in 45 (44.1%) patients and 19 (18.6%) were treatment related. Conclusions In this study, geptanolimab showed promising activity and manageable safety profile in patients with r/r PTCL. Anti-PD-1 antibody could be a new treatment approach for this patient population. Trial registration: This clinical trial was registered at the ClinicalTrials.gov (NCT03502629) on April 18, 2018.

Download Full-text

An open-label phase II study of intravenous bortezomib and oral panobinostat (LBH589) in adult patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) or NK/T-cell lymphoma (NKL) after failure of conventional chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.15_suppl.tps224 ◽

2011 ◽

Vol 29 (15_suppl) ◽

pp. TPS224-TPS224

Author(s):

D. C. Tan ◽

P. Chan ◽

B. L. Ng ◽

B. K. Yap ◽

Y. H. Chan ◽

...

Keyword(s):

T Cell ◽

Phase Ii ◽

Phase Ii Study ◽

Cell Lymphoma ◽

T Cell Lymphoma ◽

Adult Patients ◽

Conventional Chemotherapy ◽

Open Label ◽

Peripheral T Cell Lymphoma ◽

Open Label Phase

Download Full-text

A phase II open-label multicenter study to assess the efficacy and safety of AFM13 in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma or transformed mycosis fungoides: The REDIRECT study design and rationale.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.tps3148 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. TPS3148-TPS3148

Author(s):

Cassandra Choe-Juliak ◽

Karenza M. Alexis ◽

Sylvia Schwarz ◽

Linta Garcia ◽

Ahmed Sawas

Keyword(s):

T Cell ◽

Hodgkin Lymphoma ◽

Mycosis Fungoides ◽

Systemic Therapy ◽

Cell Lymphoma ◽

T Cell Lymphoma ◽

Phase 2 ◽

Efficacy And Safety ◽

Open Label ◽

Peripheral T Cell Lymphoma

TPS3148 Background: AFM13 is a tetravalent, bispecific (anti-CD30/anti-CD16A) recombinant antibody being developed for the treatment of CD30-positive T-cell malignancies and Hodgkin lymphoma. AFM13 selectively kills CD30-positive tumor cells by engaging and activating natural killer cells and macrophages. AFM13 was well tolerated at doses of 0.01 to 7 mg/kg and showed clinical activity in patients with relapsed/refractory (R/R) Hodgkin lymphoma in a Phase 1 study. In an ongoing biomarker Phase 1b/2a study in patients with R/R CD30-positive lymphomas with cutaneous involvement, 4 of 8 patients responded (at different doses) including one CR. Based on these findings, this Phase 2 study (REDIRECT) has been initiated. Methods: This is a Phase 2, open-label, multicenter global study investigating the efficacy and safety of AFM13 in patients with R/R CD30-positive peripheral T cell lymphoma (PTCL) or transformed mycosis fungoides (TMF). AFM13 is administered at 200 mg weekly via an intravenous infusion until disease progression, unacceptable toxicity, investigator discretion or withdrawal of consent. Cohorts A and B include PTCL patients with ≥10%, and ≥1% to <10% CD30 expression by IHC, respectively. Cohort C includes patients with TMF who express ≥1% CD30. Eligible PTCL patients must have received at least 1 prior line of systemic therapy and, if diagnosed with systemic anaplastic large cell lymphoma, must have failed or be intolerant to brentuximab vedotin. Eligible patients with TMF must have received at least 1 prior line of systemic therapy and have exhausted systemic therapies with regular approval for their disease. This global trial started enrollment in Oct 2019. The primary endpoint is objective response rate as confirmed by an Independent Review Committee for all cohorts. The study will also assess investigator-measured efficacy parameters, safety, PK, immunogenicity and QOL. Disease assessment will be done at screening and every 8 weeks for the first 3 assessments, then every 12 weeks thereafter, regardless of any treatment/cycle delays that may occur. ClinicalTrials.gov identifier: NCT04101331. References: Reusch U et al. mAbs. 2014;6(3):728-739. Rothe A et al. Blood. 2015;125(26):4024-4031. Clinical trial information: NCT04101331 .

Download Full-text