623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Indolent Lymphomas, Novel Therapies, and Diagnostics


The Chemotherapy-Free Combination of Vemurafenib and Rituximab Produces Deep and Durable Responses in Relapsed or Refractory Hairy Cell Leukemia (HCL) Patients

Enrico Tiacci1 et al.

The authors of the study conclude:

Vemurafenib plus rituximab represents a short, safe and non-myelotoxic regimen that produces deep and durable responses in heavily pre-treated relapsed/refractory HCL patients, and is clearly superior to historical results obtained with vemurafenib or rituximab alone. Testing this regimen in the frontline setting is warranted, and should be carried out in a randomized clinical trial against the chemotherapy-based standard of care.



Results from a Phase 1/2 Study of INCB050465, a Highly Selective and Highly Potent PI3Kδ Inhibitor, in Patients with Relapsed or Refractory B-Cell Malignancies (CITADEL-101)

Andres Forero-Torreset al.

The authors of the study conclude:

In patients with relapsed or refractory B-cell malignancies, INCB050465 demonstrated manageable toxicities with no clinically meaningful transaminitis or PJP. Objective response rates were generally high and 93% of patients with NHL who responded did so at the first assessment. The QW schedule appears to improve tolerability and prolong time on study treatment in NHL subtypes. Phase 1 and 2 studies are underway to investigate this and other dosing regimens in patients with NHL. Updated data will be presented.



CC-122, a Novel Cereblon Modulating Agent, in Combination with Obinutuzumab (GA101) in Patients with Relapsed and Refractory (R/R) B–Cell Non–Hodgkin Lymphoma (NHL)

Jean-Marie Michot, et al.

The authors of the study conclude:

The novel, chemotherapy-free combination of CC–122 and obinutuzumab was well tolerated with promising response rates, and durable remissions in R/R B-cell NHL. The safety profile was consistent with other studies of CC-122, with AEs being mainly hematological and manageable. Notably, subgroup analysis showed that the combination has similar efficacy in the high-risk ER and DR subgroups of RR FL compared with the overall FL population. A CC-122 dose of ≥3 mg with obinutuzumab shows the best response rates to date, with deep response upon prolonged treatment. Expansion part B is currently on-going in both lenalidomide naïve and lenalidomide refractory FL pts.



Validation of POD24 As a Robust Early Clinical Endpoint of Poor Survival in Follicular Lymphoma: Results from the Follicular Lymphoma Analysis of Surrogacy Hypothesis (FLASH) Investigation Using Individual Data from 5,453 Patients on 13 Clinical Trials

Carla Casulo, et al.

The authors of the study conclude:

This pooled analysis of >5,000 patients with FL included in 13 prospective clinical trials is the largest cohort to date validating early progression as a robust indicator of poor FL survival. We identified male gender, poor PS, high FLIPI score, and elevated baseline B2M as predictors of early death and progression. These provide well-defined clinical factors for building comprehensive prognostic models in the future that incorporate clinical and molecular predictors of POD24. Results on maintenance and response to therapy as factors impacting POD24 will be updated in the presentation. Our results confirm POD24 as an early clinical endpoint of poor survival in FL that should be utilized to identify patients for prospective clinical trials.



Discovery and Validation of a Simplified Scoring System (the PRIMA-Prognostic Index) in De Novo Follicular Lymphoma Treated Initially with Immunochemotherapy

Emmanuel Bachy, et al.

The authors of the study conclude:

We developed and validated a new prognostic tool comprising only 2 parameters (bone marrow involvement and ß2m) which are easily measured clinically. The PRIMA-PI is a new and easy-to-compute prognostic index for patients treated upfront with immunochemotherapy. This could serve as a basis for building more sophisticated and integrated biomolecular scores.



High Complete Response Rates with Pembrolizumab in Combination with Rituximab in Patients with Relapsed Follicular Lymphoma: Results of an Open-Label, Phase II Study

Loretta Nastoupil, et al.

The authors of the study conclude:

Promising efficacy was observed with pembrolizumab and R in relapsed FL with meaningful overall and CR rates. The combination also appears to be well tolerated. Analysis of immune cell gene signatures in baseline tumors may identify a potential predictive biomarker. Further investigation is warranted.