Mini Oral session
Date
18.09.2020
Chairs
  • Andrew J. Davies (Southampton, United Kingdom)
Mini Oral - Haematological malignancies Mini Oral session

Open & welcome

Speakers
  • Andrew J. Davies (Southampton, United Kingdom)
Mini Oral - Haematological malignancies Mini Oral session

886MO - Health-related quality of life (HRQoL) from KEYNOTE-204: A phase III, randomized, open-label study of pembrolizumab (pembro) vs brentuximab vedotin (BV) in relapsed or refractory classical Hodgkin lymphoma (R/R cHL)

Presentation Number
886MO
Speakers
  • Pier Luigi Zinzani (Bologna, Italy)

Abstract

Background

In the phase III KEYNOTE-204 (NCT02684292) study, pembro demonstrated clinically meaningful improvement in PFS vs BV in patients (pts) with R/R cHL. HRQoL was evaluated.

Methods

Pts aged ≥18 y, were post−autologous stem cell transplant (auto-SCT) or ineligible for auto-SCT, measurable disease and ECOG PS 0 or 1 were randomized 1:1 to pembro 200 mg IV Q3W or BV 1.8 mg/kg IV Q3W. EORTC QLQ-C30 and EuroQoL EQ5D scales were protocol-specified exploratory end points administered electronically at baseline (BL) and Q6W up to wk 24 and Q12W thereafter. Analysis population included pts who received ≥1 dose of study treatment and completed ≥1 HRQoL assessment. Least-squares mean (LSM) changes from BL to prespecified wk 24 end point were calculated. Time to deterioration (TTD; ≥10-point decline from BL) was assessed by Kaplan-Meier. Differences evaluated using two sided p-values not controlled for multiplicity.

Results

296 pts were included (pembro, 146; BV, 150). Completion and compliance rates were >90% for both groups at BL and remained high (>80%) at wk 24. Improvement was observed at wk 24 with pembro in the QLQ-C30 global health status/quality of life (GHS/QoL; LSM difference [95% CI]: 8.60 [3.89-13.31]; P=0.0004) and physical functioning (6.42 [1.87-10.62]; P=0.0054) scores vs BV, which showed a worsening. Similar improvements were seen for pembro in EQ5D utility (0.09 [0.04-0.14); P=0.0004) and VAS scores (6.12 [1.91-10.34]; P=0.0046). Pembro demonstrated an improvement in QLQ-C30 GHS/QoL score vs BV in pts who progressed (11.76 [5.66-17.86]; P=0.0002) and did not progress (5.10 [–2.53, 12.73]; P=0.187). Prolonged TTD was observed with pembro vs BV for QLQ-C30 GHS/QoL (HR, 0.40; 95% CI, 0.22-0.74; P=0.003) and physical functioning score (HR, 0.56; 95% CI, 0.32-0.97; P=0.034).

Conclusions

Among R/R cHL pts, pembro demonstrated improvement in HRQoL compared with BV, which showed a worsening. These data, along with statistically significant and clinically meaningful improvements in PFS, support pembro as new standard of care for pts who relapsed post auto-SCT or are ineligible for auto-SCT.

Clinical trial identification

NCT02684292.

Editorial acknowledgement

Medical writing and/or editorial assistance was provided by Matthew Grzywacz, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Legal entity responsible for the study

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Funding

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Disclosure

P.L. Zinzani: Advisory/Consultancy, Speaker Bureau/Expert testimony: Verastem; Advisory/Consultancy, Speaker Bureau/Expert testimony: Celltrion; Advisory/Consultancy, Speaker Bureau/Expert testimony: Gilead; Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen-Cilag; Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony: Servier; Advisory/Consultancy: Sandoz; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Immune Design; Advisory/Consultancy, Speaker Bureau/Expert testimony: Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony: Portola; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eusa Pharma; Advisory/Consultancy, Speaker Bureau/Expert testimony: Kyowa Kirin; Advisory/Consultancy: Sanofi. R. Ramchandren: Advisory/Consultancy: Seattle Genetics, Sandoz-Novartis, Pharmacyclics/Janssen, Bristol-Myers Squibb; Research grant/Funding (self): Research Grant/Funding Merck, Seattle Genetics, Janssen, Genentech You. A. Santoro: Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Servier; Advisory/Consultancy, Speaker Bureau/Expert testimony: Gilead Sciences; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eisai; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy: Sanofi; Advisory/Consultancy, Speaker Bureau/Expert testimony: ArQule; Speaker Bureau/Expert testimony: Takeda; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: AbbVie; Speaker Bureau/Expert testimony: Amgen; Speaker Bureau/Expert testimony: Celgene; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Lilly; Speaker Bureau/Expert testimony: Sandoz; Speaker Bureau/Expert testimony: Novartis. E. Paszkiewicz-Kozik: Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Takeda; Travel/Accommodation/Expenses: Celgene. R. Gasiorowski: Honoraria (self): MSD; Honoraria (self): Takeda; Honoraria (self): Novartis; Honoraria (self): AbbVie. N.A. Johnson: Honoraria (self), Advisory/Consultancy: Roche/Genentech; Honoraria (self), Advisory/Consultancy: Merck; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (self): AbbVie. V. Buccheri: Advisory/Consultancy, Advisory board: AstraZeneca; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Seattle Genetics; Research grant/Funding (institution), Travel/Accommodation/Expenses: Takeda; Travel/Accommodation/Expenses: AbbVie. G.F. Perini: Honoraria (self), Speaker Bureau/Expert testimony: Janssen; Honoraria (self): Takeda; Honoraria (self): AbbVie. M. Dickinson: Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): MSD; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Roche; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Takeda; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Celgene; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Novartis. M. Ozcan: Research grant/Funding (institution): MSD; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Celgene; Honoraria (self), Research grant/Funding (institution): Roche; Research grant/Funding (institution): Janssen; Honoraria (self), Research grant/Funding (institution): Takeda; Research grant/Funding (institution): Archigen; Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): AbbVie; Honoraria (self): Amgen; Honoraria (self): BMS. N. Sekiguchi: Research grant/Funding (institution): Ono; Research grant/Funding (institution): A2 Healthcare; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Astellas; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): Merck Sharp & Dohme; Research grant/Funding (institution): Otsuka; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): PPD-SNBL,; Research grant/Funding (institution): Sumitomo Dainippon. M. Raut, Y. Zhu, A. Nahar: Full/Part-time employment: Merck & Co., Inc. P. Marinello: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: Merck & Co., Inc. J. Kuruvilla: Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb; Honoraria (self): Amgen; Honoraria (self): Celgene; Honoraria (self): AstraZeneca; Honoraria (self), Advisory/Consultancy: Gilead Sciences; Honoraria (self), Research grant/Funding (self): Janssen; Honoraria (self), Advisory/Consultancy: Karyopharm Therapeutics; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self): Novartis; Honoraria (self), Research grant/Funding (self): Roche; Honoraria (self), Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Roche/Genentech. All other authors have declared no conflicts of interest.

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Mini Oral - Haematological malignancies Mini Oral session

887MO - Real-world treatment management of patients with advanced-stage classic Hodgkin lymphoma receiving front line therapy

Presentation Number
887MO
Speakers
  • Abraham Avigdor (Ramat Gan, Israel)

Abstract

Background

Despite the therapeutic success in the management of Hodgkin lymphoma (HL), customization of therapy requires skillful decisions taking into consideration the risk of adverse events (AEs), even among subpopulations treated with low intensity regimens. This study aims to evaluate the usage of PET-adapted strategies and the management of AEs in cHL patients receiving front line therapies in Italy (IT), Spain (SP), and Israel (IL).

Methods

At 28 sites in IT, SP and IL, medical records were abstracted for patients diagnosed between March 2014 and August 2018 with advanced cHL and treated with conventional 1L systemic therapies.

Results

The aggregate sample (N=256) comprised of patients with advanced- stage cHL, treated in 1L with ABVD (86.3%), AVD (2.7%), BEACOPPinitiation-based (8.6%), or other systemic therapy (2.3%), and distributed across IT (35.5%), SP (41.3%), and IL (23.2%). Median (range) age at initial cHL diagnosis was 39 (19 – 91), males- 54.3%. Among 221 patients who received 1L ABVD (the most prevalent regimen type), 187 (84.6%) patients completed six cycles of therapy, 142 (66.6%) underwent interim PET2, of which 30.4% were positive, however few (n= 25, 17.6%) had PET-adapted modifications. A majority (89.1%) of patients received at least one supportive care product. AEs were more prevalent among older patients (>60 years). All grade neutropenia occurred in 47.1% of the patients receiving ABVD; the rate of febrile neutropenia was 6.8%. Other AEs included: infections (22.2%), anemia (27.6%), thrombocytopenia (2.7%). Cardiovascular or pulmonary complications occurred in 5 (2.3%) and 22 (10%) ABVD patients, respectively, 11 of whom had undergone PET2 assessment - 3 with treatment de-escalation.

Conclusions

Unmet needs exist with respect to the balance between therapeutic efficacy and safety risks of 1L chemotherapies in cHL. Even when PET2 scans are available to monitor tumour response, they are not always used to modify treatment management. Most patients continue to rely on supportive care products, or experience avoidable toxicities, underscoring the importance of new treatment combinations with novel agents.

Legal entity responsible for the study

Takeda Pharmaceuticals International AG.

Funding

Takeda Pharmaceutical International AG.

Disclosure

A. Avigdor: Advisory/Consultancy: Takeda; Advisory/Consultancy, Research grant/Funding (institution): Janssen; Advisory/Consultancy: Roche. F. Trinchese, F. Gavini, N. Bent-Ennakhil, A. Zomas: Full/Part-time employment: Takeda. M. Dalal: Full/Part-time employment, Stock ownership: Millennium Pharmaceuticals, Inc. G. Gini: Advisory/Consultancy: Takeda. All other authors have declared no conflicts of interest.

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Mini Oral - Haematological malignancies Mini Oral session

888MO - Effectiveness of brentuximab vedotin in relapsed/refractory classic Hodgkin lymphoma: A systematic review and meta-analysis

Presentation Number
888MO
Speakers
  • Bastian Von Tresckow (Essen, Germany)

Abstract

Background

Brentuximab vedotin (BV), an anti-CD30 antibody drug conjugate, was shown to be effective and well-tolerated in relapsed/refractory classic Hodgkin lymphoma (RRcHL) according to a pivotal phase II trial. This study aimed to assess the effectiveness of BV in RRcHL in the real-world.

Methods

Systematic review of observational studies and meta-analysis based on literature (MEDLINE, Embase, Web of Science), pragmatic searches and snowballing (01/01/2010 – 06/02/2020). Data of interest were patterns of BV use, treatment responses, progression-free survival (PFS), overall survival (OS), and adverse events. Statistical heterogeneity assessed through I2 statistics. Estimates pooled using a random effects model. Primary analysis included only studies of good methodological quality. Publication bias was assessed by a funnel plot. Sensitivity analyses included studies of moderate quality and estimates reported in abstracts.

Results

The literature search yielded 2,460 references and pragmatic searches found 21 additional ones. Upon abstract screening and in-depth review, eligibility was confirmed for 32 sources. In 26 sources, the dosing regimen of BV in RRcHL was 1.8 mg/kg every 3 weeks. Median number of cycles administered ranged from 4 to 8, uniformly distributed across studies. In real-world environment, the overall response rate (ORR) to BV based on the revised response criteria for malignant lymphoma ranged from 46.6% to 84.0% (28 sources) with 21.1% to 45.8% patients achieving complete response (26 sources). After 4 cycles, pooled estimate of ORR was 62.6% (95% confidence interval [CI]: 56.0 - 68.9; I2 = 9.5%) while after 4-6 cycles, it was 66.7% (95% CI: 58.5 - 74.5; I2 = 43.9%). Similar results were found in sensitivity analyses. The 1-year, 2-year and 5-year PFS ranged from 52.1% to 63.2% (2 sources), 45.2% to 56.2% (3 sources) and 31.9% to 33.0% (2 sources), respectively. The 1-year, 2-year and 5-year OS ranged from 68.2% to 82.7% (6 sources), 58.0% to 81.9% (7 sources) and 58.0% to 62.0% (2 sources), respectively.

Conclusions

The present study corroborates the effectiveness of BV in RRcHL patients managed in the real-world setting by showing results which are consistent with those of the pivotal phase II trial.

Legal entity responsible for the study

Takeda Pharmaceuticals.

Funding

Takeda Pharmaceuticals.

Disclosure

B. von Tresckow: Advisory/Consultancy, Personal fees: Amgen; Advisory/Consultancy, Personal fees: Pfizer; Advisory/Consultancy, Personal fees and Non-financial support: MSD; Advisory/Consultancy, Personal fees: Gilead; Advisory/Consultancy, Personal fees: Roche; Advisory/Consultancy, Personal fees and Non-financial support: Takeda pharmaceuticals; Research grant/Funding (self), Non-financial support: Novartis. A. Bergamasco, G. Castillon, T. Arredondo-Bisono, T. Cristarella, Y. Moride: Research grant/Funding (institution): Takeda Pharmaceuticals. F. Trinchese. F. Gavini, N. Bent-Ennakhil, A. Zomas: Full/Part-time employment: Takeda Pharmaceuticals. W.J. Plattel: Advisory/Consultancy: Takeda Pharmaceuticals; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: MSD.

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Mini Oral - Haematological malignancies Mini Oral session

889MO - Long-term follow-up of patients with nodular lymphocyte predominant Hodgkin lymphoma: A report from the Spanish Lymphoma Oncology Group

Presentation Number
889MO
Speakers
  • Beatriz Nunez Garcia (Majadahonda, Spain)

Abstract

Background

Nodular lymphocytic predominance Hodgkin lymphoma (NLPHL) is a very unfrequent subtype of Hodgkin lymphoma, representing approximately 5% of all LH cases, with an incidence of 0.3 / 100,000 cases per year and with unique characteristics that distinguish it from classic Hodgkin lymphoma (HLc). Given its low frequency, it is very difficult to design randomized studies, being the accumulated experience of academic groups a source of relevant information for the management of these patients.

Methods

85 patients recruited by the Spanish Lymphoma Group of 12 hospitals have been retrospectively analysed describing their clinical and sociodemographic characteristics.

Results

The median follow-up was 16 years, with a 10-year OS of 92.9% and 81.2% at 20 years. 5 patients developed a second tumor. There is no transformation to more aggressive lymphoma. There was a 31% relapse, being 77% a single and supradiaphragmatic relapse. The percentage of progression to first-line treatment was: 50% in those under observation, 26% of those who received QT-RT, 27% of those who received only RT, and 47% of those who received CH exclusively. The mean time to relapse was 3 years and 47% presented relapses beyond 5 years (higher probability in stages IV p <0.001).

VARIABLE N (%)*
Gender
Men 65 (76.5)
Women 20 (23,5)
Age at diagnosis
Mean 37
Median 35 (23-48)
Stage at diagnosis
I 39 (46.4)
II 34 (40.5)
III 7 (8.3)
IV 4 (4.8)
Follow-up time (years)
Mean 16
Median 14,5 (5,5-27,2)
VARIABLE LOG-RANK
10-year overall survival 92.9% 0.142
Men 90.8%
Women 100%
10-year (lymphoma survival) 98.8% 0.560
Men 98.5%
Women 100%
20-year overall survival 81.2% 0.208
Men 78.5%
Women 90%
20-year (lymphoma survival) 96.5% 0.298
Men 95.4%
Women 100%

Conclusions

This is one of the longest follow-ups of NLPHL published confirming its excellent prognosis. Treatment could be adapted to exclusive RT when possible in the initial stages.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Mini Oral - Haematological malignancies Mini Oral session

Invited Discussant 886MO, 887MO, 888MO and 889MO

Speakers
  • Stefan Balabanov (Zurich, Switzerland)
Mini Oral - Haematological malignancies Mini Oral session

LBA37 - A blinded, randomized, parallel group, comparative investigation of a novel device (Cooral) for cryoprevention of oral mucositis

Presentation Number
LBA37
Speakers
  • Java Walladbegi (Göteborg, Sweden)

Abstract

Background

Cryoprevention using ice chips (IC) have effectively been used to alleviate the onset and duration of chemotherapy-induced oral mucositis (OM). However, the use of IC may entail adverse reactions e.g., chills, nausea and shooting pain in the teeth, which will influence the tolerability and, thus, compliance. In addition, IC requires water of good quality to minimize risk of serious infections in already immunocompromised patients. To eliminate these adverse incidents, this study was conducted to evaluate the efficacy of a novel intraoral cooling device (ICD) for cryoprevention of OM.

Methods

In total 182 patients with multiple myeloma or lymphoma, scheduled to receive high-dose chemotherapy prior to hematopoietic stem cell transplantation, were included and randomly assigned (1:1) to cooling with IC or the ICD. Each cooling session started 30 minutes prior to the chemotherapy infusion and continued for 30 minutes after the infusion was completed. Patients were followed up for up to 28 days and OM was assessed employing the Oral Mucositis Assessment Scale (OMAS). The primary endpoint, peak OMAS, was analyzed by a multiple linear regression model with fixed explanatory variables, treatment group and type of cancer.

Results

When the entire patient material was analyzed for OMAS-total, the two cooling methods were equally effective, and severe OM was found to be below 10%. However, when the lymphoma group was analyzed separately, the ICD significantly reduced the OMAS-total score to a greater extent compared to IC (mean = 1.77 vs 3.08; p=0.047). Both diagnostic groups reported a higher degree of tolerability when ICD was compared with IC (OR=0.245; p<0.02).

Conclusions

Cryoprevention is an effective strategy to prevent chemotherapy-induced oral mucositis. The conventional cooling method of using ice was shown to be further improved by the use of the intraoral device both regarding the prevention of oral mucositis for specific diagnostic groups as well as for the reported tolerability.

Clinical trial identification

NCT03203733.

Legal entity responsible for the study

Braincool AB.

Funding

Braincool AB.

Disclosure

J. Walladbegi: Honoraria (self), Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: BrainCool AB. A. Svanberg: Advisory/Consultancy: BrainCool AB. M. Jontell: Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options: BrainCool AB. R.K. Henriksson: Shareholder/Stockholder/Stock options, Officer/Board of Directors: BrainCool AB; Advisory/Consultancy: Alivia. F. Schjesvold: Advisory/Consultancy, Shareholder/Stockholder/Stock options: Oncopeptides; Honoraria (self): SkyliteDX; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Celgene; Honoraria (self): Takeda; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Janssen; Advisory/Consultancy: Novartis Pharma SAS; Research grant/Funding (institution): Braincool; Advisory/Consultancy: Sanofi . G. Larfors: Research grant/Funding (institution): BrainCool AB. M. Jädersten: Research grant/Funding (institution): BrainCool AB. All other authors have declared no conflicts of interest.

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Mini Oral - Haematological malignancies Mini Oral session

890MO - Phase I Alexander study of AUTO3, the first CD19/22 dual targeting CAR.T cell, with pembrolizumab in patients with relapsed/refractory (r/r) DLBCL

Presentation Number
890MO
Speakers
  • Eleni Tholouli (Manchester, United Kingdom)

Abstract

Background

CD19 directed CAR T cells are effective in patients with r/r DLBCL, however relapses due to CD19 loss or PDL1 upregulation are common. In this study, we evaluate the safety and efficacy of AUTO3, a CAR T targeting CD19/22 with limited duration of PD-1 blockade.

Methods

We constructed a bicistronic retroviral vector encoding both an anti-CD19 (OX40 co-stim) and an anti-CD22 (41BB co-stim) CAR with humanized binders. The cell product was manufactured in a semi-automated and closed process using CliniMACS Prodigy. Patients (≥ 18 years) with r/r DLBCL (NOS) or transformed (tDLBCL); ECOG < 2, adequate organ function are eligible. Lymphodepletion was Flu/Cy prior to AUTO3. Bridging therapy was allowed. The three dose levels explored are 50, 150, and 450 x 106 CAR T-cells. Patients received AUTO3 alone, or with 3 doses of pembrolizumab (pem) 200 mg q 3 wks starting on D14 (regimen A), or with a single dose of pem 200 mg on D-1 (regimen B). The primary endpoint is frequency of DLTs and grade (G) 3-5 adverse events (AE) and secondary endpoints included ORR, CRR, and biomarkers.

Results

As of April 27, 2020, 23 patients were treated with AUTO3 in the ongoing phase I study. The median age was 57 (28 - 83) and median number of prior therapies was 3 (2 - 10). 87% had refractory disease, 74% were DLBCL NOS, and 26% were tDLBCL. Dose escalation from 50 to 450 x 106 cells with pem regimen A and B have been completed without DLTs. G ≥ 3 treatment emergent AEs that occurred ≥ 25% were neutropenia (87%), thrombocytopenia (57%), and anemia (48%). Majority of Serious AE were hematological related and reversible. There were 0 cases of severe cytokine release syndrome (sCRS) or neurotoxicity (NT) of any grade at > 50 x 106 cells. Among the 16 patients treated at dose > 50 x 106, the ORR was 69% and CRR was 56%, and all CRs are ongoing at a median f/u 3 months (1-12 months). Among the 8 patients treated at a dose > 50 x 106 with D-1 pem, the ORR was 75% and CRR was 63%. Additional data from patients treated at the recommended phase II dose as well as patients treated in an out-patient setting and longer follow up, as well as relevant biomarkers will be presented.

Conclusions

AUTO3 at > 50 x 106 CAR T cells with pembrolizumab induces CRs without severe CRS or NT of any grade.

Clinical trial identification

EudraCT Number: 2016-004682-11.

Legal entity responsible for the study

Autolus Therapeutics.

Funding

Autolus Therapeutics.

Disclosure

E. Tholouli: Advisory/Consultancy: Astellas; Advisory/Consultancy: Celgene; Advisory/Consultancy: Daiichi-Sankyo; Advisory/Consultancy: Kite; Advisory/Consultancy: Janssen; Advisory/Consultancy: Jazz; Advisory/Consultancy: Kiadis; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer. W. OSBORNE: Advisory/Consultancy: Autolus Therapeutics; Advisory/Consultancy: Roche; Advisory/Consultancy: Takeda; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Servier; Advisory/Consultancy: Kite; Advisory/Consultancy: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Beigene. A. Ramakrishnan: Advisory/Consultancy: Takeda; Advisory/Consultancy: Amgen; Honoraria (self): Cigna. Y. Zhang: Full/Part-time employment: Autolus Therapeutics. S. Thomas, M. Al-Hajj, M. Pule, M. Jonnaert, V. Peddareddigari, N. Khokhar, R. Chen: Full/Part-time employment: Autolus Therapeutics. All other authors have declared no conflicts of interest.

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Mini Oral - Haematological malignancies Mini Oral session

891MO - Role of baseline PET SUVmax in predicting early progression in follicular lymphoma (FL): A single-center retrospective analysis

Presentation Number
891MO
Speakers
  • Ayushi Chauhan (Washington, United States of America)

Abstract

Background

FL is biologically and clinically heterogeneous with wide variations in outcomes. Progression of disease within 24 months after treatment (POD24) predicts overall survival (OS) in patients (pts) treated with rituximab-based therapy. Pts with POD24 have a < 50% long-term survival. Identifying predictors of POD24 at outset is an area of unmet need. Total metabolic tumor volume (TMTV) is an independent predictor of outcomes in FL. However, TMTV calculations are not routinely available, unlike SUVmax. Thus, we aimed at determining the correlation of baseline SUVmax with POD24 in FL.

Methods

We performed a retrospective chart review of pts with newly diagnosed FL from January 2011-January 2019. Comparison of PFS was done with log-rank test and multivariate analysis was conducted with Cox regression.

Results

100 pts with median age 60 years (29-86 years) were included. Baseline characteristics are mentioned in the attached figure. 21% of pts relapsed within 24 months (POD24) however median OS was unable to be calculated due to insufficient OS events. Baseline PET-CT analysis showed median SUV max value of 8.55 (0-38.9). No difference in correlation was noted between baseline SUVmax and initial laboratory data collected (ANC, ALC, Hgb, Plt, LDH, albumin, and globulin). Median SUV max for POD24 pts was higher at 9.19 vs 7.40 for non-POD24 however, comparison of SUVmax by POD24 status showed no statistically significant difference between the two groups (p=0.95). T-test also failed to note a difference between baseline laboratory variables and PET-CT determinates (number of nodal and extranodal sites) between POD24 and non-POD24 pts.

Conclusions

In our analysis, baseline SUVmax did not predict POD24 nor were there significant differences in the comparison of clinical variables between the two POD24 groups. Gene-expression profiling (GEP) scores have been developed to predict PFS in FL and high-risk signatures have been found to react differently to different chemotherapy backbones. Future research efforts should focus on increasing the feasibility and adoption of GEP in clinical practice, defining molecular subtypes of FL prior to treatment, and assigning therapy on the basis of those results.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Mini Oral - Haematological malignancies Mini Oral session

892MO - High-dose chemotherapy with autologous hematopoietic stem cell transplantation in patients with HIV-related lymphoma

Presentation Number
892MO
Speakers
  • Marina Popova (Saint Petersburg, Russian Federation)

Abstract

Background

The number of prospective matched case-controlled studies to prove the safety and efficacy of autologous stem cell transplantation (ASCT) in HIV-related lymphoma is limited.

Methods

Between January 2016 and January 2020, twelve patients with HIV-related lymphoma who have undergone ASCT were included in this prospective matched case-control study (study group, n=12). Forty eight non-HIV-infected patients were enrolled to the control group (n=48, 1:4). The median age was 34 (19-66) y.o. The underlying diseases in the study group were Hodgkin lymphoma (HL) n=7 (58,3%) and non-Hodgkin lymphoma (NHL) n=5 (41,7%), complete remission at the moment of ASCT – 66,7%. Conditioning regimen was BEAM with BCNU replacement by Bendamustine 160 mg/m2/day at D-7, D-6. HIV viral load was undetectable; the median number of CD4+ cells was 471,5 (210-715) cells/mcl; all patients were on anti-retroviral therapy (ART). The median follow up time was 16 (1-43) months.

Results

The 2-year overall survival (OS) (n=60) was 90%; 91,7% in the study group and 89,9% in the control group, and this was not significantly different between the groups (P= 0,763). Progression-free survival (PFS) at 2 years in the study group was 75%, and was not significantly different to the control group (70,8%; P=0,777). Time to progression (TTP) at 2 years was 14,6% in the study group and 16,7% in the control group (P=0,643). Complete remission at the moment of ASCT improved PFS (P =0,03) and TTP (P =0,044) in the whole group. The median time for recovery of leukocytes, neutrophils, and platelets was D+14,5 (10-25), D+17 (12-30), D+15,5 (11-31), respectively, in the study group and D+14 (10-22), D+15 (10-23), D+15 (8-31) in the control group. Neutrophil recovery was significantly delayed in study group (P=0,04). There was no difference in the rate of organ toxicity according to CTCAE. The transplant-related mortality (TRM) at 2 years was 8,3% in the study group and 6,2% in the control group (P=0,8).

Conclusions

Two-year overall survival in patients with HIV-related lymphoma was 91.7%, PFS was 75%, TTP was 14,6% and TRM was 8,3% and did not differ significantly from the control group. Only neutrophil recovery was significantly delayed after ASCT in patients with HIV-related lymphoma. Our data provide further evidence that ASCT is a safe and effective approach for patients with HIV-related lymphoma.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Mini Oral - Haematological malignancies Mini Oral session

893MO - An open-label, single-center, phase II, single-arm trial of camrelizumab combined with apatinib in patients with relapsed or refractory peripheral T-cell lymphoma

Presentation Number
893MO
Speakers
  • Yan Xie (Beijing, China)

Abstract

Background

The outcome of relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) is dismal. PD1 blockade was effective in patients (pts) with R/R PTCL in a retrospective study. However, the efficacy and safety of PD1 blockade with camrelizumab combined with anti-angiogenic drug apatinib remains undefined.

Methods

In this trial (NCT03701022), pts with histologically confirmed PTCL, ECOG performance status of 0–1, and measurable lesion(s) by the Lugano 2014 criteria; those who aged 18 years or more; and those who previously received chemotherapy were eligible. PTCL included not-otherwise-specified PTCL (PTCL NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large-cell lymphoma (ALCL), and extranodal NK/T-cell lymphoma nasal type (ENKTL). All pts received camrelizumab 200 mg every 2 weeks and apatinib 500 mg once a day with a cycle of 28 days until the evaluation of disease progression, unaccepted toxicity, withdrawal, or death. Response to treatment was evaluated with computed tomography images by the Lugano 2014 criteria. The objective response rate (ORR) was the primary endpoint, and progression-free survival (PFS) was the secondary endpoint.

Results

A total of 15 pts were enrolled by May 1, 2020, including four pts with PTCL NOS, four pts with AITL, two pts with ALCL, and five pts with ENKTL. The median age was 56 years, 10 pts were male, and the number of previous chemotherapy regimens was 1–6 with a mean of 3. Among 11 pts with evaluable results, 36.4% achieved ORR, including one patient with complete response (CR) and three pts with partial response (PR). Three pts were evaluated with stable disease. Pts with ALCL and ENKTL had more clinical benefits compared with other subtypes; all pts with ALCL and two of three pts with evaluable ENKTL had remission (one CR and three PR). The median PFS was 5.47 months (range 0.97–7.37 months). Most adverse events (AEs) were of grade 1 to 2, and AEs of grade 3 included thrombocytopenia (10.1%), neutropenia (4.5%), hypertension (4.5%), and rash (4.5%). No grade 4 or higher AEs were observed.

Conclusions

Camrelizumab combined with apatinib showed high activity and safety, and might be a feasible option for pts with R/R PTCL.

Clinical trial identification

NCT03701022.

Legal entity responsible for the study

Peking University Cancer Hospital & Institute.

Funding

Jiangsu Hengrui Medicine Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

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Mini Oral - Haematological malignancies Mini Oral session

Invited Discussant LBA37, 890MO, 891MO, 892MO and 893MO

Speakers
  • Andrew J. Davies (Southampton, United Kingdom)