Beyond clinical trials in B-cell malignancies: what real-world experience tells us

Watch interviews from the presenting experts of the Kite Satellite Symposium ‘Beyond clinical trials in B-cell malignancies: what real-world experience tells us’, hosted during the European Hematology Association (EHA) 24th Congress in Amsterdam, The Netherlands.

Gain insights as experts present data from clinical trials of idelalisib [indicated for the treatment of follicular lymphoma (FL) after two lines of prior treatment and chronic lymphocytic leukemia (CLL) after ≥ one prior lines of therapy or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies] and axicabtagene ciloleucel [indicated for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) after ≥ two lines of systemic therapy] and compare findings with real-world evidence. Consideration is also given to how patient registries can benefit drug development.

Real-world experience with idelalisib in FL and CLL

Loic Ysebaert, MD, PhD, from the University Cancer Institute Toulouse, France, presents his real-world experience with PI3Kδi therapy in FL and CLL. He describes the efficacy and safety profile characterization of idelalisib in clinical trials versus real-world experience.

The value of real-world evidence

John New, MBBS, FRCP, from Salford Royal NHS Foundation Trust, UK, shares his experience of managing real-world evidence from patients in a randomized controlled trial and the value it brings to drug development. He discusses the key considerations when collecting real-world data, including inclusion and exclusion criteria, patient experiences and utilizing digital tools.

Do patients and clinicians report outcomes differently?

Prof. New discusses whether treatment results are perceived differently by the patient in comparison to the clinician. He explores ways of measuring patient health in terms of quality of life measures, as well as survival.

Real-world experience with CAR-T in aggressive non-Hodgkin lymphoma

Patients treated with axicabtagene ciloleucel in the real world experienced similar outcomes to those in the ZUMA-1 trial. Yi Lin, MD, PhD, from the Mayo Clinic, Rochester, MN, shares her perspective on the reported findings of real-world evidence for patients with relapsed/refractory DLBCL and PMBCL treated with CAR T-cell therapy.

Addressing patient and caregiver concerns to improve the CAR
T-cell therapy experience

Dr Lin discusses the challenges faced by patients undergoing CAR T-cell therapy and current immediate care strategies, including patient education. She moves on to speak about how patient care needs may be addressed in the future.

Communicating effectively about the referral process: Mayo Clinic experience

Dr Lin explains how referral access can be improved in CAR T-cell therapy, from the referring physician to post-treatment. She discusses how to ensure patients are fully supported, including a patient
pre-screening and evaluation process before the start of treatment.

The power of patient registries

Patient registries are useful resources when evaluating novel interventions such as CAR T-cell therapy. Eoin McGrath, BA, from the Joint Accreditation Committee ISCT-Europe & EBMT (JACIE), Barcelona, Spain, explains the role of treatment registries and how they can provide insights into best clinical practices.

Axicabtagene ciloleucel is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. Axicabtagene ciloleucel must be administered at a qualified clinical setting.

Idelalisib is indicated in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. Idelalisib is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.

Adverse events should be reported. For the UK, reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
For Ireland, reporting forms and information can be found at www.hpra.ie and can be reported to HPRA on +353 1 6764971.
Adverse events should also be reported to Gilead at safety_FC@gilead.com or +44 (0) 1223 897500.

YESCARTA® (axicabtagene ciloleucel), Kite and the Kite logo are registered trademarks of Kite Pharma Inc © 2019 Kite Pharma, Inc.
ZYDELIG® (idelalisib) is a registered trademark, Gilead and the Gilead logo are registered trademarks of Gilead Sciences Inc © 2019 Gilead Sciences, Inc.