Abstract 506P
Background
Guidance for the management of nausea/vomiting (N/V) based on clinical studies of zolbetuximab is limited. This study aims to develop consensus guidelines for management of N/V in patients treated with zolbetuximab + chemotherapy.
Methods
An international RAND/UCLA modified Delphi panel will include clinicians involved in the phase 2 or 3 clinical studies of zolbetuximab + chemotherapy. A rating survey (questionnaire), developed based on literature review and panelist interviews, will consist of hypothetical scenarios of patients and potential interventions to prevent/manage N/V during treatment with zolbetuximab + chemotherapy. Panelists will rate the appropriateness of each intervention in each scenario on a 1–9 scale before and after a virtual meeting. The RAND/UCLA Appropriateness Method will be used to determine consensus guidance.
Results
Of the literature review are reported here, summarizing primary manuscripts for zolbetuximab phase 1 (n = 3), phase 2 (n = 3), and phase 3 (n = 2) studies, a meta-analysis of zolbetuximab studies, and ASCO, MASCC/ESMO, and NCCN guidelines for management of chemotherapy-induced N/V (CINV). The most common adverse events with zolbetuximab were N/V. Despite dose interruptions, infusion rate adjustments, and antiemetics, N/V led to higher rates of discontinuations in zolbetuximab versus placebo arms. While investigators were directed to administer antiemetics before study treatment administration, the clinical studies of zolbetuximab were not designed to evaluate specific antiemetic regimens as prophylaxis. Choice of prophylaxis depends on the level of emetogenic risk faced by patients. Patients receiving zolbetuximab had moderate emetogenic risk. Recommended antiemetic regimens for acute CINV resulting from chemotherapies with moderate emetogenic risk include 5-HT3 receptor antagonist (RA) + dexamethasone ± NK-1 RA ± 5-HT2A/C RA. The Delphi panel is ongoing and consensus results will be reported at the time of presentation.
Conclusions
To our knowledge, this Delphi study is expected to provide the first consensus guidance for the management of N/V in patients treated with zolbetuximab + chemotherapy.
Editorial acknowledgement
Medical writing support was provided by Ann Ferguson, PhD, of Oxford PharmaGenesis Inc., and was funded by Astellas Pharma Inc.
Legal entity responsible for the study
Astellas Pharma Inc.
Funding
Astellas Pharma Inc.
Disclosure
S.J. Klempner: Financial Interests, Personal, Other, Payment to me - All support for the present abstract (e.g., funding, provision of study materials, medical writing, article processing charges, etc.): Astellas; Financial Interests, Personal, Other, Consulting fees - Payment to me: Astellas; Financial Interests, Personal, Other, Consulting fees - Payment to me, ended 1/2024: Novartis; Financial Interests, Personal, Other, Consulting fees - Payment to me, ended 7/2023: Merck; Financial Interests, Personal, Advisory Board, Payment to me, gastric cancer advisory board: Astellas, Amgen, Pfizer, Sanofi-Aventis, Merck, BMS, I-Mab, Mersana, Natera, AstraZeneca, Daiichi Sankyo, Servier, Coherus; Financial Interests, Personal, Stocks/Shares, Me, ended in 6/2022: Turning Point Therapeutics; Financial Interests, Personal, Stocks/Shares, Me, ended 11/2022: Nuvalent; Non-Financial Interests, Personal, Other, NCCN Guidelines - Unpaid relationship, member of guidelines committee: NCCN Guidelines. S. Braun: Financial Interests, Personal and Institutional, Full or part-time Employment, I am an employee of Astellas: Astellas Pharma Global Development, Inc. S.N. Gibbs: Financial Interests, Institutional, Other, I am an employee of PHAR, which was paid by Astellas to conduct the research described in this abstract: Astellas; Financial Interests, Institutional, Other, I am an employee of PHAR, which was paid by Astellas to conduct the research described in this abstract. PHAR also discloses financial relationships with the following entities outside of the submitted work: Akcea, Amgen, BioMarin Pharmaceuticals, Bristol Myers Squibb, Boston Scientific Corporation, Celgene, Delfi Diagnostics, Dompe, Eisai, Exact Sciences, Genentech, Gilead, GRAIL, Greenwich Biosciences, Ionis, Janssen, Nobelpharma, Novartis, Pfizer, Recordati, Regeneron, Sanofi US Services, Takeda Pharmaceuticals USA. R. Fuldeore: Financial Interests, Personal and Institutional, Full or part-time Employment, Employee of Astellas: Astellas Pharma Global Development, Inc.