Treatment decision for recurrences in non-small cell lung cancer during or after adjuvant osimertinib: an international Delphi consensus report.

Osimertinib is recommended by major guidelines for use in the adjuvant setting in patients with EGFR mutation-positive NSCLC following the significant improvement in disease-free survival observed in the Phase III ADAURA trials. Due to limited real-world data in the adjuvant setting, little guidance exists on how to approach potential recurrences either during or after the completion of the treatment. This study aimed to reach a broad consensus on key treatment decision criteria in the events of recurrence. To reach a broad consensus, a modified Delphi panel study was conducted consisting of two rounds of surveys, followed by two consensus meetings and a final offline review of key statements. An international panel of experts in the field of NSCLC (n=12) was used to provide clinical insights regarding patient management at various stages of NSCLC disease including patient monitoring, diagnostics, and treatment approach for specific recurrence scenarios. This study tested recurrences occurring 1) within or outside the central nervous system (CNS), 2) during or after the adjuvant-osimertinib regimen in NSCLC disease which is 3) amenable or not amenable to local consolidative therapy. Panellists agreed on various aspects of patient monitoring and diagnostics including the use of standard techniques (e.g., CT, MRI) and tumour biomarker assessment using tissue and liquid biopsies. Consensus was reached on 6 statements describing treatment considerations for the specific NSCLC recurrence scenarios. Panellists agreed on the value of osimertinib as a monotherapy or as part of the overall treatment strategy within the probed recurrence scenarios and acknowledged that more clinical evidence is required before precise recommendations for specific patient populations can be made. This study provides a qualitative expert opinion framework for clinicians to consider within their treatment decision-making when faced with recurrence during or after adjuvant-osimertinib treatment.

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Copyright © 2024 Mirza, Shrivastava, Matthews, Leighl, Ng, Planchard, Popat, Rotow, Smit, Soo, Tsuboi, Yang, Stiles, Grohe and Wu.

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NL reports research funding from Amgen, AstraZeneca Canada, Bayer, EMD Serono, Guardant Health, Lilly, MSD, MSD Oncology, Roche Canada, and Takeda; travel and accommodation support from Merck Sharp & Dohme. CN reports advisor to Medtronic, Johnson & Johnson; speaker fees from AstraZeneca, Merck Sharp & Dohme, Roche, Medtronic, Johnson & Johnson. DP reports being an advisor to AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Merck, Novartis, Pfizer, Roche, Janssen, and Abbvie; honoraria from AstraZeneca, Bristol-Myers Squibb, Celgene, Eli Lilly, Merck, Novartis, Pfizer, Roche, Janssen, and Abbvie; travel and accommodation grants from AstraZeneca, Roche, Novartis, and Pfizer; and conducting clinical trials research as principal or co-investigator institutional financial interests for AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Pfizer, Roche, Medimmun, Sanofi-Aventis, Taiho Pharma, Novocure, Daiichi Sankyo, Abbvie, and Janssen. SP reports consultancy to Amgen, AstraZeneca, Bayer, BeiGene, Blueprint, BMS, Boehringer Ingelheim, Daiichi Sankyo, EQRx, GlaxoSmithKline, Guardant Health, Janssen, Lilly, Merck KGaA, MSD, Novartis, Pfizer, Roche, Sanofi, Seattle Genetics, Takeda, and Turning Point Therapeutics. JR reports being an advisor to AbbVie, Amgen, AstraZeneca, BioAtla, BMS, Daichi-Sankyo, G1 Therapeutics, Genentech, Gritstone Bio, Guardant, Janssen, Lilly, Jazz, Summit Therapeutics Takeda; speaker fees from AstraZeneca; institutional research funding from BioAtla, AbbVie, AstraZeneca, Blueprint, RedCloud, Loxo Oncology, Daiichi Sankyo, Enliven, ORIC, and Summit. ES reports being an advisor to AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Lilly, Merck KGaA, MSD Oncology, Novartis, Roche/Genentech, Seagen, and Takeda; honoraria from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo/Astra Zeneca, and Merck KGaA; research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Roche/Genentech. RS reports being an advisor to Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Janssen, Lily, Merck, Merck Serono, Novartis, Pfizer, Puma, Roche, Taiho, Takeda, Thermo Fisher, Yuhan and has received research grants from AstraZeneca and Boehringer Ingelheim. MT reports being an advisor to AstraZeneca Japan, Chugai Pharma, Lilly Japan, MSD, Novartis and MiREXS; honoraria from AstraZeneca Japan, Bristol-Myers Squibb Japan, Chugai Pharma, Johnson & Johnson, Lilly Japan, Medtronic, MSD K.K, Novartis, Ono Pharmaceutical, Taiho Pharmaceutical, and Teijin Pharma; research funding from AstraZeneca Japan, Boehringer Ingelheim KK, Bristol-Myers Squibb KK, Merck, Ono Pharmaceutical, BMG Incorporated, and MiREXS. FY reports speaker fees from MSD, Pfizer, Roche, AstraZeneca, and Bristol-Myers Squibb. BS reports wife’s employment with PPD and Xalud Therapeutics; leadership at Verrica Pharmaceuticals; stock and other ownership interests in Pfizer, PPD, and Xalud Therapeutics; personal honoraria from AstraZeneca, Bristol Myers Squibb, Genentech, and Pfizer; consulting or advisor role at AstraZeneca, Gala Therapeutics, Medtronic, Arcus Biosciences, and Pfizer; research funding from Bristol Myers Squibb Foundation; patents, royalties, and other intellectual property related with a therapeutic antibody targeting ART1, an extracellular mono-ADP ribosyltransferase, for the treatment of cancer patent application filed; other relationship with Lung Cancer Research Foundation and Lungevity. CG reports being an advisor to AstraZeneca, Boehringer Ingelheim, and MSD Oncology; honoraria from AstraZeneca, Boehringer Ingelheim, Lilly, MSD Oncology, Novartis, Roche, and Takeda; research funding from AstraZeneca; travel and accommodation support from Boehringer Ingelheim, Bristol-Myers Squibb, and Roche. Y-LW reports being an advisor to AstraZeneca, Boehringer Ingelheim, Roche, and Takeda; honoraria from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb/China, Hengrui Pharmaceutical, Lilly, MSD Oncology, Pfizer, and Roche; research funding from Boehringer Ingelheim, Pfizer, and Roche. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.