New systemic treatment paradigms in resectable non-small cell lung cancer and variations in patient access across Europe.

The treatment landscape of resectable early-stage non-small cell lung cancer (NSCLC) is set to change significantly due to encouraging results from randomized trials evaluating neoadjuvant and adjuvant immunotherapy, as well as adjuvant targeted therapy. As of January 2024, marketing authorization has been granted for four new indications in Europe, and regulatory approvals for other study regimens are expected. Because cost-effectiveness and reimbursement criteria for novel treatments often differ between European countries, access to emerging developments may lead to inequalities due to variations in recommended and available lung cancer care throughout Europe. This Series paper (i) highlights the clinical studies reshaping the treatment landscape in resectable early-stage NSCLC, (ii) compares and contrasts approaches taken by the European Medicines Agency (EMA) for drug approval to that taken by the United States Food and Drug Administration (FDA), and (iii) evaluates the differences in access to emerging treatments from an availability perspective across European countries.

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© 2024 The Author(s).

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I.H., C.D., N.R., and I.B. declare no competing interests. C.A.G. has received grants or contracts from Boehringer Ingelheim, Astellas, Celgene, Sanofi, Janssen-Cilag, Bayer, Amgen, Genzyme, Merck, Gilead, Novartis, AstraZeneca, Roche, NIH, and ASCERTAIN, all payments were made to the institute, outside the submitted work. M.P. has received research funding from MSD, AstraZeneca, Roche, Boehringer Ingelheim, and Takeda, outside the submitted work; consulting fees from Bristol-Meyers, Roche, MSD, AstraZeneca, Takeda, Eli Lilly, F Hoffman-La Roche, Janssen, Pfizer, and Takeda, outside the submitted work; honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bristol-Meyers, Roche, MSD, AstraZeneca, Takeda, Eli Lilly, F Hoffman-La Roche, Janssen, and Pfizer, outside the submitted work; and support for attending meetings and/or travel from AstraZeneca, Boehringer Ingelheim, Bristol-Meyers Eli Lilly, F Hoffman-La Roche, Phierre Fabre Pharmaceuticals, and Takeda, outside the submitted work. A.L. has received grants for academic research from PharMamar, Beigene, Roche, AstraZeneca, and Amgen, outside the submitted work. R.D. has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, AstraZeneca, Takeda, Novartis, BMS, MSD, Pfizer, and Amgen, outside the submitted work; support for attending meetings and/or travel from Pfizer, outside the submitted work; drug samples from Novartis, outside the submitted work; and participated on a Data Safety Monitoring Board or Advisory Board of GlaxoSmithKline, outside the submitted work. C.P. has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, outside the submitted work. M.D.M. has received institutional research funding from Tesaro/GlaxoSmithKline and institutional funding for work in clinical trials/contracted research from Beigene, Exelixis, MSD, Pfizer and Roche, outside the submitted work; and personal fees for consultancy or participation to advisory boards from AstraZeneca, Boehringer Ingelheim, Janssen, Merck Sharp & Dohme (MSD), Novartis, Pfizer, Roche, GlaxoSmithKline, Amgen, Merck, and Takeda, outside the submitted work. M.T. has received institutional research funding from AstraZeneca, BMS, MSD, Roche, and Takeda, outside the submitted work; payment or honoraria (personal) for speakers bureaus from Amgen, AstraZeneca, Beigene, BMS, Boehringer Ingelheim, Celgene, Chugai, Daiichi Sankyo, GlaxoSmithKline, Janssen Oncology, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, and Takeda, outside the submitted work; and support for attending meetings and/or travel from AstraZeneca, BMS, Boehringer Ingelheim, Daiichi Sankyo, Janssen Oncology, Lilly, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, and Takeda, outside the submitted work. A.B. has received consulting fees (personal) from AstraZeneca, BMS, MSD, and Roche, outside the submitted work; and payment or honoraria (personal) for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, BMS, MSD, and Roche, outside the submitted work. S.P. has received consulting fees (personal) from Amgen, AstraZeneca, Bayer, Blueprint, BMS, Boehringer Ingelheim, Daiichi Sankyo, GSK, Guardant Health, Incyte, Janssen, Lilly, Merck Serono, MSD, Novartis, Roche, Takeda, Pfizer, Seattle Genetics, Turning Point Therapeutics, and EQRx, outside the submitted work; payment or honoraria (personal) for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Bayer, Guardant Health, Janssen, Merck Serono, Roche and Takeda, outside the submitted work; payment for expert testimony from Roche and Merck Serono, outside the submitted work; support for travel from Janssen and Roche, outside the submitted work; consulting fees for participation on an Advisory Board, outside the submitted work; unpaid leadership role in the British Thoracic Oncology Group, ALK Positive UK, Lung Cancer Europe, Ruth Strauss Foundation, Mesothelioma Applied Research Foundation, and ETOP-IBCSG Partners Foundation Board, outside the submitted work. S.S. has received research grants (institution) from AstraZeneca and personal honoraria for participating in the trial steering committee for immunotherapy in small cell lung cancer from AstraZeneca, outside the submitted work; consulting fees from AstraZeneca and BMS, outside the submitted work; speaker honoraria (self) from AstraZeneca, outside the submitted work; participates on a Data Safety Monitoring Board as a review panel member for lung toxicity adjudication with immunotherapy (MSD), outside the submitted work; and has a leadership role as an ETOP member of the scientific committee for lung cancer, outside the submitted work.