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. 2025 Jul 22:S1556-0864(25)00938-4.
doi: 10.1016/j.jtho.2025.07.115. Online ahead of print.

Brief Report: Post Hoc Validation of Platinum Ineligibility in NSCLC From the Phase III IPSOS Study

Solange Peters  1 , Christian Schulz  2 , Martin Reck  3 , Kumar Prabhash  4 , Dariusz Kowalski  5 , Aleksandra Szczesna  6 , Baohui Han  7 , Achim Rittmeyer  8 , Toby Talbot  9 , David Vicente  10 , Raffaele Califano  11 , Diego Cortinovis  12 , Anh Tuan Le  13 , Dingzhi Huang  14 , Geoffrey Liu  15 , Federico Cappuzzo  16 , Jessica Reyes Contreras  17 , Ramon Palmero  18 , Milena Perez Mak  19 , Sanjay Popat  20 , Youyou Hu  21 , Stefanie Morris  21 , Minu K Srivastava  22 , Monika Kaul  22 , Vilma Graupner  21 , Barbara Gitlitz  22 , Siow Ming Lee  23
Affiliations

Brief Report: Post Hoc Validation of Platinum Ineligibility in NSCLC From the Phase III IPSOS Study

Solange Peters et al. J Thorac Oncol. .

Abstract

Introduction: The phase III IPSOS study (NCT03191786) demonstrated that atezolizumab was associated with improved survival, stable patient-reported outcomes, and a favorable safety profile versus single-agent chemotherapy in patients with NSCLC ineligible for platinum-based chemotherapy. As no established consensus criteria for platinum ineligibility exist for NSCLC, we performed a post hoc analysis from IPSOS to evaluate clinical outcomes in a selected platinum-ineligible (sPI) population meeting a refined definition.

Methods: Patients with stage IIIB or IV NSCLC who were ineligible for platinum-doublet chemotherapy were randomized (2:1) to receive atezolizumab or single-agent chemotherapy (vinorelbine or gemcitabine). Patients in the sPI subgroup were defined as those with Eastern Cooperative Oncology Group performance status of 3, age older than 80 years, Eastern Cooperative Oncology Group performance status of 2 with relevant comorbidities, or age 70 years or older with relevant comorbidities.

Results: Of 453 patients from the IPSOS intention-to-treat population, 405 (89%) met sPI criteria. Compared with chemotherapy, atezolizumab improved overall survival (unstratified hazard ratio 0.78; 95% confidence interval: 0.63-0.98). Atezolizumab was associated with fewer grade 3 or 4 treatment-related adverse events (46 of 266 [17.3%] versus 46 of 134 [34.3%] with chemotherapy), grade 5 treatment-related adverse events (two of 266 [0.8%] versus four of 134 [3.0%]), and stabilization or improvement of patient-reported health-related quality of life.

Conclusions: This subanalysis suggests that first-line treatment with atezolizumab provides long-term overall survival, consistent with the results from the intention-to-treat population, and a favorable safety profile compared with single-agent chemotherapy in the sPI population. In addition, the selection criteria for platinum ineligibility from the sPI population may provide a structured approach for treatment selection in NSCLC in clinical practice.

Keywords: Atezolizumab; Non–small cell lung cancer; Platinum ineligibility; Platinum-based chemotherapy.

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Conflict of interest statement

Disclosure All authors have received research support in the form of third-party writing assistance for this manuscript from F. Hoffmann-La Roche Ltd. Dr. Peters has received education grants, provided consultation, attended advisory boards, and/or provided lectures for the following organizations, from whom she received honoraria (all fees to institution): Dr. Peters declares a consultation and/or advisory role with AbbVie, Amgen, Arcus, AstraZeneca, Bayer, Beigene, BioNTech, BerGenBio, Bicycle Therapeutics, Biocartis, BioInvent, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F-Star, Foundation Medicine, Genmab, Genzyme, Gilead, GlaxoSmithKline, Hutchmed, Illumina, Incyte, Ipsen, iTeos, Janssen, Qlucore, Merck Sharp & Dohme, Merck Serono, Merrimack, Mirati, Nuvation Bio, Nykode Therapeutics, Novartis, Novocure, Pharma Mar, Promontory Therapeutics, Pfizer, Regeneron, Roche/Genentech, Sanofi, Seattle Genetics, Takeda, and Zymeworks; has provided lectures for organized public events from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Foundation Medicine, GlaxoSmithKline, Illumina, Ipsen, Merck Sharp & Dohme, Mirati, Novartis, Pfizer, Roche/Genentech, Sanofi, Seattle Genetics, and Takeda; and has received grants and/or research support as a principal investigator (institutional financial support for clinical trials) in trials sponsored by Amgen, Arcus, AstraZeneca, Beigene, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, iTeos, Merck Sharp & Dohme, Mirati, Pharma Mar, Promontory Therapeutics, Roche/Genentech, and Seattle Genetics. Dr. Schulz received support (to institution) for the present manuscript from Roche for medical writing support and study materials; declares grants or contracts from AstraZeneca, Roche, and Takeda; consulting fees (to self) from AstraZeneca, Boehringer, Johnson & Johnson, and Roche; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events (to self) from AstraZeneca, Bristol Myers Squibb, and Lilly; and support for attending meetings and/or travel (to self) from AstraZeneca, Johnson & Johnson, and Roche. Dr. Reck reports a relationship with Amgen that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with AstraZeneca that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with BeiGene that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Boehringer Ingelheim that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Bristol Myers Squibb that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Lilly that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Merck that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Merck Sharp & Dohme that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Mirati that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Novartis that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with GlaxoSmithKline that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Pfizer that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Roche that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Regeneron that includes consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Sanofi that includes board membership, consulting or advisory, speaking and lecture fees, and travel reimbursement; a relationship with Daiichi Sankyo that includes: board membership, consulting or advisory, speaking and lecture fees, and travel reimbursement; and a relationship with Janssen that includes consulting or advisory, speaking and lecture fees, and travel reimbursement. Dr. Prabhash received grants for research support from Aurigene Oncology Limited, Alkem Laboratories, Dr. Reddy’s Laboratories, Johnson & Johnson, and Roche. Dr. Kowalski reports a consulting or advisory role with Amgen, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Johnson & Johnson/Janssen, Merck Serono, Merck Sharp & Dohme, Pfizer, Roche/Genentech, and Takeda. Dr. Rittmeyer received grants as an advisor or speaker from AbbVie, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Dr. Talbot received honoraria and speakers’ fees from Bristol Myers Squibb, Merck Sharp & Dohme, Regeneron, and Roche; and travel grants from Bristol Myers Squibb, Merck Sharp & Dohme, Regeneron, and Roche. Dr. Vicente received consulting fees (to self), payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events, support for attending meetings and/or travel, and declares participation on a data safety monitoring or advisory board from AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Gilead, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, and Roche. Dr. Califano received grants or contracts from Merck Sharp & Dohme, Roche, PharmaMar, GlaxoSmithKline, Janssen, AstraZeneca, Taiho, and Arrivent; consulting fees from Merck Sharp & Dohme, PharmaMar, Arrivent, Roche, Bristol Myers Squibb, AstraZeneca, Janssen, GlaxoSmithKline, and Takeda; payment or honoraria from Janssen, GlaxoSmithKline, and Takeda; support for attending meetings and/or travel from Janssen and Takeda; participation on a data safety monitoring board or advisory board for PharmaMar and Janssen; declares a leadership or fiduciary role for ESMO Educational Publication Working Group; and has stock or stock options with Supportive Care UK and LOC at the Christie Private Care. Dr. Cortinovis received grants for honoraria, speakers bureaus, or scientific advisor from Amgen, AstraZeneca, Beigene, Boehringer Ingelheim, Bristol Meyers Squibb, GlaxoSmithKline, Johnson & Johnson, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Seagen, and Takeda. Dr. Liu declares paid participation for speakers bureaus from AstraZeneca, Pfizer, and Janssen; and research funding from AstraZeneca, Bayer, Takeda, Pfizer, EMD Serono, Nuvation Bio, and Bristol Myers Squibb. Dr. Cappuzzo received fees for membership on an advisory board or lectures from Amgen, AstraZeneca, Bayer, Beigene, Bristol Myers Squibb, Galecto, Illumina, Lilly, Mirati, Novocure, Ose Immunotherapeutics, Merck Sharp & Dohme, Roche, PharmaMar, Pfizer, Sanofi, Takeda, and Thermo Fisher. Dr. Palmero Sánchez received consulting fees (to self) from AstraZeneca; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Guardant Health and Pfizer; support for attending meetings and/or travel from Merck Sharp & Dohme; and participation on a data safety monitoring board or advisory board with AstraZeneca. Dr. Perez Mak received honoraria from Bristol Myers Squibb, Eli Lilly, Johnson & Johnson/Janssen, Merck KGaA, Sanofi, and United Medical. Dr. Popat received consulting fees for advisory boards (to self) from Amgen, AnHeart Therapeutics, Arcus Biosciences, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Ellipses, Erasca, Gilead, GlaxoSmithKline, Guardant Health, IO Biotech, Janssen, Lilly, Merck KGaA, Mirati, Merck Sharp & Dohme, Novocure, Novartis, Pfizer, PharmaMar, Pierre Fabre, Regeneron, Roche, Sanofi, Takeda, and Turning Point Therapeutics and declares an unpaid leadership or fiduciary role for British Thoracic Oncology Group, ALK Positive UK, Lung Cancer Europe, Ruth Strauss Foundation, and ETOP-IBCSG Partners Foundation Board; received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Amgen, AstraZeneca, Bayer, Gilead, Guardant Health, Janssen, Merck KGaA, Novocure, PharmaMar, Pfizer, Roche, and Takeda; and received travel expense reimbursement from Gilead. Drs. Hu, Morris, and Graupner are employees of F. Hoffmann-La Roche and own Roche shares. Drs. Srivastava and Gitlitz are employees of Genentech and own Roche shares. Dr. Kaul is an employee of F. Hoffmann-La Roche. Dr. Lee declares support from Roche for attending meetings and traveling to present the first-line atezolizumab versus single-agent chemotherapy in patients with NSCLC ineligible for treatment with a platinum-containing regimen (IPSOS) trial at the European Society of Medical Oncology 2022 meeting, and membership for the UK commission on Human Medicines and the Oncology and Haematology Expert Advisory Group. The remaining authors declare no conflict of interest.

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