Induction chemo-immunotherapy followed by chemo-radiotherapy and immunotherapy maintenance in stage III NSCLC (APOLO): a phase 2 trial

Unresectable stage III NSCLC standard treatment is chemo-radiotherapy (CT-RT) followed by immunotherapy (IO) with durvalumab. We investigated adding an induction phase with chemo-immunotherapy (ChIO). APOLO was a multicentre, single-arm, phase 2 trial (NCT04776447). Non-resectable stage IIIA-IIIC NSCLC patients received induction ChIO (atezolizumab + carboplatin + paclitaxel, for 3 cycles), followed by concurrent CT-RT (3 cycles), and IO maintenance (atezolizumab for 16 cycles). Primary objective was 12-month progression-free survival (PFS). Secondary endpoints included 12- and 24-month overall survival (OS), ORR, first-site failure pattern, and safety. Exploratory endpoints included PD-L1, TMB, and ctDNA. 38 patients were enrolled. Median follow-up was 29.6 months (data cutoff, February 2024). PFS was 68.4% (95% CI, 51.1-80.7) at 12 months (statistically significant compared to null hypothesis of 55%) and 50.0% at 24 months; OS was 86.8% and 60.5%, respectively. After induction, 18 (47.4%) had partial response, 14 (36.8%) stable disease, and 5 (13.2%) progressive disease. Overall, 18 patients had disease progression: 8 local (44.4%) and 10 distant (55.6%). Grade ≥3 TRAEs occurred in 11 (28.9%) during induction, 10 (26.3%) during CT-RT, and 2 (5.3%) during maintenance. ChIO induction before CT-RT and IO maintenance showed activity and safety, warranting confirmation in larger studies.

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Nature Communications
Published
2025-12-23
DOI
https://doi.org/10.1038/s41467-025-66097-w
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1
Primary Topic
Cancer Immunotherapy and Biomarkers
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article
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article

Induction chemo-immunotherapy followed by chemo-radiotherapy and immunotherapy maintenance in stage III NSCLC (APOLO): a phase 2 trial

E. Sánchez Saugar, Laura Torrado, Virginia Calvo, Julia Giner et al.
1 citations
Nature Communications
Cancer Immunotherapy and Biomarkers
1.05
article

Induction chemo-immunotherapy followed by chemo-radiotherapy and immunotherapy maintenance in stage III NSCLC (APOLO): a phase 2 trial

E. Sánchez Saugar, Laura Torrado, Virginia Calvo, Julia Giner, A. Blasco, Rafael Castro López, Asia Ferrández, Cristina Martínez-Toledo, M. Guirado, Pilar Mediavilla, Raquel Marsé, B. Campos, Laura Vila, Mariano Provencio, Ana López Martín, Manuel Fernández Bruno, Rosario García Campelo, Sergio Vázquez Estévez, Kirill Matskov, María Carmen Areses, Amelia Insa, Miriam Dorta, Delvys Rodriguez-Abreu, Joaquim Bosch-Barrera, Ana Laura Ortega, Ivana Sullivan, Atocha Romero, Alberto Cruz-Bermúdez, M. Ángeles Sala
article en
1 citations

Abstract

Unresectable stage III NSCLC standard treatment is chemo-radiotherapy (CT-RT) followed by immunotherapy (IO) with durvalumab. We investigated adding an induction phase with chemo-immunotherapy (ChIO). APOLO was a multicentre, single-arm, phase 2 trial (NCT04776447). Non-resectable stage IIIA-IIIC NSCLC patients received induction ChIO (atezolizumab + carboplatin + paclitaxel, for 3 cycles), followed by concurrent CT-RT (3 cycles), and IO maintenance (atezolizumab for 16 cycles). Primary objective was 12-month progression-free survival (PFS). Secondary endpoints included 12- and 24-month overall survival (OS), ORR, first-site failure pattern, and safety. Exploratory endpoints included PD-L1, TMB, and ctDNA. 38 patients were enrolled. Median follow-up was 29.6 months (data cutoff, February 2024). PFS was 68.4% (95% CI, 51.1-80.7) at 12 months (statistically significant compared to null hypothesis of 55%) and 50.0% at 24 months; OS was 86.8% and 60.5%, respectively. After induction, 18 (47.4%) had partial response, 14 (36.8%) stable disease, and 5 (13.2%) progressive disease. Overall, 18 patients had disease progression: 8 local (44.4%) and 10 distant (55.6%). Grade ≥3 TRAEs occurred in 11 (28.9%) during induction, 10 (26.3%) during CT-RT, and 2 (5.3%) during maintenance. ChIO induction before CT-RT and IO maintenance showed activity and safety, warranting confirmation in larger studies.

Nature CommunicationsVol. 16(1)
Hospital Universitario Insular de Gran Canaria (ES), Hospital de Sant Pau (ES), Hospital de Basurto (ES), Hospital Clínico Universitario de Valencia (ES), Hospital Universitario Puerta de Hierro Majadahonda (ES), Institut Català d'Oncologia (ES), Institut d'Investigació Biomèdica de Girona (ES), Corporació Sanitària Parc Taulí (ES), Hospital General Universitario de Elche (ES), Complejo Hospitalario de Jaén (ES), Hospital General Universitario De Valencia (ES), Hospital Universitario HM Sanchinarro (ES), Complexo Hospitalario Universitario A Coruña (ES), Hospital Universitario Lucus Augusti (ES), Hospital Universitario Son Espases (ES), Hospital Clínico Universitario de Valladolid (ES), Hospital Universitario Severo Ochoa (ES), Complejo Hospitalario de Ourense (ES)
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