# DOMAJOR: prolgolimab with chemotherapy first line in advanced non-squamous lung cancer

Source: https://onco.cc/key-papers/paper-laktionov-prolgolimab-domajor-ejc-2025/  
OnCo record `paper-laktionov-prolgolimab-domajor-ejc-2025` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A 292-patient randomised phase 3 in Russia, China, Hungary and Slovakia in which adding the Russian PD-1 antibody prolgolimab to pemetrexed and platinum roughly halved the risk of death, with the benefit holding in PD-L1-negative tumours.

## Summary

292 patients with advanced non-squamous non-small-cell lung cancer were randomised one to one to four cycles of pemetrexed and a platinum drug with either prolgolimab 3 mg/kg every three weeks or placebo, followed by prolgolimab or placebo with pemetrexed until progression or toxicity for up to 36 months. The primary endpoint was overall survival.

After a median follow-up of 18 months, median overall survival was not reached in the prolgolimab arm against 14.6 months with placebo (hazard ratio 0.51, 95 per cent confidence interval 0.35 to 0.73, p 0.0001), and the improvement was independent of PD-L1 status. Median progression-free survival by RECIST 1.1 was 7.7 against 5.5 months (hazard ratio 0.65, 95 per cent confidence interval 0.49 to 0.85, p 0.0004). The only adverse events reported in at least 10 per cent of patients and significantly more common with prolgolimab were raised blood creatinine and breathlessness. The trial is registered as NCT03912389.

## Fields

- Kind: Key paper
- Last checked: 2026-09-25
- Journal: European Journal of Cancer
- Year: 2025
- DOI: 10.1016/j.ejca.2025.115255
- Authors: Laktionov K, Smolin A, Stroyakovskiy D, et al.
- Findings: Median overall survival not reached with prolgolimab plus chemotherapy against 14.6 months with chemotherapy alone (hazard ratio 0.51, 95% CI 0.35 to 0.73, p 0.0001).; Median progression-free survival 7.7 against 5.5 months (hazard ratio 0.65, 95% CI 0.49 to 0.85, p 0.0004).; The survival benefit was retained in PD-L1-negative tumours.; Raised blood creatinine and breathlessness were the only adverse events in at least 10 per cent of patients that were significantly more common with prolgolimab.
- What it means: A domestically developed checkpoint antibody has now produced a positive phase 3 overall-survival result in lung cancer, which is the strongest evidence yet that Russian oncology can supply its own immunotherapy rather than import it. The trial ran in Russia with sites in China, Hungary and Slovakia and has not been reviewed by the European Medicines Agency or the United States Food and Drug Administration.
- Caveats: Placebo-controlled against chemotherapy alone, which was no longer the first-line standard in countries where pembrolizumab combinations were available when the trial ran.; Sponsored by the manufacturer; no head-to-head comparison with an established PD-1 antibody.

## Sources

- Eur J Cancer 2025: https://doi.org/10.1016/j.ejca.2025.115255
- PubMed: https://pubmed.ncbi.nlm.nih.gov/39879779/
- ClinicalTrials.gov NCT03912389: https://clinicaltrials.gov/study/NCT03912389

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- drugs: [BCD-100](https://onco.cc/drugs/bcd-100/)
- companies: [Biocad](https://onco.cc/companies/biocad/)
- journals: [European Journal of Cancer](https://onco.cc/journals/european-journal-of-cancer/)

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