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Clinical Trial
. 2025 Feb 25:217:115255.
doi: 10.1016/j.ejca.2025.115255. Epub 2025 Jan 21.

Prolgolimab with chemotherapy as first-line treatment for advanced non-squamous non-small-cell lung cancer

K Laktionov  1 , A Smolin  2 , D Stroyakovskiy  3 , V Moiseenko  4 , M Dvorkin  5 , T Andabekov  6 , Y Cheng  7 , B Liu  8 , V Kozlov  9 , S Odintsova  10 , S Dvoretsky  11 , A Mochalova  12 , M Urda  13 , T Yi  14 , X Li  15 , U László  16 , V Müller  17 , K Bogos  18 , N Fadeeva  19 , G Musaev  20 , Q Liu  21 , D Kirtbaya  22 , J Shi  23 , O Gladkov  24 , M Narimanov  25 , T Semiglazova  26 , A Khasanova  27 , J Chovanec  28 , I Andrašina  29 , A Szabová  30 , O Rosinská  31 , D Sudekova  32 , P-S Zsolt  33 , F Ran  34 , M Sun  35 , O Jiang  36 , R Chen  37 , E Zhao  38 , C Liu  39 , W Tan  40 , A Pirmagomedov  41 , E Poddubskaya  42 , N Kislov  43 , I Shumskaya  44 , I Sorokina  45 , A Zinkina-Orikhan  46 , Yu Linkova  46 , S Fogt  46 , D Liaptseva  46 , A Siliutina  46 , O Basova  46 , F Kryukov  46
Affiliations
Clinical Trial

Prolgolimab with chemotherapy as first-line treatment for advanced non-squamous non-small-cell lung cancer

K Laktionov et al. Eur J Cancer. .

Abstract

Background: Prolgolimab is an IgG1 anti-PD-1 monoclonal antibody with the Fc-silencing 'LALA' mutation. The phase III DOMAJOR study assessed efficacy and safety of prolgolimab in combination with pemetrexed and platinum-based chemotherapy vs placebo in combination with pemetrexed and platinum-based chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC).

Methods: 292 patients with advanced non-squamous NSCLC were randomized 1:1 to receive 4 cycles of pemetrexed, platinum-based drug and either prolgolimab (3 mg/kg Q3W) or placebo followed by prolgolimab/placebo with pemetrexed until disease progression or toxicity (≤36 months). The primary endpoint was overall survival (OS).

Results: After a median follow-up of 18 months, the median OS was not reached (95 % CI, 22.28 - NA) in the prolgolimab-combination group vs 14.6 months (95 % CI, 11.73 - 19.15) in the placebo-combination group (HR, 0.51; 95 % CI, 0.35 - 0.73, p = 0.0001). The OS improvement was independent of PD-L1 status. Median progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was 7.7 months in the prolgolimab-combination group and 5.5 months in the placebo-combination group (HR, 0.65; 95 % CI, 0.49 - 0.85, p = 0.0004). The only adverse events that were reported in at least 10 % of the patients that were significantly more frequent in the prolgolimab-combination group were blood creatinine increased and dyspnoea.

Conclusion: Among patients with advanced NSCLC the addition of prolgolimab to pemetrexed and a platinum-based drug increased OS and PFS, with no new safety concerns. This benefit was retained in patients with PD-L1 negative tumors. (ClinicalTrials.gov, NCT03912389).

Keywords: Anti-PD-1; Non-small cell lung cancer; PD-L1 expression; Prolgolimab.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The authors declare a potential conflict of interest and state it below. The study was funded by JSC BIOCAD. LK, DL,AS, DS, VM, MD, TA, YC, BL, VK, SO, SD, AM, M U, TY, XL, UL, VM, KB, NF, GM, QL, DK, JS, OG, MN, TS, AK, JC, IA, AS, OR, DS, PSZ, FR, MS, OJ, RC, EZ, CL, WT, AP, EP, NK, ISH and KL report clinical trial investigator's fee (BCD-100–3/DOMAJOR). LK, DL report honoraria from BIOCAD for participation as a speaker at scientific and educational meetings. AZO, YL, SF, DL, IS, AS, OB, FK are BIOCAD employees.

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