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Prolgolimab with chemotherapy as first-line treatment for advanced non-squamous non-small-cell lung cancer
K Laktionov1, A Smolin2, D Stroyakovskiy3
1FSBI "N.N. Blokhin National Medical Research Center of Oncology" of the Russian Ministry of Health, Moscow, Russia.
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).
Insights
The addition of prolgolimab to standard chemotherapy significantly improved overall survival and progression-free survival in advanced non-small cell lung cancer patients. This combination therapy demonstrated a favorable safety profile, including in PD-L1 negative cases.
Area of Science:
- Immunotherapy
- Oncology
- Clinical Trials
Background:
- Prolgolimab is an IgG1 anti-PD-1 monoclonal antibody with an Fc-silencing mutation.
- The DOMAJOR study investigated prolgolimab in first-line advanced non-small cell lung cancer (NSCLC).
Purpose of the Study:
- To assess the efficacy and safety of prolgolimab combined with chemotherapy versus placebo plus chemotherapy.
- To evaluate overall survival (OS) and progression-free survival (PFS) as primary endpoints.
Main Methods:
- 292 patients with advanced non-squamous NSCLC were randomized.
- Treatment involved 4 cycles of chemotherapy with either prolgolimab (3 mg/kg Q3W) or placebo, followed by maintenance therapy.
- Patients received treatment until disease progression or toxicity, for up to 36 months.
Main Results:
- Median OS was not reached in the prolgolimab group versus 14.6 months in the placebo group (HR, 0.51; p=0.0001).
- Median PFS was 7.7 months with prolgolimab and 5.5 months with placebo (HR, 0.65; p=0.0004).
- Increased blood creatinine and dyspnea were the most frequent adverse events, with no new safety concerns.
Conclusions:
- Adding prolgolimab to chemotherapy significantly improved OS and PFS in advanced NSCLC patients.
- The survival benefit was observed regardless of PD-L1 expression status.
- The combination therapy showed no new safety concerns.
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