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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.
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.
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.
Shares BCD-100, Biocad, European Journal of Cancer.