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In a randomized Phase III trial, Axitinib and Pembrolizumab showed better overall survival (OS), progress-free survival (PFS) and objective response rates (ORR) than Sunitinib in patients with advanced kidney cancer.
report on the efficacy and safety of the joint program's long-term follow-up in a Phase I trial.
the trial, 52 patients with advanced kidney cancer were given oral assitinib 5 mg x 2 times a day and 2 mg/kg once every 3 weeks.
the Kaplan-Meier method to evaluate PFS, reaction duration (DOR), and OS.
total survival period as of July 23, 2019, the medium follow-up period was 42.7 months (95% CI:41.1-44.1), which did not reach the mid-OS, and 38 patients (73.1%) survived.
four-year survival rate was 66.8 per cent (95 per cent CI: 49.1-79.5).
PFS for the total population was 23.5 months (95% CI: 15.4-30.4).
orR was 73.1 per cent, with five of the patients in complete remission.
the medium lifetime was 22.1 months (95% CI: 15.1 to 34.5).
38 patients (73.1%) reported class III/IV adverse events, of which 20 (38.5%) stopped treatment due to adverse reactions: 17 (32.7%) discontinued assytinib, 13 (25.0%) discontinued Pim monotherapy, and 10 (19.2%) stopped using two drugs at the same time.
common adverse reactions were diarrhea (84.6%), fatigue (80.8%), hypertension (53.8%), cough (48.1%) and difficulty in pronunciation (48.1%).
no new adverse reactions were reported and there were no treatment-related deaths.
overall, the study showed that in patients with advanced kidney cancer who followed for about four years, a joint program of axithinib and pim monoantigen continued to show clinical benefits without new adverse reactions.