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Background: This first-in-human phase 1 trial is to evaluate the safety, pharmacokinetics, preliminary efficacy, and biomarkers of sugemalimab, a full-length, fully human anti-PD-L1 monoclonal antibody, in Chinese patients with advanced malignancies. Methods: Eligible patients with unresectable advanced or metastatic solid tumors or lymphomas were enrolled in phase 1a to receive sugemalimab following a modified 3 + 3 design. The primary endpoints included safety, tolerability, and the recommended Phase 2 dose (RP2D). In phase 1b, patients with 7 selected types of tumor received sugemalimab at the RP2D alone (monotherapy cohorts) or in combination with standard-of-care (SOC) chemotherapy (combination cohorts). The primary endpoint of phase 1b was investigator-assessed objective response rate (ORR). Results: As of 19 February 2020, 29 and 178 patients were treated in phase 1a and 1b, respectively. No dose-limiting toxicities were observed in phase 1a, and the RP2D of sugemalimab was determined as 1200 mg fixed dose once every 3 weeks. Sugemalimab-related adverse events (AEs) were mostly (75.9%) grade 1–2 in phase 1a. Antitumor activity was observed across dose levels with an ORR of 24.1%. In phase 1b, 15.9% and 40.4% of patients in the monotherapy and combination cohorts, respectively, reported grade 3–5 sugemalimab-related AEs. Promising efficacy was observed in all combination cohorts, with ORRs ranging from 47.6 to 75.0%. Exploratory biomarker analysis did not indicate significant differences in responses at different PD-L1 expression/tumor mutation burden levels. Conclusions: Sugemalimab was well-tolerated and showed promising antitumor activity as monotherapy or in combination with SOC chemotherapy in advanced malignancies. This trial was registered with ClinicalTrials.gov on Oct 18, 2017, number NCT03312842. [ABSTRACT FROM AUTHOR]

To investigate the efficacy and safety of combined therapy with adrenergic beta-antagonist and lasers in infantile hemangiomas (IH). A search of Pubmed, Cochrane, Embase, Wanfang Date, CNKI (China National Knowledge Infrastructure) and CBM (China Biology Medicine) databases was conducted to identify studies that examined response to combined therapy with adrenergic beta-antagonist and laser in IH patients. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) in random-effects or fixed-effects models were calculated with Review Manger 5.3. Efficacy of combined therapy with oral propranolol and lasers was significantly better than that of propranolol (OR 5.79, 95% CI 2.52–13.31, P < 0.00001) or lasers (OR 5.09, 95% CI 3.04–8.54, P < 0.00001) alone. Combined therapy with topical timolol and lasers was more effective than topical timolol (OR 3.71, 95% CI 2.46–5.59, P < 0.00001) or lasers (OR 10.92, 95% CI 1.90–62.70, P = 0.007) alone. We did not observe statistically significant differences of adverse reactions between combined therapy with oral propranolol and lasers and propranolol (OR 1.09, 95% CI 0.64–1.84, P = 0.75) or lasers (OR 0.83, 95% CI 0.28–2.50, P = 0.74). The incidence of adverse reactions in combined therapy with topical timolol and lasers and monotherapy with topical timolol therapy (OR 0.50, 95% CI 0.14–1.80, P = 0.75) or lasers (OR 0.29, 95% CI 0.06–1.55, P = 0.15) has no significant difference. The average treatment duration of combined therapy may be shorter than that of monotherapy. Combination therapy of adrenergic beta-antagonist and lasers on IH is significantly more effective than monotherapy, while the safety of combination therapy was not significantly higher than that of monotherapy. [ABSTRACT FROM AUTHOR]