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Clin Cancer Res: AZD4635 monotherapy treatment or combination with duvalibumab for solid tumors well tolerated
▎ Clinical problems: The safety of
AZD4635 monotherapy treatment or combination with duvalibumab for solid tumors is not yet clear.
A study from Clin Cancer Res showed that AZD4635 monotherapy or combined with duvalilizumab for solid tumors is well tolerated.
▎ Research Protocol:
This study is a multi-center study with phase Ia/b, open label. In stage Ia (dose escalation phase), the subjects were patients with relapsed/refractory solid tumors; in stage Ib (dose escalation phase), the subjects were patients with metastatic castration-resistant prostate cancer (mCRPC) or colorectal cancer without checkpoint inhibitor treatment, non-small cell lung cancer previously treated with anti-PD-1/PD-L1, or other solid tumors (previously not treated with checkpoint inhibitor treatment or previously treated with anti-PD-1/PD-L1). Enrolled patients will receive AZD4635 monotherapy (75-200 mg once daily or 125 mg twice daily) or combined with duvalilizumab (AZD4635 dose is 75 or 100 mg once daily). The main objectives of this study were the safety of treatment; secondary objectives included antitumor activity and pharmacokinetics; and exploratory objectives included evaluation of adenosine gene tags in mCRPC patients.
▎ Mainly found:
(1) As of September 8, 2020, a total of 250 patients received treatment (AZD4635, n=161; AZD4635+duvalizumab, n=89).
(2)Dose-limiting toxicity (DLTs) were observed in 2 and 1 person in patients treated with single-agent (125 mg, twice daily) and combined treatment (75 mg) through nanosuspension during Phase Ia. The most common treatment-related adverse events include nausea, fatigue, vomiting, decreased appetite, dizziness and diarrhea.
(3) The recommended dose (RP2D) of the Phase II trial of AZD4635 capsule preparation is 75 mg once a day, for monotherapy or combined with duvalibumab.
(4) The pharmacokinetic characteristics of AZD4635 are proportional to the dose, and in addition, the exposure of 100 mg nanosuspension or 75 mg capsule preparations once daily is sufficient to achieve the target.
(5) Tumor response (2/39 and 6/37, respectively) and prostate-specific antigen response (3/60 and 10/45, respectively) were observed in mCRPC patients undergoing monotherapy or combination therapy. The median progression-free survival (PFS) in patients based on high and low blood adenosine gene tags were 21 weeks and 8.7 weeks, respectively.
▎ Outlook:
AZD4635 monotherapy treatment or combined with duvalilizumab is well tolerated. The result of the treatment can achieve the target response and supports the further development of phase II joint research among mCRPC patients.
References:
[1]https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-22-0612/709575/Phase-Ia-b-Open-Label-Multicenter-Study-of-AZD4635
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This article was first published: Medical World Tumor Channel
Author: Dingchao Jingyao Group
Editor: Sweet
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