(Solid Tumors) Is Opdivo Effective?
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On November 25, 2019, Nilofer S. Azad published in the Journal of Clinical Oncology the "Efficacy and Safety Results of Single-Agent Opdivo (nivolumab) Anti-PD-1 Antibody Therapy in Patients with dMMR Solid Tumors Other Than Colorectal Cancer in the NCI-MATCH (EAY131) Phase II Clinical Trial."
In this Phase II clinical trial, patients with dMMR solid tumors other than colorectal cancer received single-agent Opdivo therapy (3mg/kg every 2 weeks for 4 cycles, then 480mg every 4 weeks). The primary endpoint was objective response rate.
This trial was initiated because clinical data on single-agent Opdivo therapy in patients with dMMR solid tumors other than colorectal cancer was limited, and the trial aimed to confirm its utility.
Background of enrolled patients (N=42):
Solid tumor types:
- Endometrial cancer: 13 patients
- Prostate cancer: 5 patients
- Uterine sarcoma: 4 patients
- Esophageal/gastroesophageal junction: 3 patients
- Cholangiocarcinoma: 3 patients
- Ductal carcinoma: 3 patients
- Pancreatic neuroendocrine tumor: 1 patient
Sex: Male 67%, Female 33%
Median age: 60 years (range 44-85)
Race: White 83%, Black 10%, Asian 5%, Hispanic 5%
Prior treatment history: 1 prior treatment 24%, 2 prior treatments 19%, 3 prior treatments 10%, 4 or more prior treatments 45%
The trial results were as follows: the primary endpoint objective response rate was 36%, with complete response at 7% (N=3) and partial response at 29% (N=13), and stable disease at 21% (N=9).
The 6-month, 12-month, and 18-month progression-free survival rates were 51.3%, 46.2%, and 31.4%, respectively. The median overall survival was 17.3 months.
Regarding safety, the most commonly observed grade 1-3 adverse events were fatigue (40%), anemia (33%), skin disorders (17%), and hypoproteinemia (17%). No grade 5 adverse events were observed.
Based on the NCI-MATCH (EAY131) trial results, Nilofer S. Azad concluded: "Single-agent Opdivo anti-PD-1 antibody therapy showed significant antitumor effects in patients with dMMR solid tumors other than colorectal cancer, without serious adverse events."
Source: Nivolumab Is Effective in Mismatch Repair–Deficient Noncolorectal Cancers: Results From Arm Z1D—A Subprotocol of the NCI-MATCH (EAY131) Study (J Clin Oncol. 2019 Nov 25:JCO1900818. doi: 10.1200/JCO.19.00818.)
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