Ongoing Phase IIIb/IV Trial Shows Consistent Safety Data with Nivolumab in NSCLC

Ongoing Phase IIIb/IV Trial Shows Consistent Safety Data with Nivolumab in NSCLC
Ongoing Phase IIIb/IV Trial Shows Consistent Safety Data with Nivolumab in NSCLC

CHICAGO–Safety and tolerability are consistent with prior nivolumab experience and no new safety signals have been identified in pretreated patients with advanced non-small cell lung cancer (NSCLC), an ongoing phase IIIb/IV trial presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL, has shown.

For the phase IIIb/IV trial, 824 patients with advanced or metastatic NSCLC who progressed after receiving 1 or more prior systemic regimens were treated with nivolumab 3 mg/kg intravenously over 60 minutes every 2 weeks until disease progression/unacceptable toxicity (Cohort A) or for 1 year with the possibility of retreatment upon disease progression (Cohort B).

Results showed that across all patients, 93% experienced adverse events; 38% had grade 3 or 4 events.

Patients with an ECOG performance status of 2 experienced a higher rate of serious adverse events compared with those with a performance status of 0 or 1; however, there was a similar incidence of treatment-related adverse events or serious adverse events between the two groups and no patients with a performance status of 2 experienced grade 5 treatment-related adverse events or serious adverse events.

“I think it played it out like we hoped it would. There was no unexpected toxicity in the older or worse performing patients,” said Todd M. Bauer, MD, principal investigator and associate director of development at Sarah Cannon Research Institute in Nashville, TN, in an interview with Cancer Therapy Advisor.

In regard to efficacy, 12% and 44% of patients experienced a partial response and stable disease, respectively, at 9 weeks. No patients experienced a complete response.

Researchers also found that immune-related toxicities are manageable in a community practice setting using previously developed safety algorithms.

The early findings suggest that “patients with pretreated advanced or metastatic NSCLC benefit from nivolumab therapy,” Bauer concluded. Patients appear to benefit regardless of histology type, performance status, EGFR/ALK mutation status, number of prior therapies, and smoking status.

Reference

1. Bauer TM, McCleod M, Chandler JC, et al. An ongoing phase IIIb/IV safety trial of nivolumab (NIVO) in patients (pts) with advanced or metastatic non-small-cell lung cancer (NSCLC) who progressed after receiving 1 or more prior systemic regimens. J Clin Oncol. 2015;33:(suppl; abstr 3013).

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