The following article features coverage from the AACR Annual Meeting 2022. Click here to read more of Cancer Therapy Advisor’s conference coverage.

Adding canakinumab to standard first-line treatment failed to improve outcomes in patients with advanced non-small cell lung cancer (NSCLC), according to results of the phase 3 CANOPY-1 trial.

The addition of canakinumab to pembrolizumab plus platinum doublet chemotherapy (PDC) did not improve response rates, progression-free survival (PFS), or overall survival (OS).

These findings were presented at the AACR Annual Meeting 2022.

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The CANOPY-1 trial ( Identifier: NCT03631199) enrolled 643 patients with previously untreated, stage IIIB/C or IV NSCLC. Patients were randomly assigned to receive canakinumab plus pembrolizumab and PDC (n=320) or placebo plus pembrolizumab and PDC (n=323). 

Baseline characteristics were similar between the treatment arms. The median age was 63 years in both arms (overall range, 56-69 years), roughly 70% of patients were men, and more than 90% had stage IV disease. 

Patients received 200 mg of canakinumab or placebo, plus pembrolizumab and histology-guided PDC, every 3 weeks for 4 cycles. This was followed by maintenance with canakinumab or placebo plus pembrolizumab, with or without pemetrexed.

The median duration of treatment exposure was 8.7 months in the canakinumab arm and 7.9 months in the placebo arm. 

The objective response rate was nearly identical in the canakinumab and placebo arms — 45.6% and 45.5%, respectively. The median duration of response was 14.3 months and 13.6 months, respectively.

At a median follow-up of 4.8 months, the median PFS was 6.8 months for both treatment arms (hazard ratio [HR], 0.85; 95% CI, 0.67-1.09; P =.1). 

At a median follow-up of 16.2 months, the median OS was 20.8 months in the canakinumab arm and 20.2 months in the placebo arm (HR, 0.87, 95% CI, 0.70-1.10; P =.123).

Canakinumab did appear to reduce the risk of patient-reported deterioration in specific lung cancer symptoms, including cough (HR, 0.59; P =.0007), chest pain (HR, 0.62; P =.002), and dyspnea (HR, 0.66; P =.0005).

Grade 3/4 treatment-related adverse events (TRAEs) occurred in 57.2% of patients in the canakinumab arm and 51.9% of patients in the placebo arm. Fatal TRAEs occurred in 3.8% and 5.0%, respectively.

Disclosures: This research was supported by Novartis Pharmaceuticals Corporation. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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Tan DSW, Felip E, Castro Jr G, et al. Canakinumab in combination with first-line (1L) pembrolizumab plus chemotherapy for advanced non‑small cell lung cancer (aNSCLC): Results from the CANOPY-1 phase 3 trial. Presented at AACR 2022; April 8-13, 2022. Abstract CT037.