KEY TAKEAWAYS
- CANOPY 1 phase 3 (NCT03631199) trial sought to look into the effectiveness of Canakinumab + 1L pembrolizumab+Chemo for patients with aNSCLC.
- The study aimed to evaluate the efficacy and safety of adding canakinumab to pembrolizumab and platinum-based doublet chemotherapy in aNSCLC patients.
- Researchers used a randomized, double-blind trial, with patients assigned to receive either canakinumab or a placebo.
- The study’s outcome shows that PFS and OS have improved but were still dismal and varied by PD-L1 status. AEs of any grade occurred in 22.5% and 18.9% of canakinumab and placebo arms, respectively.
Pembrolizumab is known for the improvement of overall survival (OS) when added to the platinum-based doublet chemotherapy (PDC) in patients with advanced non-small cell lung cancer (aNSCLC). However, although PFS and OS have improved, they are still dismal for most patients and can differ according to PD-L1 status. This emphasizes the requirement for supplementary treatment choices. Canakinumab is a monoclonal anti-interleukin-1 antibody that has the potential to synergize with programmed death one inhibitor and chemotherapy by reducing pro-tumor inflammation and increasing anti-tumor immune responses.
Canakinumab (CAK) or a placebo (PBO) was added to 1L of pembrolizumab and pembrolizumab-containing (PD-1) cells in the randomized, double-blind CANOPY-1 study. Canakinumab 200 mg or PBO every three weeks, plus pembrolizumab and histology-guided PDC for four cycles, followed by maintenance canakinumab or PBO, with pembrolizumab pemetrexed, was administered to patients with previously untreated stage IIIB/C or IV NSCLC of any histology and no known EGFR or ALK alterations. The primary objectives were investigator-assessed progression-free survival (PFS) and OS. Moreover, preliminary biomarker studies were conducted and will be presented at the congress. These evaluations ended on May 18, 2020 (PFS) and August 9, 2021.
Canakinumab (n=320) or placebo (n=323) was added to the standard treatment of pembrolizumab + PDC for 643 individuals. There was a good balance of baseline characteristics between the therapy groups. Both therapy groups had similar median PFS of 6.8 months (HR 0.85, 95% CI, 0.67-1.09; one-sided P=0.102). In the canakinumab group, the median OS was 20.8 months, while in the PBO group, it was 20.2 months (HR 0.87, 95% CI, 0.70-1.10; one-sided P=0.123). There were 205 patients in the canakinumab arm (64.1%) and 191 patients in the PBO arm (59.3%) who reported experiencing adverse events (AEs) of grade 3/4, and 37 patients in the canakinumab arm (11.6%) and 47 patients in the PBO arm (14.6%) who reported experiencing fatal AEs. Seventy-two patients in the canakinumab arm (22.5%) and 61 patients in the PBO arm (18.9%) reported AEs (any grade), resulting in the withdrawal of any study treatment.
For 1L therapy of aNSCLC, adding canakinumab to pembrolizumab with PDC did not significantly enhance PFS or OS. Canakinumab was added to pembrolizumab with PDC, and there were no unanticipated safety concerns.
Source: https://www.abstractsonline.com/pp8/#!/10517/presentation/20382
Clinical trial: https://clinicaltrials.gov/ct2/show/NCT03631199
Tan, D, Felip, E., Castro, G., Solomon, B. J., Greystoke, A., Cho, B., Cobo, M., Kim, T. M., Ganguly, S., Carcereny, E., Paz-Ares, L., Bennouna, J., Garassino, M., Schenker, M., Kim, S.-W., Mookerje, B., Passos, V. Q., Deudon, S., Dharan, B., Song, Y, Caparica, R, & Johnson B. (2022). Abstract CT037: 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. Cancer Research, 82(12_Supplement), CT037–CT037. https://doi.org/10.1158/1538-7445.am2022-ct037
