Novartis won’t can canakinumab

Novartis is keeping the faith in canakinumab in oncology, despite the project’s latest failure, this time in first-line non-small cell lung cancer. The phase 3 Canopy-1 trial, which combined cana with Keytruda and chemo, did not show a benefit on its co-primary endpoints of PFS and OS, but Novartis said it saw promising signs in patients with baseline inflammatory biomarkers including high-sensitivity C-reactive protein. Any remaining hopes for the anti-IL-1 beta antibody now rest in adjuvant and neoadjuvant settings. Novartis is clinging to the fact that patients in the adjuvant Canopy-A study are apparently similar to those in Cantos, the cardiovascular study that kicked off the group’s efforts in cancer. But cana’s chances in cancer now look even slimmer than in March, when the second-line Canopy-2 trial failed. The news could also be bad for Cantargia, which is testing its rival IL-1 blocker nidanilimab in various cancers. Interim NSCLC data presented at Esmo, from the Canfour trial, were hard to interpret, concerning just 27 patients with both first and second-line disease, and including those who had received Keytruda first line – a particularly hard setting to judge given the lack of data in post-PD(L)1 patients.   

Anti-IL-1 projects in development for cancer
Project Company Description Indication(s)  Trial details & readouts
Phase 3
Canakinumab Novartis Anti-IL-1 beta MAb (competitive inhibitor) NSCLC  Canopy-2, 2L, failed Mar 2021;
Canopy-1, 1L + Keytruda + chemo, failed Oct 2021;
Canopy-A, adjuvant, data due 2023;
ph2 Canopy-N, neoadjuvant +/- Keytruda, ends Nov 2022
Phase 1/2
Can04 (nidanilimab) Cantargia Anti-IL1RAP MAb Solid tumours incl pancreatic cancer & NSCLC Canfour in NCSLC & PDAC, interim data at Esmo 2021;
Cestafour in NSCLC, BTC, CRC, started Oct 2021;
Cirifour, + Keytruda in solid tumours, ends Jan 2022;
Capafour, + FOLFIRINOX in 1L PDAC, ends Jun 2023
Phase 1
VPM087 (gevokizumab) Novartis Anti-IL-1 beta MAb (allosteric inhibitor) Colorectal, renal & gastro-oesophageal cancers 1L (NCT03798626)
BTC=biliary tract cancer; CRC=colorectal cancer; NSCLC=non-small cell lung cancer; PDAC=pancreatic ductal adenocarcinoma. Source: Evaluate Pharma &

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