Enhertu’s additional approval this morning for Her2-positive gastric cancer coincided with the Asco-GI conference, which featured a front-line gastric cancer study of Five Prime’s bemarituzumab as a late-breaker. The green light, the first for a Her2-directed therapy for this cancer since Herceptin, will also remind investors what the Astra/Daiichi drug has to do to meet expectations: EvaluatePharma consensus forecasts see 2026 sales of $4.1bn, mostly in breast cancer. Meanwhile, much of Five Prime’s data was a retread of that toplined last November, and with continuing doubts about bemarituzumab’s relevance beyond FGFR2b-overexpressing cancers the stock fell 11%. Also off on Asco-GI data was Cardiff Oncology, down 31% after reminding the markets that, with four more Kras-mutant colorectal cancer subjects treated, the overall response rate to onvansertib was still around 40%. Bridgebio Pharma’s infigratinib showed a 23% ORR in FGFR2-positive cholangiocarcinoma, underperforming the 36% on the approved label of Incyte’s similarly acting Pemazyre. Perhaps the most intriguing dataset came from Arcus’s AB680 in front-line pancreatic cancer: 41% ORR in 17 subjects could give the company a focus beyond Tigit inhibition. Still, the study also included chemo and an anti-PD-1, so AB680’s effect is hard to tease out.
|Selected data presented at the 2021 Asco-GI meeting|
|Bemarituzumab||Five Prime||Anti-FGFR2b||Fight study: a 1L gastric/GEJ (chemo combo)||In FGFR2b ≥10% expressers (n=96) mPFS 14.1 vs 7.3 mth, mOS NR vs 11.1 mth|
|Infigratinib||Bridgebio Pharma||Anti-FGFR1-3||2L FGFR2+ve cholangio||1 CR & 24 PRs in 108 evaluable pts, mPFS 7.3mth, mOS 12.2mth|
|Tibsovo||Agios||Anti-IDH1||Final Claridhy study data: 2L IDH1-mut cholangio||HR 0.37 for PFS, and 0.49 for OS, both highly stat sig|
|AB680 + AB122||Arcus||Anti-CD79 + anti-PD-1||Arc-8 study: 1L pancreatic adenocarcinoma||7/17 PRs|
|Onvansertib||Cardiff Oncology||Anti-PLK1||2L Kras-mut colorectal (Avastin + chemo combo)||5/12 PRs|
|CYAD-101||Celyad||Allo (TIM-expressing) Car-T vs NKG2D ligands||Alloshrink study: metastatic colorectal||2/15 PRs, including 1 Kras-mutant|