
Astra keeps pushing on with rilvegostomig

Despite various TIGIT blow-ups, AstraZeneca continues to believe in its anti-TIGIT x PD-1 MAb rilvegostomig, with yet another phase 3 trial about to begin, according to a recent listing on clinicaltrials.gov. Like the ongoing Artemide-Lung02 and 03 trials, the new Artemide-Lung04 will be in first-line NSCLC; unlike these studies it will recruit across squamous and non-squamous disease. The earlier trials are also evaluating chemo combos in patients with PD-L1 expression at 1% or higher, while Artemide-Lung04 will test monotherapy in PD-L1-high patients – expression levels aren’t specified, but are presumably ≥50%. A benchmark here comes from the phase 1/2 Artemide-01 trial, which at last year’s World Lung meeting showed a 62% ORR (including unconfirmed responses) with a 750mg rilvegostomig dose in checkpoint inhibitor-naive PD-L1 ≥50% expressers. Astra appears to be covering all the bases in first-line NSCLC, but the omens aren’t good: Merck recently scrapped its TIGIT contender vibostolimab after it flunked the first-line Keyvibe-003 and Keyvibe-007 lung cancer trials; this news followed the final flop for Roche’s Skyscraper-01 trial of tiragolumab. Astra must believe that rilvegostomig is different, but the onus is on the company to prove this.
Phase 3 trials of rilvegostomig
Trial | Setting | Regimen | Primary endpoint(s) | Timing |
---|---|---|---|---|
Artemide-Biliary01 | Adjuvant biliary tract cancer | Rilvegostomig + chemo, vs chemo | Recurrence-free survival | Started Dec 2023; primary completion Jun 2029 |
Tropion-Lung10 | 1st-line non-squam NSCLC (PD-L1 ≥50%) | Rilvegostomig +/- Datroway, vs Keytruda | PFS, OS in TROP2+ve pts | Started Apr 2024; primary completion Apr 2028 |
Destiny-BTC01 | 1st-line HER2+ve biliary tract cancer | Enhertu +/- rilvegostomig, vs chemo | OS | Started Aug 2024; primary completion Jun 2028 |
Tropion-Lung12 | Adjuvant ctDNA+ve stage I adenocarcinoma NSCLC | Rilvegostomig +/- Datroway, vs chemo | DFS | Started Oct 2024; primary completion May 2033 |
Artemide-Lung02 | 1st-line squam mNSCLC (PD-L1 ≥1%) | Rilvegostomig + chemo, vs Keytruda + chemo | PFS, OS | Started Nov 2024; primary completion Feb 2029 |
Artemide-Lung03 | 1st-line non-squam NSCLC (PD-L1 ≥1%) | Rilvegostomig + chemo, vs Keytruda + chemo | PFS, OS | Started Nov 2024; primary completion May 2029 |
Artemide-Gastric01 | 1st-line HER2+ gastric cancer (PD-L1 ≥1%) | Rilvegostomig + Enhertu + chemo, vs Keytruda + Herceptin + chemo | PFS, OS | To start Mar 2025; primary completion Apr 2029 |
Artemide-Lung04 | 1st-line mNSCLC (PD-L1-high) | Rilvegostomig, vs Keytruda | PFS, OS | To start Apr 2025; primary completion Jan 2030 |
Source: OncologyPipeline & clinicaltrials.gov.
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