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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

TrialSettingRegimenPrimary endpoint(s)Timing
Artemide-Biliary01Adjuvant biliary tract cancerRilvegostomig + chemo, vs chemoRecurrence-free survivalStarted Dec 2023; primary completion Jun 2029
Tropion-Lung101st-line non-squam NSCLC (PD-L1 ≥50%)Rilvegostomig +/- Datroway, vs KeytrudaPFS, OS in TROP2+ve ptsStarted Apr 2024; primary completion Apr 2028
Destiny-BTC011st-line HER2+ve biliary tract cancerEnhertu +/- rilvegostomig, vs chemoOSStarted Aug 2024; primary completion Jun 2028
Tropion-Lung12Adjuvant ctDNA+ve stage I adenocarcinoma NSCLCRilvegostomig +/- Datroway, vs chemoDFSStarted Oct 2024; primary completion May 2033
Artemide-Lung021st-line squam mNSCLC (PD-L1 ≥1%)Rilvegostomig + chemo, vs Keytruda + chemoPFS, OSStarted Nov 2024; primary completion Feb 2029
Artemide-Lung031st-line non-squam NSCLC (PD-L1 ≥1%)Rilvegostomig + chemo, vs Keytruda + chemoPFS, OSStarted Nov 2024; primary completion May 2029
Artemide-Gastric011st-line HER2+ gastric cancer (PD-L1 ≥1%)Rilvegostomig + Enhertu + chemo, vs Keytruda + Herceptin + chemoPFS, OSTo start Mar 2025; primary completion Apr 2029
Artemide-Lung041st-line mNSCLC (PD-L1-high)Rilvegostomig, vs KeytrudaPFS, OSTo start Apr 2025; primary completion Jan 2030

Source: OncologyPipeline & clinicaltrials.gov.

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