AstraZeneca Launches Global Phase III ARTEMIDE-Lung03 Trial of PD-1/TIGIT Bispecific Rilvegostomig vs. Pembrolizumab in First-Line NSCLC

This is the second Phase 3 clinical trial in first-line NSCLC that has gone head-to-head with Keytruda in the past two months; the previous one was registered by BMS in August, combining Opdivo with LAG3 monoclonal antibody.In patients with Stage IV or recurrent non-squamous NSCLC with PD-L1 1-49%Compared with K drugHead-to-head comparison, both groups also received chemotherapy. Planned enrollment is 800 people.

BMS previously introduced the research plan at an investor event, mainly based on the fact that the combination regimen showed more benefits than O drug alone without additional safety burden in the Phase 2 study. The benefit trend was more obvious in non-squamous patients with PD-L1 expression of 1-49%. Therefore, this population was selected for the Phase 3 study to compare the combination therapy + chemotherapy with the currently most commonly used first-line K drug + chemotherapy regimen.

Data on AstraZeneca's TIGIT bispecific antibody for lung cancer was first reported at this year's WCLC conference.1/2 Phase Artemide-01 Study Includedrilvegostomig Monotherapy for patients who have not received checkpoint inhibitor therapy, these patients may have undergone frontline chemotherapy.The efficacy of Rilvegostomig is correlated with PD-L1 expression. In patients with PD-L1 expression ≥50%, the 750mg dose groupORRReach62%(Including unconfirmed responses). Paradoxically, the 1500mg dose group had an ORR of only 37% in the same population and led to a higher incidence of adverse events, including hepatotoxicity. Therefore, 750mg was selected as the pivotal dose.

Two MNCs Successively Launch First-Line NSCLC Trials to Compete with K Drug,ThisIsKangfang's bispecific antibody and Summit's stock priceEncouraged?? Unlike the combination of Akeso's bispecific antibody and anti-angiogenic mechanism, these two newly registered study drugsAll are combinations of dual immune mechanisms. The early failures of attempting to surpass K drug through dual immune mechanisms, such as TGFβ and PEG-IL2, are still fresh in memory. TIGIT has not yet truly succeeded, and the attempt with LAG-3 in colorectal cancer has already failed.AstraZeneca launched a program two months ago targetingPhase 3 Tropion-Lung10 Trial in First-Line PD-L1 ≥50% Non-Squamous NSCLC, Featuring Trop2 ADC Dato-Dxd Combined with PD-1/TIGIT Bispecific Antibody.

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