Roche Announces Positive Phase III Results for Tiragolumab-Based Combination Therapy in First-Line Esophageal Squamous Cell Carcinoma

Jan 18, 2024 09:17 CST Updated 09:17

Roche

Oncology Drug Research, Development, and Manufacturing

On January 17, Roche presented the phase III SKYSCRAPER-08 study data of its TIGIT monoclonal antibody Tiragolumab in combination therapy for first-line treatment of esophageal squamous cell carcinoma (ESCC) at the ASCO Gastrointestinal Cancers Symposium.

This study is a randomized, double-blind, placebo-controlled clinical trial (n=461) that evaluated the efficacy and safety of Tiragolumab + Atezolizumab + chemotherapy compared with placebo + chemotherapy as first-line treatment in patients with unresectable locally advanced, recurrent, or metastatic ESCC. The primary endpoints of the study are progression-free survival (PFS) and overall survival (OS).

The results showed,The study met its dual primary endpoints.As of June 15, 2022, the median PFS assessed by the Independent Central Review Facility (IRF) was 6.2 months in the Tiragolumab group and 5.4 months in the placebo group (HR=0.56; 95% CI: 0.45, 0.70; p<0.0001). The investigator-assessed PFS was 7.0 months in the Tiragolumab group and 5.5 months in the placebo group (HR=0.57; 95% CI: 0.46, 0.72).

As of February 13, 2023, the median OS assessed by IRF in the Tiragolumab group was 15.7 months, compared to 11.1 months in the placebo group (HR=0.70; 95% CI: 0.55, 0.88; p=0.0024).

In terms of safety, 98.2% of patients in both groups experienced treatment-related adverse events (TRAE). The incidence of grade 3/4 TRAE was 59.6% in the Tiragolumab group and 56.4% in the placebo group, while the incidence of grade 5 TRAE was 2.6% and 0.9%, respectively.

Previously, RocheThe efficacy of Tiragolumab has been explored multiple times, with a Phase III clinical trial conducted for both non-small cell lung cancer and small cell lung cancer. However, both studies ended in failure (see:Roche's PD-L1+TIGIT Combination Fails in Phase III Trial as First-Line Treatment for PD-L1 High-Expressing Non-Small Cell Lung Cancer). This time, the drug achieved positive results for the first time in a Phase III study, which further boosted Roche's and the industry's confidence in the TIGIT target.

However, Roche inThe control group selected in the SKYSCRAPER-08 study was placebo + chemotherapy, which is not sufficient to fully demonstrate.The efficacy of Tiragolumab in ESCC patients has thus prepared for further demonstration of the drug's effectiveness.SKYSCRAPER-07 Study (Control group: Atezolizumab + Chemoradiotherapy). This study is expected to be completed by the end of this year, at which time its efficacy will also be known.

In addition to Roche, several other pharmaceutical companies are advancing the clinical development of TIGIT antibody drugs. Currently, there are four TIGIT-targeted drugs in Phase III studies globally, respectively.Tiragolumab (Roche),Vibostolimab（The TIGIT portion in MK-7684A,MSD）Domvanalimab (Gilead/Arcus Biosciences/Taiho Pharmaceutical) andOspolimab (BeiGene).

Merck is conducting 5ItemMK-7684A’s global Phase III clinical trial challenges include durvalumab, pembrolizumab, and atezolizumab; Gilead/Arcus BiosciencesAlso launched 4 itemsDomvanalimabGlobalPhase III clinical trials, the challenges includeDurvalumab,PembrolizumabAnd nivolumab; BeiGene has conducted 2 itemsOspolimabGlobalPhase III clinical trials also include challenging targetsDurvalumab andPembrolizumab.

Among these, the tislelizumab +Phase III Study of Osuprelimab versus Pembrolizumab + Placebo in Non-Small Cell Lung CancerThe study willTake the leadInMay 2025Completed. It remains to be seen whether Chinese pharmaceutical companies can catch up and take the lead in the TIGIT target.

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