Cases of G/GEJ adenocarcinoma are forecasted to reach 284,638 in 2029, according to a report on GlobalData’s Pharma Intelligence Center. Credit: Phynart Studio via Getty Images.

BeiGene has won approval from the US Food and Drug Administration for its PD-1 inhibitor Tevimbra (tislelizumab) in combination with chemotherapy to treat advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. 

This approval expands Tevimbra’s indication in the US, where it was previously approved for treating unresectable or metastatic oesophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy in March 2024. 

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The decision is supported by Phase III RATIONALE-305 trial data (NCT03777657), which demonstrated improved overall survival (OS). Patients receiving Tevimbra plus chemotherapy achieved a median OS of 15 months compared to 12.9 months with placebo and chemotherapy, representing a 20% reduction in mortality risk. Progression-free survival (PFS) was also longer at 6.9 months versus 6.2 months, along with higher response rates. 

BeiGene regained full global rights to Tevimbra from Novartis in September 2023, ending a joint development and licensing agreement established in 2021. As part of the previous agreement, both the entities were jointly developing Tevimbra in Canada, EU member countries, Iceland, Japan, Liechtenstein, Mexico, Norway, Russia, Switzerland, the UK, and the US. Under the new arrangement, BeiGene now controls development, manufacturing, and commercialisation without owing royalties.  

Tevimbra targets the PD-1 receptor, a checkpoint protein that suppresses the immune response. By inhibiting PD-1, Tevimbra enhances the activity of T cells, allowing them to recognise and attack tumour cells more effectively. BeiGene’s trials suggest that this mechanism, combined with chemotherapy, offers survival benefits in PD-L1-expressing cancers. 

Tevimbra is part of a competitive PD-1 inhibitor market, facing rivals like MSD’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab). According to GlobalData’s Pharma Intelligence Center, Tevimbra is set to generate $1.7bn in 2030, whereas Keytruda and Opdivo are forecast to pull in $23.2bn and $9.1bn in sales each, respectively.  

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Checkpoint inhibitors like Tevimbra continue to drive revenue growth, with Keytruda alone accounting for 40% of MSD’s pharmaceutical sales in 2023. However, patent expirations, including Keytruda’s in 2028, may soon open the market to biosimilar competition. 

According to a report on GlobalData’s Pharma Intelligence Center, there will be 284,638 cases of G/GEJ adenocarcinoma in 2029 in the eight major markets (US, UK, France, Germany, Spain, Italy, Japan, and South Korea), an increase from 251,366 in 2019. The G/GEJ adenocarcinoma market is forecast to be worth $4.72bn in 2029.