Tevimbra by BeiGene approved in US for initial gastric cancer treatment

BeiGene has received approval from the US Food and Drug Administration (FDA) for its PD-1 inhibitor, Tevimbra (tislelizumab), to be used in combination with chemotherapy for the treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. This marks an extension of Tevimbra’s indication in the United States, where it had earlier been authorized for treating unresectable or metastatic esophageal squamous cell carcinoma (ESCC) following prior systemic chemotherapy as of March 2024.

The FDA's approval follows the positive outcomes from the Phase III RATIONALE-305 clinical trial (NCT03777657), which demonstrated a significant improvement in overall survival (OS) for patients. Those who received Tevimbra in conjunction with chemotherapy had a median OS of 15 months, compared to 12.9 months for those who were given a placebo with chemotherapy. This represents a 20% decrease in the risk of death. Moreover, the progression-free survival (PFS) was extended to 6.9 months from 6.2 months, alongside increased response rates for patients treated with Tevimbra.

In September 2023, BeiGene reclaimed full global rights to Tevimbra from Novartis, terminating a joint development and licensing agreement that had been in place since 2021. Previously, both companies were collaboratively working on Tevimbra’s development in several regions including Canada, the European Union member states, Iceland, Japan, Liechtenstein, Mexico, Norway, Russia, Switzerland, the UK, and the US. With the new agreement, BeiGene now exclusively manages the development, manufacturing, and commercialization of Tevimbra, free from any royalty obligations.

Tevimbra functions by targeting the PD-1 receptor, a checkpoint protein involved in dampening the immune response. By inhibiting PD-1, Tevimbra enhances the action of T cells, enabling them to better identify and destroy tumor cells. Studies conducted by BeiGene hint that this mechanism, when paired with chemotherapy, yields survival benefits particularly in cancers expressing PD-L1.

Within the competitive PD-1 inhibitor market, Tevimbra faces competition from established players like MSD’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab). According to GlobalData’s Pharma Intelligence Center, Tevimbra is projected to generate $1.7 billion in sales by 2030. In contrast, Keytruda and Opdivo are expected to bring in $23.2 billion and $9.1 billion, respectively.

Checkpoint inhibitors such as Tevimbra have continued to boost revenue growth, with Keytruda alone making up 40% of MSD’s pharmaceutical sales in 2023. Nonetheless, upcoming patent expirations, including that of Keytruda in 2028, may pave the way for biosimilar competitors to enter the market.

A report from GlobalData’s Pharma Intelligence Center highlights that cases of G/GEJ adenocarcinoma are projected to reach 284,638 by 2029 in eight major markets—namely the US, UK, France, Germany, Spain, Italy, Japan, and South Korea. This marks an increase from 251,366 cases identified in 2019. The market for G/GEJ adenocarcinoma is anticipated to grow to a valuation of $4.72 billion by 2029.